Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.

Device Description

Puritan Opti-Tranz Cary-Blair Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene tube containing 5 ml of Cary-Blair medium.

Cary-Blair medium is a nonnutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of enteric bacteria during the transport to the laboratory.

AI/ML Overview

The document describes the Puritan Opti-Tranz Cary-Blair Collection and Transport System, a device for collecting and transporting clinical fecal and rectal swab specimens to preserve enteric bacteria viability for bacteriological examination and culture.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Implicit)	Reported Device Performance
Microbial Recovery	Maintain viability of different strains of enteric bacteria comparable to predicate device.	"No notable differences in recovery were detected between the Puritan Opti-Tranz Cary-Blair Collection and Transport System and the predicate device."
Fecal Material Impact on Recovery	Clinical fecal material should not notably alter recovery of challenge organisms.	"It was determined that clinical fecal material does not notably alter the recovery of the challenge organisms from the Puritan Opti-Tranz Cary-Blair Collection and Transport System."
pH Stability	Maintain pH within the specified range (6.90-7.50) over the shelf life.	"All samples tested were found to maintain pH within the specified range." (up to 20 months)
Cytotoxicity	No evidence of cytotoxicity from device components.	"No evidence of cytotoxicity was detected."
Sterilization	Sterilization validated according to ANSI/AAMI/ISO 11137:2006.	"Sterilized by gamma irradiation and validated following ANSI/AAMI/ISO 11137:2006."
Shelf Life	Maintain performance up to the expiry date (20 months).	Stability tests performed "up to the expiry date."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for specific tests (e.g., microbial recovery, pH stability). For microbial recovery, "known inoculum of clinically significant ATCC type culture microorganisms" were used, along with "three representative challenge organisms" for the fecal material impact test. For pH stability, "random samples from three different lots" were used.
Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." All studies appear to be laboratory-based performance tests conducted by the manufacturer, Puritan Medical Products LLC, for regulatory submission purposes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the device is not an AI/diagnostic device that requires expert-derived ground truth from an image or clinical assessment. The ground truth for this device's performance relates to objective laboratory measurements (e.g., microbial viability, pH levels, cytotoxicity, sterility).

4. Adjudication Method for the Test Set

This information is not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies among human readers in diagnostic studies.

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

This information is not applicable. This is a medical device for specimen collection and transport, not an AI diagnostic tool or software.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of this device is established through:
- Objective laboratory measurements: Microbial counts/viability for recovery testing.
- Predicate device comparison: Performance is compared against a legally marketed predicate device (Copan Venturi Transystem Cary-Blair Medium product (132C)).
- Standardized methods: Adherence to guidelines like CLSI M40-A2 for microbial recovery and ANSI/AAMI/ISO 11137:2006 for sterilization.
- Physicochemical tests: pH measurements, cytotoxicity assays.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2016

PURITAN MEDICAL PRODUCTS LLC MEHDI KARAMCHI VICE PRESIDENT OF SCIENTIFIC AFFAIRS 31 SCHOOL STREET P.O. BOX 149 GUILFORD ME 04443-0149

Re: K160082

Trade/Device Name: Puritan Opti-Tranz Cary-Blair Collection and Transport System Regulation Number: 21 CFR 866,2390 Regulation Name: Transport culture medium Regulatory Class: I Product Code: JSM, LIO, JTW Dated: July 14, 2016 Received: July 18, 2016

Dear Mr. Karamchi:

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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (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/Resourcesfor You/Industry/default.htm. 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.

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

Uwe Scherf, M.Sc., Ph.D. For 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) K160082

Device Name

Puritan Opti-Tranz Cary-Blair Collection and Transport System

Indications for Use (Describe)

Puritan Opti-Tranz Cary-Blair Collection and Transport System is in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteria during transport from the collection site to the testing laboratory for bacteriological examination and 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

Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System

5.1 Sponsor

Puritan Medical Products LLC

31 School St., Guilford, ME

04443

Contact:	Mehdi Karamchi
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Telephone Number:	207-876-3311
Fax Number:	207-876-2680

Date: May 25, 2016

5.2 Device Name

Classification Name:	Transport Culture Medium
Common Name:	Specimen Collection and Transport System
Proprietary Name:	Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System

5.3 Regulatory Information

A. Regulatory Section:	21 CFR 866.2390
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B. Classification: Class I
C. Product Code: LIO, JSM, JTW
D. Panel: Microbiology (83)

5.4 Predicate Device

Copan Venturi Transystem Cary-Blair Medium product (132C)

510K Number: K946286

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5.5 Device Description

5.6 Intended Use

5.7 Indication(s) For Use

Substantial Equivalence statement 5.8.

Puritan Opti-Tranz Cary-Blair Collection and Transport System is similar in design, manufacturing and intended usage to the predicate device. Both the Puritan and the predicate device are single-use devices intended for collection and transport of clinical specimens containing enteric bacteria from the patient site to the testing laboratory for bacteriological examination and culture.

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Puritan and Predicate Device Comparision
Item	Puritan Test Device	Predicate
Intended USE	Puritan Opti-Tranz Cary-BlairCollection and TransportSystem is a sterile ready-to- usesystem intended for collectionand transport of clinical fecaland rectal swab specimens topreserve the viability of entericbacteria during transport fromthe collection site to the testinglaboratory for bacteriologicalexamination and culture.	Copan Venturi TransystemCary-Blair Medium product(132C) is a sterile ready-to-usesystem intended for the safecollection, transport, andpreservation of clinicalspecimens for bacteriologicalexamination. Product 132C issupplied with a plasticapplicator swab. The VenturiTransystem with Cary-BlairTransport Medium isrecommended for thecollection and transport offecal and rectal swab samplesfor the investigation of entericpathogenic bacteria.
Single-use Device	Yes	Same
Medium Formulation	Sodium chlorideDisodium phosphateSodium thioglycollateCalcium chlorideAgarWater	Same
pH	6.90-7.50	$8.4 ± 0.2$
Storage Temperature	2-25°C (refrigerated and roomtemperature)	Same
Container	Plastic round bottom tube	Same
Product Configuration	Medium in tubes & PlugSystem including Medium and	Same

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	swab in peel pouch option.
Swab Shaft	Plastic	Same
Swab Tip	Rayon tipped swab	Same
Shelf Life	20 months	24 months

5.9 Recovery Testing

To determine the ability of the Puritan Opti-Tranz Cary-Blair Collection and Transport System to maintain viability of different strains of enteric bacteria, known inoculum of clinically significant ATCC type culture microorganisms were inoculated into the Puritan Opti-Tranz Cary-Blair Collection and Transport medium and compared to the predicate device following Clinical and Laboratory Standards Institute (CLSI) M40-A2 guidelines. No notable differences in recovery were detected between the Puritan Opti-Tranz Cary-Blair Collection and Transport System and the predicate device.

Recovery was also evaluated using three representative challenge organisms to demonstrate that the performance of the Puritan Opti-Tranz Cary-Blair Collection and Transport medium is not adversely affected by fecal material. It was determined that clinical fecal material does not notably alter the recovery of the challenge organisms from the Puritan Opti-Tranz Cary-Blair Collection and Transport System.

5.10 Stability Testing

Stability tests were performed on Puritan Opti-Tranz Cary-Blair Collection and Transport System to verify the ability of the aged products to maintain microbial recovery up to the expiry date.

5.11 pH Stability

The pH of the test device was measured at predetermined time intervals for up to 20 months after manufacturing date. The test was performed using calibrated pH meter with random samples from three different lots of Puritan Opti-Tranz Cary-Blair Collection and Transport System. All samples tested were found to maintain pH within the specified range.

5.12 Cytotoxicity

Cytotoxicity testing was conducted to evaluate the glue, shaft and the rayon tipped swabs for potential cytotoxicity effect following ISO Elution Method-1X MEM Extract. No evidence of cytotoxicity was detected.

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5.13 Sterilization

Puritan Opti-Tranz Cary-Blair Collection and Transport System is sterilized by gamma irradiation and validated following ANSI/AAMI/ISO 11137:2006, Sterilization of health care products Radiation guidelines.

5.14 Conclusion

The conclusions drawn from the nonclinical tests demonstrate the device is as safe and effective as the legally marketed device identified above.

Regulation Number and 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).