(86 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The intended use describes a mechanical device for fracture management.
Yes
The device is used for the "general management of fractures," which directly addresses a health condition.
No
The "Intended Use / Indications for Use" states that the device is "indicated for use in the general management of fractures and ...ass litht bearing applications with proper postoperative immobililzation." This describes a device used for treatment or support, not for identifying or diagnosing a condition.
Unknown
The provided text only contains the "Intended Use / Indications for Use" section and states "Not Found" for all other sections, including "Device Description". Without a description of the device, it is impossible to determine if it is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "general management of fractures" and "light bearing applications with proper postoperative immobilization." This describes a device used on a patient for treatment and support, not a device used to test samples from a patient to diagnose a condition.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's intended use falls outside of that definition.
N/A
Intended Use / Indications for Use
This device is indicated for use in the general management of fractures and This device is indication for ass litht bearing applications with proper postoperative immobililzation.
Product codes
HWC
Device Description
Bone-Lok™ Bioabsorbable Compression Anchor with Titanium Fixture and Bone-Lok™ Bioabsorbable Compression Anchor
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 representation of a human figure, with three overlapping profiles suggesting a sense of community and support.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2002
Mr. Brad Culbert Vice President, Engineering Research and Development Triage Medical, Inc. 13700 Alton Parkway Suite 167 Irvine, Calfornia 92618
Trade/Device Name: Bone-Lok™ Bioabsorbable Compression Anchor with Titanium Fixture and Bone-Lok™ Bioabsorbable Compression Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: HWC Dated: December 21 and December 28, 2001 Received: December 26 and December 31, 2001
Dear Mr. Culbert:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.
1
Page 2 - Mr. Brad Culbert
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r teaso oe acribed that its resemination that your devices comply with other requirements of the Act that I Dri has made a actorinations administered by other Federal agencies. You must or any I catal stututes and regaranents, including, but not limited to: registration and listing (21 Comply with an the rice 5 requirements, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your devices as described in your Section 510(k) I this letter will anow you to begal finding of substantial equivalence of your devices to legally premarket notification - results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and If you desire specific advice for for in vitro diagnostic devices), please contact the Office of additionally 21 Of ICP at 0675 . Additionally, for questions on the promotion and advertising of Compliance at (301) 59 - 21 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation ontined, "Thisoranaling on your responsibilities under the Act may be obtained from the Ource general information of your car reational 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,
Mark McMillan
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
2
Page 1 of 1
510(k) Number (if known):__K014304
Device Name: Bone-Lok™ Bioabsorbable Compression
Indications For Use:
This device is indicated for use in the general management of fractures and This device is indication for ass litht bearing applications with proper postoperative immobililzation.
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millen
(Division Sign-Off) Division of General. Restorative and Neurological Devices KO14304
(Optional Format 3-10-98)
510(k) Number _