(252 days)
Not Found
No
The device description and performance studies focus on the collection, transport, and preservation of bacterial specimens using a physical swab and medium, with no mention of AI or ML technologies.
No.
The device is intended for the collection, transport, and preservation of specimens, not for treating a disease or condition.
No
This device is designed for the collection, transport, and preservation of specimens for later diagnostic testing, not for performing the diagnostic test itself.
No
The device description clearly outlines physical components including a plastic tube, transport medium, and a specimen collection swab. There is no mention of software as the primary or sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for the collection, transport, and preservation of specimens for testing in the laboratory. This is a key characteristic of IVDs.
- Device Description: The description details a system designed to maintain the viability of bacteria for subsequent laboratory processing using standard clinical laboratory operating procedures for culture. This further reinforces its role in the diagnostic process.
- Performance Studies: The performance studies described focus on evaluating the ability of the system to maintain the viability of bacteria for bacterial recovery studies, which are conducted in a laboratory setting for diagnostic purposes.
- Predicate Device: The predicate device listed is a "Transystem Cary-Blair Medium," which is a known transport medium used for the collection and transport of specimens for laboratory testing, specifically for enteric pathogens.
While the device itself is a collection and transport system, its sole purpose is to facilitate in vitro diagnostic testing of the collected specimens. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
The Copan FecalSwab Collection, Transport and Preservation System is intended for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture.
Product codes
JSM, LIO
Device Description
The Copan FecalSwab Collection, Transport and Preservation System (Copan FecalSwab System) is supplied in a sterile collection kit format. Each collection kit consists of a package containing a plastic screw-cap tube with conical shaped bottom filled with 2ml of FecalSwab transport and preservation medium and a specimen collection swab that has a tip flocked with soft nylon fiber.
The FecalSwab transport and preservation medium is a maintenance medium comprised of: Chloride salts, Sodium salts, Phosphate buffer, L-Cysteine and Agar. The medium is designed to maintain the viability of enteric pathogenic bacteria during transit to the testing laboratory.
The nylon flocked specimen collection swabs provided with the Copan FecalSwab Collection, Transport and Preservation System have a solid plastic shaft with a molded breakpoint site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectal Specimen
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)
Studies were conducted to evaluate the performance characteristics of the Copan FecalSwab System components as well as the complete FecalSwab collection kit formats.
Bacterial recovery studies were performed using the Copan FecalSwab and the predicate device to determine the ability of the product to maintain viability of various strains of enteric pathogenic bacteria.
Key results include:
- Escherichia coli ATCC 25922: Tested at 2-8°C and 20-25°C. At 2-8°C, showed -0.17 log reduction at 72 hours. At 20-25°C, showed 1.73 log increase at 48 hours.
- Escherichia coli O157:H7 ATCC 700728: At 2-8°C, showed 0.06 log increase at 72 hours. At 20-25°C, showed 1.66 log increase at 48 hours.
- Salmonella typhimurium ATCC 14028: At 2-8°C, showed -0.15 log reduction at 72 hours. At 20-25°C, showed 1.85 log increase at 48 hours.
- Shigella sonnei ATCC 12022: At 2-8°C, showed -0.04 log reduction at 72 hours. At 20-25°C, showed 1.88 log increase at 48 hours.
- Clostridium difficile ATCC 9689: At 2-8°C, showed -1.85 log reduction at 48 hours. At 20-25°C, showed -1.92 log reduction at 24 hours.
- Vibrio parahaemolyticus ATCC 17802: At 2-8°C, showed -0.11 log reduction at 72 hours. At 20-25°C, showed 1.90 log increase at 48 hours.
- Enterococcus faecalis vancomycin resistant (VRE) ATCC 51299: At 2-8°C, showed -0.16 log reduction at 72 hours. At 20-25°C, showed 1.13 log increase at 48 hours.
- Yersinia enterocolitica ATCC 9610: At 2-8°C, showed -0.05 log reduction at 72 hours. At 20-25°C, showed 1.92 log increase at 48 hours.
- Campylobacter jejuni ATCC 33291: At 2-8°C, showed -0.80 log reduction at 72 hours. At 20-25°C, showed -1.70 log reduction at 48 hours.
Bacterial Recovery in Fecal Matrix:
- Escherichia coli O157:H7 ATCC 700728: At 2-8°C, showed 0.11 log increase at 72 hours. At 20-25°C, showed 1.79 log increase at 48 hours.
- Salmonella typhimurium ATCC 14028: At 2-8°C, showed 0.18 log increase at 72 hours. At 20-25°C, showed 1.83 log increase at 48 hours.
- Vibrio parahaemolyticus ATCC 17802: At 2-8°C, showed 0.09 log increase at 72 hours. At 20-25°C, showed 1.82 log increase at 48 hours.
Stability testing was performed on aged Copan FecalSwab products to support the 15-month expiration date. Additionally, the recommended sample fill line was established as well as the buffering capacity of the medium.
No clinical testing was conducted to support this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health and 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 three human profiles facing to the right, with flowing lines representing hair or other features.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2016
COPAN ITALIA S.P.A. C/O TINA WU REGULATORY PROJECT MANAGER ICON PLC 62 FOREST STREET, SUITE 300 MARLBOROUGH, MA 01752
Re: K142094
Trade/Device Name: Copan FecalSwab 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: July 30, 2014 Received: August 1, 2014
Dear Dr. Wu:
This letter corrects our substantially equivalent letter of April 10, 2015.
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
1
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
2
Indications for Use
510(k) Number (if known) K142094
Device Name
Copan FecalSwab Collection, Transport and Preservation System
Indications for Use (Describe)
The Copan FecalSwab Collection, Transport and Preservation System is intended for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture.
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 Copan FecalSwab Collection, Transport and Preservation System
1. APPLICANT/SPONSOR
Copan Italia S.p.A. Via F. Perotti 10 25125 Brescia, Italy Contact Person: Elisabetta Zanella Telephone: +39 030 2687247 Date Prepared: April 8, 2015
2. DEVICE
| Proprietary Name: | Copan FecalSwab Collection, Transport and Preservation System |
|---|---|
| Common/Usual Name: | Collection and Transport Device |
| Classification Name: | Culture Media, Non-Propagating Transport |
| Classification Panel: | Microbiology |
| Classification Regulation: | 866.2390 |
| Product Code: | JSM, LIO |
| Class: | 1 |
3. PREDICATE DEVICE
- · Copan Venturi Transystem Cary-Blair Medium K946286
4. DEVICE DESCRIPTION
The Copan FecalSwab Collection, Transport and Preservation System (Copan FecalSwab System) is supplied in a sterile collection kit format. Each collection kit consists of a package containing a plastic screw-cap tube with conical shaped bottom filled with 2ml of FecalSwab transport and preservation medium and a specimen collection swab that has a tip flocked with soft nylon fiber.
The FecalSwab transport and preservation medium is a maintenance medium comprised of: Chloride salts, Sodium salts, Phosphate buffer, L-Cysteine and Agar. The medium is designed to maintain the viability of enteric pathogenic bacteria during transit to the testing laboratory.
The nylon flocked specimen collection swabs provided with the Copan FecalSwab Collection, Transport and Preservation System have a solid plastic shaft with a molded breakpoint site.
4
5. INTENDED USE
The Copan FecalSwab Collection, Transport and Preservation System is intended for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture.
Indications for Use
The Copan FecalSwab Collection, Transport and Preservation System is intended for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE
The Copan FecalSwab System is substantially equivalent to the predicate specimen collection and transport device. The Copan FecalSwab System and the predicate device 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 enteric pathogenic bacteria. The Copan FecalSwab and Copan Venturi Transystem are both offered in collection kit format with specimen collection swab for rectal sampling. The specimen collection swab can also be used as a transferring tool for stool specimens.
| Characteristics | Copan FecalSwab Collection, Transport and
Preservation System | Copan Venturi Transystem Cary-Blair Medium
(Copan Diagnostics Inc.) |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Status | New Device | K946286 |
| Product Code | JSM, LIO | JSM |
| Intended Use | The Copan FecalSwab Collection, Transport and
Preservation System is intended for the collection of
rectal swab and fecal specimens and to preserve the
viability of enteric pathogenic bacteria during
transport from the collection site to the testing
laboratory. In the laboratory, FecalSwab specimens
are processed using standard clinical laboratory
operating procedures for culture. | The Copan Venturi Transystem Cary-Blair product is a
sterile, single use specimen collection chamber 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. |
| Anatomical Sites | Rectal Specimen | Rectal Specimen |
| Characteristics | Copan FecalSwab Collection, Transport and
Preservation System | Copan Venturi Transystem Cary-Blair Medium
(Copan Diagnostics Inc.) |
| Performance | Viability of target micro-organisms up to 48 hours at
room temperature and 72 hours at 2°C-8°C. For C.
difficile, up to 48 hours at 2 – 8 °C and up to 24 hours
at 20 – 25 °C. | Viability of target micro-organisms up to 48 hours at
room temperature |
| Microorganisms
supported | Enteric pathogenic bacteria | Enteric pathogenic bacteria |
| Microorganisms
tested | Echerichia coli
Echerichia coli O157:H7
Salmonella typhimurium
Shigella sonnei
Campylobacter jejuni
Yersinia enterocolitica
Vibrio parahaemoliticus
Enterococcus faecalis vancomycin resistant (VRE)
Clostridium difficile | Echerichia coli
Shigella flexneri
Campylobacter jejuni
Yersinia enterocolitica |
| Product
Configuration | Film-film peel-pouch containing 1 tube filled with 2
ml of liquid medium and 1 regular size flocked swab | Film-film peel-pouch containing 1 tube filled with 5 ml
of gel medium and 1 regular size rayon (viscose) swab |
| Medium
Formulation | Chloride salts
Sodium salts
Phosphate buffer
L-Cysteine
Agar
Water | Sodium Chloride
Calcium Chloride
Disodium Hydrogen Phosphate
Sodium Thioglycolate
Bacteriological Agar
Water |
| pH | 6.90 – 7.50 | 6.90-7.50 |
| Storage
Temperature | 5-25°C | 5-25°C |
| Medium Volume | 2 ml | 5 ml |
| Ratio between
sample and
elution volume | 80 mg/ml | Not Applicable |
| Container | Tube; Plastic, conical bottom | Tube; Plastic |
| Collection tool | Flocked Swab | Viscose Swab |
| Swab Tip | Flocked nylon | Viscose |
| Swab Shaft | Plastic | Plastic |
| Shelf Life | 15 months | 20 months |
| Biocompatible | Yes | Yes |
| Sterility | Gamma Radiation – SAL 10⁻⁶ | Gamma Radiation – SAL 10⁻⁶ |
Table 5-1. Side-by-Side Comparison of Copan fecalSwab Collection. Transport and Preservation System and Predicate Device
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7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
Studies were conducted to evaluate the performance characteristics of the Copan FecalSwab System components as well as the complete FecalSwab collection kit formats.
Recovery
Bacterial recovery studies were performed using the Copan FecalSwab and the predicate device to determine the ability of the product to maintain viability of various strains of enteric pathogenic bacteria.
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| AVERAGE CFU RECOVERED | T=48HRS -72 | ||||||
|---|---|---|---|---|---|---|---|
| Organism* | Holding | Time 0 | Time 6 | (N = 3 LOTS TESTED) | |||
| Time 24 | Time 48 | Time 72 | HRS | ||||
| LOG | |||||||
| Temperature | hrs | hrs | hrs | hrs | hrs | REDUCTION (- | |
| OR | |||||||
| LOG | |||||||
| INCREASE (+) | |||||||
| Escherichia coli | 2-8°C | 1.07E+02 | 1.12E+02 | 8.46E+01 | 8.31E+01 | 7.29E+01 | -0.17 |
| ATCC 25922 | 20-25°C | 1.07E+02 | 1.35E+02 | 1.32E+03 | 5.72E+03 | NA | 1.73 |
| Escherichia coli 0157:H7 | 2-8°C | 8.99E+01 | 1.01E+02 | 1.04E+02 | 1.07E+02 | 1.04E+02 | 0.06 |
| ATCC 700728 | 20-25°C | 8.99E+01 | 1.28E+02 | 2.57E+02 | 4.12E+03 | NA | 1.66 |
| Salmonella typhimurium | 2-8°C | 1.38E+02 | 1.41E+02 | 1.59E+02 | 1.58E+02 | 9.70E+01 | -0.15 |
| ATCC 14028 | 20-25°C | 1.38E+02 | 5.84E+02 | 2.27E+03 | 9.72E+03 | NA | 1.85 |
| Shigella sonnei | 2-8°C | 1.27E+02 | 1.26E+02 | 4.16E+01 | 1.46E+02 | 1.16E+02 | -0.04 |
| ATCC 12022 | 20-25°C | 1.27E+02 | 4.76E+02 | 1.91E+03 | 9.67E+03 | NA | 1.88 |
| Clostridium difficile | 2-8°C | 4.42E+01 | 2.26E+01 | 6.03E+00 | 6.30E-01 | NA | -1.85 |
| ATCC 9689 | 20-25°C | 4.42E+01 | 1.77E+01 | 5.30E-01 | NA | NA | -1.92 |
| Vibrio parahaemolyticus | 2-8°C | 2.00E+02 | 1.78E+02 | 1.76E+02 | 1.68E+02 | 1.54E+02 | -0.11 |
| ATCC 17802 | 20-25°C | 2.00E+02 | 2.22E+02 | 1.62E+03 | 1.58E+04 | NA | 1.90 |
| Enterococcus faecalis | 2-8°C | 1.68E+02 | 1.67E+02 | 1.52E+02 | 4.38E+02 | 1.16E+02 | -0.16 |
| vancomicin resistant (VRE) | 20-25°C | 1.68E+02 | 1.70E+02 | 4.39E+02 | 2.26E+03 | NA | 1.13 |
| ATCC 51299 | |||||||
| Yersinia enterocolitica | 2-8°C | 1.17E+02 | 1.14E+02 | 1.12E+02 | 1.09E+02 | 1.04E+02 | -0.05 |
| ATCC 9610 | 20-25°C | 1.17E+02 | 1.72E+02 | 1.24E+03 | 9.78E+03 | NA | 1.92 |
| Campylobacter jejuni | 2-8°C | 2.14E+02 | 1.66E+02 | 1.33E+02 | 8.63E+01 | 3.42E+01 | -0.80 |
| ATCC 33291 | 20-25°C | 2.14E+02 | 1.68E+02 | 5.83E+01 | 4.28E+00 | NA | -1.70 |
Table 5-2. Summary of Results for Bacterial Recovery in PBS
- the organism was diluted in PBS and the pure suspension tested in studies based on CLSI M40-A2.
Table 5-3. Summary of Results for Bacterial Recovery in Fecal Matrix
| Organism* | Holding
Temperature | AVERAGE CFU RECOVERED
(N = 3 LOTS TESTED) | | | | | T=48HRS -
72HRS
LOG
REDUCTION (-)
OR
LOG
INCREASE (+) |
|------------------------------------------------|------------------------|----------------------------------------------|---------------|----------------|----------------|----------------|-------------------------------------------------------------------------|
| | | Time 0
hrs | Time 6
hrs | Time 24
hrs | Time 48
hrs | Time 72
hrs | |
| Escherichia coli O157:H7
ATCC 700728 | 2-8°C | 1.23E+02 | 1.37E+02 | 1.38E+02 | 1.53E+02 | 1.60E+02 | 0.11 |
| Escherichia coli O157:H7
ATCC 700728 | 20-25°C | 1.23E+02 | 1.34E+02 | 7.48E+02 | 7.54E+03 | NA | 1.79 |
| Salmonella typhimurium
ATCC 14028 | 2-8°C | 9.46E+01 | 1.05E+02 | 1.20E+02 | 1.32E+02 | 1.43E+02 | 0.18 |
| Salmonella typhimurium
ATCC 14028 | 20-25°C | 9.46E+01 | 1.17E+02 | 6.51E+02 | 6.38E+03 | NA | 1.83 |
| Vibrio parahaemolyticus
ATCC 17802 | 2-8°C | 1.11E+02 | 1.21E+02 | 1.29E+02 | 1.26E+02 | 1.36E+02 | 0.09 |
| Vibrio parahaemolyticus
ATCC 17802 | 20-25°C | 1.11E+02 | 1.34E+02 | 1.14E+03 | 7.36E+03 | NA | 1.82 |
- the organism was diluted in fecal matrix and the suspension tested in studies based on CLSI M40-A2
Stability
Stability testing was performed on aged Copan FecalSwab products to support the 15-month expiration date. Additionally, the recommended sample fill line was established as well as the buffering capacity of the medium.
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8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical testing was conducted to support this submission.
9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed Copan FecalSwab System and the predicate lead to a conclusion of substantial equivalence between the proposed and predicate device. A side-byside comparison of the proposed device and predicate device is provided in the table at the end of this section.