(67 days)
The Spacevision™ Cage System is intended for use as partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body in the thoracolumbar spine (T1-L5). The Spacevision Cage System is also indicated in the treatment of trauma/fractures of the thoracic and lumbar spine.
The Spacevision cage implant is an oval shaped device with teeth on the upper and lower portions. The implant is hollow and can be used with bone graft when implanted. The implant is manufactured from PEEK Optima® LT1 and contains tantalum beads for location on radiographs. A variety of sizes are available, and the implants may be inserted individually or in pairs.
This document is a 510(k) summary for the "Spacevision™ Cage System," a medical device intended for vertebral body replacement. The key takeaway from this document is that the device's acceptance criteria and its demonstration of meeting these criteria are solely based on mechanical testing for substantial equivalence to previously cleared predicate devices.
Therefore, the following information regarding AI/algorithm performance, ground truth, expert opinions, and multi-reader studies is not applicable to this submission, as it predates and does not involve AI or diagnostic algorithms.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in mechanical properties to predicate devices for VBR. | Mechanical testing demonstrated equivalence of the construct design to currently marketed spinal systems. |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the Spacevision™ Cage System itself undergoing mechanical testing, not a dataset for an algorithm. The data provenance is mechanical test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for a mechanical device is established through engineering and material science principles, typically evaluated by qualified engineers or test facilities. The document does not specify the number or qualifications of individuals who performed or reviewed the mechanical testing.
4. Adjudication method for the test set: Not applicable. Adjudication methods are relevant for subjective assessments or when reconciling differing expert opinions, which is not the case for mechanical testing of a medical device's physical properties.
5. 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 device is a physical implant, not an AI or diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an AI or diagnostic algorithm.
7. The type of ground truth used:
- Mechanical Testing Results: The "ground truth" for the device's performance is established by its ability to meet the defined mechanical performance specifications that demonstrate equivalence to predicate devices. This typically involves biomechanical tests to assess strength, fatigue, and stability.
8. The sample size for the training set: Not applicable. This device is a physical implant, not an AI or diagnostic algorithm, and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established: Not applicable, for the same reason as above.
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DEC 2 8 2004
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | SpineVision, Inc.3003 Summit Blvd., Suite 1400Atlanta, GA 30319Phone: 404-460-5077 |
|---|---|
| 510(K) CONTACT: | Lynnette WhitakerVice President, Regulatory Affairs574-269-9776 |
| TRADE NAME: | Spacevision™ Cage System |
| COMMON NAME: | Vertebral Body Replacement |
| CLASSIFICATION:Orthosis | 888.3060 Spinal Intervertebral Body Fixation |
| DEVICE PRODUCT CODE: | Product code: 87 MQP |
| SUBSTANTIALLYEQUIVALENT DEVICES: | K041888, Tetris™ Spinal Implant, SignusMedizintechnik GMBHK040928, Expandable PEEK VBR Implant, InterporeCross InternationalK042268, EBI CAS Spine Spacer System, EBI, L.P.K003709, Mesh Cage System, Surgical Dynamics™ |
DEVICE DESCRIPTION AND INTENDED USE:
The Spacevision cage implant is an oval shaped device with teeth on the upper and lower portions. The implant is hollow and can be used with bone graft when implanted. The implant is manufactured from PEEK Optima® LT1 and contains tantalum beads for location on radiographs. A variety of sizes are available, and the implants may be inserted individually or in pairs.
INDICATIONS FOR USE:
The Spacevision™ Cage System is intended for use as partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body in the thoracolumbar spine (T1-L5). The
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Spacevision Cage System is also indicated in the treatment of trauma/fractures of the thoracic and lumbar spine.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The components of the Spacevision Cage System are identical in design, material, and intended use to other spinal instrumentation systems that have been cleared by FDA for vertebral body replacement. Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal 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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing-like shapes and a curved body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 8 2004
Ms. Lynnette Whitaker Vice President, Regulatory Affairs SpineVision, Inc. 3003 Summit Boulevard, Suite 1400 Atlanta, Georgia 30319
Re: K042930
Trade/Device Name: Spacevision™ Cage System (Partial Vertebrectomy) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: October 20, 2004 Received: October 22, 2004
Dear Ms. Whitaker:
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.
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Page 2 -- Ms. Lynnette Whitaker
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N. Millenson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Spacevision™ Cage System Device Name:__
Indications For Use:
The Spacevision™ Cage System is intended for use as partial replacement (i.e. partial vertebrectorny) of a I he opacevision - Cago Dycted or excised for the treatment of tumors in order to achieve anterior ulscassd veriebral of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body in the thoracolumbar spine (TI-L5). The Spacevision Cage System is also indicated in the treatment of trauma/fractures of the thoracic and lumbar spine.
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)
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Mark N. Milliman
Division Sign Off
Division of General, Restorative,
and Neurological Devices
510(k) Number_
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§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.