The Copan Venturi Transystem Amies Medium With Charcoal products are sterile, singleuse specimen collection chambers intended to preserve the viability of microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of clinical specimens for bacteriological examination. Copan Venturi Transystem Amies Medium With Charcoal is designed to support the viability of a wide variety of clinically important aerobic and anaerobic bacteria.

Device Description

The Copan Venturi Transystem Amies Medium With Charcoal products are comprised of a sterile peel pouch containing a swab applicator and a tube containing the Amies Transport Medium With Charcoal and are offered in six models. The only difference in the six models is the type of applicator used for the collection of the bacteriological sample. The applicator shafts vary for facilitation of the collection of the specimen from various sites of the patient. The six types of Copan Venturi Transystem Amies Medium With Charcoal products are:

Product Code 114C with plastic applicator .
Product Code 136C with two plastic applicators .
Product Code 116C with regular aluminum applicator .
Product Code 125C with soft aluminum applicator .
Product Code 129C with slim paper applicator .
Product Code 192C with flexible twisted wire applicator .

AI/ML Overview

The provided document is a 510(k) summary for the Copan Venturi Transystem Amies Medium With Charcoal, a specimen collection and transport system. It is a premarket notification for a Class I medical device, which generally means it's considered low-risk and doesn't require extensive clinical trials like higher-risk devices.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or provide specific numerical performance metrics. Instead, it refers to "acceptable performance." This is common for Class I devices and 510(k) submissions where the focus is on substantial equivalence to predicate devices rather than proving specific performance against predefined thresholds.

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Maintain viability of anaerobic bacteria during storage and use	"The results of this testing demonstrated acceptable performance of the proposed device under the intended conditions of use."
Ability of packaging to retard oxygen penetration	"The results of this testing demonstrated acceptable performance of the proposed device under the intended conditions of use."
Substantially equivalent to predicate devices in design and function	"The Copan Venturi Transystem Amies Medium With Charcoal products and the substantially equivalent products are all sterile, single-use devices intended for use in collection, transport and preservation of clinical specimens for bacteriological examination. The proposed and predicate devices are equivalent in design and function..."

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

Sample Size: The document does not specify exact sample sizes for the "recovery studies" or "additional studies" performed. It only mentions "Studies were conducted to evaluate the performance characteristics."
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission from a US-based company (Copan Diagnostics Inc., Corona, CA), it's highly probable the studies were conducted in the US. The timeframe suggests they would have been prospective studies specifically designed for regulatory submission, rather than retrospective analysis of existing data.

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

This type of information is not applicable to this device and the context of its 510(k) submission. Ground truth established by medical experts (e.g., radiologists) is typically relevant for interpretative diagnostic devices (e.g., AI for medical imaging), not for specimen collection and transport systems where a definitive microbiological culture or molecular diagnostic result would serve as the "truth." The studies would have focused on the viability of microbial samples, not on expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpretive tasks, which is not the nature of the performance testing described for this device.

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

An MRMC comparative effectiveness study is not applicable to this device. These studies are conducted for devices, particularly AI-driven ones, that assist human readers in making diagnoses (e.g., medical imaging interpretation). The Copan Venturi Transystem is a physical device for specimen collection and transport, not an interpretive aid. Therefore, there is no "human reader improvement with AI vs without AI assistance" to measure.

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

This information is not applicable as the device is a physical specimen collection system and not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document implies that the ground truth for performance evaluation would be based on microbiological viability (e.g., culture growth) outcomes. For example, "Recovery studies were performed... to determine the ability of the products to maintain viability of anaerobic bacteria." The "truth" would be whether the bacteria remained viable to allow for subsequent laboratory examination and identification.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical collection and transport system, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

Summary

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KCn2449

AUG 20 11:97

APPENDIX F

510(k) Summary

Copan Diagnostics Inc. Amies Medium With Charcoal 510(k)

6/27/97

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510(k) Summary for Copan Venturi Transystem Amies Medium With Charcoal

Applicant 1.

Copan Diagnostics Inc. 2175 Sampson Avenue Suite 124 Corona, CA 91719

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

Date Prepared: June 27, 1997

Device Name 2.

Copan Venturi Transystem Amies Medium With Charcoal Proprietary Name: Common/Usual Name: Specimen Collection and Transport System Microbiological Specimen Collection and Transport Device Classification Name:

Classification Status: Class I

Predicate Devices 3.

Starswab Culture Collection and Transport System . Starplex Scientific K960997
Port-A-Cul Specimen Collection and Transport Products . Becton Dickinson K854986

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Device Description 4.

Product Code 114C with plastic applicator .
Product Code 136C with two plastic applicators .
Product Code 116C with regular aluminum applicator .
Product Code 125C with soft aluminum applicator .
Product Code 129C with slim paper applicator .
Product Code 192C with flexible twisted wire applicator .

Intended Use 5.

The Copan Venturi Transystem Amies Medium With Charcoal products are sterile, single-use specimen collection chambers intended to preserve the viability of microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of clinical specimens for bacteriological examination. Copan Venturi Transystem Amies Medium With Charcoal is designed to support the viability of a wide variety of clinically important aerobic and anaerobic bacteria.

Technological Characteristics 6.

The Copan Venturi Transystem Amies Medium With Charcoal Products are substantially equivalent in design, intended use, and overall function to the predicate devices identified above.

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The Copan Venturi Transystem Amies With Charcoal products and the substantially equivalent products are all sterile, single-use devices intended for use in collection, transport and preservation of clinical specimens for bacteriological examination. The proposed and predicate devices are equivalent in design and function in that single or double swab applicators are used for collection of the specimen, different types of applicator shafts are available, and color-coded caps are used for ease of product recognition. The Copan and Starplex devices are also similar in that they incorporate design features intended to enhance the viability of anaerobic bacteria.

7. Performance Testing

Studies were conducted to evaluate the performance characteristics of the Copan Venturi Transystem Amies Medium With Charcoal products. Recovery studies were performed using Copan and comparative products to determine the ability of the products to maintain viability of anaerobic bacteria during storage and use. Additional studies were performed to determine the ability of the packaging to retard oxygen penetration over the shelf life of the Copan products. The results of this testing demonstrated acceptable performance of the proposed device under the intended conditions of use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a globe, suggesting the department's mission of protecting and promoting the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Copan Diagnostics, Inc. c/o Medical Device Consultants, Inc. Atten: Cynthia A. Sinclair, RAC -Senior Staff Consultant 49 Plain Street

AUG 20 1997

North Attleboro, Massachusetts 02760

K972449 Re: Trade Name: Copan Venturi Transystem Amies Medium with Charcoal Regulatory Class: I Product Code: JSL Dated: June 27, 1997

Received: June 30, 1997

Dear Ms. Sinclair:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Pari 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Copan Venturi Transystem Amies Medium With Charcoal

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhieme Hurvitz, for Arlen Penhos
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K972449

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Copan Diagnostics Inc. Amies Medium With Charcoal 510(k)

6/27/97

Page v

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).