(119 days)
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.
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.
The provided text describes the 510(k) summary for the Stryker Spine AVS® A-LAT PEEK Spacers, which are intervertebral body fusion devices. This document focuses on demonstrating substantial equivalence to predicate devices based on design and mechanical testing, rather than a clinical study evaluating the performance of an AI-powered diagnostic device. Therefore, many of the requested categories related to AI device evaluation (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable to this submission.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
The "acceptance criteria" for this device are implicitly tied to demonstrating "substantial equivalence" to existing predicate devices, particularly through meeting relevant ASTM standards for mechanical performance. The study shows the device meets these criteria by performing the specified mechanical tests and demonstrating comparable results to predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Demonstrated static compression strength (per ASTM F2077) | Performed and demonstrated substantially equivalent performance to predicate devices. |
| Demonstrated dynamic compression strength (per ASTM F2077) | Performed and demonstrated substantially equivalent performance to predicate devices. |
| Demonstrated static compression shear strength (per ASTM F2077) | Performed and demonstrated substantially equivalent performance to predicate devices. |
| Demonstrated dynamic compression shear strength (per ASTM F2077) | Performed and demonstrated substantially equivalent performance to predicate devices. |
| Demonstrated resistance to subsidence (per ASTM F2267) | Performed and demonstrated substantially equivalent performance to predicate devices. |
| Similar design features to predicate devices | Lateral fenestrations, serrations, comparable dimensions, Tantalum marker pins included. |
| Similar materials to predicate devices | Machined from medical grade PEEK OPTIMA LTI per ASTM F2026, Tantalum marker pins per ASTM F560. |
| Intended Use as intervertebral body fusion device | Intended for use with autogenous bone graft in DDD patients at L2-S1, with supplemental fixation. |
Study Details (as applicable)
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Sample size used for the test set and the data provenance: Not applicable. This was a mechanical engineering study, not a clinical study on human subjects or a dataset for an AI model. "Test set" here refers to the actual physical devices tested in a lab. The document does not specify the number of devices tested for each mechanical test, but it would typically be a statistically relevant sample size for engineering testing. The data provenance is from laboratory testing of the device prototypes.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by the physical properties and performance measured against engineering standards, not expert consensus.
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Adjudication method for the test set: Not applicable. Adjudication methods are relevant for human interpretation tasks, not for objective mechanical testing.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (spinal implant), not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (spinal implant), not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this submission is based on established engineering standards (ASTM F2077, ASTM F2267) and material specifications (ASTM F2026, ASTM F560) for mechanical performance and material composition. The comparison is made against the known performance and characteristics of legally marketed predicate devices.
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The sample size for the training set: Not applicable. This refers to an AI training set, which is not relevant for this medical device submission.
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How the ground truth for the training set was established: Not applicable, as there is no training set for an AI model.
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| 510(k) Summary: AVS® A-LAT PEEK Spacers | |
|---|---|
| Submitter: | Stryker Spine2 Pearl CourtAllendale, New Jersey 07401 |
| Contact Person | Mrs. Kimberly LaneRegulatory Affairs SpecialistPhone: 201-760-8215FAX: 201-760-8415Email: kimberly.lane@stryker.comAUG1 2 2010 |
| Date Prepared | August 11, 2010 |
| Trade Name | Stryker Spine AVS® A-LAT PEEK Spacers |
| Proposed Class | Class II |
| Classification Nameand Number | Intervertebral body fusion device, 21 CFR 888.3080 |
| Product Code | MAX |
| Predicate Devices | The AVS® A-LAT PEEK Spacer was shown to be substantiallyequivalent to the devices listed below:• DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP® SpineSystem, 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 andK081611 |
| Device Description | The AVS® A-LAT Peek Spacers are intervertebral body fusiondevices intended for use as an aid in spinal fixation. The AVS®A-LAT PEEK Spacers are rectangular shaped, hollow frameimplants with lateral fenestrations, machined from medical gradePEEK 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 theTechnologicalCharacteristics | The subject AVS® A-LAT PEEK Spacers and the predicatesshare 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
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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
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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.
§ 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.