The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Device Description

The PERIMETER® Interbody Fusion Device consists of cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.

The device is offered in both Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) and PEEK (Polyetheretherketone). This interbody device is offered in both sterile and non-sterile forms.

The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15 mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Alloy devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally; the Titanium Alloy version of this device offers lateral windows for visibility of the autogenous bone graft.

The purpose of this submission is to add a new inserter to the PERIMETER® Interbody Fusion Device system and to provide the package insert for this reusable device as well as other instruments for use with PERIMETER® Interbody Fusion Device. Additionally, the package insert for Medtronic's CATALYST® instruments, which can also be used with PERIMETER® Interbody Fusion Device, is provided. The modified design of the subject PERIMETER® Interbody Fusion Device does not affect the device's intended use or alter the device's fundamental scientific technology.

AI/ML Overview

This 510(k) premarket notification (K113642) is for a modification to an existing medical device, the PERIMETER® Interbody Fusion Device. The primary purpose of the submission is to add a new inserter to the system and provide updated package inserts. It explicitly states that the "modified design of the subject PERIMETER® Interbody Fusion Device does not affect the device's intended use or alter the device's fundamental scientific technology." Therefore, there are no clinical studies on human subjects to prove device performance or establish new acceptance criteria. The approval relies on demonstrating substantial equivalence to previously cleared devices and adherence to relevant non-clinical testing standards.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (as per relevant standards)	Reported Device Performance (as described in the 510(k))
Device Design	Substantially equivalent to predicate PERIMETER® Interbody Fusion Device (K090353 & K111525) and CAPSTONE® Spinal System (K103731) inserter for design, materials, and fundamental scientific technology.	The subject PERIMETER® Interbody Fusion Device and the new two-piece inserter are constructed of the same materials and represent the same fundamental scientific technology as their respective predicate devices.
Cleaning & Sterilization	Validation and assessment according to ISO 17664, ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO TIR 17665-2, AAMI TIR 12, ANSI/AAMI ST79 & A1, AAMI TIR 30, and ANSI/AAMI ST81.	Cleaning and sterilization validations and assessments have been conducted according to the listed standards.
Risk Analysis	Comprehensive risk analysis completed.	A risk analysis was completed.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. This submission is for a modification to an existing device, focusing on non-clinical testing and substantial equivalence. There are no new clinical studies or test sets involving human patients where a sample size would be traditionally reported for device performance.
Data Provenance: Not applicable for clinical data. The data provenance described relates to manufacturing and reprocessing standards for medical devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts/Qualifications: Not applicable. As there is no clinical test set for new device performance, there's no "ground truth" to be established by experts in the context of clinical outcomes or diagnostic accuracy. The "ground truth" here is compliance with engineering and sterilization standards.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This type of study is for evaluating diagnostic accuracy or reader performance with medical imaging devices, which is not relevant to an interbody fusion device and its inserter.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No. This applies to AI/ML algorithms, which are not part of this device submission.

7. Type of Ground Truth Used

The "ground truth" for this submission is established through:

Engineering specifications and material properties: Demonstrating that the new inserter design and materials are equivalent to already cleared devices.
Compliance with recognized industry standards: For cleaning, sterilization, and manufacturing processes (listed in section V, IX, and X).
Risk analysis: Identifying and mitigating potential risks associated with the device and its modifications.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This refers to AI/ML device development, which is not relevant here.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. As above, this is for AI/ML device development.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is a non-clinical equivalency assessment and adherence to recognized standards.

The key aspects of this "study" are:

Comparison to Predicate Devices: The submission establishes substantial equivalence by demonstrating that the PERIMETER® Interbody Fusion Device, including the new inserter, is identical in terms of indications for use, intended use, performance specifications, and fundamental technological characteristics to its predicate devices (PERIMETER® Interbody Fusion Device cleared in K090353 and K111525, and the CAPSTONE® Spinal System [K103731] for the inserter design).
Design Control Processes: Medtronic's internal design control processes were used to assess the instrument modifications.
Cleaning and Sterilization Validations: Extensive validations were performed and submitted demonstrating adherence to a comprehensive set of international and national standards (ISO 17664, ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO TIR 17665-2, AAMI TIR 12, ANSI/AAMI ST79 & A1, AAMI TIR 30, ANSI/AAMI ST81). These validations ensure that the new reusable inserter and other instruments can be safely cleaned and sterilized for clinical use.
Risk Analysis: A completed risk analysis supports the safety and effectiveness of the modified system.

In essence, the "proof" is a comprehensive documentation package demonstrating that the changes made (primarily a new inserter and updated instructions) do not introduce new safety or effectiveness concerns and that the device remains functionally equivalent to its cleared predicate.

Summary

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K113642

PERIMETER® Interbody Fusion Device 510(k) Summary December 5, 2011

I.	Company:	Medtronic Sofamor Danek1800 Pyramid PlaceMemphis, TN 38132Telephone: (901) 396-3133FAX: (901) 346-9738
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II. Contact: Lauren Kamer Senior Regulatory Affairs Specialist

III. Proprietary Trade Name: PERIMETER® Interbody Fusion Device
IV. Classification Name: Intervertebral Body Fusion Device (21 CFR 888.3080) Class: II Product Code: MAX

V. Product Description

The device is offered in both Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) and PEEK (Polyetheretherketone). This interbody device is offered in both sterile and non-sterile forms.

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K113642

VI. Indications for Use

VII. Summary of Technological Characteristics

The purpose of this Special 510(k) submission is to seek clearance to add a new twopiece threaded inserter to the PERIMETER® Interbody Fusion Device system. The design, materials, and fundamental scientific technology of the subiect PERIMETER® Interbody Fusion Device are identical to the predicate PERIMETER® Interbody Fusion Device, except for the addition of the subject inserter. The subject inserter is constructed of the same materials and represents the same fundamental scientific technology as the predicate inserter; however, the design consists of a two-piece construction in contrast to the 4-piece construction of the predicate inserter.

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

Documentation was provided which demonstrated that the subject PERIMETER® Interbody Fusion Device system is substantially equivalent to the predicate PERIMETER® Interbody Fusion Device system cleared in K090353 (SE Sept 29, 2009) for the PEEK version, and K111525 (SE Aug 24, 2011) for the Titanium Alloy version. Additionally, CAPSTONE® Spinal System was used as a predicate for this submission since the design of the subject inserter is similar to the two-piece inserter recently cleared as part of CAPSTONE ® Spinal System (K103731, SE July 18, 2011).

IX. Brief Discussion of the Non-Clinical Tests Submitted

The subject and predicate PERIMETER® Interbody Fusion Device devices are identical in terms of indications for use, intended use, performance specifications, and fundamental technological characteristics. Assessment of the instrument modifications has been completed in accordance with Medtronic design control processes. Cleaning and sterilization validations and assessments have been conducted according to the following standards to provide the appropriate disassembly, cleaning, and sterilization instructions for the new inserter, as well as the other instruments for use with PERIMETER® Interbody Fusion Device:

ISO 17664:2004 , Sterilization of medical devices- Information to be provided by the . manufacturer for the processing of resterilizable medical devices
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K113642

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
A AMI 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

X. Conclusions Drawn from the Non-Clinical Tests

A risk analysis was completed. Based on the risk analysis and additional supporting documentation provided in this premarket notification, Medtronic believes that the subject PERIMETER® Interbody Fusion Device demonstrates substantial equivalence to the predicate PERIMETER® Interbody Fusion Device.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, wave-like shapes that resemble a caduceus without the staff.

Public Health Service

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

FEB - 6 2012

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

Re: K113642

Trade/Device Name: PERIMETER® Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 09, 2011 Received: December 12, 2011

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 E. 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/CDRH/CDRHOffices/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. Melkerson

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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113642

510(k) Number (if known):

PERIMETER® Interbody Fusion Device Device Name:

Indications for Use:

The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 nonoperative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Prescription Use (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)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113642

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.