(22 days)
P960025
No
The document describes a physical implant (PEEK spacer) and its intended use and mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an "intervertebral body fusion device" used to treat "degenerative disc disease (DDD)", which aims to alleviate back pain and degeneration of the disc, indicating a therapeutic purpose.
No
The device is an intervertebral body fusion device used for treatment, not for diagnosis.
No
The device description clearly states it is a "Hollow frame PEEK Implant" and mentions "Materials and mechanical testing results," indicating it is a physical implantable device made of PEEK material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Stryker Spine AVS® PL PEEK Spacers are physical implants designed to be surgically placed between vertebrae in the spine. They are used to facilitate bone fusion.
- Intended Use: The intended use clearly states the device is for "intervertebral body fusion" in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a sample.
The provided information describes a medical device used for treatment (fusion), not for diagnosing a condition using a sample outside the body.
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 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).
Product codes
MAX
Device Description
This Special 510(k) premarket notification is intended to introduce the same design modifications applied to the AVS® PL PEEK Spacers cleared under K080758, K082014 and K090816.
Note that the AVS® PL PEEK Spacers may also be referred to as AVS® Plus or AVS® PL-UniLIF.
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 of the 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)
P960025
Reference Device(s)
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.
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K093704 Page 1 of 2
Special 510(k) Premarket Notification
Special 510(k) Summary of Safety and Effectiveness: Modifications to the AVS® PL PEEK Spacer System
Proprietary Name:
DEC 2 3 2009
AVS® PL PEEK Spacer System
Common Name:
Spinal Fixation Appliances
Proposed Regulatory Class:
Class II
Intervertebral body fusion device 21 CFR 888.3080
Device Product Code:
MAX
Kimberly Lane
For Information contact:
Date Summary Prepared:
Predicate Device
Predicate Device Information
Regulatory Affairs Specialist 2 Pearl Court Allendale, NJ 07401 Telephone: (201) 760-8215 Fax: (201) 760-8415 Email: kimberly.lane@stryker.com
November 30, 2009
AVS® PL PEEK Spacers and DePuy AcroMed, Inc. Lumbar I/F Cage with VSP Spine System: P960025 (i.e., Brantigan Cage) 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.
1
K093704 Page Lot
Special 510(k) Premarket Notification
Description of Device Modification
Intended Use
Summary of the Technological Characteristics
This Special 510(k) premarket notification is intended to introduce the same design modifications applied to the AVS® PL PEEK Spacers cleared under K080758, K082014 and K090816.
Note that the AVS® PL PEEK Spacers may also be referred to as AVS® Plus or AVS® PL-UniLIF.
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).
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized graphic of an abstract bird-like figure, possibly representing a crane or similar bird in flight.
Public Health Service
DEC 2 3 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Stryker Corp. % Stryker Spine Ms. Kimberly Lane 2 Pearl Court Allendale, New Jersey 07401
Re: K093704
Trade/Device Name: Stryker Spine AVS® PL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: November 30, 2009 Received: December 1, 2009
Dear Ms. Lane:
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 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 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.
3
Page 2 – Ms. Kimberly Lane
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
Indications for Use
510(k) Number (if known): K 09 3704
Device Name: Stryker Spine AVS® PL PEEK Spacers
Indications For Use:
The Stryker Spine A VS® 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 × (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)
l
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093704