(48 days)
Not Found
No
The device description and performance studies focus on the physical components and the ability to maintain bacterial viability, with no mention of AI or ML.
No
This device is for collection, transport, and preservation of specimens for bacteriological examination, not for treating a condition or disease.
No
The device is a specimen collection and transport system intended to preserve the viability of aerobic microorganisms for bacteriological examination in a laboratory. It does not perform a diagnostic function itself, but rather facilitates the diagnostic process by ensuring proper specimen preservation.
No
The device description clearly outlines physical components (swab applicator, transport tube, cap, pouch) and their materials (polyurethane foam, plastic, polypropylene). The intended use and performance studies focus on the physical collection and transport of biological specimens, not software functionality.
Based on the provided text, the Copan Easy-Swab Collection and Transport System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the devices are "intended to preserve the viability of aerobic microorganisms after their collection and during their transport from the collecting area to the laboratory" and are for the "collection, transport, and preservation of aerobic clinical specimens for bacteriological examination." This clearly indicates the device is used in vitro (outside the body) for diagnostic purposes (bacteriological examination).
- Purpose: The device's function is to facilitate the process of obtaining and transporting a biological sample for subsequent laboratory analysis to aid in diagnosis. This is a core function of IVD devices.
- Performance Studies: The document describes performance studies focused on the "recovery" and "viability" of aerobic bacteria, which are relevant to ensuring the sample is suitable for diagnostic testing.
Therefore, the Copan Easy-Swab Collection and Transport System fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JTY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 Transport |
| Device |
3. PREDICATE DEVICES
Becton Dickinson Culturette EZ and Culturette EZ II Transport Products subject of K913789.
DEVICE DESCRIPTION 4.
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
1
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:
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.
(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