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:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for any test sets.
Number or qualifications of experts for ground truth establishment.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone performance studies.
Type of ground truth used.
Sample size for the training set.
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.

Summary

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Image /page/0/Picture/0 description: The image shows the word "OHMEDA" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. There is some minor distortion or artifacting visible, particularly around the base of the letters.

7// THE BOC GROUI

Medical Devices Division

K974374

Ohmeda Inc The BOC Group Technical Center 100 Mountain Avenue Murray Hill NJ 07974 2005 Fax 908 771 6488 908 771 6100

Attachment 8

JAN - 2

510(k) Summary Safe Needle Direct Transfer Device - TA-STV

Submitted by:

Ohmeda Inc. Medical Devices Division 100 Mountain Ave. Murray Hill, NJ 07974

November 19, 1997

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Contact Person: 1.
Ms. Jing Zhang Fax: (908)771-1971 Phone: (908)771-6290

Device Name and Classification: 2.

Trade Name: Safe Needle Direct Blood Transfer Device, Model TA-STV Blood specimen collection device Classification Name: Clinical Chemistry & Clinical Toxicology Classification Panel: 21 CFR §862.1675 CFR Section: Class II Device Class: 75 JKA Device Code:

Substantial Equivalence: 3.

The modified TA-STV is substantially equivalent to Ohmeda Inc.'s currently marketed TA-STV device.

র্বা. Device Description:

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Intended Use of the Device: 5.

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.

Summary of Technological Characteristics of the Device Compared to 6. the Predicate Device:
The modified TA-STV has the same technological characteristics as the currently marketed TA-STV. They both provide the means of allowing blood samples to be transferred directly to a vacuum tube from Ohmeda Inc.'s Safedraw® Closed Loop Blood Sampling system.

Jing Zhang Manager, Regulatory Affairs Medical Devices Division Ohmeda Inc.

ーのお得ないと思います。

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right and has three curved lines representing its wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 2 1998

Ms. Jing Zhang . Manager, Regulatory Affairs Ohmeda Inc. 100 Mountain Avenue 07974 Murray Hill, New Jersey

K974374 Re : Safe Needle Direct Blood Transfer Device, Model TA-STV Requlatory Class: II Product Code: JKA November 19, 1997 Dated: November 20, 1997 Received:

Dear Ms. Zhang:

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 Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (Ž1 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. 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 requlations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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) 594-4588. 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,
Steven Sitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1

Indications For Use

510(k) Number (if known): _ 16974374

Device Name: Safe Needle Direct Transfer Device - TA-STV

Indications for Use:

AUPon Aom
Division Sign-Off

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

Over-The-Counter Use _ OR

510(k) for Modified Safe Needle Direct Blood Transfer Device, Model TA-STV Ohmeda Inc.

Regulation Number and Section

§ 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.