(239 days)
The subject device is intended to stabilize the spine as an aid to fusion by transfacet fixation.
The subject device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels including: 1)Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm.
The SpineFrontier, Inc. CHAMELEON™ Fixation System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine.
The facet screw included in the CHAMELEON™ Fixation System is a partially threaded 4.5mm diameter screw offered in lengths of 30-50mm (in 5mm increments). The device is composed no mairal grade Titanium (Ti6Al4V) that complies with ASTM F-136. The devices are offered with in washer or without a washer.
Washers: Integral to the screw design, washers increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screws to provide optimal bony contact over a range of screw trajectories.
The devices are sold non-sterile and are packaged in a clear poly bag. These devices are sterilized by a healthcare professional using Steam Autoclave in accordance to the instructions for use provided by SpineFrontier, Inc., as well as the instructions provided by the manufacturer of the Autoclave.
The SpineFrontier, Inc. CHAMELEON™ Fixation System is a medical device and, as such, the provided text describes its performance data and compliance with standards rather than "acceptance criteria" and "device performance" in the context of an AI/ML algorithm. Therefore, the information requested for AI/ML studies (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this document.
The document describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting results from an AI/ML clinical study.
Here's an interpretation of the relevant information provided in the context of a medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standards/Guidance) | Reported Device Performance |
|---|---|
| ASTM F-2003 (Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System) | Device performed well during various mechanical tests, including comparison to predicate devices. |
| ASTM F-543 (Standards Specifications and Test Methods for Metallic Bone Screws) | Device performed well during various mechanical tests, including comparison to predicate devices. |
| Overall Goal: Substantial Equivalence to Predicate Devices (K012773, K994308) | The device is composed of biocompatible materials that have a long successful history in the orthopedic industry. The device satisfies the applicable performance standards and demonstrates substantial equivalence in physical and performance characteristics. |
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study. Performance was demonstrated through mechanical testing against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML is not relevant here. Device performance was assessed through engineering tests.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this medical device submission is compliance with established ASTM standards and successful mechanical performance relative to predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/1 description: The image contains the logo for SpineFrontier. The logo consists of the word "SpineFrontier" in a stylized font, with the tagline "Where Surgeons Innovate" underneath. To the left of the text is a black and gray graphic that resembles a medical device or implant.
510 (k) Summary
JAN 1 6 2008
Date Prepared |21 CFR 807.92(a)(1)] 5/21/07 Revised 10-17-2007
Submitter's Information [21 CFR 807.92(a)(1)]
Contact Tom Carlson SpineFrontier, Inc. 100 Cummings Center, Suite 240C Beverly, Massachusetts 01915 Phone: 978-232-3990 Fax: 978-232-3991
FDA Establishment Registration# 3005977257
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)|
The device trade names are:
CHAMELEON™ Fixation System
Device Common, Usual, or Classification Names
System facet Screw Spinal Device
Classification
Unclassified, Product Code MRW
Predicate Device [21 CFR 807.92(a)(3)]
Depuy Discovery - K012773 Nuvasive Inc. - Townley Transfacet Screw - K994308
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Description of the Device [21 CFR 807.92(a)(4)]
The SpineFrontier, Inc. CHAMELEON™ Fixation System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine.
The facet screw included in the CHAMELEON™ Fixation System is a partially threaded 4.5mm diameter screw offered in lengths of 30-50mm (in 5mm increments). The device is composed no mairal grade Titanium (Ti6Al4V) that complies with ASTM F-136. The devices are offered with in washer or without a washer.
Washers: Integral to the screw design, washers increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screws to provide optimal bony contact over a range of screw trajectories.
The devices are sold non-sterile and are packaged in a clear poly bag. These devices are sterilized by a healthcare professional using Steam Autoclave in accordance to the instructions for use provided by SpineFrontier, Inc., as well as the instructions provided by the manufacturer of the Autoclave.
Intended Use [21 CFR 807.92(a)(5)]
The subject device is intended to stabilize the spine as an aid to fusion by transfacet fixation.
The subject device is indicated for posterior surgical treatment of any or all of the following at the I.1 to SI (inclusive) spinal levels including: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm.
Technological Characteristics [21 CFR 807.92(a)(6)|
The device is substantially equivalent to the predicate devices based on comparison on physical and performance characteristics.
Performance Data |21 CFR 807.92(b)(1)|
The device is composed of biocompatible materials that have a long successful history in the orthopedic industry. The device performed well during various mechanical tests including comparison to predicate devices. The device was tested using the following standards as guidance: ASTM F-2003 (Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System) and ASTM F-543 (Standards Specifications and Test Methods for Metallic Bone Screws).
Conclusion [21 CFR 807.92(b)(3)|
We believe that the subject device is substantially equivalent and as safe and effective as the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
JAN 1 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SpineFrontier, Inc. % Mr. Tom Carlson 100 Cummings Center Suite 240C Beverly, MA 01915
Re: K071420
Trade/Device Name: CHAMELEON™ Fixation System Regulation Number: Unclassified Regulation Name: Facet screw spinal device system Regulatory Class: Unclassified Product Code: MRW Dated: October 17, 2007 Received: October 19, 2007
Dear Mr. Carlson:
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. Isting 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 - Mr. Tom Carlson
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 the reporting 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 M. Milliman
Mark N. Melkerson 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 K071420
Device Name: SpineFrontier Inc. - CHAMELEON™ Fixation System
Indications For Use:
The subject device is intended to stabilize the spine as an aid to fusion by transfacet fixation.
The subject device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels including: 1)Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm.
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 Ge and Neurolegical Devices
510(k) Number K071420
N/A