(34 days)
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No
The device description focuses on the physical components and intended use for specimen collection and transport, with no mention of AI or ML capabilities.
No
Explanation: The device is described as a "disposable, sterile culture collection device for use in the collection, preservation, and transportation of microbiological specimens." It does not provide any treatment or therapy.
No
The device is a collection and transport system for microbiological specimens, not a diagnostic device itself. It is used to preserve and transport samples for later analysis.
No
The device description clearly outlines physical components (plastic parts, swabs, transport media) and sterilization processes, indicating it is a hardware-based medical device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "collection, preservation, and transportation of microbiological specimens." This is a key function in the process of performing in vitro diagnostic tests to identify microorganisms.
- Device Description: The device contains "clinical transport media" and is designed to collect and transport specimens for microbiological analysis. This media is crucial for maintaining the viability of microorganisms for subsequent testing in a laboratory setting.
- Predicate Devices: The predicate devices listed are also culture collection and transport systems, which are commonly classified as IVDs.
While the device itself doesn't perform the diagnostic test, it is an essential component in the in vitro diagnostic process by providing the means to collect and transport the specimen to the laboratory where the diagnostic testing will be performed.
N/A
Intended Use / 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.
Product codes
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Device Description
The CULTURE-PAK™ Collection and Transport System is composed of two plastic parts. The top plastic part holds 0.4 mL of clinical transport media and a plastic shaft, Rayon® tipped swab. The configuration 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 (referred to as: collection device) and fits tightly into the top plastic part. The CULTURE-PAK™ Collection and Transport System is packaged sterile. 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.2390 Transport culture medium.
(a)
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.(b)
Classification. Class I (general controls).
0
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 2 4 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.
1
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 ﺘﻪ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ 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.
2
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.
(Daniel V. Lewis Date: 12 FEBRUARY 1997
Patricia V. Willis Director, Customer Service and Regulatory Affairs