(96 days)
The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical discase is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.
The PERIMETER® C (Titanium) Spinal System consists of spacers/cages of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures.
The purpose of this submission is to include additional interbody cages manufactured from medical grade titanium alloy (Ti-6A1-4V ELI) that are packaged sterile via gamma irradiation.
The provided document is a 510(k) premarket notification for a medical device called the PERIMETER® C (Titanium) Spinal System. This document does not describe an AI/ML device or a study that evaluates its performance against acceptance criteria in the way described in the prompt.
Instead, this document is for a traditional medical implant (intervertebral body fusion device) and focuses on demonstrating substantial equivalence to already legally marketed predicate devices. The performance data discussed here relates to biocompatibility and mechanical testing of the physical implant, not the performance of an algorithm or AI system.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study that proves an AI device meets them. The prompt's questions pertain to AI/ML device evaluations (e.g., sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance), which are not present in this physical medical device's 510(k) submission.
In summary, the provided text does not contain the information requested in your prompt as it is not about an AI/ML device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2016
Medtronic Sofamor Danek USA, Incorporated Ankit K. Shah Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K153438
Trade/Device Name: PERIMETER® C (Titanium) Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: February 8, 2016 Received: February 10, 2016
Dear Ankit Shah:
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 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153438
Device Name PERIMETER® C (Titanium) Spinal System
Indications for Use (Describe)
The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in sketally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical discase is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.
Type of Use (Select one or both, as applicable)
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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PERIMETER® C (Titanium) Spinal System 510(k) Summary January 2016
| I. | Submitter: | Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, TN 38132Telephone: (901)396-3133Fax: (901) 346-9738 |
|---|---|---|
| Contact: | Ankit K. ShahSenior Regulatory Affairs Specialist | |
| Date Prepared: | January 6, 2016 | |
| II. | Device | |
| Name of Device: | PERIMETER® C (Titanium) Spinal System | |
| Common or Usual Name: | Intervertebral body fusion device | |
| Classification Name: | Intervertebral fusion device with bone graft,cervical: 21 CFR 888.3080 | |
| Regulatory Class: | Class II | |
| Product Code: | ODP | |
| III. | Predicate Device | K132584 (S.E. 12/04/2013) PERIMETER® C SpinalSystem - Primary Predicate |
| K133645 (S.E. 01/03/2014) – PERIMETER® C SpinalSystem - Additional Predicate | ||
| The predicates device have not been subjectto a design related recall |
IV. Device Description:
The PERIMETER® C (Titanium) Spinal System consists of spacers/cages of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant
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are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures.
The purpose of this submission is to include additional interbody cages manufactured from medical grade titanium alloy (Ti-6A1-4V ELI) that are packaged sterile via gamma irradiation.
V. Indications for Use:
The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of nonoperative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.
VI. Comparison of Technological Characteristics with Predicate Device
The subject PERIMETER® C (Titanium) Spinal System Devices have identical: indications for use, intended use, design, material (Titanium Alloy per ASTM F136), sterilization methods, levels of attachment and fundamental scientific technology as the PERIMETER® C Spinal System predicate previously cleared by the FDA in K132584 (S.E. 12/04/2013). Additionally, the new PERIMETER® C (Titanium) Spinal System Devices are provided sterile identical to that of the predicate 2 devices found in K133645 (S.E. 01/03/2014).
VII. Performance Data
The following performance data are provided in support of the substantial equivalence determination.
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Biocompatibility
The biocompatibility evaluation for the PERIMETER® C (Titanium) Spinal System devices was conducted in accordance with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" issued April, 23, 2013.
The subject PERIMETER® C (Titanium) Spinal System intervertebral body fusion devices are permanent implants and will be classified as permanent, >30 day body contact according to with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing''. The subject intervertebral body fusion devices are manufactured from identical materials as the predicate devices, in accordance with the following ASTM standard:
ASTM F136 – Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
The titanium alloy material used for the subject PERIMETER® C (Titanium) Spinal System intervertebral body fusion devices has a long clinical history of safe and effective use in similar medical devices. Therefore, no additional biocompatibility testing is required.
Mechanical Testing
In accordance with, Guidance for Industry and FDA Staff – Spinal System 510(k)'s", Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. It was determined that subject devices do not represent a new worst case. An engineering rationale was used to demonstrate substantial equivalence. As a new worst case has not been indicated and an engineering rationale was deemed adequate to prove equivalence to the predicate device, no additional mechanical testing is required.
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VIII. Conclusion
Based on a risk analysis, engineering rationale, and additional supporting documentation provided in the pre-market notification, the subject PERIMETER® C (Titanium) Spinal System intervertebral body fusion devices are as safe and effective as the following predicates: K132584 (S.E. 12/04/2013) – Primary Predicate and K133645 (S.E. 01/03/2014) - Predicate 2.
§ 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.