(80 days)
Not Found
No
The device is a collection and transport system for biological specimens and does not involve any computational analysis or processing that would utilize AI/ML. The description focuses on the physical components and the chemical properties of the transport medium.
No
The device is described as a collection and transport system for clinical specimens containing bacteria, intended for bacteriological examination and culture. Its purpose is to maintain the viability of bacteria for diagnostic purposes, not to treat or prevent a disease or condition.
No
This device is a collection and transport system for clinical specimens, intended to maintain the viability of bacteria for later examination and culture. It is not designed to diagnose conditions itself.
No
The device is a collection and transport system comprised of physical components (swab, vial, liquid medium) and is not solely 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 and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture." This is a classic description of a device used in vitro (outside the body) to analyze a specimen for diagnostic purposes.
- Device Description: The description details a system for collecting and transporting a specimen to a laboratory for analysis. The medium is designed to maintain the viability of bacteria for subsequent testing.
- Performance Studies: The performance studies focus on "Recovery Testing" of bacteria in the medium, which is directly related to the device's function in supporting in vitro diagnostic testing.
- Predicate Device: The predicate device listed is also a "Collection and Transport System," which are typically classified as IVDs.
The device is designed to facilitate the diagnostic process by ensuring the integrity of the specimen for laboratory analysis, which is a core function of an IVD.
N/A
Intended Use / Indications for Use
Puritan Liquid Amies 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 (comma separated list FDA assigned to the subject device)
JTW, JTX, LIO
Device Description
Puritan Liquid Amies Collection and Transport System is comprised of a sterile peel pouch containing a polyester flock swab applicator for collecting specimen and a polypropylene vial containing 1 ml of modified Amies liquid transport medium. The polyester flock swab applicators are provided in two different tip sizes to accommodate various specimen types.
Amies liquid 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. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic, anaerobic and fastidious bacteria during the transport to the laboratory.
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 Amies liquid medium to maintain viability of different strains of aerobes, anaerobes and fastidious bacteria, known inocula of ATCC type culture and clinically significant microorganisms were inoculated into the Puritan liquid Amies transport medium and compared to the predicate device following Clinical and Laboratory Standards Institute(CLSI), M40-A guidelines. The Puritan Liquid Amies system showed recovery of bacteria within the acceptance criteria like the predicate device.
Stability Testing: Stability tests were performed on Puritan Amies liquid 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 Liquid Amies Collection and Transport System. All samples tested were found to maintain pH within the specified range.
Cytotoxicity: Cytotoxicity test was conducted to evaluate glue, shaft and the polyester (flock) 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): 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
§ 866.2900 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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JUN - 8 2012
510(k) Summary
Puritan Liquid Amies Collection and Transport System
5.1 Sponsor
Puritan Medical Products LLC
31 School St., Guilford, ME 04443
Mehdi Karamchi Contact:
Telephone Number: 207-876-3311
Date: May 24, 2012
5.2 Device Name
| - Classification Name: . | Transport Culture Medium . |
|---|---|
| - Common Name: . | Microbiological Specimen Collection and Transport System . |
| Proprietary Name: . | Puritan Liquid Amies Swab Collection and Transport System . |
Regulatory Information 5.3
| A. Regulatory Section: | 21 CFR 866.2900 |
|---|---|
| B. Classification: | Class I |
| C. Product Code: | JTW, JTX |
| D. Panel: | Microbiology |
. 5.4 Predicate Device
BD (Copan) Liquid Amies Collection and Transport System
510K Number: K061301
5.5 Device Description
Puritan Liquid Amies Collection and Transport System is comprised of a sterile peel pouch containing a polyester flock swab applicator for collecting specimen and a polypropylene vial
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containing 1 ml of modified Amies liquid transport medium. The polyester flock swab applicators are provided in two different tip sizes to accommodate various specimen types.
Amies liquid 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. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic, anaerobic and fastidious bacteria during the transport to the laboratory.
5.6 Intended Use
Puritan Liquid Amies 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.
5.6.1 Indication(s) For Use
Puritan Liquid Amies 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 Substantial Equivalence statement
Puritan Liquid Amies Collection and Transport Systems is similar in design, manufacturing and intended usage to the predicate device. Both Puritan and predicate devices are single-use devices intended for collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria.
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2
| Puritan Versus Competitor Similarities | ||
|---|---|---|
| Item | Test Device | Predicate |
| Intended Use | Collection and transport of clinical | |
| specimens from the patient to the | ||
| laboratory for bacterial examination | ||
| and culture | Same | |
| Single-use Devise | Yes | Yes |
| Medium Formulation | Sodium chloride | |
| Disodium phosphate | ||
| Sodium thioglycollate | ||
| Monopotassium phosphate | ||
| Potassium chloride | ||
| Calcium chloride | ||
| Magnesium Chloride | Same | |
| pH | $7.3 \pm 0.2$ | Same |
| Storage Temperature | 2-25°C (refrigerated and room | |
| temperature) | Same | |
| Container | Plastic; conical bottom | Same |
| Product Configuration | Medium in tubes & Cap | |
| System including Medium and swab in | ||
| peel pouch option. | Same |
.
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| Puritan Versus Competitor Differences | ||
|---|---|---|
| Item | Device | Predicate |
| Swab Tip | HydraFlock Swab (Polyester) | Nylon Flock swab |
| Shelf Life | 18 months | 15 months |
5.8 Recovery Testing
To determine the ability of the Puritan Amies liquid medium to maintain viability of different strains of aerobes, anaerobes and fastidious bacteria, known inocula of ATCC type culture and clinically significant microorganisms were inoculated into the Puritan liquid Amies transport medium and compared to the predicate device following Clinical and Laboratory Standards Institute(CLSI), M40-A guidelines. The Puritan Liquid Amies system showed recovery of bacteria within the acceptance criteria like the predicate device.
5.9 Stability Testing
Stability tests were performed on Puritan Amies liquid products to verify the ability of the aged products to maintain microbial recovery up to the expiry date.
5.10 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 Liquid Amies Collection and Transport System. All samples tested were found to maintain pH within the specified range.
5.11 Cytotoxicity
Cytotoxicity test was conducted to evaluate glue, shaft and the polyester (flock) swabs for potential cytotoxicity effect following ISO Elution Method-1X MEM Extract. No evidence of cytotoxicity was detected.
5.12 Sterilization
Puritan Liquid Amies Transport Systems 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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
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
JUN - 8 2012
Re: K120846
Trade/Device Name: Puritan® Liquid Amies Collection and Transport System Regulation Number: 21 CFR 866.2900 Regulation Name: Microbiological specimen collection and transport device Regulatory Class: Class I Product Code: LIO, JTW, JTX Dated: March 20, 2012 Received: March 20, 2012
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 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
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Page 2 - Mehdi Karamchi B. Sc. RM
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,
Sally, attgum
Sally A. Hojvat, 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: K120846
Device Name: Puritan® Liquid Amies Collection and Transport System
Indications for Use:
Puritan® Liquid Amies 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 × (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)
Laura Feldbolz
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120846
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