Puritan® Amies Medium Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

Device Description

Puritan Amies Medium Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimen and a polypropylene tube containing 4 ml of Amies medium with or without charcoal. The rayon tipped swab applicators are provided in different tip sizes to accommodate various specimen types.

Amies medium is a nonnutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semi-solid texture to the medium. Sodium thioglycollate 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

Here's a breakdown of the acceptance criteria and study information for the Puritan Amies Medium Collection and Transport System, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance	Study that Proves Device Meets Acceptance Criteria
Microbial Viability	Ability to maintain viability of different strains of aerobes, anaerobes, and fastidious bacteria, comparable to the predicate device.	No significant differences in recovery were detected between Puritan Amies Medium and the predicate device.	Recovery Testing (following CLSI M40-A guidelines)
Stability	Maintain microbial recovery up to the expiry date.	Aged products maintain microbial recovery up to the expiry date.	Stability Testing
pH Stability	Maintain pH within the specified range ($7.3 \pm 0.2$) up to 24 months after manufacturing.	All samples tested were found to maintain pH within the specified range.	pH Stability Test (measured at predetermined time intervals up to 24 months)
Biocompatibility	No cytotoxicity from glue, shaft, and rayon-tipped swabs.	No evidence of cytotoxicity was detected.	Cytotoxicity Test (ISO Elution Method-1X MEM Extract)
Sterilization	Sterilized by gamma irradiation according to guidelines.	Sterilized by gamma irradiation and validated following ANSI/AAMI/ISO 11137:2006.	Sterilization Validation

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: The document states "known inoculum of ATCC type culture and clinically significant microorganisms" were used. It does not provide a specific number for the sample size (i.e., number of bacterial strains or replicates).
- Data Provenance: Not explicitly stated, but the use of ATCC type cultures suggests a lab-based study rather than patient-derived retrospective or prospective data. The clinical significance of some microorganisms suggests they might be strains commonly isolated in clinical settings, but their exact provenance (e.g., country, specific source) is not detailed.
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 study's ground truth for microbial recovery would typically be established by laboratory methods (e.g., colony counting) rather than expert interpretation in the way, for example, a radiology study would use expert readers.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This concept is not applicable to this type of microbiology recovery study. Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging or diagnostic studies where human readers interpret results and consensus is needed. For microbial recovery studies, quantitative measures (e.g., colony-forming units) are the primary endpoint.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Puritan Amies Medium is a specimen collection and transport device, not an AI diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical medical device (collection and transport medium), not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the recovery testing was established by quantitative microbiological methods, specifically by comparing the recovery (viability) of known inoculums of ATCC type cultures and clinically significant microorganisms in the Puritan Amies Medium versus a predicate device. This would involve standard laboratory techniques like plating and colony counting to quantify viable organisms.
The sample size for the training set:
- Not applicable. This device is a physical medical device, not an AI model or algorithm, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set for this type of device, this question is not relevant.

Summary

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K131630

510(k) Summary

Puritan Amies Medium

5.1	Sponsor
	Puritan Medical Products LLC
	31 School St., Guilford, ME
	04443	OCT 21 2013
	Contact:	Mehdi Karamchi
	Telephone Number:	207-876-3311
	Date:	May 29, 2013
5.2	Device Name
	Classification Name:	Microbiological Specimen Collection and Transport Device
	Common Name:	Specimen Collection and Transport System
	Proprietary Name:	Puritan Amies Medium Collection and Transport System
5.3	Regulatory Information
A.	Regulatory Section:	21 CFR 866.2900
B.	Classification:	Class I
C.	Product Code:	LIO, JTW, JTX
D.	Panel:	Microbiology

Predicate Device 5.4

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

510K Number: K972448

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5.5 Device Description

5.6 Intended Use

Puritan Amies Medium Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

5.7 Indication(s) For Use

5.8. Substantial Equivalence statement

Puritan Amies Medium 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 Competitor Similarities
Item	Test Device	Predicate
Intended USE	Puritan Amies Medium Collectionand Transport System is intended foruse in the collection and transport ofclinical specimens containing aerobic,anaerobic and fastidious bacteriafrom the patient to the laboratory forbacteriological examination andculture.	The Copan VenturiTransystem Amies MediumWithout Charcoal productsare sterile,single-use specimencollection chambersintended to preserve theviability of microorganismsafter their collection andduring their transport fromthe collecting area to thelaboratory. These devicesare intended for thecollection, transport, andpreservation of clinicalspecimens forbacteriologicalexamination. CopanVenturiTransystem Amies MediumWithout Charcoal isdesigned to support theviability of a wide variety ofclinically important aerobicand anaerobic bacteria.
Single-use Device	Yes	Same
Medium Formulation	Sodium chlorideDisodium phosphateSodium thioglycollateMonopotassium phosphatePotassium chloride	Same

	Calcium chlorideMagnesium ChlorideBacteriological AgarCharcoal (with Amies Charcoal)
pH	$7.3 \pm 0.2$	Same
Storage Temperature	4-25°C (refrigerated and roomtemperature)	Same
Container	Plastic round bottom tube	Same
Product Configuration	Medium in tubes & PlugSystem including Medium andswab in peel pouch option.	Same
Swab Shaft	Plastic	Same
Swab Tip	Rayon tipped swab	Same
Shelf Life	24 months	Same

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5.9 Recovery Testing

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

5.10 Stability Testing

Stability tests were performed on Puritan Amies Medium 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 24 month after manufacturing date. The test was performed using calibrated pH meter with random samples from three different lots of Puritan Amies Medium. All samples tested were found to maintain pH within the specified range.

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5.12 Cytotoxicity

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

5.13 Sterilization

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the three branches of government. The eagle is facing right, and its wings are spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

October 21, 2013

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

Re: K131630

Trade/Device Name: Puritan Amies Medium Collection and Transport System Regulation Number: 21 CFR 866.2900 Regulation Name: Microbiological specimen collection and transport device Regulatory Class: I Product Code: LIO, JTW. JTX Dated: September 9, 2013 Received: September 11, 2013

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. Insting 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 (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.

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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 Small Manufacturers, International and Consumer Assistance 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 Small Manufacturers, International and Consumer Assistance 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 A. 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 Statement

510(k) Number (if known): K131630

Device Name: Puritan Amies Medium Collection and Transport System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

Ribhi Sha

2013.10!

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Center for Devices and Radiological Health

Regulation Number and Section

§ 866.2900 Microbiological specimen collection and transport device.

(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.