(137 days)
Not Found
No
The 510(k) summary describes a specimen collection and transport system, which is a physical device and medium, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is designed for the collection and transport of clinical specimens for bacteriological examination and culture, not for treating a disease or condition.
No
Explanation: The device is a collection and transport system intended to maintain the viability of bacteria for later examination and culture in a laboratory. It does not perform any diagnostic function itself.
No
The device is a collection and transport system comprised of physical components (swab applicator, vial, liquid medium) and is not software-based.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "collection and transport of clinical specimen containing aerobic and fastidious bacteria from patient to the laboratory for bacteriological examination and culture." This clearly indicates the device is used in vitro (outside the body) to prepare a specimen for diagnostic testing in a laboratory setting.
- Device Description: The description details a "collection and transport system" comprised of a swab for collecting the specimen and a vial containing a "liquid medium" for maintaining the viability of the microorganisms during transport to the laboratory. This entire system is designed to facilitate the in vitro diagnostic process.
- Performance Studies: The performance studies described, such as "Recovery Testing" and "Stability Testing," are focused on evaluating the device's ability to maintain the integrity and viability of the specimen for subsequent laboratory analysis. This is a key characteristic of IVD devices.
- Predicate Device: The predicate device listed (BD CultureSwab™ Collection and Transport System) is also a well-known IVD device used for specimen collection and transport for microbiological testing.
The device is not used for direct diagnosis or treatment, but it is an essential component in the process of obtaining and preparing a specimen for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JSM, LIO, JTW
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.
For prescription use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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.
1
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)
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.
| 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
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.
For prescription use only.
5.6 Intended Use
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.
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 Stuart | |
| Collection and Transport System | ||
| K142366 | BD CultureSwabTM | |
| Collection and | ||
| Transport | ||
| K946283 | ||
| Intended USE | 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. | Copan Venturi | |
| Transystem Liquid | ||
| Stuarts Medium | ||
| products (141C, | ||
| 143C & 139C) are | ||
| sterile ready-to-use | ||
| systems intended | ||
| for the safe | ||
| collection, transport, | ||
| and preservation of | ||
| clinical specimens | ||
| for bacteriological | ||
| examination. | ||
| Product 141C | ||
| (plastic applicator) is | ||
| intended for | ||
| collecting samples | ||
| from the throat, | ||
| vagina, or from | ||
| wounds. Product | ||
| 143C (aluminum | ||
| applicator) is | ||
| intended for | ||
| collection of | ||
| specimens from | ||
| small or less | ||
| accessible areas | ||
| such 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 Glycerophosphate | ||||
| Calcium Chloride | |||||
| Mercaptoacetic acid | Same | ||||
| pH | $7.3 \pm 0.2$ | Same | |||
| Storage Temperature | 2-25°C (refrigerated and room | ||||
| temperature) | 5-25°C (refrigerated | ||||
| and room | |||||
| temperature) | |||||
| Container | Plastic round bottom tube | Same | |||
| Product Configuration | Medium in tubes, Plug & polyurethane | ||||
| foam | |||||
| System including medium and swab in | |||||
| peel 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.