The Starswab Multitrans Collection and Transport System (Cat. No. S160) is intended for the collection and transportation of Chlamydia, Mycoplasmas and viruses obtained from clinical specimens.

Device Description

Starswab Multitrans Collection and Transport System provides a safe and convenient way to collect and transport clinical specimens without leakage under optimum storage conditions. The osmotically balanced buffered medium will maintain the viability of viral, chlamydia and mycoplasma specimens during transportation to the laboratory. Antibiotics are incorporated into the medium to inhibit growth of competing bacteria and yeast. The addition of serum albumin provides a stabilizing effect. The high concentration of sucrose aids in the preservation of viruses and chlamydia if the specimens are frozen (-70℃) for prolonged storage.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Starswab Multitrans Collection and Transport System, focusing on a change in the recommended storage condition. It does not contain information about a study proving the device meets specific performance criteria with detailed metrics like sensitivity, specificity, or reader performance.

However, based on the information provided, we can infer some details related to the "study" mentioned for the change in storage conditions.

Here's a breakdown of what can be extracted and what is not available in the given text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Maintain viability of viral, chlamydia, and mycoplasma specimens during transportation and storage under new conditions (2-25°C).	"Performance characteristics of the product held under new storage conditions is not compromised."
Inhibition of competing bacteria and yeast by incorporated antibiotics.	Not explicitly stated but implied to be maintained if performance is "not compromised."
Preservation of viruses and chlamydia during prolonged frozen storage (-70°C) with sucrose.	Not explicitly stated but implied to be maintained if performance is "not compromised."

Explanation: The document does not provide specific quantitative acceptance criteria (e.g., "X% viability of viral load"). Instead, the "acceptance criterion" is implicitly that the device's performance under the new storage conditions (2-25°C) should be equivalent to its performance under the old conditions (2-8°C). The reported performance is a qualitative statement that this was met.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified.
Data Provenance: The "Clinical evaluation has been carried out by the Ontario Provincial Public Health Laboratory." This suggests the data is likely from Canada. The document does not explicitly state if it was retrospective or prospective, but clinical evaluation often implies prospective testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The Ontario Provincial Public Health Laboratory would imply trained laboratory professionals, but specific qualifications (e.g., virologists, microbiologists, years of experience) are not detailed.

4. Adjudication Method for the Test Set

Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study is not indicated or described. The evaluation focuses on the device's performance rather than human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No, a standalone algorithm performance study is not indicated. This device is a physical transport system, not an AI algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: The context suggests that the ground truth would have been based on established laboratory methods for detecting and quantifying viable viruses, chlamydia, and mycoplasmas in clinical specimens. This would likely involve viability assays, culture methods, and potentially molecular diagnostics to confirm the presence and viability of the target organisms after transport and storage.

8. Sample Size for the Training Set

Not applicable. This device is a physical transport system, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm.

Summary of Device Performance Study (as described for the storage condition change):

Study Goal: To ensure the performance characteristics of the Starswab Multitrans Collection and Transport System are not compromised when the recommended storage condition prior to use is changed from 2-8°C to 2-25°C.
Study Conducted By: Ontario Provincial Public Health Laboratory.
Outcome: "Clinical evaluation has been carried out... to ensure performance characteristics of the product held under new storage conditions is not compromised." This is a qualitative statement indicating that the device met its implied performance criteria under the extended storage temperature range. Specific quantitative data, sample sizes, and detailed methodology are not provided in this 510(k) summary.

Summary

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AUG 1 3 2003

510(k) SUMMARY

Starplex Scientific Inc. Sponsor: 50 Steinway Blvd. Etobicoke, Ontario, Canada M9W 6Y3

Sponsor Contact: Mehdi Karamchi, Director, QA/Regulatory Affairs Tel: 416-674-7474 ext. 3018 Fax: 416-674-6067 Email: mkaramch(@starplexscientific.com

Date Prepared: July 17, 2003

Device Classification Name

Transport System Aerobic

Common Name

Sterile swab culture collection and transport system for virus, chlamydia and mycoplasma.

Proprietory Name

Multitrans Culture Collection and Transport System

Legally marketed device. Multitrans (code S160) Docket # K962843

Device Description

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Statement of Intended Use

Multitrans is intended for the collection and transportation of viruses, chlamydia and mycoplasmas obtained from clinical specimens.

Description of Change

The recommended storage condition prior to use has been changed from 2-8°C to 2-25°C.

Summary of Performance Data

Clinical evaluation has been carried out by the Ontario Provincial Public Health Laboratory to ensure performance characteristics of the product held under new storage conditions is not compromised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The symbol in the center consists of three curved lines that resemble a stylized bird or abstract design. The text around the perimeter is partially obscured but appears to be related to health and human services.

AUG 1 3 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mehdi Karamchi, B.Sc. RM (CCM) Director, QA/Regulatory Starplex Scientific Inc. 50 Steinway Boulevard, Etobicoke Ontario, CANADA M9W 6Y3

K032246 Re:

Trade/Device Name: Starswab Multitrans Collection and Transport System (Cat. No. S160) Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I Product Code: JSM Dated: July 17, 2003 Received: July 24, 2003

Dear Mr. Karamchi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K032246 510(k) Number:

Device Name:

Starswab Multitrans Collection and Transport System (Cat. No. $160)

Indications of Use:

The Starswab Multitrans Collection and Transport System (Cat. No. S160) is intended for the collection and transportation of Chlamydia, Mycoplasmas and viruses obtained from clinical specimens.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Sall, aHtyr 8/12/03.
K032246

Prescription Use Division Sign-Off
(Per 21 CFR 801.109)
OR
Office of In Vitro Diagnos.
Evaluation and Safety
Over-The-Counter Use __
510(k) K032246

Regulation Number and Section

§ 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).