(139 days)
No
The device is a collection and transport system for biological specimens and does not involve any computational analysis or processing.
No
The device is intended for the collection and transport of clinical specimens for bacteriological examination and culture, not for treating a disease or condition.
No
The device is a collection and transport system intended to maintain the viability of microbial specimens for subsequent laboratory examination and culture, not to diagnose a condition itself.
No
The device description clearly states it is comprised of a sterile peel pouch containing a rayon tipped swab applicator and a polypropylene tube containing Amies medium, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture." This is a key characteristic of an IVD - it's used to collect and transport samples for subsequent diagnostic testing in a laboratory setting.
- Device Description: The description details the components used for specimen collection and transport, which are integral to the in vitro diagnostic process.
- Performance Studies: The performance studies focus on the ability of the medium to maintain the viability of microorganisms for "bacteriological examination and culture," which are in vitro diagnostic procedures.
- Comparison to Predicate Device: The comparison to a predicate device (BD CultureSwab™ Collection and Transport System) which is also a collection and transport system for microbiological specimens, further supports its classification as an IVD.
While the device itself doesn't perform the diagnostic test (like analyzing the bacteria), it is a crucial component in the in vitro diagnostic process by ensuring the integrity and viability of the specimen until it reaches the laboratory for analysis.
N/A
Intended Use / Indications for 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.
Product codes
LIO, JTW, JTX
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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
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.
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
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.
5.8. 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 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. | The Copan Venturi | |
| Transystem Amies Medium | ||
| Without Charcoal products | ||
| are sterile, | ||
| single-use specimen | ||
| collection chambers | ||
| intended to preserve the | ||
| viability of microorganisms | ||
| after their collection and | ||
| during their transport from | ||
| the collecting area to the | ||
| laboratory. These devices | ||
| are intended for the | ||
| collection, transport, and | ||
| preservation of clinical | ||
| specimens for | ||
| bacteriological | ||
| examination. Copan | ||
| Venturi | ||
| Transystem Amies Medium | ||
| Without Charcoal is | ||
| designed to support the | ||
| viability of a wide variety of | ||
| clinically important aerobic | ||
| and anaerobic bacteria. | ||
| Single-use Device | Yes | Same |
| Medium Formulation | Sodium chloride | |
| Disodium phosphate | ||
| Sodium thioglycollate | ||
| Monopotassium phosphate | ||
| Potassium chloride | Same | |
| Calcium chloride | ||
| Magnesium Chloride | ||
| Bacteriological Agar | ||
| Charcoal (with Amies Charcoal) | ||
| pH | $7.3 \pm 0.2$ | Same |
| Storage Temperature | 4-25°C (refrigerated and room | |
| temperature) | Same | |
| Container | Plastic round bottom tube | Same |
| Product Configuration | Medium in tubes & Plug | |
| System including Medium and | ||
| swab 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:
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.
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