(257 days)
The Merit Cultura™ Collection and Transport System is intended for collection and transport of clinical specimens to the laboratory for standard diagnostic/identification techniques. The Merit Cultura™ Collection and Transport System is a culture-based media that can be used for upper respiratory viral diagnostic assays including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus.
The Merit Cultura™ Collection and Transport System contains a sterile nylon-flocked collection swab with a plastic shaft, a vial with 3.0mL of Viral Transport Medium (VTM) and a sealable biohazard bag. Prior to use, vials should be stored at 2-8°C and 23-25°C. After collection, the transport tube containing the specimen can be stored for up to 120 hours at 2-8°C and 23-25°C.
The provided text describes the 510(k) premarket notification for the Merit Cultura™ Collection and Transport System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and detailed performance of an AI-powered device.
Therefore, many of the requested categories for AI device evaluation (such as multi-reader multi-case studies, number of experts, adjudication methods, and sample sizes for test and training sets for an AI algorithm) are not applicable to this submission, as it is for a medical device (a collection and transport system), not an AI/ML algorithm.
However, I can extract the relevant performance testing data for the physical device based on the provided text.
Here's the breakdown of the information that is available in the document, structured to best match your request, with an explanation for the non-applicable sections:
Acceptance Criteria and Device Performance for Merit Cultura™ Collection and Transport System (Non-AI Device)
The submission demonstrates the ability of the Cultura Collection and Transport System to maintain the viability and detectability of specific viruses over defined periods and temperatures. The acceptance criteria are implicitly defined by the successful recovery and detection of these viruses under testing conditions.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Culture-Based Studies: | Organism Viability: Virus should be viable (present) after specified storage times and temperatures. | RSV: Present at T-0 and T-120 hours at 2-8°C and 23-25°C. Influenza A Virus: Present at T-0 and T-120 hours at 2-8°C and 23-25°C. Influenza B Virus: Present at T-0 and T-120 hours at 2-8°C and 23-25°C. Rhinovirus: Present at T-0 and T-120 hours at 2-8°C and 23-25°C. |
| Amplification-Based Studies (SARS-CoV-2): | Qualitative Concordance: 100% concordance (Ct < 40 for positive results) at various time points and temperatures compared to T=0. Ct Value Stability: Ct values should be stable (within acceptable variation) across time points and storage conditions. | 100% concordance of qualitative results (Ct < 40 is positive) across all tested samples, storage times (T=0, 72, 120, 240 hours), and temperatures (2-8°C and 20-25°C). Ct values were stable for all samples according to lot number, incubation time, or storage condition. |
| Storage Time for Specimen | Specimen should be processed within 120 hours (differentiator from predicate) | The device preserved samples for up to 120 hours. |
| Shelf Life | 12 months (differentiator from predicate) | 12 months. |
2. Sample Size Used for the Test Set and Data Provenance
- Culture-Based Studies:
- Sample Size: Unspecified number of organism suspensions (Influenza A, Influenza B, RSV, and Rhinovirus) were inoculated into the Cultura VTM in quadruplicate for each condition (0, 48, 72, 120 hours at 2-8°C and 23-25°C). The initial viral titers (TCID50) are provided.
- Data Provenance: Commercial strains (ATCC# provided) were used. This indicates laboratory-controlled experiments rather than clinical patient data. This is a prospective lab study.
- Amplification-Based Studies (SARS-CoV-2):
- Sample Size: 12 unique SARS-CoV-2 positive clinical specimens. Each was tested in triplicate.
- Data Provenance: "12 unique, SARS-CoV-2 positive clinical specimens." This suggests human clinical samples, though the country of origin is not specified. The study design described (testing at T=0, 72, 120, 240 hours) is prospective for evaluating the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable for this device. This device is a specimen collection and transport system, not an AI diagnostic algorithm. The "ground truth" for the performance studies was based on laboratory assays (viral culture for viability, RT-PCR for nucleic acid detection/quantification). There were no human readers/experts evaluating the "results" as they would for an AI output.
4. Adjudication Method for the Test Set
- Not applicable for this device. As explained above, no human expert adjudication was required for the performance testing of this physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a specimen collection and transport system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This entire submission is for a physical medical device (collection and transport system), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
- Culture-Based Studies:
- Ground Truth: Organism viability determined by the Reed-Muench method calculation of TCID50 (50% Tissue Culture Infectious Dose) and confirmed by standard laboratory culture techniques. This is a direct measure of viral infectivity/presence.
- Amplification-Based Studies (SARS-CoV-2):
- Ground Truth: Detection of SARS-CoV-2 nucleic acid (RNA) using the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel, with Ct values used as quantitative markers. The qualitative ground truth was a positive rRT-PCR result (Ct < 40).
8. The Sample Size for the Training Set
- Not applicable. This submission is for a physical device, not an AI/ML algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
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March 3, 2021
Merit Medical Systems, Inc. Alex Bohorquez Regulatory Affairs Specialist II 1600 West Merit Parkway South Jordan, Utah 84095
Re: K201674
Trade/Device Name: Cultura Collection and Transport System Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I, reserved Product Code: JSM,LIO Dated: January 12, 2021 Received: January 13, 2021
Dear Alex Bohorquez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part
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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201674
Device Name
Merit Cultura™ Collection and Transport System
Indications for Use (Describe)
The Merit Cultura™ Collection and Transport System is intended for collection and transport of clinical specimens to the laboratory for standard diagnostic/identification techniques. The Merit Cultura™ Collection and Transport System is a culture-based media that can be used for upper respiratory viral diagnostic assays including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Sponsor | Submitter Name:Address:Telephone Number:Contact Person:Date Prepared:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095801-208-4685Alex Bohorquez27 July 20201721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | Merit Cultura™ Collection and TransportSystemSpecimen Collection and Transport SystemTransport Culture Medium DevicesClass IJSM, LIO866.2390Microbiology |
| Predicate Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product code:21 CFR §:Premarket Notification:Manufacturer: | Puritan Universal Transport Medium (UTM-RT) Collection and Transport SystemSpecimen Collection and Transport SystemTransport Culture Medium DevicesClass IJSM, LIO866.2390K113249Puritan Medical Products LLC |
| DeviceDescription | The Merit Cultura™ Collection and Transport System contains asterile nylon-flocked collection swab with a plastic shaft, a vial with3.0mL of Viral Transport Medium (VTM) and a sealable biohazard bag.Prior to use, vials should be stored at 2-8°C and 23-25°C. Aftercollection, the transport tube containing the specimen can be storedfor up to 120 hours at 2-8°C and 23-25°C. | |
| Indications forUse | The Merit Cultura™ Collection and Transport System is intended forcollection and transport of clinical specimens to the laboratory forstandard diagnostic/identification techniques. The Merit Cultura™Collection and Transport System is a culture-based media that can beused for upper respiratory viral diagnostic assays including Severe |
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Predicate
Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus.
The subject and predicate devices are based on the following same technological elements:
- Provide a device for the collection of patient specimens .
- . Provide a transport media to preserve specimen in transit to the testing laboratory
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Intended Use | The Merit Cultura™ Collection and TransportSystem is intended forcollection and transportof clinical specimens tothe laboratory forstandarddiagnostic/identificationtechniques. The MeritCultura™ Collection andTransport System is aculture-based media thatcan be used for upperrespiratory viraldiagnostic assaysincluding Severe AcuteRespiratory SyndromeCoronavirus 2 (SARS-CoV-2), Influenza A,Influenza B, RespiratorySyncytial Virus (RSV),and Rhinovirus. | Puritan UTM-RTCollection andTransport System isintended for thecollection andtransport of clinicalsamples containingviruses, chlamydiae,mycoplasmas orureaplasmas fromthe collection site tothe testing laboratory.The specimentransported in thePuritan UTM-RT canbe used in thelaboratory to performviral, chlamydial,mycoplasmal andureaplasmal culture. | |
| Comparison toPredicate Device | Device Similarities | ||
| Storage Temp. | 2-8°C and 23-25°C | Same | |
| List ofIngredients | Hanks Balanced SaltSolution enriched withproteins and sugars witha neutral pH and pHindicator. | Same | |
| Tube Material | Plastic | Same | |
| Single UseDevice | Yes | Same | |
| Sterile Device | Yes | Same | |
| Device Differences | |||
| Storage Time | Specimen should beprocessed within 120hours | Specimen should beprocessed within 48hours | |
| Shelf Life | 12 months | 15 months |
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| SamplesTransported toPerform | Assays to detect viruses | Assays to detectviruses, chlamydiae,mycoplasmas, orureaplasmas |
|---|---|---|
| List ofIngredients | FBS as proteinstabilizer D-glucose as sugar | BSA as proteinstabilizer Sucrose as sugar Gelatin Glutamic acid HEPES |
| Swab Material | Flocked Nylon Fiber Tipwith Breaking Point | Flocked NylonFiber Tip withBreaking Point Polyester tippedwith breakingpoint |
Performance Testing:
Culture-Based Studies
Performance of the Cultura Collection and Transport System was evaluated for virus viability using commercial strains of Influenza A, Influenza B, RSV, and Rhinovirus. 600 µL of organism suspension was used to inoculate the Cultura VTM in quadruplicate and stored for 0, 48 hrs., 72 hrs., and 120 hrs. at 2-8°C and at controlled room temperature (23-25°C). At each timepoint, an aliquot of the Cultura VTM and orqanism suspension was inoculated into the appropriate host cell line. All the cultures were processed using the standard laboratory culture technique. Organism viability was determined by the Reed-Muench method calculation of TCID50.
Performance Data
Merit Cultura™ Collection and Transport System preserved the samples of all the organisms tested for up to 120 hours at both controlled room temperature and refrigerated. The organisms evaluated and the results obtained are given in Table 1 below. The table below represents the titer of virus inoculated at T-0. The word "present" confirms the viability of the virus.
Table 1. Viral recovery results for viruses at T0 and T120 hours at 2-8°C and 23-25°C.
| Organism | ATCC# | Host Cell lines | ATCC# | Virus recovered at T-0 (TCID50) | T-0 Hour | T-120 Hours | ||
|---|---|---|---|---|---|---|---|---|
| 2-8°C | 23-25°C | 2-8°C | 23-25°C | |||||
| RSV | VR-26 | Hep-2 | CCL-23 | 101.5 | Present | Present | Present | Present |
| Influenza A Virus | VR-1496-TC | MDCK | CCL-34 | 101 | Present | Present | Present | Present |
| Influenza B Virus | VR-284 | MDCK | CCL-34 | 101.5 | Present | Present | Present | Present |
| Rhinovirus | VR-1535 | H1- Hela | CRL-1958 | 101.5 | Present | Present | Present | Present |
Amplification-Based Studies
Performance of the Cultura Collection and Transport System was
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evaluated by Real-Time PCR amplification studies using 12 unique, SARS-CoV-2 positive clinical specimens. Testing has been performed in triplicate to show the suitability of the Cultura VTM for the preservation of nucleic acids (RNA and DNA) for down-stream nucleic acid extraction and molecular testing when VTM and collection samples are stored per the instructions provided.
Nucleic acid was detected using the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel (catalog No. 2019-nCoVEUA-01). The rRT-PCR enzyme used in the master mix was the Thermofisher TagPath™ 1-Step RT-qPCR Master Mix (catalog No. A15299). RNA was extracted using the Qiagen QlAcube using the QlAmp Viral RNA Mini Kit (catalog No. 52906) per the manufacturer's instructions. Samples were run on the Applied Biosystems 7500 Fast Dx PCR System with SDS version 1.4 software (catalog No. 4406985). T=0 hours. T=72 hours, T=120 hours, and T=240 hours samples were stored in temperature-controlled environments of 2-8°C and 20-25°C.
Results show 100% concordance of the qualitative result (Ct < 40 is a positive result). Ct values were stable for all samples according to lot number, incubation time, or storage condition. See below for details.
Table 2. Test results (Ct, Δ Ct) for samples at storage times (hours) and temperature of 2-8°C
| Storage Time (T, hours) and Detected Markers (N1, N2) | Δ Ct | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| T₀ | T₇₂ | T₁₂₀ | T₂₁₆ | T₀ vs. T₁₂₀ | |||||||
| Sample | N1 | N2 | N1 | N2 | N1 | N2 | N1 | N2 | N1 | N2 | |
| A | 18.56 | 18.39 | 18.83 | 18.48 | 18.36 | 18.33 | 18.14 | 18.73 | -0.20 | -0.06 | |
| B | 18.45 | 18.55 | 18.36 | 18.98 | 18.47 | 18.64 | 18.86 | 19.13 | 0.02 | 0.09 | |
| C | 25.22 | 24.66 | 24.36 | 24.85 | 25.57 | 25.05 | 24.74 | 24.34 | 0.36 | 0.39 | |
| D | 31.20 | 31.40 | 31.02 | 30.98 | 30.51 | 31.40 | 30.64 | 31.56 | -0.69 | 0.00 | |
| E | 25.72 | 24.65 | 24.95 | 24.79 | 25.02 | 24.57 | 24.99 | 25.08 | -0.69 | -0.09 | |
| F | 38.01 | 38.58 | 38.04 | 39.19 | 37.95 | 38.08 | 38.91 | 38.60 | -0.06 | -0.50 | |
| G | 37.51 | 37.21 | 38.13 | 37.82 | 38.54 | 37.90 | 37.77 | 38.64 | 1.03 | 0.70 | |
| H | 33.85 | 34.45 | 33.81 | 34.58 | 33.75 | 33.86 | 33.84 | 34.29 | -0.10 | -0.59 | |
| I | 22.05 | 22.91 | 22.74 | 22.98 | 23.15 | 23.52 | 21.91 | 21.82 | 1.11 | 0.61 | |
| J | 32.40 | 31.78 | 31.09 | 31.32 | 31.70 | 31.16 | 31.19 | 31.63 | -0.70 | -0.61 | |
| K | 20.00 | 19.38 | 20.95 | 19.87 | 19.68 | 20.12 | 19.88 | 19.63 | -0.32 | 0.74 | |
| L | 32.08 | 32.71 | 32.12 | 32.70 | 32.60 | 32.15 | 33.75 | 32.28 | 0.52 | -0.57 |
Table 3. Test results (Ct, & Ct) for samples at storage times (hours) and temperature of 23-25°C
| Storage Time (T, hours) and Detected Markers (N1, N2) | Δ Ct | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| T0 | T72 | T120 | T216 | T0 vs. T120 | ||||||
| Sample | N1 | N2 | N1 | N2 | N1 | N2 | N1 | N2 | N1 | N2 |
| A | 18.40 | 18.50 | 18.57 | 18.67 | 17.94 | 18.84 | 18.00 | 18.27 | -0.46 | 0.34 |
| B | 18.73 | 18.59 | 18.49 | 18.52 | 19.10 | 18.21 | 18.07 | 18.41 | 0.37 | -0.38 |
| C | 24.80 | 24.88 | 24.89 | 24.58 | 24.91 | 25.17 | 25.10 | 25.82 | 0.11 | 0.29 |
| D | 31.29 | 30.10 | 30.85 | 30.21 | 30.76 | 30.45 | 30.81 | 30.87 | -0.53 | 0.35 |
| E | 25.43 | 25.53 | 24.34 | 24.79 | 24.98 | 24.84 | 24.88 | 25.00 | -0.45 | -0.69 |
| F | 38.03 | 39.08 | 38.82 | 38.06 | 38.13 | 38.86 | 37.92 | 39.66 | 0.10 | -0.22 |
| G | 37.91 | 38.29 | 37.81 | 38.13 | 38.93 | 38.33 | 37.57 | 38.01 | 1.02 | 0.04 |
| H | 34.51 | 33.89 | 34.41 | 33.36 | 33.59 | 34.82 | 33.74 | 33.70 | -0.92 | 0.93 |
| I | 21.82 | 23.18 | 22.43 | 22.75 | 21.88 | 22.61 | 22.76 | 23.00 | 0.06 | -0.57 |
| J | 31.71 | 31.70 | 31.03 | 31.36 | 31.86 | 31.01 | 31.61 | 31.58 | 0.15 | -0.69 |
| K | 20.14 | 19.61 | 19.95 | 19.86 | 19.92 | 19.34 | 20.64 | 19.75 | -0.23 | -0.28 |
| L | 33.04 | 32.15 | 32.40 | 33.10 | 32.46 | 32.16 | 32.28 | 32.70 | -0.58 | 0.01 |
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Stability Testing:
| Stability tests were performed on the Merit CulturaTM Collection andTransport System to verify the ability of the aged products to maintainSARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV), and Rhinovirus samples for standard diagnostic/identificationtechniques up to the expiry date. | |
|---|---|
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, safety,and performance testing, the subject device Merit CulturaTM Collectionand Transport System meets the requirements that are consideredessential for its intended use and is substantially equivalent to thepredicate device, the Puritan UTM-RT Collection and TransportSystem, K113249. |
§ 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).