BTI HUMERAL INTRAMEDULLARY ROD SYSTEM by BIODYNAMIC TECHNOLOGIES, INC.

This looks like a 510(k) clearance letter from the FDA for a medical device (BTI™ Humeral Intramedullary Rod System). It doesn't contain the kind of detailed study information you're asking for regarding acceptance criteria, sample sizes, expert involvement, and ground truth.

This document primarily states:

The device name: BTI™ Humeral Intramedullary Rod System
Its intended use: Fractures of the humerus
Its regulatory class: II
The FDA's determination of substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information based on the provided text.

To answer your questions, I would need a detailed study report or clinical trial documentation, which would typically accompany a 510(k) submission but is not included in this FDA clearance letter.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 1998

Mr. Danny Hodgeman Biodynamic Technologies, Inc. 1425 East Newport Center Drive Deerfield Beach, Florida 33442

Re: K980102 BTI™ Humeral Intramedullary Rod System Regulatory Class: II Product Code: HSB Dated: January 6, 1998 January 12, 1998 Received:

Dear Mr. Hodgeman:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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. Please note: concerning your device in the Federal Register. 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 regulations.

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Page 2 - Mr. Danny Hodgeman

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 regulation (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

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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-Unknown K980102 510(k) Number:

Device Name: BTI™ Humeral Intramedullary Rod System

Indications For Use:

The BT™ Humeral Intramedullary Rod device is indicated for fractures of the humerus.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Divisi (Division of General Restorative Devices એ જ ર 510(k) Number

Prescription Use X

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.