(20 days)
No
The summary describes a physical interbody fusion device and its materials and mechanical properties. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated for interbody fusion in patients with degenerative disc disease, aiming to provide support and correction, which classifies it as a therapeutic device.
No
The device is described as an "Interbody Fusion Device" which provides "support and correction during lumbar interbody fusion surgeries." Its purpose is to facilitate fusion and provide structural support, not to diagnose medical conditions.
No
The device description clearly states it consists of "interbody cages of various widths and heights," which are physical implants, not software. The summary also details biocompatibility and mechanical testing, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The PERIMETER® Interbody Fusion Device is an implantable device designed to be surgically inserted into the body (between vertebral bodies) to provide structural support during spinal fusion. It does not analyze biological specimens.
- Lack of IVD Characteristics: The description does not mention any analysis of blood, urine, tissue, or other bodily fluids. It focuses on the physical structure and function of the implant.
Therefore, the PERIMETER® Interbody Fusion Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 non-operative 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.
Product codes
MAX
Device Description
The PERIMETER® Interbody Fusion Device consists of interbody 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar or lumbosacral vertebral bodies, 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)
Biocompatibility: Identical to the primary predicate devices the implants in the subject PERIMETER® Interbody Fusion Device are made using Titanium alloy. The non-sterile instruments are manufactured using stainless steel and are identical to the materials used for the instruments cleared under predicate submissions. The titanium alloy and stainless steel material used for the subject PERIMETER® Interbody Fusion Devices implants and instruments (trials) have a long clinical history of safe and effective use in similar commercially available 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. Therefore, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ankit K. Shah Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
March 7, 2016
Re: K160418
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: February 15, 2016 Received: February 16, 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
1
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160418
Device Name
PERIMETER® Interbody Fusion Device
Indications for Use (Describe)
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 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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PERIMETER® Interbody Fusion Device 510(k) Summary February 2016
| I. | Submitter: | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: (901)396-3133
Fax: (901) 346-9738 |
|------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| | Contact: | Ankit K. Shah
Senior Regulatory Affairs Specialist |
| | Date Prepared: | February 25, 2016 |
| II. | Device | |
| | Name of Device: | PERIMETER® Interbody Fusion Device |
| | Common or Usual Name: | Intervertebral body fusion device (21 CFR 888.3080) |
| | Classification Name: | Intervertebral fusion device with bone graft,
lumbar |
| | Regulatory Class: | Class II |
| | Product Code: | MAX |
| III. | Predicate Device | K111525 (S.E. 08/24/2011) PERIMETER® Interbody
Fusion Device – Primary Predicate |
| | | K090353 (S.E. 09/29/2009) – PERIMETER® Interbody
Fusion Device - Additional Predicate |
| | | The predicates device have not been subject
to a design related recall. |
IV. Device Description:
The PERIMETER® Interbody Fusion Device consists of interbody 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.
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The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.
Indications for Use: v.
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.
VI. Comparison of Technological Characteristics with Predicate Device
The subject PERIMETER® Interbody Fusion Devices have identical: indications for use, intended use, design, material (Titanium Alloy per ASTM F136), levels of attachment and fundamental scientific technology as the PERIMETER® Interbody Fusion Devices predicate previously cleared by the FDA in K111525 (S.E. 08/24/2011). Additionally, the new PERIMETER® Interbody Fusion Devices are provided sterile identical to that of the predicate 2 devices found in K090353 (S.E. 09/29/2009). The purpose of this submission is to include additional interbody cages manufactured from medical grade titanium alloy (Ti-6Al-4V ELI) that are packaged sterile via gamma irradiation.
Instruments (trials) are also being added to provide appropriate sizing options for implant sizes already cleared in predicate 510(k)s. The non-sterile trials are manufactured using stainless steel and have identical indications for use, intended use, materials and design to the instruments cleared under the predicate 510(k)s.
VII. Performance Data
The following performance data are provided in support of the substantial equivalence determination.
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Biocompatibility
Identical to the primary predicate devices the implants in the subject PERIMETER® Interbody Fusion Device are made using Titanium alloy.
The non-sterile instruments are manufactured using stainless steel and are identical to the materials used for the instruments cleared under predicate submissions.
The titanium alloy and stainless steel material used for the subject PERIMETER® Interbody Fusion Devices implants and instruments (trials) have a long clinical history of safe and effective use in similar commercially available 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. Therefore, 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.
Conclusion VIII.
Based on a risk analysis, engineering rationale, and additional supporting documentation provided in this pre-market notification, the subject PERIMETER® Interbody Fusion Devices (implants and instruments) are as safe and effective as the following predicates K111525 (S.E. 08/24/2011) PERIMETER® Interbody Fusion Device – Primary Predicate and K090353 (S.E. 09/29/2009) - PERIMETER® Interbody Fusion Device -Predicate 2.