The Copan Easy-Swab Collection and Transport System products are sterile, single-use specimen collection chambers intended to preserve the viability of aerobic 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 aerobic clinical specimens for bacteriological examination. The Copan Easy-Swab Collection and Transport System products are designed to support the viability of a wide variety of clinically important aerobic bacteria.

Device Description

The Copan Easy-Swab is offered in two configurations. The Copan Easy-Swab I is offered with a single swab applicator and the Copan Easy-Swab II is offered with two swab applicators. The Copan Easy-Swab is composed of a sterile peel pouch containing one or two swab applicators inside the transport tube. The swab applicator incorporates a polyurethane foam tip on a plastic shaft secured to a cap. The tube is manufactured from polypropylene.

To use the Copan Easy-Swab Collection and Transport System, the sterile peel pouch is opened and discarded. The applicator swab is removed from the tube and used to collect the clinical specimen. During specimen collection, the applicator tip should only touch the area where the infection is suspected. The applicator swab is returned to the transport tube, the cap firmly closed, and the specimen sent to the laboratory for analysis. After use, the tubes and swabs must be disposed of according to hospital or laboratory procedures for infectious waste.

AI/ML Overview

Here's an analysis of the provided text regarding the Copan Easy-Swab Collection and Transport System, focusing on the acceptance criteria and the study that proves the device meets them:

Overall Assessment:

The provided document (K993161) is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with strict acceptance criteria for novel performance claims. Therefore, many of the requested elements (like specific effect sizes for human readers in MRMC studies, details on ground truth for training sets, etc.) are not applicable or not explicitly provided in this type of regulatory submission. The "study" here refers to performance testing to show viability and stability.

Acceptance Criteria and Device Performance:

Acceptance Criteria	Reported Device Performance
Maintenance of Viability for Aerobic Bacteria:	"All organisms tested remained viable for at least 24 hours when maintained at room temperature." (This is the primary performance claim related to the device's intended use of preserving microorganisms during transport.)
Stability/Shelf-Life:	"The test results demonstrate the stability of the Easy-Swab device over its 24-month expiration-dating period." (This confirms the device maintains its performance characteristics over its declared shelf-life.)
Substantial Equivalence to Predicate Device (Becton Dickinson Culturette EZ and Culturette EZ II):	The document asserts substantial equivalence in: DesignIntended UseOverall FunctionSterile, single-use natureCollection and preservation of aerobic specimens for bacteriological examinationDesign for single or double swab applicators inserted into an empty tubeUse of polyurethane for swab tip materialColor-coded caps

Study Details:

Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated in terms of a specific number of individual swabs or patient samples. The text mentions "a variety of aerobic organisms" were used for recovery studies.
- Data Provenance: Not specified. It's likely an in-vitro laboratory study conducted by the manufacturer (Copan Diagnostics Inc. is based in Corona, CA, USA), but this is not explicitly stated. It is a prospective study as it involves active testing of the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable / Not Provided. For a device like a specimen collection and transport system, "ground truth" would typically be established by standard microbiological culture techniques performed by trained laboratory personnel. The document does not describe the use of "experts" in the sense of clinical specialists establishing a diagnosis. The viability assessment would be based on standard lab protocols.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / None. Adjudication methods like 2+1 are typically used in studies involving subjective interpretation (e.g., imaging studies). For a device like this, performance is assessed by objective microbiological viability counts, not subjective interpretation.
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:
- Not Applicable. This is not an AI-assisted diagnostic device, nor does it involve human "readers" interpreting results in the way an MRMC study would measure. It's a collection and transport system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm. Performance is inherent to the device's ability to maintain organism viability.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Microbiological Culture Viability. The ground truth for the performance claim ("All organisms tested remained viable...") is established by standard microbiological culture methods, where the presence and growth of viable microorganisms are directly observed and quantified after the transport period. This is an objective, laboratory-based measurement.
The sample size for the training set:
- Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the computational sense.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for a machine learning model, this element is not relevant.

Summary

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K993161

510(k) SUMMARY FOR COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM

1. SPONSOR

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

Contact Person:	Norman Sharples
Telephone:	1-800-216-4016

Date Prepared: September 21, 1999

2. DEVICE NAME

Proprietary Name:	Copan Easy-Swab Collection and Transport System
Common/Usual Name:	Specimen Collection and Transport System
Classification Name:	Microbiological Specimen Collection and TransportDevice

3. PREDICATE DEVICES

Becton Dickinson Culturette EZ and Culturette EZ II Transport Products subject of K913789.

DEVICE DESCRIPTION 4.

To use the Copan Easy-Swab Collection and Transport System, the sterile peel pouch is opened and discarded. The applicator swab is removed from the tube

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During specimen collection, the and used to collect the clinical specimen. applicator tip should only touch the area where the infection is suspected. The applicator swab is returned to the transport tube, the cap firmly closed, and the specimen sent to the laboratory for analysis. After use, the tubes and swabs must be disposed of according to hospital or laboratory procedures for infectious waste.

INTENDED USE 5.

The Easy-Swab is a sterile, single-use specimen chamber intended to preserve the viability of aerobic 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 aerobic clinical specimens for bacteriological examination. The Copan Easy-Swab Collection and Transport System products are designed to support the viability of a wide variety of clinically important aerobic bacteria.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Copan Easy-Swab products are substantially equivalent in design, intended use, and overall function to other commercially distributed products used for the collection and transport of aerobic bacteria. Specifically, the Copan Easy-Swab products are substantially equivalent to the Becton Dickinson Culturette EZ and Culturette EZ II Collection and Transport System products subject of K913789.

The Copan Easy-Swab Collection and Transport System products and the substantially equivalent products are all sterile, single-use devices intended for use in the collection, transport and preservation of aerobic specimens for bacteriological examination. The Copan Easy-Swab Collection and Transport System products and the predicate devices are equivalent in design and function in that single or double swab applicators are used for collection of the specimen and the swab applicator(s) then inserted into an empty tube for transport and preservation.

Both the Copan Easy-Swab applicators and the Becton-Dickinson Culturette EZ applicators use polyurethane as the tip material. All of the products use colorcoded caps for ease in product recognition.

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7. PERFORMANCE TESTING

Studies were conducted to evaluate the performance characteristics of the Copan Easy-Swab. Recovery studies were performed using Copan and comparative products to determine the ability of the products to maintain viability of aerobic bacteria during storage and use. Recovery studies were performed using a variety of aerobic organisms. Swabs were dosed with inoculum and inserted into the transport tube. The tubes were stored at room temperature prior to sub-culturing onto appropriate media. All organisms tested remained viable for at least 24 hours when maintained at room temperature.

Stability studies were performed on the Copan Easy-Swab products to support performance for a 24-month expiration-dating period. All testing was performed at least 24 months after manufacture and gamma radiation sterilization of the finished product The test results demonstrate the stability of the Easy-Swab device over its 24-month expiration-dating period.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three overlapping wing-like shapes.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 9 1999

Copan Diagnostics, Inc. c/o Ms. Maryl McNamara-Cullinane, RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K993161 Trade Name: Copan Easy-Swab Collection and Transport System Regulatory Class: I Product Code: JTY Dated: September 21, 1999 Received: September 22, 1999

Dear Ms. Cullinane:

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 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). 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 Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 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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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 Butman

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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K993161 510(k) Number (if known):

Device Name: Copan Easy-Swab Collection and Transport System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubose

Division Sign Off Division of Clinical Laboratory Devices 510(k) Number_199316

Prescription Use _X (Per 21 CFR 801.109) OR

Over-The-Counter Use Optional Format 1-2-96

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.