(147 days)
Not Found
No
The document describes a physical interbody fusion device and its associated instrumentation, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The submission focuses on a modification to a physical inserter tool.
Yes
The device is used for interbody fusion with autogenous bone graft in patients with degenerative disc disease, which involves treating a medical condition.
No
The device is an interbody fusion device designed for surgical implantation to provide support and correction during lumbar interbody fusion surgeries, not to diagnose medical conditions.
No
The device is a physical implant (cage) made of Titanium Alloy or PEEK, along with associated surgical instrumentation. It is not software.
Based on the provided text, the PERIMETER® Interbody Fusion Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The PERIMETER® Interbody Fusion Device is a physical implant designed to be surgically inserted between vertebral bodies in the lumbar spine. Its purpose is to provide support and correction during fusion surgeries for degenerative disc disease.
- No Mention of Samples or Testing: The description focuses on the physical characteristics of the implant, its materials, sizes, and the surgical procedure for implantation. There is no mention of analyzing biological samples or performing diagnostic tests.
Therefore, the PERIMETER® Interbody Fusion Device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
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. PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.
The device is offered in both Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) and Polyetheretherketone (PEEK). The PEEK implants include tantalum markers for imaging purposes. This interbody device is offered in both sterile (by gamma irradiation) and non-sterile forms.
PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15mm 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 PERIMETER® Interbody Fusion Device system includes instrumentation that enables the surgeon to implant the devices via either an open or a minimallyinvasive approach (including anterior, lateral, and oblique).
The purpose of this submission is to modify the two piece implant inserter used with PERIMETER® Interbody Fusion Device. The modified design of the subject device does not affect the device's intended use or alter the device's fundamental scientific technology. No changes are being made to PERIMETER® Interbody Fusion Device implants as part of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Medtronic is not aware of any performance standards or bench testing that would be specifically applicable to the subject inserter device.
A failure modes and effects analysis of the design changes was completed in accordance with Medtronic design control procedures. An engineering assessment and mechanical testing were conducted, and demonstrated that the subject PERIMETER® Interbody Fusion Device. including the modified inserter. is substantially equivalent to the predicate PERIMETER® Interbody Fusion Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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PERIMETER® Interbody Fusion Device 510(k) Summary October 25, 2013 K131669
NOV 0 1 2013
| I. Company: | Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, TN 38132
Telephone: (901) 396-3133
FAX: (901) 346-9738 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------|
| II. Contact: | Lauren Kamer
Senior Regulatory Affairs Specialist |
| III. Proprietary Trade Name: | PERIMETER® Interbody Fusion Device |
| IV. Common Name: | Intervertebral Body Fusion Device with Bone Graft. Lumbar |
| V. Classification Name: | Intervertebral Body Fusion Device
(21 CFR 888.3080) |
| Class: | Class II |
| Product Code: | MAX |
VI. Product Description
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. PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.
The device is offered in both Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) and Polyetheretherketone (PEEK). The PEEK implants include tantalum markers for imaging purposes. This interbody device is offered in both sterile (by gamma irradiation) and non-sterile forms.
1
PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15mm 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 PERIMETER® Interbody Fusion Device system includes instrumentation that enables the surgeon to implant the devices via either an open or a minimallyinvasive approach (including anterior, lateral, and oblique).
The purpose of this submission is to modify the two piece implant inserter used with PERIMETER® Interbody Fusion Device. The modified design of the subject device does not affect the device's intended use or alter the device's fundamental scientific technology. No changes are being made to PERIMETER® Interbody Fusion Device implants as part of this submission.
VII. Indications for Use
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.
2
VIII. Summary of Technological Characteristics
The fundamental scientific technology of the subject PERIMETER® Interbody Fusion Device, including the modified inserter, is identical to the predicate PERIMETER® Interbody Fusion Device.
Both the subject and predicate PERIMETER® Interbody Fusion Device implants are annular interbody devices, designed to contain autograft material, and to facilitate fusion between two vertebral bodies. Both the subject and predicate interbody devices are either made from PEEK with tantalum markers for x-ray visualization, or are made from titanium alloy with fateral windows. No changes are being made to PERIMETER® Interbody Fusion Device implants as part of this submission.
Both the subject and predicate PERIMETER® Interbody Fusion Device systems include instrumentation that enables the surgeon to implant the devices via either an open or a minimally-invasive approach (including anterior, lateral, and oblique). Both the subject and predicate implant inserters are a threaded shaft/sleeve design and are used to securely hold the interbody implant during insertion and impaction into the vertebral disc space. Both are constructed of stainless steels which have a long clinical history of safe and effective use in similar devices.
IX. Identification of the Legally Marketed Predicate Device Used to Claim Substantial Equivalence
Documentation was provided which demonstrated that the subject PERIMETER® Interbody Fusion Device, including the modified inserter, is substantially equivalent to the predicate PERIMETER® Interbody Fusion Device (K113642, SE Feb 6, 2013: K090353, SE Sep 29, 2009)
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X. Brief Discussion of the Non-Clinical Tests Submitted
Medtronic is not aware of any performance standards or bench testing that would be specifically applicable to the subject inserter device.
A failure modes and effects analysis of the design changes was completed in accordance with Medtronic design control procedures. An engineering assessment and mechanical testing were conducted, and demonstrated that the subject PERIMETER® Interbody Fusion Device. including the modified inserter. is substantially equivalent to the predicate PERIMETER® Interbody Fusion Device.
XI. Conclusions Drawn from the Non-Clinical Tests
Based on the documentation provided in this premarket notification, Medtronic believes that the subject PERIMETER® Interbody Fusion Device, including the modified inserter, demonstrates substantial equivalence to the predicate PERIMETER® Interbody Fusion Device.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings outstretched, and three wavy lines below it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
November 1. 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ms. Lauren Kamer Senior Regulatory Affairs Specialist · 1800 Pyramid Place Memphis. Tennessee 38132
Re: K131669
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: September 24, 2013 Received: September 25, 2013
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. Issing 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Lauren Kamer
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Nemelkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: PERIMETER® Interbody Fusion Device
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 I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc contirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These 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 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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices