(140 days)
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Not Found
No
The summary describes a mechanical fastener for bone fractures and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is intended to fasten fractured bone fragments together while the fracture heals, which is a therapeutic function addressing a medical condition.
No
The device is described as a "Trans-Osseous Fastening" device intended for fastening fractured bone fragments together, which is a therapeutic function, not a diagnostic one.
No
The description clearly indicates the device is a "Trans-Osseous Fastening" device used to fasten bone fragments, implying a physical implant or hardware component, not software alone.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fasten fractured bone fragments together while the fracture heals." This is a therapeutic and structural function performed in vivo (within the living body).
- Anatomical Site: The device is applied directly to "fractured bone fragments" and "tibial buttress fractures," which are parts of the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or disease state based on sample analysis.
- Using reagents or calibrators.
IVDs are devices used in vitro (outside the living body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device clearly operates in vivo for a structural purpose.
N/A
Intended Use / Indications for Use
Indications for use of the SD Trans-Osseous Fastening fractured bone fragments together while the fracture heals. This fastener is specifically useful in fastening split fractures, such as found in tibial buttress fractures.
Product codes
HTN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
tibial buttress
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings and two lines representing its feet.
NOV 2 3 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph J. Spranza CEO Special Devices, Inc. 12493 Old Rough and Ready Highway Grass Valley, California 95945
K982354 Re: SD Trans-Osseous Fastener Models TOB 6 Bolt 32/50, 50/80, and 80/140 Regulatory Class: II Product Code: HTN October 28, 1998 Dated: Received: November 3, 1998
Dear Mr. Spranza:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Joseph J. Spranza
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use.
Indications for use of the SD Trans-Osseous Fastening fractured bone fragments together while the fracture heals. This fastener is specifically useful in fastening split fractures, such as found in tibial buttress fractures.
Prescription Use . (Per 21 CFR 801.109)
Pàòee