(74 days)
Not Found
No
The device is a urine collection, transport, and preservation system, which is a physical product designed to maintain specimen integrity. There is no mention of any software, algorithms, or data processing that would involve AI or ML. The performance studies focus on the biological viability and recovery of microorganisms, not on computational analysis.
No This device is intended for the collection, transport, and preservation of urine specimens for diagnostic purposes, not for treating a disease or condition.
No
Explanation: This device is a urine collection, transport, and preservation system, intended to maintain the integrity of urine specimens for later processing in a laboratory. It does not perform any diagnostic function itself, such as analyzing the specimen or providing a diagnosis.
No
The device description clearly outlines physical components (tube, cap, plastic stick, sponges) and their function in collecting, transporting, and preserving urine specimens. There is no mention of software as a component of this device.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "collection, transport and preservation of urine specimens from the collection site to the testing laboratory" and that these specimens are "processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts." This clearly indicates that the device is intended to be used in vitro (outside the body) for diagnostic purposes (identifying uropathogenic bacteria and yeasts).
- Device Description: While the description focuses on the physical components, the mention of "preservative substances" within the sponges further supports its role in maintaining the integrity of the specimen for subsequent laboratory testing.
- Performance Studies: The detailed description of performance studies involving spiking urine with microorganisms and evaluating recovery and viability directly relates to the device's function in supporting in vitro diagnostic testing.
- Predicate Device: The mention of a predicate device (K024240; BD Vacutainer Plus Plastic Urine C&S Tube & Kits) which is also a urine collection and transport system for culture and sensitivity testing, strongly suggests that this type of device is classified as an IVD.
Therefore, the Copan UriSwab™ - Urine Collection, Transport and Preservation System fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Copan UriSwab™ - Urine Collection, Transport and Preservation System is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. UriSwab™ specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.
Product codes (comma separated list FDA assigned to the subject device)
JSM, LIO
Device Description
Copan's UriSwab™ - Urine Collection, Transport and Preservation System (UriSwabTM) consists of screw cap self-standing tube with conical shaped bottom. Inside the tube, the cap holds a plastic stick with sponges made of hydrophilic polyurethane. The sponges incorporate preservative substances. Two types of collection systems are available: the regular size (100 mm length X 16 mm diameter) plastic tube and the mini size (80 mm length x 12 mm diameter) plastic tube.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed for the suitability of UriSwab™ as sampling and transport system for microbiological specimen using procedures outlined in the Clinical Laboratory Standard Institute (CLSI) M40-A2, "Quality Control of Microbiological Transport Systems". Viability and recovery testing was performed with recommendation from M40-A2, ATCC® cultures of potential urinary tract pathogens including Candida albicans, Escherichia coli, Enterococcus faecalis, Pseudomonas aeruginosa, Proteus mirabilis and Staphylococcus saprophyticus, as well as other relevant urinary track pathogens, were used to spike sterile synthetic urine to 10^2, 10^3 and 10^4 CFU/ml. All analyses were performed in triplicate using UriSwab™ tests stored at room temperature and refrigerated temperature.
Additional testing was performed to verify the release of organisms present in the urine sample using the centrifugation and manual method described in the UriSwab™ package insert. The test was conducted on a selection of microorganisms among those recommended in the CLSI M40-A2 "Quality Control of Microbiological Transport Systems". Candida albicans, Escherichia coli and Staphylococcus saprophyticus were used to spike sterile synthetic urine to 10^2, 10^3 and 10^4 CFU/ml and inoculate the UriSwab™. Spiked urine specimens in UriSwab™ stored at room temperature and refrigerated temperature were extracted using centrifugation and the manual method after 24 and 48 hours. The concentration of microorganisms extracted from UriSwab™ using each method was compared to the initial spiked synthetic urine for three production lots.
To verify that incomplete saturation of the sponges does not cause any toxic effect on the urine flora, a study was conducted on a selection of microorganisms among those recommended in the CLSI M40-A2. Specifically, the ability of UriSwab™ to maintain the initial concentration was verified in case of non-saturated sponges for three production lots spiked with Escherichia coli, Pseudomonas aeruginosa and Proteus mirabilis in filtered synthetic urine after storage at room temperature for up to 48 hours.
Key Results: UriSwab™ fulfills the requirements set in the CLSI standard M40-A2, "Quality Control of Microbiological Transport Systems" demonstrating that the recovered organisms are within +/- 1 log from the original spiked concentration is considered acceptable performance, even in case of partial saturation and using both centrifugation and manual extraction. The data provided shows that acceptable performance was demonstrated for all organisms tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 866.2390 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 23, 2018
Copan Italia S.p.A. % Melissa Traylor, Consultant 4133 Mayfield Street Santa Maria, California 93455
Re: K180052
Trade/Device Name: UriSwab-Urine Collection, Transport and Preservation System Regulation Number: 21 CFR 866,2390 Regulation Name: Transport culture medium Regulatory Class: Class I Product Code: JSM, LIO Dated: November 28, 2017 Received: January 8, 2018
Dear Melissa Traylor:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S
For
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180052
Device Name
UriSwab™ - Urine Collection, Transport and Preservation System
Indications for Use (Describe)
Copan UriSwab™ - Urine Collection, Transport and Preservation System is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. Un'iSwab™ specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and veasts.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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3
510(K) SUMMARY
I. SUBMITTER
| Applicant Name: | Copan Italia S.p.A.
Via F. Perotti 10
25125 Brescia, Italy |
|------------------------------------|-------------------------------------------------------------------------|
| Contact Person: | Melissa M. Traylor
4133 Mayfield Street
Santa Maria, CA 93455 USA |
| Telephone: | 805.878.8042 |
| Establishment Registration Number: | 3002444944 |
| Date Prepared: | November 28, 2017 |
II. DEVICE - CLASSIFICATION
| Proprietary Name | UriSwab™ - Urine Collection, Transport and
Preservation System |
|-----------------------|-------------------------------------------------------------------|
| Common/Usual Name | UriSwab™ |
| Device | Culture Media, Non-Propagating Transport |
| Classification Number | 21 CFR 866.2390, Transport Culture
Medium |
| Product Code | JSM, LIO |
| Device Class | Class I |
| Review Panel | Microbiology |
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III. PREDICATE DEVICE – CLASSIFICATION
| Device Name | BD Vacutainer Plus Plastic Urine C&S Tube
& Kits |
|-----------------------|-----------------------------------------------------|
| 510(k) Number | K024240 |
| Device | Culture Media, Non-Propagating Transport |
| Classification Number | 21 CFR 866.2390, Transport Culture
Medium |
| Product Code | JSM |
| Device Class | Class I |
| Review Panel | Microbiology |
IV.DEVICE DESCRIPTION
Copan's UriSwab™ - Urine Collection, Transport and Preservation System (UriSwabTM) consists of screw cap self-standing tube with conical shaped bottom. Inside the tube, the cap holds a plastic stick with sponges made of hydrophilic polyurethane. The sponges incorporate preservative substances. Two types of collection systems are available: the regular size (100 mm length X 16 mm diameter) plastic tube and the mini size (80 mm length x 12 mm diameter) plastic tube.
V.INDICATION FOR USE
Copan UriSwab™ - Urine Collection, Transport and Preservation System is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. In the laboratory, UriSwab™ specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.
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VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Microbial quantification of clean-voided midstream collected urine is widely used to evaluate urinary tract infections. The maintenance of the bacterial and yeast load in urine samples depends on many factors including the type and concentration of the microorganisms, duration of transport and storage temperature.
Copan UriSwab™ is substantially equivalent to the predicate device, BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tube (BD Vacutainer™ PLUS).
- UriSwabTM and the predicate device, BD Vacutainer™ PLUS, are similar in intended use and overall function. Both are for single and professional use only. UriSwab™ is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. In the laboratory, urine specimens transported/maintained in UriSwab™ are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts. BD Vacutainer™ PLUS is intended for the collection and transport of urine samples for culture and sensitivity testing of bacteria.
- UriSwabTM and the predicate device, BD Vacutainer™ PLUS, incorporate preservative substances in a sterile tube that is suitable for transport of urine specimens. UriSwab™ incorporates a urine maintenance formula onto applicator sponges within a conical bottom, screw-cap tube, which maintains the bacterial and yeast load during transport for up to 48 hours at 2-25 ℃. The BD Vacutainer™ PLUS tube contains a lyophilized urine maintenance formula and is evacuated to draw approximately 4 - 10 ml (depending on the tube size) of urine. The lyophilized maintenance formula is reconstituted by the urine specimen drawn and maintains the bacterial load in the specimen when held at room temperature for a period of 48 hours.
See Table 1: Side-by-Side Comparison of Copan UriSwab™ - Urine Collection, Transport and Preservation System and Predicate Device
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VII. PERFORMANCE DATA
Testing was performed for the suitability of UriSwab™ as sampling and transport system for microbiological specimen using procedures outlined in the Clinical Laboratory Standard Institute (CLSI) M40-A2, "Quality Control of Microbiological Transport Systems". Viability and recovery testing was performed with recommendation from M40-A2, ATCC® cultures of potential urinary tract pathogens including Candida albicans, Escherichia coli, Enterococcus faecalis, Pseudomonas aeruginosa, Proteus mirabilis and Staphylococcus saprophyticus, as well as other relevant urinary track pathogens, were used to spike sterile synthetic urine to 102, 103 and 104 CFU/ml. All analyses were performed in triplicate using UriSwab™ tests stored at room temperature and refrigerated temperature.
Additional testing was performed to verify the release of organisms present in the urine sample using the centrifugation and manual method described in the UriSwab™ package insert. The test was conducted on a selection of microorganisms among those recommended in the CLSI M40-A2 "Quality Control of Microbiological Transport Systems". Candida albicans, Escherichia coli and Staphylococcus saprophyticus were used to spike sterile synthetic urine to 102, 103 and 104 CFU/ml and inoculate the UriSwab™. Spiked urine specimens in UriSwab™ stored at room temperature and refrigerated temperature were extracted using centrifugation and the manual method after 24 and 48 hours. The concentration of microorganisms extracted from UriSwab™ using each method was compared to the initial spiked synthetic urine for three production lots.
To verify that incomplete saturation of the sponges does not cause any toxic effect on the urine flora, a study was conducted on a selection of microorganisms among those recommended in the CLSI M40-A2. Specifically, the ability of UriSwab™ to maintain the initial concentration was verified in case of non-saturated sponges for three production lots spiked with Escherichia coli, Pseudomonas aeruginosa and Proteus mirabilis in filtered synthetic urine after storage at room temperature for up to 48 hours.
VIII.CONCLUSIONS
UriSwab™ fulfills the requirements set in the CLSI standard M40-A2, "Quality Control of Microbiological Transport Systems" demonstrating that the recovered organisms are within +/- 1 log from the original spiked concentration is considered acceptable performance, even in case of partial saturation and using both centrifugation and manual extraction. The data provided shows that acceptable performance was demonstrated for all organisms tested.
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| Table 1: Side-by-Side Comparison of Copan UriSwabTM and Predicate Device. | ||||||
|---|---|---|---|---|---|---|
| Characteristics | Copan UriSwab™-Urine Collection, Transport
and Preservation System | BD Vacutainer Plus Plastic Urine C&S
Tube |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Status | Proposed Device | K024240 |
| Product Code | JSM, LIO | JSM |
| Intended Use | Copan UriSwab™ - Urine Collection,
Transport and Preservation System is intended
for the collection, transport and preservation
of urine specimens from the collection site to
the testing laboratory. In the laboratory,
UriSwab™ specimens are processed using
standard clinical laboratory operating
procedures for the cultivation of
uropathogenic bacteria and yeasts. | The BD Vacutainer™ PLUS Plastic Urine
C&S Preservative Tubes and Kits are
intended for the collection and transport of
urine samples for culture and sensitivity
testing of bacteria. |
| Single use device | Yes. | Same. |
| Device Storage
Temperature | 2-25 °C | 4-25 °C |
| Inoculated Device
Temperature | 2-25 °C | 20-25 °C |
| Urine Specimen
Stability at Room
Temperature | Up to 48 hours. | Same. |
| Sterile | Yes. | Same. |
| Tube | Plastic. | Same. |
| Additives | Boric acid, sodium formate. | Boric acid, sodium formate and sodium
borate. |
| Collection device | Plastic stick with sponge. | Plastic holder plus needle. |