(119 days)
K 04 2970
K 04 2970
No
The device is a collection and transport system for biological samples, consisting of a vial, medium, and swabs. There is no mention of any computational or analytical components that would utilize AI/ML.
No
The device is described as a "Collection and Transport System" intended for collecting and transporting clinical samples for laboratory testing, not for directly treating a patient's condition.
No
Explanation: The device is described as a "Collection and Transport System" for clinical samples, indicating its purpose is to preserve and transport samples for later testing, not to perform diagnosis itself. The performance studies focus on microbial recovery and viability within the transport medium, confirming its role in sample integrity rather than diagnostic interpretation.
No
The device description clearly outlines physical components including a vial, cap, transport medium, glass beads, and various types of swabs. This indicates it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for the "collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the testing laboratory." It also states that the transported specimen "can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture." This clearly indicates that the device is intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a "culture medium" and a system for collecting and transporting samples for laboratory testing.
- Performance Studies: The document describes "Microbial recovery studies" to establish the performance of the system, which is a typical requirement for IVD devices to demonstrate their ability to maintain the viability of microorganisms for subsequent diagnostic testing.
- Predicate Device: The mention of a "Predicate Device" (K042970; Copan (BD) UTM-RT) which is also a Universal Transport Medium, strongly suggests that this device is being compared to an existing IVD device for regulatory purposes.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
JSM, LIO
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
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)
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).
Stability and shelf life
a. Recovery stability
The following strains were chosen for shelf life stability testing: 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 under 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
§ 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).
0
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
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 .
1
- 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
2
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 Serum | |
| Albumin | ||
| L-cysteine | ||
| Gelatin | ||
| Sucrose | ||
| L-glutamic acid | ||
| Hepes buffer | ||
| Vancomycin | ||
| Amphotericin B | ||
| Colistin | ||
| Phenol red | Hank's Balanced Salt Solution Bovine Serum | |
| Albumin | ||
| L-cysteine | ||
| Gelatin | ||
| Sucrose | ||
| L-glutamic acid | ||
| Hepes buffer | ||
| Vancomycin | ||
| Amphotericin B | ||
| Colistin | ||
| Phenol 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 |
3
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:
4
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, Sterility Tests.
5
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
6
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
7
Indications for Use
510(k) Number: K113249
Puritan UTM-RT Collection and Transport System Device Name
Indications For Use:
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.
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
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