(97 days)
Not Found
No
The summary describes a passive implant (a PEEK spacer) used in spinal fusion surgery. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The device description focuses on the material, shape, and physical features of the implant.
Yes.
The device is used to treat degenerative disc disease and facilitate spinal fusion, which are therapeutic interventions.
No
The device is an interbody fusion cage (spacer) for the cervical spine, designed to aid in spinal fusion by holding bone graft material, not to diagnose medical conditions.
No
The device description clearly states it is a physical implant made of PEEK with Tantalum marker pins, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
- The Stryker Spine AVS® AS PEEK Spacers are physical implants used in surgical procedures to fuse vertebrae in the cervical spine. They are a therapeutic device, not a diagnostic one.
The description clearly outlines its use as a surgical implant for spinal fusion, not for testing biological samples.
N/A
Intended Use / Indications for Use
The Stryker Spine AVS® AS PEEK Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AVS® AS PEEK Spacers are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.
The AVS® AS PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Product codes
ODP
Device Description
The Stryker Spine AVS® AS PEEK Spacer is a hollow, ring-shaped PEEK Optima® LT1 cage (per ASTM F2026) with three Tantalum marker pins (per ASTM F560). It is intended for use as an interbody fusion device of the cervical spine and is offered in a variety of lengths, heights, and lordotic angles to adapt to varying patient anatomies. The hollow, ring-shaped implant has serrations on the top and bottom for fixation. The hollow space of the implant is intended to hold bone graft material for fusion purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2-C3 disc to the C7-T1 disc
Indicated Patient Age Range
skeletally mature patients
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)
Published clinical data for the cervical interbody fusion devices similar to the AVS® AS PEEK Spacer was provided in support of this application. The published clinical outcomes demonstrated that the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in anterior cervical interbody fusion procedures to treat patients diagnosed with cervical disc disease as defined above does not adversely affect performance of the system and does not represent a new worst case scenario. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2014
Stryker Spine Garry T. Haveck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K142251
Trade/Device Name: AVS® AS PEEK Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: August 13, 2014 Received: August 15, 2014
Dear Dr. Hayeck:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Garry T. Hayeck, Ph.D.
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/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 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 vours.
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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Indications for Use
510(k) Number (if known) K142251
Device Name AVS® AS PEEK Spacer
Indications for Use (Describe)
The Stryker Spine AVS® AS PEEK Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AVS® AS PEEK Spacers are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.
The AVS® AS PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| 510(k) Summary: Expanded Indications for Use, Stryker Spine AVS® AS PEEK Spacer | |
|---|---|
| Submitter | Stryker Spine |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Contact Person | Garry T. Hayeck, Ph.D. |
| Senior Regulatory Affairs Specialist | |
| Phone: 201-760-8043 | |
| Fax: 201-962-4043 | |
| E-mail: garry.hayeck@stryker.com | |
| Date Prepared | October 22, 2014 |
| Trade Name | AVS® AS PEEK Spacer |
| Common Name | Intervertebral fusion device with bone graft, cervical |
| Proposed Class | Class II |
| Additional Classification | |
| • Codification | 21 CFR § 888.3080 |
| • Name | Intervertebral body fusion device |
| Product Codes | ODP |
| Predicate Devices | The AVS® AS PEEK Spacer was shown to be substantially equivalent to |
| the devices listed below: | |
| Primary Predicate Device: | |
| Stryker Spine, AVS® AS PEEK SPACER, K120486 | |
| Additional Predicate Device: | |
| Medtronic Sofamor Danek, ANATOMIC PEEK CERVICAL FUSION | |
| SYSTEM, K130177 | |
| Device Description | The Stryker Spine AVS® AS PEEK Spacer is a hollow, ring-shaped PEEK |
| Optima® LT1 cage (per ASTM F2026) with three Tantalum marker pins | |
| (per ASTM F560). It is intended for use as an interbody fusion device of | |
| the cervical spine and is offered in a variety of lengths, heights, and | |
| lordotic angles to adapt to varying patient anatomies. The hollow, | |
| ring-shaped implant has serrations on the top and bottom for fixation. | |
| The hollow space of the implant is intended to hold bone graft | |
| material for fusion purposes. | |
| Indications for Use | The Stryker Spine AVS® AS PEEK Spacers are indicated for use in |
| cervical interbody fusion procedures in skeletally mature patients with | |
| degenerative disc disease (DDD) at one level from the C2-C3 disc to | |
| the C7-T1 disc. DDD is defined as neck pain of discogenic origin with | |
| degeneration of the disc confirmed by history and radiographic | |
| studies. The AVS® AS PEEK Spacers are to be used with autogenous | |
| bone graft and/or allogenic bone graft comprised of cancellous | |
| and/or corticocancellous bone graft. | |
| open, anterior approach. | |
| The AVS® AS PEEK Spacers are intended to be used with supplemental | |
| fixation systems that have been cleared for use in the cervical spine. | |
| This cervical device is to be used in patients who have had six weeks | |
| of non-operative treatment. | |
| Summary of | |
| Technological | |
| Characteristics | The subject AVS® AS PEEK Spacer and the predicates share similar |
| design features: | |
| • Graft windows for packing autogenous or allogenic bone | |
| • Serrations on the superior and inferior surfaces | |
| • Comparable heights, widths, depths, and lordotic angles | |
| The purpose of this 510(k) submission is to seek clearance for use of | |
| allogenic bone graft comprised of cancellous and/or | |
| corticocancellous bone graft as an alternative to autogenous bone | |
| graft. No changes have been made to the actual implants. | |
| Summary of the | |
| Performance Data | Published clinical data for the cervical interbody fusion devices similar |
| to the AVS® AS PEEK Spacer was provided in support of this | |
| application. The published clinical outcomes demonstrated that the | |
| use of allogenic bone graft comprised of cancellous and/or | |
| corticocancellous bone graft in anterior cervical interbody fusion | |
| procedures to treat patients diagnosed with cervical disc disease as | |
| defined above does not adversely affect performance of the system | |
| and does not represent a new worst case scenario. No changes were | |
| made to the existing devices, nor were any new components added | |
| to the system. Therefore, no additional testing was required or | |
| performed. | |
| Conclusion | The design features, materials used, manufacturing, and sterilization |
| methods are identical to the previously cleared AVS® AS PEEK Spacer | |
| components with the exception of broadening the indications to | |
| include the use of allogenic bone graft comprised of cancellous | |
| and/or corticocancellous bone graft as an alternative graft material. |
The data presented in this submission demonstrates that the safety
and effectiveness of the AVS® AS PEEK Spacers when used with
allogenic bone graft comprised of cancellous and/or
corticocancellous bone graft is substantially equivalent to the safety
and effectiveness of the predicate systems when used with autograft. |
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