CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA

K964637 · Medical Packaging Corp. · JSM · Dec 24, 1996 · Microbiology

Device Facts

• Record ID: K964637
• Device Name: CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
• Applicant: Medical Packaging Corp.
• Product Code: JSM · Microbiology
• Decision Date: Dec 24, 1996
• 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 Modified Amies Transport Media, 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 system for microbiological specimen collection and transport. Comprises two plastic parts: top section containing 0.4 mL Modified Amies transport media and collection device (Rayon-tipped swab, aluminum shaft Rayon Mini-Tip swab, or CytoSoft cytology brush); bottom section acts as protective housing. Operation: user separates parts, collects specimen, re-fits bottom into top, and bends top 45° to break internal plastic plug, releasing media into bottom chamber to maintain specimen moisture for up to 48 hours at room temperature. Used in clinical settings by healthcare professionals. Facilitates laboratory analysis by preserving specimen viability during transit.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Two-part plastic housing; Rayon-tipped swabs (plastic or aluminum shafts) or CytoSoft cytology brush; 0.4 mL Modified Amies transport media; plastic plug media release mechanism; sterile; validated sterilization process.

Indications for Use

Indicated for the collection, preservation, and transport of clinical microbiological specimens to the laboratory for analysis.

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

• Culture Collection and Transport Device (K881105)
• CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K932337/S1)
• CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K936078)

Submission Summary (Full Text)

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510(k) Notification • 17 November, 1996
Medical Packaging Corporation
CULTURE-PAK™ Collection and Transport System
with Modified Amies Media
K964637
DEC 24 1996

# 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:** 17 November, 1996

**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,
Modified Amies Transport Media

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

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

**PREDICATE DEVICE(S):**
Culture Collection and Transport Device (K881105), CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K932337/S1 and K936078)
Medical Packaging Corporation
Camarillo, CA

## Intended Use

Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Modified Amies Transport Media, 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 • 17 November, 1996

Medical Packaging Corporation

CULTURE-PAK™ Collection and Transport System

with Modified Amies Media

## Substantial Equivalence

Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, is substantially equivalent to Medical Packaging Corporation's Culture Collection and Transport Device (K881105), and CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K936078) and (K932337/S1). 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, Modified Amies 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; or a CytoSoft™ cytology brush.

- 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™ and the Culture Collection and Transport Device are 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 similar for the CULTURE-PAK™ and the Culture Collection and Transport Device. The two plastic parts are pulled apart, exposing the swab(s) or brush. 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 48 hours at room temperature.

The primary differences between Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System and the Culture Collection and Transport Device are how the media is contained, how to free the media so it will flow down into the bottom plastic part, and the provision of additional specimen collection devices as configured. The CULTURE-PAK™ has a plastic plug that holds the media in the top part. The top is bent 45° to break the plug allowing the media to flow into the bottom. The Culture Collection and Transport Device has a glass ampule that holds the media in the top plastic part. The top is squeezed to crush the ampule allowing the media to flow into the bottom. The CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media will also be available with an aluminum shaft Rayon® Mini-Tip rayon swab and a CytoSoft™ cytology brush.

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510(k) Notification • 17 November, 1996

Medical Packaging Corporation

CULTURE-PAK™ Collection and Transport System

with Modified Amies Media

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

Patricia V. Willis
Date: 11.18.96

Director, Product Management and Regulatory Affairs

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