VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET

K965202 · Bd Becton Dickinson Vacutainer Systems Preanalytic · JKA · Feb 10, 1997 · Clinical Chemistry

Device Facts

• Record ID: K965202
• Device Name: VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
• Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
• Product Code: JKA · Clinical Chemistry
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

A needle and attached tubing for venipuncture and the collection of blood specimens from patients. Includes a safety shield to minimize the possibility of needlesticks.

Device Story

VACUTAINER® Brand Safety-Lok™ Blood Collection Set; needle with attached tubing for venipuncture; integrated safety shield to prevent needlestick injuries; used by clinicians for blood specimen collection; device modification involves alternate manufacturing site and material suppliers; functional performance verified via bench testing and simulated use studies.

Clinical Evidence

Bench testing only. Comparative study between current and modified devices evaluated flow rates, shield activation/sustaining/override forces, heat stake break force, pressure, and I.V. penetration/drag forces. Simulated use study evaluated package opening, shield activation, and disposal; results showed equivalent or improved performance for the modified device.

Technological Characteristics

Needle and tubing assembly with integrated safety shield mechanism. Materials sourced from alternate suppliers; functional performance equivalent to predicate. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients requiring venipuncture for blood specimen collection.

Regulatory Classification

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.

Predicate Devices

• VACUTAINER® Brand Safety-Lok™ Blood Collection Set (K965202)

Submission Summary (Full Text)

{0}

Becton Dickinson VACUTAINER Systems
1 Becton Drive
Franklin Lakes, New Jersey 07417-1885
[phone]
K965202

# BECTON DICKINSON

## G. SUMMARY OF SAFETY AND EFFECTIVENESS

FEB 10 1997

### G.1. Summary

Submitter: Eileen Schweighardt
Becton Dickinson VACUTAINER Systems
1 Becton Drive
Franklin Lakes, NJ 07417-1885
[phone]

Date: December 19, 1996

Device: VACUTAINER® Brand Safety-Lok™ Blood Collection Set

Classification: Accessory To: Tubes, Vials, Systems, Serum Separators, Blood Collection (75JKA)

Predicate Device: VACUTAINER® Brand Safety-Lok™ Blood Collection Set

Intended Use and Product Description: A needle and attached tubing for venipuncture and the collection of blood specimens from patients. Includes a safety shield to minimize the possibility of needlesticks.

Proposed Modification: Alternate manufacturing site and alternate material suppliers.

Becton Dickinson VACUTAINER Systems has determined that the establishment of an additional manufacturing site and alternate material suppliers does not affect the safety or effectiveness of the product for its intended use. Testing has shown that functional performance of the product is equivalent to the current product.

There are no new product claims associated with this 510(k).

{1}

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# Synopsis of Test Methods and Results

Equivalent functional performance is demonstrated between the current Safety-Lok™ Blood Collection Set and the modified Safety-Lok™ Blood Collection Set in a study comparing flow rates; shield activation force; shield sustaining force; shield override force; heat stake break force; pressure testing; I.V. penetration and drag forces. The studies identified some differences; however these differences will not affect the overall performance of the modified product.

A simulated use study was conducted to evaluate the ease of package opening, ease of safety shield activation, ease of disposal and successful activation of the safety shield of the modified Safety-Lok™ Blood Collection Set manufactured by BDVS in comparison to the current Safety-Lok™ Blood Collection Set manufactured by Nissho. The principal device manufactured by the BDVS demonstrated equivalent or improved ease of package opening/product accessibility, shield activation and disposal. The Simulated Use and Actual Use studies for successful safety shield activation exhibited successful activation for both the principal and predicate devices.

Eileen Schweighardt
Manager, Regulatory Affairs
12/23/96
Date