Case 3:18-cv-00347-CAB-MDD Document 307-1 Filed 02/16/21 PageID.29642 Page 1 of 7
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`EXHIBIT 1
`
`TO THE DECLARATION OF BRIAN J.
`NISBET IN SUPPORT OF DEFENDANTS’
`OPPOSITION TO NUVASIVE’S MOTION
`FOR PARTIAL SUMMARY JUDGMENT
`AND MOTION TO EXCLUDE
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 307-1 Filed 02/16/21 PageID.29643 Page 2 of 7
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`~NUVASIVE*
`
`Creative Spine Te c hnology*
`
`l0065 OLD GROVE ROAD• SAN DIEGO. CA 92131
`
`858.211. 7070
`
`toll free: 800.455.1476
`
`lax : 858.271.7101
`
`www.nuvaslve.com
`
`June 25, 2004
`
`Via Federal Express
`
`Food and Drug Administration
`Center for Devices and Radiological Health
`Office of Device Evaluation
`Document Mail Center (HFZ-401)
`9200 Corporate Boulevard
`Rockville, Maryland 20850
`
`Attn. : Division of General and Restorative Devices (HFZ-410)
`Re:
`510(k) Premarket Notification
`NuVasive CoRoent™ System
`
`Ladies and Gentlemen:
`
`In accordance with Section 5 lO(k) of the Federal Food, Drug, and Cosmetic Act (the Act), as
`amended, and with Title 21 of the Code of Federal Regulations (21 CFR), Part 807, SubPart
`E, this Premarket Notification is being submitted to advise the Food and Drug Administration
`(FDA) of the intent of NuVasive to market its vertebral body replacement CoRoent System.
`Pursuant to Title 21 CFR, §807.87, we enclose the following information pertaining to the
`subject device:
`
`[a]
`
`Device Name
`
`Trade or Proprietary Name:
`Common or Usual Name:
`Classification Name:
`
`NuVasive CoRoent™ System
`Vertebral Body Replacement :Device
`Vertebral Body Replacement Device
`
`[b] Manufacturing Establishment Registration Number
`
`Nu Vasi ve, Incorporated
`10065 Old Grove Road
`San Diego, California 92131
`Establishment Registration Number: 2031966
`
`Continued ...
`
`Highly Confidential - Outside Attorney's Eyes Only
`
`NUVA_ATEC0252170
`
`EXHIBIT 1 - PAGE 1
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 307-1 Filed 02/16/21 PageID.29644 Page 3 of 7
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`NUVASIVE , INC .
`
`10065 OLD GROVE ROAD • SAN DIEGO, CA 92131
`
`Document Mail Center
`Premarket Notification: Nu Vasive® CoRoent™ System
`June 25, 2004
`Page -2-, Continued
`
`[c]
`
`Classification
`
`Per Title 21 CPR, § 888.3060 a spinal intervertebral body fixation orthosis is
`identified as:
`
`" ... a device intended to be implanted made of titanium. It consists of various
`vertebral plates that are punched into each of a series of vertebral bodies. An eye(cid:173)
`type screw is inserted in a hole in the center of each of the plates. A braided cable is
`threaded through each eye-type screw. The cable is tightened with a tension device
`and it is fastened or crimped at each eye-type screw. The device is used to apply
`force to a series of vertebrae to correct "away back" scoliosis (lateral curvature of
`the spine), or other conditions".
`
`The NuVasive CoRoent System is a vertebral body replacement device indicated for
`use in the thoracolumbar spine (Tl to L5) to replace a diseased or damaged vertebral
`body caused by tumor or fracture, to restore height of a collapsed vertebral body, and
`to achieve decompression of the spinal cord and neural tissues. The NuVasive
`CoRoent System is intended to be used with supplemental internal spinal fixation
`systems that are cleared by the FDA for use in the thoracic and lumbar spine. As
`such, the subject device is representative of the type of devices described in Title 21
`CPR, § 888.3060.
`
`[d]
`
`Performance Standards
`
`No performance standards applicable to the subject device have been promulgated as
`of the date of this submission.
`
`[e]
`
`Labeling
`
`Draft labels and labeling for the subject device are described in Section V of the
`enclosed 510(k) submission, and are contained in an Appendix attached thereto.
`
`[f]
`
`Substantial Equivalence ..
`
`The NuVasive CoRoent System has the same intended use, design, materials,
`performance characteristics, and the same or equivalent labeling, and is therefore
`substantially equivalent to, other vertebral bode replacement devices cleared by the
`agency for commercial distribution in the United States. A comparison of all
`pertinent characteristics of the subject device to its predicate device may be found in
`Section VI of the enclosed Premarket Notification submission.
`
`Highly Confidential - Outside Attorney's Eyes Only
`
`NUVA_ATEC0252171
`
`EXHIBIT 1 - PAGE 2
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`

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`Case 3:18-cv-00347-CAB-MDD Document 307-1 Filed 02/16/21 PageID.29645 Page 4 of 7
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`NUVASIVE, INC .
`
`10065 OLD GROVE ROAD• SAN DIEGO, CA 92131
`
`Document Mail Center
`Premarket Notification: NuVasive CoRoent System
`June 25, 2004
`Page-3-, Continued
`
`The following information is being submitted in the enclosed Premarket Notification, to
`establish and support substantial equivalence of the NuVasive CoRoent System to medical
`devices currently cleared by the agency for commercial distribution in the U.S.:
`
`Section I
`
`Section II
`
`Section III
`
`Section IV
`
`Section V
`
`Section VI
`
`Section VII
`
`Premarket Submission Cover Sheet
`
`Premarket Notification [510(k)] Checklist for Acceptance
`Decision
`
`Truthful and Accurate Statement
`
`Device Description
`
`Draft Labeling
`
`Rationale for Substantial Equivalence
`
`510(k) Summary of Information Supporting
`Substantial Equivalence
`
`Section VIII
`
`Appendices
`
`For convenience of review, it is suggested that the reader first refer to Section VII for a
`summary of the information contained in the Premarket Notification, including a description
`of the subject device, its intended use, and its technological characteristics, as well as
`identification of commercially available predicate devices, and a summary of the basis for
`our demonstration of substantial equivalence.
`
`It is the position of NuVasive that the descriptions and information contained in this
`Premarket Notification constitute confidential commercial information, and we ask that the
`agency regard the contents of this submission as subject to protection from public disclosure
`in accordance with the provisions of Title 21 CPR, §21.61.
`-
`
`The intent to market the subject device, and the descriptions and information contained in the
`enclosed 510(k) Premarket Notification, have not been disclosed to persons outside
`NuVasive excepting only consultants and/or suppliers subject to non-disclosure agreement.
`We therefore ask that the agency consider the existence of this submission to be "trade
`secret" confidential commercial information subject to protection from public disclosure in
`accordance with the provisions of Title 21 CPR, §807.95(b).
`
`Highly Confidential - Outside Attorney's Eyes Only
`
`NUVA_ATEC0252172
`
`EXHIBIT 1 - PAGE 3
`
`

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`Case 3:18-cv-00347-CAB-MDD Document 307-1 Filed 02/16/21 PageID.29646 Page 5 of 7
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`NUVASIVE, INC.
`
`10065 OLD GROVE ROAD• SAN DIEGO, CA 92151
`
`Document Mail Center
`Premarket Notification: Nu Vasive CoRoent System
`June 25, 2004
`Page-4-, Continued
`
`We understand that the submission to the U.S. Government of false information is prohibited
`by Title 18 of the United States Code (USC), part 1001, and by Title 21 UCS , Part 331(q).
`
`We trust that the information and descriptions provided in this Premarket Notification will
`prove sufficient to facilitate a determination of substantial equivalence of the Nu Vasive
`CoRoent System to other medical devices currently cleared by the agency for commercial
`distribution in the U.S. If you should have any questions or require additional information,
`please do not hesitate to contact me at (858) 527-1918, or by telefacsimile at (858) 271-7101.
`
`Sincerely,
`
`Laetitia Cousin
`Director of Regulatory Affairs and Quality Assurance
`
`Enclosures:
`
`510(k) Premarket Notification (submitted in triplicate),
`Sections I through Vill and Appendices, as noted above.
`
`cc: Keith Valentine
`Executive Vice President
`
`Highly Confidential - Outside Attorney's Eyes Only
`
`NUVA_ATEC0252173
`
`EXHIBIT 1 - PAGE 4
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`

`

`Case 3:18-cv-00347-CAB-MDD Document 307-1 Filed 02/16/21 PageID.29647 Page 6 of 7
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`Medical Device User Fee Cover Sheet - Form FDA 3601
`
`Page 1 of 1
`
`Form Approved:OMB No. 0910-0511 Expiration Date: August 31, 2006. See instructions for 0MB Statement.
`
`DEPARTMENT OF HEAL TH AND HUMAN SERVICES
`FOOD AND DRUG ADMINISTRATION
`MEDICAL DEVICE USER FEE COVER SHEET
`
`PAYMENT IDENTIFICATION NUMBER: 013895 • 956733
`
`Write the Payment Identification Number on your check.
`
`A completed Cover Sheet must accompany each original application or supplement subject to fees. The following actions must be taken to
`properly submit your application and fee payment:
`
`4.
`
`1. Electronically submit the completed Cover Sheet to the Food and Drug Administration (FDA) before payment is sent.
`2.
`Include a printed copy of this completed Cover Sheet with a check made payable to the Food and Drug Administration . Remember
`that the Payment Identification Number must be written on the check.
`3. Mail Check and Cover Sheet to the US Bank Lock Box, FDA Account, P.O. Box 956733 , St. Louis, MO 63195-6733. (Note: In no
`case should payment be submitted with the application.)
`If you prefer to send a check by a courier, the courier may deliver the check and Cover Sheet to: US Bank, Attn: Government
`Lockbox 956733, 1005 Convention Plaza, St. Louis, MO 63101 . (Note: This address is for courier delivery only. Contact the US
`Bank at 314-418-4821 if you have any questions concerning courier delivery.)
`5. For Wire Transfer Payment Procedures, please refer to the MDUFMA Fee Payment Instructions at the following URL:
`http://www.fda.gov/cdrh/mdufma/fags.html#3a. You are responsible for paying all fees associated with wire transfers.
`Include a copy of the completed Cover Sheet in volume one of the application when submitting to the FDA at either the CBER or
`CDRH Document Mail Center.
`
`6.
`
`1. COMPANY NAME AND ADDRESS (Include name, street
`address, city, state, country, and post office code)
`
`2. CONTACT NAME
`LAETITIA BERNARD
`
`NUVASIVE, INCORPORATED
`10065 OLD GROVE ROAD
`SAN DIEGO, CA 92131
`
`1.1 EMPLOYER IDENTIFICATION NUMBER (EIN)
`330768598
`
`2.1 E-MAIL ADDRESS
`lbernard@ nuvasive .com
`
`2.2 TELEPHONE NUMBER (Include Area Code)
`858-527-1918
`
`2.3 FACSIMILE (FAX) NUMBER (Include Area Code)
`858-271-7101
`
`3. TYPE OF PREMARKET APPLICATION (Select one of the following in each column ; if you are unsure, please refer to the application
`descriptions at the following web site: http://www.fda.gov/oc/mdufma
`
`Select an application type :
`Iii" Premarket notification (510(k)); except for third party reviews
`D Biologics License Application (BLA)
`D Premarket Approval Application (PMA)
`□ Modular PMA
`D Product Development Protocol (PDP)
`D Premarket Report (PMR)
`
`3.1 Select one of the types below:
`Iii" Original Application
`Supplement Types:
`□ Efficacy (BLA)
`□ Panel Track (PMA, PMR, PDP)
`□ Real-Time (PMA, PMR, PDP)
`□ 180-day (PMA, PMR, PDP)
`
`4. ARE YOU A SMALL BUSINESS? (See the instructions for more information on determining this status.)
`Iii" YES, I meet the small business criteria and have submitted the
`D NO, I am not a small business
`required qualifying documents to FDA
`
`4.1 If Yes, please enter your Small Business Decision Number:
`030063
`
`5. IS THIS PREMARKET APPLICATION COVERED BY ANY OF THE FOLLOWING USER FEE EXCEPTIONS? IF SO, CHECK THE
`APPLICABLE EXCEPTION.
`D This application is the first PMA submitted by a qualified small
`business, including any affiliates, parents, and partner firms
`D This biologics application is submitted under section 351 of the
`'·
`Public Health Service Act for a product licensed for further
`manufacturing use only
`
`O The sole purpose of the application is to support
`conditions of use for a pediatric population
`D The application is submitted by a state or federal
`government entity for a device that is not to be distributed
`commercially
`
`6. IS THIS A SUPPLEMENT TO A PREMARKET APPLICATION FOR WHICH FEES WERE WAIVED DUE TO SOLE USE IN A
`PEDIATRIC POPULATION THAT NOW PROPOSES CONDITION OF USE FOR ANY ADULT POPULATION? (If so, the application is
`subject to the fee that applies for an original premarket approval application (PMA) .)
`liJ" NO
`□ YES
`7. USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKET APPLICATION (FOR FISCAL YEAR 2004)
`
`$2,784.00
`Form FDA 3601 (08/2003)
`
`https://fdasfinapp4.fda.gov/CFAPPS/mdufma/coversheet/Index.cfm?fuseaction=fuse_Rot. .. 04/29/2004
`
`Highly Confidential - Outside Attorney's Eyes Only
`
`NUVA_ATEC0252174
`
`EXHIBIT 1 - PAGE 5
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`

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`Case 3:18-cv-00347-CAB-MDD Document 307-1 Filed 02/16/21 PageID.29648 Page 7 of 7
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`NuVasive®, Incorporated
`
`5 IO(k) Premarket Notification
`CoRoent™ System.
`
`(
`
`SlO(k) PREMARKET NOTIFICATION
`
`Nu Vasive, Incorporated,
`CoRoent System
`
`Sponsored by:
`
`NuVasive, Inc.
`10065 Old Grove Road
`San Diego, California 92131
`
`Date Prepared: June 24, 2004
`
`Hiahlv Confidential - Outside Attorney's Eyes Only
`
`Page -i-
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`NUVA_ATEC0252175
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`EXHIBIT 1 - PAGE 6
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`