(9 days)
The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The AVS PL PEEK Spacers are to be implanted via posterior approach.
The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
This Special 510(k) premarket notification is intended to introduce the following design changes to the 0° AVSTM PL PEEK Spacers: The ogival shaped nose of the implant has been changed to a tapered design to facilitate insertion. The threaded hole on the front side of the implant has been omitted as it is not needed to remove the implant and field feedback confirms it would likely not be used. In the smaller heights, the back sided threaded hole has been adapted to remain consistent with the existing instruments (i.e., the two Inserters), and the back side of the spacer has been tapered in the frontal plane to match the geometry of the vertebral endplates and the two flat surfaces have been increased to improve connection with the Inserters. Note that the AVS PL PEEK Spacers are also referred to as AVS Plus.
I'm sorry, but based on the provided text, I cannot describe the acceptance criteria or a study proving the device meets them. The document is primarily a "Special 510(k) Summary of Safety and Effectiveness" for modifications to an existing spinal implant system, not a detailed study report with specific performance metrics and acceptance criteria.
Here's why the requested information cannot be extracted:
- Acceptance Criteria and Reported Device Performance: The document states that "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems." However, it does not provide a table of specific acceptance criteria (e.g., minimum compression strength, fatigue life) or the numerical 'reported device performance' values for these criteria. It only indicates that the device met the requirements for substantial equivalence.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): None of these details are present in the provided text. The document is a regulatory submission summary, not a scientific paper detailing the methodology and results of specific tests with a test set. It mentions "mechanical testing results" but does not elaborate on the specifics of these tests as would be required to answer your questions.
- Training Set Information: Similarly, there is no mention of a training set, how its ground truth was established, or its sample size. This type of information is relevant for AI/machine learning models, which are not described as being part of this device or its evaluation. This device is a physical intervertebral body fusion device.
In summary, the provided text confirms that certain tests were conducted to demonstrate substantial equivalence to a predicate device, but it lacks the granular detail about acceptance criteria, performance metrics, and study methodologies that you are requesting.
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Special 510(k) Summary of Safety and Effectiveness: Modifications to the AVSTM PL PEEK Spacer System
LO80758
MAR 2 7 2008
| Proprietary Name: | AVST™ PL PEEK Spacer System |
|---|---|
| Common Name: | Spinal Fixation Appliances |
| Proposed Regulatory Class: | Class IIInterevertebral body fusion device21 CFR 888.3080 |
| Device Product Code: | MAX |
| For Information contact: | Vikki M. O'ConnorRegulatory Affairs Project Manager2 Pearl CourtAllendale, NJ 07401Telephone: (201) 760-8206Fax: (201) 760-8345Email: Vikki.O'Connor@Stryker.com |
| Date Summary Prepared: | March 13, 2008 |
| Predicate Device | AVS PL PEEK Spacer, K073470DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP SpineSystem: P960025 (i.e., Brantigan Cage) |
| Predicate Device Information | The subject AVS PL PEEK Spacers and the predicates AVS PLPEEK Spacers and DePuy's Lumbar I/F Cage (i.e., BrantiganCage) share similar design features:• Rectangular angled shape• Lateral fenestrations |
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- · Comparable heights, widths, and angles
- · Materials and mechanical testing results are similar between the subject device and the listed predicates.
Description of Device Modification This Special 510(k) premarket notification is intended to introduce the following design changes to the 0° AVSTM PL PEEK Spacers: The ogival shaped nose of the implant has been changed to a tapered design to facilitate insertion. The threaded hole on the front side of the implant has been omitted as it is not needed to remove the implant and field feedback confirms it would likely not be used. In the smaller heights, the back sided threaded hole has been adapted to remain consistent with the existing instruments (i.e., the two Inserters), and the back side of the spacer has been tapered in the frontal plane to match the geometry of the vertebral endplates and the two flat surfaces have been increased to improve connection with the Inserters. Note that the AVS PL PEEK Spacers are also referred to as AVS Plus.
Intended Use
The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The AVS PL PEEK Spacers are to be implanted via posterior approach.
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The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
Summary of the Technological Characteristics
Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract eagle-like symbol with three tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2008
Stryker Corporation % Ms. Vikki M. O'Connor 2 Pearl Court Allendale, NJ 07401
Re: K080758
Trade/Device Name: AVS™ PL PEEK Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: March 17, 2008 Received: March 18, 2008
Dear Ms. O'Connor:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Vikki M. O'Connor
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K
Device Name: Stryker Spine AVS PL PEEK Spacers
Indications For Use:
The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The AVS PL PEEK Spacers are to be implanted via posterior approach.
The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Onetu
(Division Sign-Off)
eral, Restorative. and Neurological Decices
510(k) Number K080758
§ 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.