(185 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for use in cervical interbody fusion procedures to treat degenerative disc disease, which is a medical condition. Its purpose is to facilitate fusion and provide support, thus directly contributing to the treatment of a health issue.
No
Explanation: The device described is an interbody fusion SPACER (AVS® AS PEEK Spacer) used in cervical spine fusion procedures. Its purpose is to facilitate bone fusion, not to diagnose a medical condition. While its use is for patients with "degenerative disc disease (DDD) ... confirmed by history and radiographic studies," the device itself is a treatment, not a diagnostic tool.
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:
- Intended Use: The intended use is for a surgical procedure (cervical interbody fusion) and involves implanting a physical device into the body. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health.
- Device Description: The device is a physical implant (a PEEK spacer) designed to be placed in the spine. This is not the nature of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
The device is clearly a surgical implant used in a therapeutic procedure.
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 back 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 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
Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the AVS® AS PEEK Spacer implants and demonstrated substantially equivalent performance to the identified predicate device systems. The following mechanical tests were performed: Static Compression (per ASTM F2077) Static Compression Shear (per ASTM F2077) Static Torsion (per ASTM F2077) Subsidence (per ASTM F2267) Dynamic Compression (per ASTM F2077) Dynamic Compression Shear (per ASTM F2077) Dynamic Torsion (per ASTM F2077)
Key Metrics
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.
0
| K1204 | ||
|---|---|---|
| 510(k) Summary: AVS® AS PEEK Spacer | ||
| Submitter: | Stryker Spine | |
| 2 Pearl Court | ||
| Allendale, New Jersey 07401 | ||
| Contact Person | Ms. Soraya King | |
| Regulatory Affairs Specialist | ||
| Phone: 201-760-8296 | ||
| Fax: 201-962-42496 | ||
| Email: Soraya.King@stryker.com | ||
| Date Prepared | August 2, 2012 | |
| Trade Name | AVS® AS PEEK Spacer | |
| Common Name | Intervertebral Body Fusion Device | |
| Proposed Class | Class II | |
| Classification Name | ||
| and Number | Intervertebral body fusion device, 21 CFR 888.3080 | |
| Product Code | ODP | |
| Predicate Devices | The AVS® AS PEEK Spacer was shown to be substantially | |
| equivalent to the device listed below: | ||
| • ORTHOVITA PEEK SPACER, 510(k) #K101171 | ||
| 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. | ||
| Intended Use | The Stryker Spine AVS® AS PEEK Spacers are indicated for use in | |
| cervical interbody fusion procedures in skeletally mature patients with | ||
| 510(k) Summary: AVS® AS PEEK Spacer | ||
| degenerative disc disease (DDD) at one level from the C2-C3 disc to | ||
| the C7-T1 disc. DDD is defined as back 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 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. | ||
| Summary of the | ||
| Technological | ||
| Characteristics | The subject AVS® AS PEEK Spacer and the predicates share | |
| similar design features: | ||
| Graft windows for packing autogenous bone Serrations on the superior and inferior surfaces Comparable heights, widths, depths, and lordotic angles | ||
| Testing in compliance with FDA's June 12, 2007 "Class II | ||
| Special Controls Guidance Document: Intervertebral Body | ||
| Fusion Device" was performed for the AVS® AS PEEK Spacer | ||
| implants and demonstrated substantially equivalent performance | ||
| to the identified predicate device systems. | ||
| The following mechanical tests were performed: | ||
| Static Compression (per ASTM F2077) Static Compression Shear (per ASTM F2077) Static Torsion (per ASTM F2077) Subsidence (per ASTM F2267) Dynamic Compression (per ASTM F2077) Dynamic Compression Shear (per ASTM F2077) Dynamic Torsion (per ASTM F2077) |
Image /page/0/Picture/3 description: The image shows the text "Page 1 of 2" enclosed in a curved shape, resembling a partial oval or parenthesis. The text indicates that this is the first page of a two-page document. The font is a serif typeface, and the text is centered within the shape.
1
Page 2 of 2
2
Image /page/2/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, composed of three thick, curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 20 2012
Stryker Spine % Ms. Soraya King Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K120486
Trade Name: Stryker Spine AVS® AS PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP Dated: August 02, 2012 Received: August 03, 2012
Dear Ms. King:
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
3
· Page 2 - Ms. Soraya King
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k)# K120486 Premarket N
Indications for Use
510(k) Number (if known): K120486
Device Name: Stryker Spine AVS® AS PEEK Spacers
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 back 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 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.
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)
Carol-R
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K1204B6 5 i 0(k) Number.
Page. 1 of 1