(252 days)
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 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.
The provided document is a 510(k) premarket notification for a medical device (Copan FecalSwab Collection, Transport and Preservation System). This type of document is for regulatory approval and focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical acceptance criteria in the same way a new drug or novel medical device might through a large-scale clinical trial.
Therefore, many of the requested elements are not applicable in this context, as the study presented is a non-clinical performance study designed to show the device functions similarly to an already approved device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the performance of the predicate device and the general expectation for transport media to maintain organism viability. The study aims to demonstrate that the Copan FecalSwab performs at least as well as the predicate device in terms of bacterial viability.
| Acceptance Criteria (Implicit) | Reported Device Performance (Copan FecalSwab) |
|---|---|
| Viability of target micro-organisms: | Viability of target micro-organisms: |
| Up to 48 hours at room temperature for general enteric pathogens. | In PBS: |
| Viability of C. difficile up to 48 hours at 2-8°C. | - All tested enteric pathogens (E. coli, E. coli O157:H7, S. typhimurium, S. sonnei, V. parahaemolyticus, E. faecalis VRE, Y. enterocolitica) showed viability and/or growth (positive LOG increase) at 20-25°C after 48 hours. |
| Viability of C. difficile up to 24 hours at 20-25°C. | - Clostridium difficile ATCC 9689: |
| Viability up to 72 hours at 2-8°C for general pathogens. | - Maintained viability at 2-8°C for 48 hours (LOG reduction -1.85, still detectable viable cells). |
| - Showed a LOG reduction of -1.92 at 20-25°C after 24 hours, indicating a decrease but still viable cells were detected at time 6 hours. | |
| - All tested enteric pathogens (except C. difficile and Campylobacter jejuni) maintained viability (LOG reduction ≤ -0.17 or positive increase, with detectable CFU) at 2-8°C up to 72 hours. | |
| Performance in fecal matrix (Escherichia coli O157:H7, | In Fecal Matrix: |
| Salmonella typhimurium, Vibrio parahaemolyticus) - | - All three tested organisms (E. coli O157:H7, S. typhimurium, V. parahaemolyticus) demonstrated viability and growth (positive LOG increase) at 20-25°C after 48 hours. |
| viability maintained. | - All three organisms also maintained viability (positive LOG increase or minor LOG reduction) at 2-8°C up to 72 hours. |
"Acceptance Criteria" Explanation: For a 510(k) submission, the "acceptance criteria" for performance studies like this are typically that the new device performs at least as well as or is comparable to the predicate device. The CLSI M40-A2 guideline mentioned (which details standards for transport media) would define what constitutes acceptable recovery and viability for such devices. The positive LOG increases for many organisms suggest that the transport medium not only preserves but in some cases, may even support proliferation, which is generally acceptable as long as it doesn't lead to overgrowth that masks other pathogens. For C. difficile and C. jejuni, where there were LOG reductions, the criteria would be that a sufficient number of viable organisms remain for detection within the specified timeframe. The document states "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" as the performance characteristic of the FecalSwab, implying these were the targets to be met to demonstrate equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The tables indicate "N = 3 LOTS TESTED" for all bacterial recovery experiments. This refers to 3 different manufacturing lots of the Copan FecalSwab device being tested. For each organism and condition (temperature/time point), there would have been multiple replicates per lot.
- Data Provenance: The study is non-clinical (laboratory-based). The organisms used are specific ATCC (American Type Culture Collection) strains, which are standardized reference microorganisms. Therefore, there is no country of origin for human data or retrospective/prospective designation in the human sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- N/A. This was a laboratory performance study of bacterial viability in a transport medium, not a study requiring expert interpretation of clinical data or images. The "ground truth" was established by quantitative microbiological methods (CFU recovery).
4. Adjudication Method for the Test Set
- N/A. As this was a microbiology laboratory study, there was no adjudication method involving human experts interpreting results in a consensus manner. Results were quantitative Colony Forming Unit (CFU) counts.
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
- N/A. This is not an AI or imaging device, and no human reader study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device (transport medium and swab), not an algorithm or software. The "standalone" performance here refers to the device's ability to maintain bacterial viability on its own, without human intervention affecting the measurement of viability post-collection. The reported CFU counts are precisely this type of standalone performance.
7. The Type of Ground Truth Used
- Quantitative Microbiological Culture (CFU counts): The ground truth for bacterial viability was established by performing standard quantitative microbiological culture methods to determine Colony Forming Units (CFU) per milliliter or per sample at various time points and temperatures. This is a direct measure of viable bacterial cells. The organisms were diluted in either Phosphate Buffered Saline (PBS) or a fecal matrix.
8. The Sample Size for the Training Set
- N/A. This is not a machine learning or AI device that requires a "training set." The study involved testing the physical device’s performance.
9. How the Ground Truth for the Training Set was Established
- N/A. See point 8.
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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
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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
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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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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.
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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 andPreservation 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 andPreservation System is intended for the collection ofrectal swab and fecal specimens and to preserve theviability of enteric pathogenic bacteria duringtransport from the collection site to the testinglaboratory. In the laboratory, FecalSwab specimensare processed using standard clinical laboratoryoperating procedures for culture. | The Copan Venturi Transystem Cary-Blair product is asterile, single use specimen collection chamber intendedto preserve the viability of microorganisms after theircollection and during their transport from the collectingarea to the laboratory. These devices are intended for thecollection, transport and preservation of clinicalspecimens for bacteriological examination. |
| Anatomical Sites | Rectal Specimen | Rectal Specimen |
| Characteristics | Copan FecalSwab Collection, Transport andPreservation System | Copan Venturi Transystem Cary-Blair Medium(Copan Diagnostics Inc.) |
| Performance | Viability of target micro-organisms up to 48 hours atroom temperature and 72 hours at 2°C-8°C. For C.difficile, up to 48 hours at 2 – 8 °C and up to 24 hoursat 20 – 25 °C. | Viability of target micro-organisms up to 48 hours atroom temperature |
| Microorganismssupported | Enteric pathogenic bacteria | Enteric pathogenic bacteria |
| Microorganismstested | Echerichia coliEcherichia coli O157:H7Salmonella typhimuriumShigella sonneiCampylobacter jejuniYersinia enterocoliticaVibrio parahaemoliticusEnterococcus faecalis vancomycin resistant (VRE)Clostridium difficile | Echerichia coliShigella flexneriCampylobacter jejuniYersinia enterocolitica |
| ProductConfiguration | Film-film peel-pouch containing 1 tube filled with 2ml of liquid medium and 1 regular size flocked swab | Film-film peel-pouch containing 1 tube filled with 5 mlof gel medium and 1 regular size rayon (viscose) swab |
| MediumFormulation | Chloride saltsSodium saltsPhosphate bufferL-CysteineAgarWater | Sodium ChlorideCalcium ChlorideDisodium Hydrogen PhosphateSodium ThioglycolateBacteriological AgarWater |
| pH | 6.90 – 7.50 | 6.90-7.50 |
| StorageTemperature | 5-25°C | 5-25°C |
| Medium Volume | 2 ml | 5 ml |
| Ratio betweensample andelution 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 | HRSLOG |
| 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* | HoldingTemperature | AVERAGE CFU RECOVERED(N = 3 LOTS TESTED) | T=48HRS -72HRSLOGREDUCTION (-)ORLOGINCREASE (+) | ||||
|---|---|---|---|---|---|---|---|
| Time 0hrs | Time 6hrs | Time 24hrs | Time 48hrs | Time 72hrs | |||
| Escherichia coli O157:H7ATCC 700728 | 2-8°C | 1.23E+02 | 1.37E+02 | 1.38E+02 | 1.53E+02 | 1.60E+02 | 0.11 |
| Escherichia coli O157:H7ATCC 700728 | 20-25°C | 1.23E+02 | 1.34E+02 | 7.48E+02 | 7.54E+03 | NA | 1.79 |
| Salmonella typhimuriumATCC 14028 | 2-8°C | 9.46E+01 | 1.05E+02 | 1.20E+02 | 1.32E+02 | 1.43E+02 | 0.18 |
| Salmonella typhimuriumATCC 14028 | 20-25°C | 9.46E+01 | 1.17E+02 | 6.51E+02 | 6.38E+03 | NA | 1.83 |
| Vibrio parahaemolyticusATCC 17802 | 2-8°C | 1.11E+02 | 1.21E+02 | 1.29E+02 | 1.26E+02 | 1.36E+02 | 0.09 |
| Vibrio parahaemolyticusATCC 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.
§ 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).