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K Number
K974374
Device Name
SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV
Manufacturer
OHMEDA MEDICAL
Date Cleared
1998-01-02

(43 days)

Product Code
JKA
Regulation Number
862.1675
Type
Traditional
Panel
Clinical Chemistry
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The TA-STV is intended to be used with Ohmeda's disposable Safedraw® Closed Loop Blood Sampling kits. It allows direct transfer of blood samples from a Safedraw® blood sampling septum to an evacuated blood collection tube. The use of TA-STV eliminates the user's direct exposure to blood, and reduces the risk of needle sticks.

Device Description

TA-STV is a direct blood transfer device which is cylindrical in shape and consists of an Ohmeda Safe Needle(TA-BPN) connected to a Vacutainer Luer Adapter from Becton Dickinson (BD), and a Sleeve Adapter solvent bonded to the TA-BPN.

AI/ML Overview

I am sorry, but there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the provided text. The document is a 510(k) summary for a medical device (Safe Needle Direct Transfer Device - TA-STV) and primarily focuses on establishing substantial equivalence to a predicate device.

The document discusses:

  • Device Name and Classification: Safe Needle Direct Blood Transfer Device, Model TA-STV, Clinical Chemistry & Clinical Toxicology, Class II.
  • Intended Use: "to be used with Ohmeda's disposable Safedraw® Closed Loop Blood Sampling kits. It allows direct transfer of blood samples from a Safedraw® blood sampling septum to an evacuated blood collection tube. The use of TA-STV eliminates the user's direct exposure to blood, and reduces the risk of needle sticks."
  • Substantial Equivalence: The modified TA-STV is substantially equivalent to Ohmeda Inc.'s currently marketed TA-STV device, having the same technological characteristics.

There are no details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for any test sets.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
  6. Standalone performance studies.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document serves as a regulatory submission (510(k)) to demonstrate substantial equivalence, not a detailed technical report of performance criteria and testing to meet those criteria.

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.