The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.

The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation.

When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws. then additional supplemental fixation for use in the lumbar spine must be used to augment stability.

Device Description

The SOVEREIGN® Spinal System is an intervertebral body fusion device with integrated screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is lens-shaped with three holes for placement of titanium screws. The SOVEREIGN® Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the PEEK interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted. The SOVEREIGN® Spinal System interbody device is manufactured from PEEK (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.

The SOVEREIGN® Spinal System includes instrumentation that enables the surgeon to implant the devices via a laparoscopic or an open anterior approach. The purpose of this Special 510(k) submission is to make modifications to the inserter sleeve that is part of SOVEREIGN® Spinal System. The inserter sleeve is a cylindrical stainless steel sleeve, incorporating a polymer bushing, which is used in conjunction with the inserter knob and one of three inserter shafts to securely hold a SOVEREIGN® interbody implant during insertion and impaction into the vertebral disc space.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the SOVEREIGN® Spinal System. It describes modifications to an inserter sleeve, intended use, and substantial equivalence to predicate devices, supported by non-clinical tests. However, it does not contain any information regarding acceptance criteria or a study that proves a device meets such criteria in a manner relevant to artificial intelligence or diagnostic performance.

Specifically, the document discusses:

Device Description: The SOVEREIGN® Spinal System is an intervertebral body fusion device with integrated screw fixation. The current submission focuses on modifications to an inserter sleeve.
Indications for Use: For degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, with autogenous bone graft, for skeletally mature patients who have had six months of non-operative treatment. It can be used as a stand-alone device with screws or with supplemental fixation.
Technological Characteristics: The subject device is largely identical to the predicate SOVEREIGN® Spinal System, with the primary modification being the material of a bushing in the inserter sleeve (Radel polyphenylsulfone vs. Delrin polyoxymethylene).
Predicate Devices: SOVEREIGN® Spinal System (K091813, K110063) as primary predicates, and CAPSTONE CONTROL™, PERIMETER®, and TELAMON® PEEK Spinal System for sterilization and cleaning rationale.
Non-Clinical Tests: Mechanical (axial pull) testing, tolerance analyses, and user validation were performed to confirm the modified instrument functions as intended. Cleaning and sterilization assessments were also conducted in accordance with various ISO and AAMI standards.
Conclusions: The sponsor concludes substantial equivalence to predicate devices based on a risk analysis and verification/validation testing of the instrument modifications.

The document does not include:

A table of acceptance criteria and reported device performance related to diagnostic accuracy or efficacy studies. The "performance" discussed is related to the mechanical function of the inserter sleeve and its cleaning/sterilization.
Sample size, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, or type of ground truth for a diagnostic test set. These concepts are not applicable to the type of device and submission described (a modification to a surgical instrument, not an AI, diagnostic, or imaging device).
Sample size or ground truth establishment for a training set. Again, this is not relevant to a surgical instrument modification.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets these criteria in the context of AI, diagnostic performance, or similar efficacy studies because the provided text is about a hardware modification to a surgical intervertebral fusion device, not a diagnostic or AI-powered system.

Summary

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KI21982

JUL 26 2012

SOVEREIGN® Spinal System 510(k) Summary July 5, 2012

I. Company:	Medtronic Sofamor Danek1800 Pyramid PlaceMemphis, TN 38132Telephone: (901) 396-3133FAX: (901) 346-9738
II. Contact:	Lauren KamerSenior Regulatory Affairs Specialist
III. Proprietary Trade Name:	SOVEREIGN® Spinal System
IV. Common Name:	Intervertebral Fusion Device with Integrated Fixation,Lumbar
V. Classification Name:	Intervertebral Body Fusion Device (21 CFR 888.3080)
Class:	II
Product Code:	OVD

VI. Product Description

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11982

VII. Indications for Use

The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation.

VIII. Summary of Technological Characteristics

The fundamental scientific technology of the subject SOVEREIGN® Spinal System is identical to the predicate SOVEREIGN® Spinal System.

Both the subject SOVEREIGN® Spinal System and predicate SOVEREIGN® Spinal System implants are lens-shaped interbody devices with integrated screw fixation. designed to contain autograft material and to facilitate fusion between two vertebral bodies. Both subject and predicate interbody devices are made from PEEK, possess tantalum markers for x-ray visualization. and are used with titanium alloy screws.

Both the subject SOVEREIGN® Spinal System and the predicate SOVEREIGN® Spinal System include instrumentation that enables the surgeon to implant the devices via a laparoscopic or an open anterior approach. The inserter sleeve used with both the subject and predicate SOVEREIGN® Spinal System is a cylindrical stainless steel sleeve, incorporating a polymer bushing, which is used in conjunction with the inserter knob and one of three inserter shafts to securely hold the interbody implant during insertion and impaction into the vertebral disc space. Both the subject and predicate inserter sleeves are constructed from materials with a history of safe and effective use in orthopedic surgical instruments. The subject inserter sleeve is made from stainless steel with a Radel polyphenylsulfone bushing; the predicate inserter sleeve is made from stainless steel with a Delrin polyoxymethylene bushing.

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KI21982

IX. Identification of the Legally Marketed Predicate Device Used to Claim Substantial Equivalence

In order to demonstrate substantial equivalence to legally marketed predicate devices, SOVEREIGN® Spinal System (K091813, SE Nov 17, 2009, and K110063, SE Oct 4, 2011) is used as the primary predicate for intended use and fundamental scientific technology. The following additional predicates are being used to support the instrument sterilization and cleaning rationale included in this submission:

CAPSTONE CONTROL™ Spinal System (K120368, SE April 9, 2012), .
PERIMETER® Interbody Fusion Device (K113642, SE Feb 6, 2012), and .
TELAMON® PEEK Spinal System (K110562, SE Nov 9, 2011) �

X. Brief Discussion of the Non-Clinical Tests Submitted

Assessment of the instrument modifications has been completed in accordance with Medtronic design control processes. Mechanical (axial pull) testing and other verification/validation activities, including tolerance analyses and user validation, were conducted to confirm that the modified instrument functions as intended and does not raise any new issues of safety or effectiveness.

A cleaning and sterilization assessment has been conducted to provide the appropriate disassembly, cleaning, and sterilization instructions for the modified inserter sleeve, as well as the other instruments for use with SOVEREIGN® Spinal System. The referenced cleaning and sterilizations were conducted in accordance with the following standards:

. ISO 17664:2004 , Sterilization of medical devices- Information to be provided by the manufacturer for the processing of resterilizable medical devices
ANSI/AAMI/ISO 17665-1:2006 , Sterilization of health care products- Moist heat-. Part 1: Requirements for development, validation, and routine control of sterilization process for medical devices
ANSI/AAMI/ISO TIR 17665-2:2009 , Sterilization of health care products- Moist . heat- Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1
AAMI TIR 12:2010 , Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers
. ANSI/AAMI ST79:2010 & A1:2010 , Comprehensive guide to steam sterilization and sterility assurance in health care facilities
. AAMI TIR 30:2003 , A compendium of processes, materials, test methods and acceptance criteria for cleaning reusable medical devices
. ANSI/AAMI ST81:2004 , Sterilization of medical devices - Information to be provided by the manufacturer for the processing of re-sterilizable medical devices

XI. Conclusions Drawn from the Non-Clinical Tests

The subject and predicate SOVEREIGN® Spinal System are identical in terms of indications for use, intended use, performance specifications, and fundamental technological characteristics. A risk analysis and associated verification/validation testing was completed for the instrument modifications. Based on the risk analysis and additional supporting documentation provided in this premarket notification, Medtronic believes the subject SOVEREIGN® Spinal System to be substantially equivalent to legally marketed predicate devices, including the previously cleared SOVEREIGN® Spinal System (K091813, SE Nov 17, 2009, and K110063, SE Oct 4, 2011).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white and has a simple, clean design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 26 2012

Medtronic Sofamor Danek % Ms. Lauren Kamer Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K121982

Trade/Device Name: SOVEREIGN Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: July 05, 2012 Received: July 06, 2012

Dear Ms. Kamer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 – Ms. Lauren Kamer

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Malkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K121982

Ki21982 510(k) Number (if known):

SOVEREIGN® Spinal System Device Name:

Indications for Use:

The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.

The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation.

When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K121982 510(k) Number_

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.