(87 days)
P950019, P960025, K072253
Not Found
No
The summary describes a physical implant (intervertebral body fusion device) and its intended use, materials, and dimensions. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Not Found" entries for mentions of AI/ML and descriptions of training/test sets further support this conclusion.
Yes
The device is an intervertebral body fusion device used to aid in spinal fixation for patients with degenerative disc disease, which is a therapeutic purpose.
No.
The device is an intervertebral body fusion device (spacer) used for spinal fixation and is implanted to treat degenerative disc disease, not to diagnose it.
No
The device description clearly states it is a physical implant made of PEEK with Tantalum marker pins, which are hardware components.
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 Description: The provided text describes the Stryker Spine AVS PL PEEK Spacers as intervertebral body fusion devices. These are implants designed to be surgically placed in the spine to aid in spinal fixation and fusion.
- Intended Use: The intended use clearly states that these are devices for surgical implantation in patients with degenerative disc disease.
- No mention of testing biological samples: The description and intended use do not involve any testing of samples taken from the body. The device is a physical implant.
Therefore, based on the provided information, the Stryker Spine AVS PL PEEK Spacers are not an In Vitro Diagnostic device. They are a surgical implant.
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 (comma separated list FDA assigned to the subject device)
MAX
Device Description
The AVS PL Peek Spacers are intervertebral body fusion devices intended for use as an aid in spinal fixation. The AVS PL PEEK Spacers are rectangular shaped, hollow frame implants with lateral fenestrations. The spacers incorporate two (2) Tantalum marker pins to aid in radiographic visualization.
The AVS PL PEEK Spacers are available in a variety of sizes, from 6 mm to 13 mm in height, two lengths: 30 mm and 33 mm and one width: 11 mm. There are also 0° and 4° wedge shaped options that allow the surgeon to best choose the size suited to the patient's anatomy and pathology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic studies
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 substantial equivalent performance characteristics to the identified predicate device systems.
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.
P950019, P960025, K072253
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.
0
MAR - 6 2008
Stryker Spine AVS PL PEEK Spacers
Traditional 510(k) Premarket Notification
510(k) Summary: AVS PL PEEK Spacers
| Submitter: | Stryker Spine
2 Pearl Court
Allendale, New Jersey 07401 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Simona Voic
Regulatory Affairs Project Manager
Phone: 201-760-8145
FAX: 201-760-8345
Email: simona.voic@stryker.com |
| Date Prepared | March 3, 2008 |
| Trade Name | Stryker Spine AVS PL PEEK Spacers |
| Proposed Class | Class II |
| Classification Name
and Number | Intervertebral body fusion device, 21 CFR 888.3080 |
| Product Code | MAX |
| Predicate Devices | Stryker Spine Ray Threaded Fusion Cage (TFC)TM with
instrumentation: P950019;
DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine
System: P960025.
Synthes Spine SynFixTM - LR: K072253. |
| Device Description | The AVS PL Peek Spacers are intervertebral body fusion devices
intended for use as an aid in spinal fixation. The AVS PL PEEK
Spacers are rectangular shaped, hollow frame implants with
lateral fenestrations. The spacers incorporate two (2) Tantalum
marker pins to aid in radiographic visualization.
The AVS PL PEEK Spacers are available in a variety of sizes,
from 6 mm to 13 mm in height, two lengths: 30 mm and 33 mm
and one width: 11 mm. There are also 0° and 4° wedge shaped
options that allow the surgeon to best choose the size suited to
the patient's anatomy and pathology. |
| Intended 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). |
| 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 substantial equivalent performance
characteristics to the identified predicate device systems. |
・
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Spine % Ms. Simona Voic 2 Pearl Court Allendale, NJ 07401
MAR - 6 2008
Re: K073470
Trade/Device Name: Stryker Spine AVS PL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: December 7, 2007 Received: December 10, 2007
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.
3
Page 2 - Ms. Simona Voic
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 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 Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Stryker Spine AVS PL PEEK Spacers
Indications for Use
510(k) Number (if known): K ( 73470 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)
Neil R R Qde for nxm
Division of General, Restorative and Neurological Devices
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510(k) Number K073470