Puritan OptiTranz Liquid Stuart Collection and Transport System is intended for use in the collection and transport of clinical specimen containing aerobic and fastidious bacteria from patient to the laboratory for bacteriological examination and culture.

Device Description

Puritan OptiTranz Collection and Transport System is comprised of a sterile peel pouch containing a rayon or flock tipped swab applicator for collecting specimen and a polypropylene vial containing 1 ml of Stuart liquid medium.

Puritan OptiTranz Liquid Stuart Medium is a nonnutritive balanced salt solution containing phosphates to provide buffering capability and calcium chloride to provide essential ions that help maintain osmotic balance. Mercaptoacetic acid provides a reduced environment. It is recommended for maintaining the viability of aerobic and fastidious bacteria during the transport to the laboratory.

AI/ML Overview

The provided document describes the Puritan OptiTranz™ Liquid Stuart Collection and Transport System, a device for collecting and transporting clinical specimens containing aerobic and fastidious bacteria. The study conducted to demonstrate its effectiveness is primarily a recovery testing study, comparing its performance to a predicate device.

Here's an breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance
Ability to maintain viability of aerobic and fastidious bacteria	No significant differences in recovery were detected between Puritan OptiTranz and the predicate device.
Stability over time (shelf life)	Products maintained microbial recovery up to the expiry date (18 months).
pH stability	All samples tested maintained pH within the specified range ($7.3 \pm 0.2$).
Cytotoxicity	No evidence of cytotoxicity was detected (for glue, shaft, and swab tips).
Sterilization	Sterilized by gamma irradiation, validated following ANSI/AAMI/ISO 11137:2006.

2. Sample size used for the test set and the data provenance:

Sample Size: The document mentions "known inoculum of ATCC type culture and clinically significant microorganisms" but does not specify the exact number of samples or isolates used in the recovery testing.
Data Provenance: The study was conducted by the manufacturer, Puritan Medical Products LLC, as part of their 510(k) submission. It appears to be a prospective study designed to evaluate the new device against an established predicate within a laboratory setting. The country of origin of the data is not explicitly stated but would likely be the USA, where the manufacturer is located.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The recovery testing relies on direct measurement of microbial viability after transport, not on expert interpretation of results.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as the study did not involve human interpretation or adjudication of outcomes in the traditional sense of medical imaging or diagnostic tests. The performance was measured directly through microbiological viability assays.

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:

Not applicable. This device is a specimen collection and transport system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical product for specimen collection and transport, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the recovery testing was established by comparing the viability of known inoculum of ATCC type culture and clinically significant microorganisms after transport in the Puritan OptiTranz system versus the predicate device. This is a microbiological ground truth based on controlled inoculation and subsequent quantitative recovery.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML model, and therefore, there is no "training set" in the context of machine learning. The studies described are performance evaluations of a physical product.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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

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

January 9, 2015

Re: K142366

Trade/Device Name: Puritan Optitranz Liquid Stuart Collection And Transport System Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: I Product Code: JSM, LIO, JTW Dated: December 3, 2014 Received: December 11, 2014

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,

Uwe Scherf - S for

Sally Hojvat, 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) K142366

Device Name

Puritan OptiTranz Liquid Stuart Collection and Transport System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Repetitive Use (Part 21 CFR 201.3 Subject to Review)
One-Time Use (Part 21 CFR 201.3 Not Subject to Review)

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® OptiTranz™ Liquid Stuart Medium

5.1 Sponsor

	Puritan Medical Products LLC
	31 School St., Guilford, ME
	04443
	Contact:	Mehdi Karamchi
	Telephone Number:	207-876-3311
	Date:	August 19, 2014
5.2	Device Name
	Classification Name:	Microbiological Specimen Collection and Transport Device
	Common Name:	Specimen Collection and Transport System
	Proprietary Name:	Puritan OptiTranz Liquid Stuart Collection and Transport System
5.3	Regulatory Information
A.	Regulatory Section:	21 CFR 866.2390
B.	Classification:	Class I
C.	Product Code:	JSM, LIO, JTW
D.	Panel:	Microbiology
5.4	Predicate Device

BD CultureSwab™ Collection and Transport System manufactured by Copan Diagnostics Inc. of Italy

510K Number: K946283

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ર્દે ર Device Description

For prescription use only.

5.6 Intended Use

5.7 Indication(s) For Use

Purtian OptiTranz Liquid Stuart Collection and Transport System is intended for use in the collection and transport of clinical specimen containing aerobic and fastidious bacteria from patient to the laboratory for bacteriological examination and culture.

5.8. Substantial Equivalence statement

Puritan OptiTranz is similar in design, manufacturing and intended usage to the predicate device. Both Puritan and predicate device are single-use devices intended for collection and transport of clinical specimens containing aerobes and fastidious bacteria.

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Puritan Versus Predicate Similarities
Item	Puritan OptiTranz Liquid StuartCollection and Transport SystemK142366	BD CultureSwabTMCollection andTransportK946283
Intended USE	Puritan OptiTranz Liquid StuartCollection and Transport System isintended for use in the collection andtransport of clinical specimencontaining aerobic and fastidiousbacteria from patient to the laboratoryfor bacteriological examination andculture.	Copan VenturiTransystem LiquidStuarts Mediumproducts (141C,143C & 139C) aresterile ready-to-usesystems intendedfor the safecollection, transport,and preservation ofclinical specimensfor bacteriologicalexamination.Product 141C(plastic applicator) isintended forcollecting samplesfrom the throat,vagina, or fromwounds. Product143C (aluminumapplicator) isintended forcollection ofspecimens fromsmall or lessaccessible areassuch as eye, ear,nose, throat

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	urogenital tract and
	for pediatric use.
	Product 139C (two
	plastic applicators) is
	used for throat,
	vaginal, or wound
	sampling. The
	double swab permits
	use of the second
	sample in the
	laboratory of gram
	stain analysis or as a
	backup for
	verification of initial
	culture.
Single-use Device	Yes	Same
Medium Formulation	Sodium GlycerophosphateCalcium ChlorideMercaptoacetic acid	Same
pH	$7.3 \pm 0.2$	Same
Storage Temperature	2-25°C (refrigerated and roomtemperature)	5-25°C (refrigeratedand roomtemperature)
Container	Plastic round bottom tube	Same
Product Configuration	Medium in tubes, Plug & polyurethanefoamSystem including medium and swab inpeel pouch option.	Same
Swab Shaft	Plastic	Same

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Item	Test Device	Predicate
Swab Tip	Rayon or flock tipped swab	Rayon tipped swab
Shelf Life	18 months	Same

5.9 Recovery Testing

To determine the ability of the Puritan OptiTranz to maintain viability of different strains of aerobes and fastidious bacteria, known inoculum of ATCC type culture and clinically significant microorganisms were inoculated into the Puritan OptiTranz and compared to the predicate device following Clinical and Laboratory Standards Institute (CLSI), M40-A2 guidelines. No significant differences in recovery were detected between samples obtained from Puritan OptiTranz vs. predicate device.

5.10 Stability Testing

Stability tests were performed on Puritan OptiTranz products 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 up to 18 month after manufacturing date. The test was performed using calibrated pH meter with random samples from three different lots of Puritan OptiTranz liquid Stuart medium. All samples tested were found to maintain pH within the specified range.

5.12 Cytotoxicity

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

5.13 Sterilization

Puritan OptiTranz Collection and Transport Systems are sterilized by gamma irradiation and validated following ANSI/AAMI/ISO 11137:2006, Sterilization of health care products Radiation guidelines.

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).