Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory. In the laboratory, ESwab specimens are processed using standard clinical laboratory operating procedures for bacterial culture.

Device Description

Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is supplied in a collection kit format. Each collection kit consists of a sterile package containing a plastic screw-cap tube with conical shaped bottom filled with 1 ml of Liquid Amies transport medium and a small sterile peel pouch containing one of two sizes of a specimen collection swab that has a tip flocked with soft nylon fiber.

The Liquid Amies transport medium is a maintenance medium comprising inorganic phosphate buffer, calcium and magnesium salts and sodium chloride with a reduced environment due to the presence of sodium thioglycollate. The medium is designed to maintain the viability of aerobic bacteria, anaerobic bacteria and fastidious bacteria such as Neisseria gonorrhoeae during transit to the testing laboratory.

The nylon flocked specimen collection swabs provided with the Copan ESwab Collection and Transport System have a solid plastic shaft with a molded breakpoint site. Copan ESwab Collection and Transport System kits are available with two different size nylon flocked swab options to facilitate the collection of specimens from various sites on a patient.

AI/ML Overview

The provided text describes the 510(k) summary for the Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System. This document focuses on demonstrating substantial equivalence to predicate devices and does not detail specific acceptance criteria or a comprehensive study report in the way typically expected for a medical device with quantifiable performance metrics like accuracy, sensitivity, or specificity.

Instead, the performance testing described is focused on the ability of the product to maintain the viability of bacterial strains. As such, the information you've requested regarding specific acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies is not explicitly present in the provided text.

However, I can extract the information that is available and indicate where details are missing based on your request.

Summary of Device Performance and Study (Based on Provided Text):

The Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System underwent performance testing to evaluate its ability to maintain the viability of various aerobic, anaerobic, and fastidious bacteria during storage and use, in comparison to predicate devices. Stability testing was also performed to support its 15-month expiration date.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from text)	Reported Device Performance (Summary)
Maintain viability of aerobic bacteria during storage and use.	Studies were conducted to determine the ability of the ESwab to maintain viability of various strains of aerobic bacteria. (Specific quantitative results not provided).
Maintain viability of anaerobic bacteria during storage and use.	Studies were conducted to determine the ability of the ESwab to maintain viability of various strains of anaerobic bacteria. (Specific quantitative results not provided).
Maintain viability of fastidious bacteria (e.g., Neisseria gonorrhoeae) during storage and use.	Studies were conducted to determine the ability of the ESwab to maintain viability of various strains of fastidious bacteria, specifying Neisseria gonorrhoeae. (Specific quantitative results not provided).
Support a 15-month expiration date.	Stability testing was performed on aged Copan ESwab products to support the 15-month expiration date. (Specific results not provided).

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text. The text mentions "various strains of aerobic, anaerobic and fastidious bacteria" but does not give a number of strains, replicates, or overall sample size for the viability studies.
Data Provenance: Not specified. It can be inferred that the testing was conducted by Copan Diagnostics Inc., as they are the sponsor. The country of origin of the data (e.g., in-house lab, external lab, specific geographic location) and whether it was retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable/Not specified. For this type of device (collection and transport system for bacterial viability), "ground truth" is typically established through laboratory culture and viability assessment, not through expert consensus on medical images or diagnoses.
Qualifications of Experts: Not applicable/Not specified, as expert consensus is not the stated method for ground truth. The studies relied on laboratory methods for assessing bacterial viability.

4. Adjudication method for the test set

Adjudication Method: Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically used when subjective assessments by multiple experts are being reconciled, such as in image interpretation. For bacterial viability studies, objective laboratory measurements are generally used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers (e.g., radiologists interpreting images). The Copan ESwab system is a physical medical device for specimen collection and transport, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: No, this is not an algorithm, so a standalone algorithm performance study is not applicable. The device's performance is tested on its ability to maintain bacterial viability as a physical system.

7. The type of ground truth used

Type of Ground Truth: The ground truth for the performance studies would be the documented presence and viability (e.g., colony-forming units or other microbiological growth metrics) of specific strains of aerobic, anaerobic, and fastidious bacteria at different time points, as determined by standard laboratory culture techniques.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not specified. This device is not an AI algorithm that requires a "training set." The performance studies described are for validation, not training.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

Summary

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K061301

510(k) Summary for Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System

1. SPONSOR

JUN 2 3 2006

Copan Diagnostics Inc. 2175 Sampson Avenue, Suite 124 Corona, CA 92879

Contact Person: Norman Sharples Telephone: 800-216-4016

Date Prepared: May 8, 2006

2. DEVICE NAME

Proprietary Name: Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System Common/Usual Name: Transport Culture Medium Devices Classification Name: Transport Culture Medium Devices

3. PREDICATE DEVICES

BBL™ Port-A-Cul™ Specimen Collection and Transport Products . (Port-A-Cul™) Becton, Dickinson and Company K854986
Copan . Venturi Transystem® Amies Medium Without Charcoal (Venturi Transystem®) Copan Diagnostics Inc. K972448 and K946287

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4. DEVICE DESCRIPTION

ട. INTENDED USE

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Copan ESwab products are substantially equivalent to the predicate transport culture medium devices. The Copan ESwab products and the predicate devices are similar in intended use and overall function.

The proposed and predicate devices are single-use products intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria. Both the Copan ESwab and the predicate devices are offered in collection kit formats with specimen collection swab options.

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7. PERFORMANCE TESTING

Studies were conducted to evaluate the performance characteristics of the Copan ESwab System components as well as the complete ESwab collection kit formats. Recovery studies were performed using the Copan ESwab and the predicate devices to determine the ability of the products to maintain viability of various strains of aerobic, anaerobic and fastidious bacteria during storage and use. Stability testing was performed on aged Copan ESwab products to support the 15month expiration date.

Copan Diagnostics Inc. 510(k) May 8, 2006 Copan ESwab Collection and Transport System

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 3 2006

Copan Diagnostics, Inc. c/o Ms. Cynthia A. Sinclair, RAC Principal Consultant, Regulatory Services Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K061301

Trade/Device Name: Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System Regulation Number: 21 CFR§866.2900 Regulation Name: Microbiological specimen collection and transport device Regulatory Class: Class I Product Code: JTW. JTX Dated: May 8, 2006 Received: May 10, 2006

Dear Ms. Sinclair:

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, Or to 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 drive, 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 (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours.

Sally a Form

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

KO 61301 510(k) Number (if known):

Copan Liquid Amies Elution Swab (ESwab) Collection and Transport Device Name: System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR '

Over-the-Counter Use (21 CFR 807 Subpart C) ﺗ

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Ferdinande Parke

Division Sign-Off

Office of In Vit-o Diagnostic Device Evaluation and suffity

K061301

Regulation Number and Section

§ 866.2900 Microbiological specimen collection and transport device.

(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.