(21 days)
No
The device description and intended use focus on a physical implant (PEEK spacer) for spinal surgery. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The "Not Found" entries for AI/ML mentions and training/test set descriptions further support this conclusion.
Yes.
The device is a vertebral body replacement intended to treat collapsed, damaged, or unstable vertebral bodies caused by tumor or trauma, aiming to decompress the spinal cord and restore height. Its use is directly for treating a diseased or injured condition.
No
The device is a vertebral body replacement that is implanted to restore spinal height and achieve decompression; it does not diagnose medical conditions.
No
The device description clearly states it is a physical implant made from PEEK material with Tantalum marker pins, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Stryker Spine AVS™ PL PEEK Spacer is a physical implant designed to replace a vertebral body in the spine. It is a surgical device used in vivo (within the body) during a surgical procedure.
- Lack of Diagnostic Testing: The description clearly outlines its purpose as a structural replacement and support device. It does not perform any tests on biological samples to diagnose or monitor a condition.
The mention of "Radiographic visualization" is for aiding in the placement and monitoring of the implant, not for diagnostic testing of a biological sample.
N/A
Intended Use / Indications for Use
The Stryker Spine AVS™ PL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable verteral body resected or excised during partial and total vertebrectory procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
It is recommended to pack bone graft material inside the implant.
The Stryker Spine AVS™ PL PEEK Spacer is intended for use with supplemental fixation. The Supplemental fixation systems that may be used with the Stryker Spine AVS™ PL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).
Product codes
MQP
Device Description
The AVSTM PL Peek Spacer is a rectangular shaped, hollow frame implant with lateral fenestrations, machined from medical grade PEEK OPTIMA LT1. The spacer incorporates two (2) Tantalum marker pins to aid in radiographic visualization. The AVSTM PL Peek System is comprised of six (6) different sized footprints with a variety of heights and lordotic angles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoraco-lumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
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)
Documentation is provided which demonstrates the additional sizes of the Stryker Spine AVS™ PL PEEK Spacer to be substantially equivalent to their predicate device in terms of its material, design, and indications for use. Compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was also demonstrated for the subject spacers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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Line Extension to the AVS™ PL PEEK Spacer System
Special 510(k) Premarket Notificatio
Special 510(k) Summary of Safety and Effectiveness: Special STo(R) Summary of PEEK Spacer System
| Proprietary Name: | AVSTM PL PEEK Spacer System
AUG 1 6 2006 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spinal Fixation Appliances |
| Proposed Regulatory Class: | Class II |
| | Spinal Vertebral Body Replacement Device, |
| | 21 CFR 888.3060 |
| Device Product Code: | MQP |
| For Information contact: | Simona Voic |
| | Regulatory Affairs Project Manager |
| | 2 Pearl Court |
| | Allendale, NJ 07401 |
| | Telephone: (201) 760-8145 |
| | Fax: (201) 760-8345 |
| | Email: Simona. Voic@stryker.com |
| Date Summary Prepared: | July 25, 2006 |
| Predicate Device | Stryker Spine AVSTM PL PEEK Spacer (K050624) |
| Predicate Device Information | The AVSTM PL Peek Spacer is a rectangular shaped, |
| | hollow frame implant with lateral fenestrations, |
| | machined from medical grade PEEK OPTIMA LT1. |
| | The spacer incorporates two (2) Tantalum marker pins |
| | to aid in radiographic visualization. The AVSTM PL |
| | Peek Spacer System is comprised of six (6) different |
| | |
| Description of Device Modification | sized footprints with a variety of heights and lordotic
angles. The AVSTM PL Peek System was determined
substantial equivalent via K040731 and K050624. |
| Intended Use | This Special 510(k) premarket notification is intended
to introduce additional sizes of the AVSTM PL Peek
Spacer. |
| | The Stryker Spine AVSTM PL PEEK Spacer is a
vertebral body replacement indicated for use in the
thoraco-lumbar spine (T1-L5) to replace a collapsed,
damaged, or unstable vertebral body resected or
excised during partial and total vertebrectomy
procedures due to tumor or trauma, to achieve anterior
decompression of the spinal cord and neural tissues,
and to restore the height of a collapsed vertebral body.
It is recommended to pack bone graft material inside
the implant.
The Stryker Spine AVSTM PL PEEK Spacer is intended
for use with supplemental fixation. The supplemental
fixation systems that may be used with the Stryker
Spine AVSTM PL PEEK Spacer include, but are not
limited to, Stryker Spine plate or rod systems (XIA,
Spiral Radius 90D, and Trio). |
1
2
Summary of the Technological Characteristics
Documentation is provided which demonstrates the additional sizes of the Stryker Spine AVS™ PL PEEK Spacer to be substantially equivalent to their predicate device in terms of its material, design, and indications for use. Compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was also demonstrated for the subject spacers.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine, and its presence in the logo signifies the department's role in promoting and protecting the health of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2006
Stryker Spine % Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
Re: K062132
Trade/Device Name: AVS™ PL PEEK Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: July 25, 2006 Received: July 26, 2006
Dear Ms. Voic:
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. This
4
Page 2 - Ms. Simona Voic
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 this, 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ontain 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/suport/index.html.
Sincerely yours.
Per Sera D. Primo no
DEO V.S.C.R.R
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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Line Extension to the AVS™ PL PEEK Spacer System
Special 510(k) Premarket Notification
Indications for Use
510(k) Number (if known):
Device Name: AVS™ PL PEEK Spacer System
Indications for Use:
The Stryker Spine AVS™ PL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable verteral body resected or excised during partial and total vertebrectory procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
It is recommended to pack bone graft material inside the implant.
The Stryker Spine AVS™ PL PEEK Spacer is intended for use with supplemental fixation. The Supplemental fixation systems that may be used with the Stryker Spine AVS™ PL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P.O. hma
(Division Sign-Of Division of General, Restorative, and Neurological Devices
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510(k) Number K062132