(13 days)
No
The document describes a physical intervertebral body fusion device (PEEK spacer) and its material properties and dimensions. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an intervertebral body fusion device indicated for use in patients with degenerative disc disease, aiming to alleviate back pain of discogenic origin, which defines it as a therapeutic device.
No
The device is an intervertebral body fusion device (spacer), which is a treatment device, not a diagnostic one. Its purpose is to facilitate fusion after diagnosis, not to diagnose a condition.
No
The device description clearly states it is a "Hollow frame PEEK Implant" and discusses physical dimensions and materials, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Stryker Spine AVS® PL PEEK Spacers are implantable devices used for intervertebral body fusion in the spine. They are surgically placed within the body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens.
This device is a surgical implant used to treat a specific medical condition (degenerative disc disease) by promoting bone fusion in the spine. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 non-operative 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).
Product codes
MAX
Device Description
This Special 510(k) premarket notification is intended to introduce the following line extensions to the AVS® PL PEEK Spacers approved under K073470: The addition of 20 and 25 mm lengths, 14, 15, 16 and 18 mm heights, 8 and 9 mm widths, and 8° angle. Additions to implants approved under K080758 include: Addition of a 14 mm length (4 implants).
All other attributes remain the same. Note that the AVS® PL PEEK Spacers may also be referred to as AVS Plus.
The subject AVS PL PEEK Spacers and the predicates AVS PL PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., Brantigan Cage) share similar design features:
• Hollow frame PEEK Implant
• Lateral fenestrations
• Serrations on the superior and inferior surfaces
• Comparable heights, widths, and angles
• Materials and mechanical testing results are similar between the subject device and the listed predicates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbosacral spine)
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)
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.
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 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.
0
K08 2014 (pg. 1 of 3
Line Extension to the AVS™ PL PEEK Spacer System
Special 510(k) Premarket Notification
Special 510(k) Summary of Safety and Effectiveness:
Modifications to the AVS™ PL PEEK Spacer System
| Proprietary Name: | AVST™ PL PEEK Spacer System |
|---|---|
| JUL 2 8 2008 | |
| Common Name: | Spinal Fixation Appliances |
| Proposed Regulatory Class: | Class II |
| Interevertebral body fusion device | |
| 21 CFR 888.3080 | |
| Device Product Code: | MAX |
| For Information contact: | Vikki M. O'Connor |
| Regulatory Affairs Project Manager | |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Telephone: (201) 760-8206 | |
| Fax: (201) 760-8306 | |
| Email: Vikki.O'Connor@Stryker.com | |
| Date Summary Prepared: | July 14, 2008 |
| Predicate Device | AVS PL PEEK Spacers, K073470 and K080758 |
| DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine | |
| System: P960025 (i.e., Brantigan Cage) | |
| Predicate Device Information | The subject AVS PL PEEK Spacers and the predicates AVS PL |
| PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., Brantigan | |
| Cage) share similar design features: | |
| • Hollow frame PEEK Implant | |
| • Lateral fenestrations | |
| • Serrations on the superior and inferior surfaces |
1
510(k) Premarket Notification
-
· Comparable heights, widths, and angles
14082014 -
· Materials and mechanical testing results are similar between the subject device and the listed predicates.
This Special 510(k) premarket notification is intended to introduce the following line extensions to the AVS® PL PEEK Spacers approved under K073470: The addition of 20 and 25 mm lengths, 14, 15, 16 and 18 mm heights, 8 and 9 mm widths, and 8° angle. Additions to implants approved under K080758 include: Addition of a 14 mm length (4 implants).
All other attributes remain the same. Note that the AVS® PL PEEK Spacers may also be referred to as AVS Plus.
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 non-operative 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).
Description of Device Modification
Intended Use
2
K032014 (pg. 3 of
AVS PL PEEK Spacer System - Line Extension
Special 510(k) Premarket Notification
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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Corp. % Stryker Spine Ms. Vikki M. O'Connor Regulatory Affairs Project Manager 2 Pearl Court Allendale, NJ 07401
JUL 28 2008
Re: K082014
Trade/Device Name: Stryker Spine AVSTM PL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: July 14, 2008 Received: July 15, 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.
4
Page 2 - Ms. Suzana Otano
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. Wilkinson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): KOS 2014
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).
Prescription Use X (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)
Division of General Restorative, and Neurological D 510(k) Number