CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION)

K970597 · Medical Packaging Corp. · JSM · Mar 24, 1997 · Microbiology

Device Facts

• Record ID: K970597
• Device Name: CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION)
• Applicant: Medical Packaging Corp.
• Product Code: JSM · Microbiology
• Decision Date: Mar 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

Indications for Use

Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Clinical Transport Media, (Cary-Blair Transport Media Option) is intended for use as a disposable, sterile culture collection device for use in the collection, preservation, and transportation of microbiological specimens.

Device Story

Disposable, sterile microbiological specimen collection and transport system. Consists of two-part plastic housing containing 0.4 mL Cary-Blair transport media and collection swabs (Rayon-tipped plastic shaft or aluminum shaft Mini-Tip). Operation: user separates plastic parts to expose swab; collects specimen; re-inserts swab into housing; bends top 45° to break internal plug; forces media into bottom chamber to maintain specimen moisture for up to 72 hours at room temperature. Used in clinical settings for transport to laboratory for analysis. Benefits: maintains specimen viability during transit.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, intended use, and functional similarity to predicate devices.

Technological Characteristics

Two-part plastic housing; Rayon-tipped swabs (plastic or aluminum shafts); 0.4 mL Cary-Blair transport media; sterile; manual operation; mechanical media release via 45° bend to break internal plug.

Indications for Use

Indicated for the collection, preservation, and transportation of microbiological specimens for clinical laboratory analysis. Applicable to general clinical specimens, including male urethral or nasopharyngeal samples.

Regulatory Classification

Identification

A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

Predicate Devices

• Modified Stuart's Media (K932337/S1)
• Modified Stuart's Media (K936078)
• CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media (K964637)

Submission Summary (Full Text)

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K970597
510(k) Notification • 12 February, 1997
Medical Packaging Corporation
CULTURE-PAK™ Collection and Transport System
with Clinical Transport Media
(Cary-Blair Transport Media Option)
MAR 24 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.

**DATE OF SUMMARY PREPARATION:** 12 February, 1997

**COMPANY:**
Medical Packaging Corporation
941 Avenida Acaso
Camarillo, CA 93012-8700
**Phone:** 805-388-2383
**Fax:** 805-388-5531

**CONTACT PERSON:** Patricia V. Willis

**DEVICE NAME:** CULTURE-PAK™
Collection and Transport System,
Clinical Transport Media
(Cary-Blair Transport Media Option)

**DEVICE CLASSIFICATION:** Class I, General Controls

**COMMON NAME:** Microbiological specimen collection and transport device

**PREDICATE DEVICE(S):** Modified Stuart's Media (K932337/S1 and K936078), and CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, K964637. Medical Packaging Corporation Camarillo, CA

## Intended Use

Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Clinical Transport Media, (Cary-Blair Transport Media Option) is intended for use as a disposable, sterile culture collection device for use in the collection, preservation, and transportation of microbiological specimens.

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510(k) Notification • 12 February, 1997

Medical Packaging Corporation

CULTURE-PAK™ Collection and Transport System

with Clinical Transport Media

(Cary-Blair Transport Media Option)

## Substantial Equivalence

Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, Clinical Transport Media, Cary-Blair Transport Media option, is substantially equivalent to Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K936078) and (K932337/S1), and CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, K964637. Listed devices are intended to collect, preserve, and transport clinical specimens to the laboratory for microbiological analysis. Devices are composed of two plastic parts:

- The top plastic part holds 0.4 mL of clinical transport media and a plastic shaft, Rayon® tipped swab. Configuration of the CULTURE-PAK™ Collection and Transport System, Clinical Transport Media, will also provide two plastic shaft, Rayon® tipped swabs; an aluminum shaft, Rayon® Mini-Tip swab for collection of either male urethral or nasopharyngeal specimens.

- The bottom plastic part protects the swab(s) or brush (hereafter referred to as: collection device) and fits tightly into the top plastic part. The CULTURE-PAK™ Collection and Transport System is packaged sterile. Sterilization is conducted at SteriGenics, International, Inc., and validated by North American Science Associates, Inc. for both devices.

The methods for use are the same for the CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K936078) and (K932337/S1), CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, K964637, and CULTURE-PAK™ Collection and Transport System, Clinical Transport Media, Cary-Blair Transport Media option. The two plastic parts are pulled apart, exposing the swab(s). After the culture is collected, the bottom is refitted into the top. The media seal is broken and the fluid is forced into the bottom extrusion to keep the collection device moist for up to 72 hours at room temperature.

The primary differences between Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System with Modified Stuart's Transport Media, Modified Amies Media and the CULTURE-PAK™ Collection and Transport System, Clinical Transport Media, Cary-Blair Transport Media, are (1) the media options available, and (2) the addition of a dropper tip configuration. The CULTURE-PAK™ has a plastic plug that holds the media in the top part of the device. The top is bent 45° to break the plug allowing the media to flow into the bottom. The CULTURE-PAK™ Collection and Transport System, Clinical Transport Media will also be available with an aluminum shaft Rayon® Mini-Tip rayon swab.

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510(k) Notification • 12 February, 1997

Medical Packaging Corporation

CULTURE-PAK™ Collection and Transport System

with Clinical Transport Media

(Cary-Blair Transport Media Option)

All used materials should be treated as potentially infectious and biohazardous. Proper handling and disposal methods should be employed.

Patricia V. Willis
Director, Customer Service and Regulatory Affairs
Date: 12 February 1997

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