Puritan UTM – RT Collection and Transport System is intended for the collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the testing laboratory. The specimen transported in the Puritan UTM - RT can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture.

Device Description

Puritan UTM-RT is an enclosed system recommended for the collection and transport of viruses, chlamydiae, mycoplasmas and ureaplasma. The osmotically balanced and buffered culture medium contains Hank's balanced salt solution with a pH indicator, sucrose as a preservative, protein and gelatin as stabilizers. Antimicrobial agents are incorporated to minimize commensal bacterial and fungus contamination.

Puritan UTM-RT is comprised of a conical polypropylene vial filled with three 3-mm glass beads and 1.5ml or 3 ml of the transport medium, affixed with a high density polyethylene cap. Each unit of Puritan UTM-RT is provided in a peel pouch containing one of the following swab combinations:

1ml UTM with ultrafine tip HydraFlock® Swab .
3ml UTM with one elongated tip HydraFlock® and one ultrafine tip swab
3ml UTM with elongated tip HydraFlock®® swab .
. 3ml UTM with mini-tip HydraFlock® swab, scored shaft
3ml UTM with ultrafine HydraFlock® tip swab
. 3ml UTM vial with 2 reg polyester tip swabs, scored shaft
3ml UTM vial with regular polyester tip and one wire/plastic shaft with polyester tip

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Puritan UTM-RT Collection and Transport System (UTM-RT)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Microbial Recovery: Ability to sustain viability and recover specified viruses, chlamydiae, mycoplasmas, and ureaplasmas.	Positive: "The results demonstrate the ability of Puritan Medical Products UTM-RT to sustain the viability and recovery of test bacteria and viruses for at least 48 hrs at 4° C and room temperature (20-25° C)."
Shelf Life Stability (Microbial Recovery): Maintain microbial recovery performance up to and including the expiration date.	Positive: "Storage stability testing indicated maintenance of the test device performance up to and including the expiration date." (Quantified through 48 hours at two storage temperatures, with higher recovery at refrigerated storage).
pH Stability: Maintain pH within the specified target range (7.3 ± 0.2).	Positive: "All samples tested were found to maintain pH within the specified target range." (Tested up to 18 months).
Antibiotic Stability: Ability to control bacterial activities (in the medium) for a specified duration.	Positive: "All products tested the ability to control bacterial activities up to 72 hours."
Non-Cytotoxicity: Absence of cellular toxicity.	Positive: "Cytotoxicity testing... demonstrated no cellular toxicity associated with three lots of test devices when statistically compared to negative controls."
Sterility: Meet sterility requirements.	Positive: "Representative samples from each lot... are tested according to the USP 34 NF, 29:2011, <71>, Sterility Tests." (Implies compliance, but no specific pass/fail rate is provided).
Substantial Equivalence to Predicate Device: Similar design, manufacturing, packaging, and intended use.	Positive: The comparison table (section 3.7.C) shows strong similarities in most aspects, with minor differences (swab tip material, shelf life) not deemed to impact substantial equivalence for the specified performance tests.

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

Sample Size for Microbial Recovery:
- Microorganisms: Adenovirus, Cytomegalovirus, Echovirus Type 30, Herpes Simplex Virus Type II, Influenza A, Respiratory Syncytial Virus, Parainfluenza Type 3, Varicella Zoster Virus, Herpes Simplex Virus Type I (9 viruses), Chlamydia pneumonia Strain CM-1, Chlamydia trachomatis Type 1 Strain UW-12/UR (2 chlamydiae), Mycoplasma hominis, Mycoplasma pneumonia, Ureaplasma urealyticum (3 mycoplasmas/ureaplasmas). A total of 14 specific strains/organisms.
- Replicates: For each organism, "100 µl were directly inoculated onto swabs in triplicate." This means 3 swabs per organism per dilution.
- Dilutions: "Two different dilutions of neat stock suspensions were prepared."
- Storage Conditions: "held at both 4° C and room temperature (20-25° C)."
- Time Points: "At key time points following inoculation (0, 24, and 48 h)."
- Total for Microbial Recovery (excluding initial stock prep variations): 14 organisms * 3 replicates * 2 dilutions * 2 storage temperatures * 3 time points = 1008 test samples.
Sample Size for Shelf Life Stability:
- Lots: "Three lots of the test device beyond the expiration point and one newly prepared lot" = 4 lots.
- Microorganisms: Cytomegalovirus, Herpes Simplex Virus Type II, Respiratory Syncytial Virus, Chlamydia pneumonia, Mycoplasma pneumonia (5 specific strains).
- Swabs: "spiking swabs that accompanied each transport system with the chosen test dilution."
- Storage Temperatures: "stored at different temperatures (refrigerated and room temperature)."
- Time Points: "held at 0, 24 and 48 hours."
- Total (excluding replicates which are not explicitly stated for stability but would typically be used): 4 lots * 5 organisms * 2 storage temperatures * 3 time points = 120 test conditions.
Sample Size for pH Stability: "random samples from three different lots of Puritan UTM-RT." (Number of samples not specified, but multiple samples per lot).
Sample Size for Antibiotics Stability Test: "3 expired lots and a new lot of test device" = 4 lots.
Sample Size for Cytotoxicity: "three lots of test devices."
Data Provenance: The study appears to be a prospective bench study conducted by Puritan Medical Products LLC, an American company. The country of origin of the data is therefore USA (Guilford, ME).

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

The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
The ground truth in this context (viability/recovery of microorganisms) is established through laboratory-based culture methods and microscopic examination (immunostaining and enumeration of fluorescent foci or colony forming units). While these methods require trained personnel, the document refers to "standard laboratory techniques" and does not imply a consensus panel of clinical experts for interpretation.

4. Adjudication Method for the Test Set

The document describes laboratory-based assays, such as shell vial assay followed by immunostaining and enumeration of fluorescent foci, or direct culture methods followed by enumeration of colony-forming units.
There is no mention of an adjudication method involving multiple human readers/experts for the interpretation of results. The assessment appears to be based on objective lab measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a MRMC comparative effectiveness study was not done.
This type of study is typically used for diagnostic devices that involve human interpretation of images or other data to assess the impact of AI on reader performance. The Puritan UTM-RT is a specimen collection and transport system, and its performance is evaluated through direct microbial recovery, not by assessing human reader accuracy.

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

This question is not applicable to the Puritan UTM-RT device.
The device itself is a collection and transport medium, not an algorithm. The performance tests are for the ability of the physical medium and swabs to preserve biological samples.

7. The Type of Ground Truth Used

The ground truth used is primarily direct microbial viability/culturability.
- For viruses and chlamydiae: Viability determined by shell vial assay followed by immunostaining and enumeration of fluorescent foci.
- For mycoplasmas and ureaplasmas: Viability determined using direct culture methods onto appropriate growth media followed by enumeration of colony forming units (CFU).
- For pH: Direct measurement using a calibrated pH meter.
- For cytotoxicity: Sulforhodamine B assay for cellular toxicity.

8. The Sample Size for the Training Set

The Puritan UTM-RT is a physical collection and transport system, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are performance validation studies for the physical product.

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

As there is no AI/ML component, the concept of a "training set" and its associated ground truth establishment is not applicable.

Summary

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K113249

3. 510(k) Summary for Puritan UTM-RT Collection and Transport System (UTM-RT)

MAR - ] 2012

3.1. Sponsor

Puritan Medical Products LLC

31 School Street, PO Box 149

Guilford, ME 04443-0149 U.S.A.

3.2 Device Name

Classification name: Transport Culture Medium Device

Common Name: Microbiological Specimen Collection and Transport System Proprietary Name: Puritan UTM-RT Collection and Transport System

3.3. Regulatory Information

A. Regulatory Section: 21 CFR 866.2390

B. Classification: I

C. Product Code: JSM

D. Panel: Microbiology

3.4. Device Description

1ml UTM with ultrafine tip HydraFlock® Swab .

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3ml UTM with one elongated tip HydraFlock® and one ultrafine tip swab �
3ml UTM with elongated tip HydraFlock®® swab .
. 3ml UTM with mini-tip HydraFlock® swab, scored shaft
� 3ml UTM with ultrafine HydraFlock® tip swab
. 3ml UTM vial with 2 reg polyester tip swabs, scored shaft
3ml UTM vial with regular polyester tip and one wire/plastic shaft with polyester tip

3.5. Intended Use

Puritan UTM-RT Collection and Transport System is intended for the collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas from the collection site to the testing laboratory. The specimen transported in the Puritan UTM-RT can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture.

3.6. Indication(s) for use

Puritan UTM – RT Collection and Transport System is intended for the collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas from the collection site to the testing laboratory. The specimen transported in the Puritan UTM - RT can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture.

3.7. Substantial Equivalence Determination

A. Predicate Device.

. Copan (BD) UTM-RT
.

B. Predicate Devise 510(k) Number(s)

K 04 2970

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C. Comparison of the test device with Predicate device

The Puritan UTM-RT Transport Systems are similar in design, manufacturing, packaging and intended use to the predicate devices. Both Puritan and predicate systems are single use devices intended for the collection and transport of viruses, chlamydiae, mycoplasmas and ureaplasmas.

Item	Test Device	Predicate Device Copan (BD)
Intended Use	Collection and transport of clinical specimens containing virus, Chlamydia, mycoplasma or ureaplasma	Same
Single-use Devise	Yes	Yes
Medium Formulation	Hank's Balanced Salt Solution Bovine SerumAlbuminL-cysteineGelatinSucroseL-glutamic acidHepes bufferVancomycinAmphotericin BColistinPhenol red	Hank's Balanced Salt Solution Bovine SerumAlbuminL-cysteineGelatinSucroseL-glutamic acidHepes bufferVancomycinAmphotericin BColistinPhenol red
pH	7.3 ± 0.2	Same
Storage Temperature	2-25°C (refrigerated and room temperature)	Same
Volume	1.5 ml; 3 ml; or 10 ml;	Same
Glass Beads	3 x 3 mm	Same
Container	Plastic; conical bottom	Same
Product Configuration	Medium in tubes & Cap System including Medium and swab in peel pouch option.	Same
Swab Shaft	Plastic	Same

Puritan Versus Competitor Differences
Item	Device	Predicate
Swab Tip	HydraFlock® Swab(Polyester)	Nylon Flock swab
Shelf Life	15 months	12 months

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3.8. Standard/Guidance Document Referenced

Quality Control of Microbiological Transport Systems M40-A, Clinical Laboratory and Standards Institute (CLSI), Wayne, PA, 2003.

3.9. Performance testing - Bench

Microbial recovery studies were carried out to establish the performance of Puritan UTM-RT system.

Recovery:

The following virus strains were chosen for recovery study: Adenovirus Cytomegalovirus Echovirus Type 30 Herpes Simplex Virus Type II Influenza A Respiratory Syncytial Virus Parainfluenza Type 3 Varicella Zoster Virus

Herpes Simplex Virus Type I

The following chlamydiae strains were chosen for recovery study: Chlamydia pneumonia Strain CM-1 Chlamydia trachomatis Type 1 Strain UW-12/UR The following mycoplasmas and ureaplasma were chosen for recovery study Mycoplasma hominis Mycoplasma pneumonia Ureaplasma urealyticum

The survival and recovery of viruses, chlamydiae, mycoplasmas and ureaplasmas was tested to determine the performance characteristics of Puritan Universal Transport Medium UTM-RT. The test methodology comprised of preparing neat stocks of the above microorganisms for testing. Two different dilutions of neat stock suspensions were prepared and, from these, 100 µl were directly inoculated onto swabs in triplicate. The swabs were transferred into the transport medium and held at both 4° C and room temperature (20-25° C) for the required amount of time. At key time points following inoculation (0, 24, and 48 h), each sample was vortexed after which an aliquot of the suspension was inoculated into shell vials or suitable culture media. Viability of viruses and chlamydiae was determined by shell vial assay followed by immunostaining and enumeration of fluorescent foci. The viability of mycoplasmas and ureaplasmas was determined using direct culture methods onto appropriate growth media followed by enumeration of colony forming units (CFU). Cultures were processed by standard laboratory techniques and examined following optimal incubation periods. The results demonstrate the ability of Puritan Medical Products UTM-RT to sustain the viability and recovery of test bacteria and viruses for at least 48 hrs at 4° C and room temperature (20-25° C).

3.10. Stability and shelf life a. Recovery stability

The following strains were chosen for shelf life stability testing:

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Cytomegalovirus Herpes Simplex Virus Type II Respiratory Syncytial Virus Chlamydia pneumonia Mycoplasma pneumonia

Prior to stability testing, neat stocks of test organisms were prepared and assessed for viable concentration. Three lots of the test device beyond the expiration point and one newly prepared lot were challenged with one concentration of each neat stock. Device performance was assessed by spiking swabs that accompanied each transport system with the chosen test dilution. Swabs were then transferred into the UTM, stored at different temperatures (refrigerated and room temperature) and held at 0, 24 and 48 hours. Viability/stability/stability/stability/stability/station/ander the defined conditions was evaluated through cell culture and immunofluorescence staining (viruses and Chlamydia) or standard bacterial culture methods (Mycoplasma). Culture data between the test and predicate devices were statistically analyzed and compared.

For all four lots, test viruses and bacteria could be quantified through 48 hours at the two storage temperatures. In general, refrigerated storage resulted in higher test strain recoveries and increased stability. One- way analysis of variance demonstrated statistical differences (p<0.05) between the lots under certain storage conditions, primarily between refrigerated and room temperature storage; this was concluded to be insignificant from the clinical stand point. Storage stability testing indicated maintenance of the test device performance up to and including the expiration date.

b. pH stability

The pH of the test device was measured at predetermined time intervals up to 18 month after the manufacturing date. The test was performed using calibrated pH meter with random samples from three different lots of Puritan UTM-RT. All samples tested were found to maintain pH within the specified target range.

c. Antibiotics Stability Test

Antibiotics stability of test device was evaluated using 3 expired lots and a new lot of test device and compared to the predicate device. All products tested the ability to control bacterial activities up to 72 hours.

3.11. Cytotoxicity

Cytotoxicity testing using an MRC-5 cell line in conjunction with a standard Sulforhodamine B assay demonstrated no cellular toxicity associated with three lots of test devices when statistically compared to negative controls.

3.12. Sterilization and Shelf Life

All plastic components of Puritan UTM-RT are validated and sterilized following ANSI/AAMI/ISO 11137:2006, Sterilization of health care products-Radiation or by ANSI/AAMI/ISO11135:2007, Sterilization of health care products-ethylene oxide.

Puritan UTM-RT tubes are filled aseptically under control conditions. Representative samples from each lot of Puritan UTM-RT are tested according to the USP 34 NF, 29:2011, <71>, Sterility Tests.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Puritan Medical Products LLC. . C/O Mehdi Karamchi B. Sc. RM (ccm) Vice President of Scientific Affairs 31 School Street, PO Box 149 Guilford, ME 04443-0149

Re: K113249

Trade/Device Name: Puritan UTM-RT Collection and Transport System Regulation Number: 21 CFR 866.2390 Regulation Name: Transport culture medium Regulatory Class: Class I Product Code: JSM, LIO Dated: October 28, 2011 Received: December 8, 2011

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

MAR - 1 2012

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Page 2 - Mehdi Karamchi B. Sc. RM

will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely yours,

Vally attypo

Sally A. Hoivat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K113249

Puritan UTM-RT Collection and Transport System Device Name

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Touara Feisblg
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113249

Page 1 of

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).