(81 days)
Not Found
No
The summary describes a mechanical implant (screw) for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an aid to fusion through bilateral immobilization of the facet joints to stabilize the spine and addresses conditions like spondylolisthesis, spondylolysis, and degenerative disc disease, indicating a therapeutic purpose.
No
Explanation: The device is a facet compression device used to stabilize the spine and aid in fusion, not to diagnose a condition. Its indications for use describe conditions it treats, not conditions it identifies or diagnoses.
No
The device description clearly states it is a physical screw made of titanium or stainless steel, intended for surgical implantation.
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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a screw with a compression-locking collar) intended to be surgically implanted into the spine to stabilize facet joints and aid in fusion. It is a physical device used in the body, not a test performed on samples from the body.
The information provided aligns with a description of a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1.
The 3.8mm CS Facet Compression Device is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
MRW
Device Description
The 3.8mm CS Facet Compression Device is a double-helix screw with a compressionlocking collar, and is provided with or without a self-retaining washer. It is available in various length ranges fabricated from either Titanium 6Al-4V, which meets the requirements of ASTM F-136 or stainless steel, which meets the requirements of ASTM F-138.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to S1 (Spine / Facet Joints)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Mechanical and biomechanical testing have established that the devices satisfies functional performance requirements and is safe when used as indicated.
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.
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
N/A
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTER INFORMATION
| A. Company Name: | Triage Medical, Inc |
|---|---|
| B. Company Address: | 13700 Alton Parkway |
| Suite 160 | |
| Irvine, CA 92618 | |
| C. Company Phone: | (949) 472-0006 |
| D. Company Facsimile: | (949) 472-0016 |
| E. Contact Person: | Gayle Hirota |
| Manager, Quality Assurance & Regulatory Affairs |
DEVICE IDENTIFICATION
| A. | Trade Name: | 3.8mm CS Facet Compression Device |
|---|---|---|
| B. | Catalog Number: | CS-38-1215 / CS-38-4050 (Titanium) |
| CSW -38-1215 / CSW-38-4050 (Titanium with Washer) | ||
| C. | Common Name: | Facet screw |
| D. | Classification Name: | Unclassified |
| E. | Product Code: | MRW |
| F. | Device Class: | Unclassified |
IDENTIFICATION OF PREDICATE DEVICE
The 3.8mm CS Facet Compression Device is similar in basic design, materials and intended use to the NuVasive™ 3.5mm Triad™ Facet Screw System cleared under 510(k) K020411.
DEVICE DESCRIPTION
The 3.8mm CS Facet Compression Device is a double-helix screw with a compressionlocking collar, and is provided with or without a self-retaining washer. It is available in various length ranges fabricated from either Titanium 6Al-4V, which meets the
CONFIDENTIAL
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requirements of ASTM F-136 or stainless steel, which meets the requirements of ASTM F-138.
INTENDED USE
The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1.
TECHNOLOGICAL CHARACTERISTICS
The 3.8mm CS Facet Compression Device is similar in materials, design, construction and mechanical performance to the predicate devices.
PERFORMANCE DATA (NON-CLINICAL)
Mechanical and biomechanical testing have established that the devices satisfies functional performance requirements and is safe when used as indicated.
BIOCOMPATIBILITY
The 3.8mm CS Facet Compression Device is made from either Titanium 6Al-4V ELI, which meets the requirements of ASTM F-136 or surgical grade Stainless Steel, which meets the requirements of ASTM F-138. These materials are currently being utilized in a myriad of legally marketed orthopedic devices.
CONCLUSIONS DRAWN FROM STUDIES
Documentation provided, and test results demonstrate that the 3.8mm CS Facet Compression Device is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 17 2005
Gayle Hirota QA/RA Manager Triage Medical, Inc. 13700 Alton Parkway, Suite 160 Irvine, California 92618
Rc: K052043
Trade/Device Name: 3.8mm CS Facet Compression Device Regulation Number: Unclassified Regulation Name: N/A Regulatory Class: Unclassified Product Code: MRW Dated: September 20, 2005 Received: September 22, 2005
Dear Ms. Hirota:
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- Gayle Hirota
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/industry/support/index.html
Sincerely yours,
Mark N. Molkerson
Sor Mark N. Melkerson Acting 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
KOSZOY3 510(k) Number (if known):
3.8mm CS Facet Compression Device Device Name:
The 3.8mm CS Facet Compression Device is indicated Indications For Use: for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis and failed previous fusion.
The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to SI.
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)
Si. 00
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_Ko 5 2043
CONFIDENTIAL