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K Number
K980102
Device Name
BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
Manufacturer
BIODYNAMIC TECHNOLOGIES, INC.
Date Cleared
1998-04-03

(81 days)

Product Code
HSB
Regulation Number
888.3020
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

BTI™ Humeral Intramedullary Rod System

AI/ML Overview

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.

§ 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.