Puritan Fecal Opti-Swab Collection and Transport System

K162284 · Puritan Medical Products, LLC · JSM · Nov 4, 2016 · Microbiology

Device Facts

• Record ID: K162284
• Device Name: Puritan Fecal Opti-Swab Collection and Transport System
• Applicant: Puritan Medical Products, LLC
• Product Code: JSM · Microbiology
• Decision Date: Nov 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

Intended Use

Puritan Fecal Opti-Swab 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 Story

Device consists of sterile polyester flock swab applicator and polypropylene vial containing 2 mL nonnutritive balanced salt transport medium. Used by clinicians to collect fecal/rectal specimens; specimens placed in vial for transport to laboratory. Medium uses phosphate buffer, chloride salts, sodium thioglycolate, and L-cysteine to maintain osmotic balance and oxygen-reduced environment for enteric bacteria. Supports viability of organisms like C. difficile, E. coli, and Salmonella during transport. Enables laboratory culture and examination. Benefits patient by ensuring specimen integrity and accurate diagnostic results.

Clinical Evidence

Bench testing only. Recovery testing performed per CLSI M40-A2 guidelines comparing subject device to predicate using ATCC and clinical strains (e.g., C. difficile, E. coli, Salmonella). Fecal matrix challenge testing confirmed no adverse impact from fecal material. Stability and pH testing verified performance over 15-month shelf life. Cytotoxicity testing per ISO Elution Method-1X MEM Extract showed no evidence of cytotoxicity.

Technological Characteristics

System includes polyester flock swab and polypropylene vial with 2 mL medium (balanced salt solution, phosphate buffer, chloride salts, L-cysteine, sodium thioglycolate, agar). pH range 6.90-7.50. Sterilized by gamma irradiation per ANSI/AAMI/ISO 11137:2006. Storage 2-25°C.

Indications for Use

Indicated for the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria for bacteriological examination and culture. For prescription use only.

Regulatory Classification

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.

Predicate Devices

• Copan FecalSwab Collection, Transport and Preservation System (K142094)

Submission Summary (Full Text)

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

November 4, 2016

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

Re: K162284

Trade/Device Name: Puritan Fecal Opti-swab Collection And Transport System Regulation Number: 21 CFR 866,2390 Regulation Name: Transport culture medium Regulatory Class: I Product Code: JSM, LIO, JTW, JTX Dated: August 11, 2016 Received: August 15, 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 [phone] or [phone] 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" (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 [phone] or [phone] 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) K162284

### Device Name

Puritan Fecal Opti-Swab Collection and Transport System

Indications for Use (Describe)

Puritan Fecal Opti-Swab 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.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span> <span style="font-size: 20px;">☑</span> </span> |
|----------------------------------------------|--------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span> <span style="font-size: 20px;">☐</span> </span> |

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# 510(k) Summary

# Puritan® Fecal Opti-Swab™ Collection and Transport System

#### 5.1 Sponsor

| 5.1 | Sponsor | |
|-----|------------------------------|-----------------------------------------------------------|
| | Puritan Medical Products LLC | |
| | 31 School St., Guilford, ME | |
| | 04443 | |
| | Contact: | Mehdi Karamchi |
| | Telephone Number: | 207-876-3311 |
| | Fax Number: | 207-876-2680 |
| | Date: | August 11, 2016 |
| 5.2 | Device Name | |
| | Classification Name: | Transport Culture Medium |
| | Common Name: | Specimen Collection and Transport System |
| | Proprietary Name: | Puritan® Fecal Opti-Swab™ Collection and Transport System |
| 5.3 | Regulatory Information | |
| | A. Regulatory Section: | 21 CFR 866.2390 |
| | B. Classification: | Class I |
| | C. Product Code: | LIO, JSM; JTW; JTX |
| | D. Panel: | Microbiology (83) |

#### 5.4 Predicate Device

Copan Fecal Swab Collection, Transport and Preservation System manufactured by Copan Diagnostics Inc. of Italy

510K Number: K142094

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#### 5.5 Device Description

Puritan Fecal Opti-Swab Collection and Transport System is comprised of a sterile peel pouch containing a sterile polyester flock swab applicator for collecting clinical fecal and rectal specimens and a polypropylene vial containing 2 ml of Fecal Opti-Swab medium.

Fecal Opti-Swab medium is a nonnutritive balanced salt solution containing phosphates to provide buffering capability, chloride salts to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent that increases the viscosity of the medium. Sodium thioglycolate and L-cysteine provides an oxygen-reduced environment. It is recommended for maintaining the viability of enteric bacteria during the transport to the laboratory.

#### 5.6 Intended Use

Puritan Fecal Opti-Swab 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.

#### 5.7 Indication(s) For Use

Puritan Fecal Opti-Swab 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.

#### 5.8. Substantial Equivalence statement

Puritan Fecal Opti-Swab 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 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.

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| Puritan and Predicate Device Comparison | | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Test Device | Predicate |
| Intended USE | Puritan Fecal Opti-Swab<br>Collection and Transport System<br>is a sterile ready-to- use system<br>intended for collection and<br>transport of clinical fecal and<br>rectal swab specimens to<br>preserve the viability of enteric<br>bacteria during transport from<br>the collection site to the testing<br>laboratory for bacteriological<br>examination and culture. | The Copan FecalSwab<br>Collection, Transport and<br>Preservation System is<br>intended for the collection<br>of rectal swab and fecal<br>specimens and to preserve<br>the viability of enteric<br>pathogenic bacteria during<br>transport from the<br>collection site to the testing<br>laboratory. In the<br>laboratory, FecalSwab<br>specimens are processed<br>using standard clinical<br>laboratory operating<br>procedures for culture. |
| Single-use Device | Yes | Same |
| Medium Formulation | Chloride salts<br>Sodium salts<br>Phosphate buffer<br>L-Cysteine<br>Agar<br>Water | Chloride salts<br>Sodium salts<br>Phosphate buffer<br>L-Cysteine<br>Agar<br>Water (different<br>formulation) |
| pH | 6.90-7.50 | Same |
| Storage Temperature | 2-25°C (refrigerated and room<br>temperature) | 5-25°C (refrigerated and<br>room temperature) |
| Container | Polypropylene conical bottom<br>vial | Same |
| Product Configuration | Medium in vial & cap<br>System including Medium and | Same |
| | swab in peel pouch option. | |
| Swab Shaft | Plastic | Same |
| Swab Tip | Flock Swab | Same |
| Shelf Life | 15 months | Same |
| Specimen Storage | For C. difficile, up to 48 hours at<br>2 – 8 °C and up to 24 hours at 20<br>– 25 °C. For other target<br>organisms organisms: up to 72<br>hours at 2 – 8 °C and up to 48<br>hours at 20 – 25 °C. | Same |
| Medium Volume | 2 mL | Same |
| Organisms Tested | Campylobacter jejuni<br>Clostridium difficile<br>Enterococcus faecalis<br>Escherichia coli<br>Salmonella typhimurium<br>Shigella sonnei<br>Vibrio parahaemolyticus<br>Yersinia enterocolitica | Same |

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#### 5.9 Recovery Testing

To determine the ability of the Puritan Fecal Opti-Swab Collection and Transport System to maintain viability of different strains of enteric bacteria, known inoculum of ATCC type culture and clinically significant microorganisms were prepared in a phosphate-buffered saline matrix and inoculated into the Puritan Fecal Opti-Swab 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 Fecal Opti-Swab Collection and Transport System and the predicate device.

Recovery was also evaluated using three representative challenge organisms prepared in a fecal matrix to demonstrate that the performance of the Puritan Fecal Opti-Swab 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 Fecal Opti-Swab Collection and Transport System.

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#### 5.10 Stability Testing

Stability tests were performed on Puritan Fecal Opti-Swab 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 15 months after manufacturing date. The test was performed using calibrated pH meter with random samples from three different lots of Puritan Fecal Opti-Swab Collection and Transport System. All samples tested were found to maintain pH within the specified range.

#### Cytotoxicity 5.12

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

#### 5.13 Sterilization

Puritan Fecal Opti-Swab 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.