(119 days)
Not Found
No
The 510(k) summary describes a passive intervertebral body fusion device made of PEEK with tantalum markers. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is an intervertebral body fusion device used to treat degenerative disc disease and aid in spinal fixation. Its purpose is to alleviate symptoms and restore function, which aligns with the definition of a therapeutic device.
No
Explanation: This device is an intervertebral body fusion device used in spinal fixation, not for diagnosing conditions. Its purpose is to aid in spinal fusion in patients previously diagnosed with degenerative disc disease.
No
The device description clearly states it is a physical implant made of PEEK and Tantalum, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes the Stryker Spine AVS® A-LAT PEEK Spacers as intervertebral body fusion devices. Their intended use is to be surgically implanted into the spine to aid in spinal fixation and fusion in patients with degenerative disc disease.
- Lack of Specimen Handling: There is no mention of this device being used to collect, prepare, or examine any specimens from the human body.
- Surgical Implant: The device is a physical implant intended for surgical placement within the body, not for laboratory testing of biological samples.
The information provided describes a Class II medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Stryker Spine A VS® A-LAT 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 SI.
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 A VS® A-LAT PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The AVS® A-LAT Peek Spacers are intervertebral body fusion devices intended for use as an aid in spinal fixation. The AVS® A-LAT PEEK Spacers are rectangular shaped, hollow frame implants with lateral fenestrations, machined from medical grade PEEK OPTIMA LTI per ASTM F2026. The spacers incorporate five (5) Tantalum (per ASTM F560) marker pins to aid in radiographic visualization. The AVS® A-LAT PEEK Spacers are available in a variety of sizes and angles 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 imaging
Anatomical Site
from 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® A-LAT PEEK Spacers and demonstrated substantially equivalent performance to the identified predicate device systems. The following mechanical tests were performed:
• Static Compression (per ASTM F2077)
• Dynamic Compression (per ASTM F2077)
• Static Compression Shear (per ASTM F2077)
• Dynamic Compression Shear (per ASTM F2077)
• Subsidence (per ASTM F2267)
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.
K082014, K093242, K083661, K071795, K081611
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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510(k) Summary: AVS® A-LAT PEEK Spacers | |
---|---|
Submitter: | Stryker Spine |
2 Pearl Court | |
Allendale, New Jersey 07401 | |
Contact Person | Mrs. Kimberly Lane |
Regulatory Affairs Specialist | |
Phone: 201-760-8215 | |
FAX: 201-760-8415 | |
Email: kimberly.lane@stryker.com | |
AUG1 2 2010 | |
Date Prepared | August 11, 2010 |
Trade Name | Stryker Spine AVS® A-LAT PEEK Spacers |
Proposed Class | Class II |
Classification Name | |
and Number | Intervertebral body fusion device, 21 CFR 888.3080 |
Product Code | MAX |
Predicate Devices | The AVS® A-LAT PEEK Spacer was shown to be substantially |
equivalent to the devices listed below: | |
• DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP® Spine | |
System, PMA# P960025 | |
• Stryker Spine AVS® PL PEEK Spacers, 510(k) # K082014 | |
• Globus PATRIOT® Transcontinental® Spacer, 510(k) # | |
K093242 | |
• Stryker Spine AVS® TL PEEK Spacers, 510(k) # K083661 | |
• NuVasive CoRoent® XL Spacers, 510(k)s # K071795 and | |
K081611 | |
Device Description | The AVS® A-LAT Peek Spacers are intervertebral body fusion |
devices intended for use as an aid in spinal fixation. The AVS® | |
A-LAT PEEK Spacers are rectangular shaped, hollow frame | |
implants with lateral fenestrations, machined from medical grade | |
PEEK OPTIMA LTI per ASTM F2026. The spacers | |
510(k) Summary: AVS® A-LAT PEEK Spacers | |
incorporate five (5) Tantalum (per ASTM F560) marker pins to | |
aid in radiographic visualization. The AVS® A-LAT PEEK | |
Spacers are available in a variety of sizes and angles that allow | |
the surgeon to best choose the size suited to the patient's | |
anatomy and pathology. | |
Intended Use | The Stryker Spine AVS® A-LAT 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® A-LAT PEEK Spacers are intended to be used with | |
supplemental fixation systems that have been cleared for use in | |
the lumbosacral spine. | |
A description of the subject devices containing the specific | |
information recommended by FDA in the "Class II Special | |
Controls Guidance Document: Intervertebral Body Fusion | |
Device" is provided in Section 11 of this 510(k) submission. | |
Summary of the | |
Technological | |
Characteristics | The subject AVS® A-LAT PEEK Spacers and the predicates |
share similar design features: | |
• Lateral fenestrations | |
• Serrations on the superior and inferior surfaces | |
• Comparable heights, widths, and angles | |
• Markers for position confirmation when using radiographic | |
510(k) Summary: AVS® A-LAT PEEK Spacers | |
imaging | |
Testing in compliance with FDA's June 12, 2007 "Class II | |
Special Controls Guidance Document: Intervertebral Body | |
Fusion Device" was performed for the AVS® A-LAT PEEK | |
Spacers and demonstrated substantially equivalent performance | |
to the identified predicate device systems. The following | |
mechanical tests were performed: | |
• Static Compression (per ASTM F2077) | |
• Dynamic Compression (per ASTM F2077) | |
• Static Compression Shear (per ASTM F2077) | |
• Dynamic Compression Shear (per ASTM F2077) | |
• Subsidence (per ASTM F2267) | |
Conclusion | The AVS® A-LAT PEEK spacers have demonstrated substantial |
equivalence in performance, material, indications and design to | |
the identified predicate device systems. |
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
AUG 1 2 2018
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 .
Stryker Spine % Ms. Kimberly Lane Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K101051
Trade/Device Name: AVS® A-LAT PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 04, 2010 Received: August 05, 2010
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. 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 fray or athe 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 I hat FDA has made a determination that your device complies with other requirements of the Act
4
Page 2 - Ms. Kimberly Lane
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.
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/ReportalProblem/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 vours.
Jartian Breems
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Traditional 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): K10105 I
AUG 1 2 2010
Device Name: Stryker Spine AVS® A-LAT PEEK Spacers
Indications For Use:
The Stryker Spine A VS® A-LAT 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 SI.
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 A VS® A-LAT PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIO1051 510(k) Number.