(269 days)
Not Found
No
The device is a viral transport medium and collection system, which is a chemical and physical product for sample collection and preservation, not a software or analytical device. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as a transport medium for collecting and preserving clinical specimens containing respiratory viruses for testing, not for treating or diagnosing a condition.
No
Explanation: The device is a transport medium intended for the collection and preservation of specimens for diagnostic testing, not the diagnostic device itself. It facilitates the transport of samples but does not perform the diagnosis.
No
The device description clearly states it is a "Non-Propagating Transport Medium Device" containing a "transport medium" and a "conical polypropylene vial filled with 3 ml of culture medium, secured with a high-density polyethylene screw-on cap." These 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 upper respiratory clinical specimens containing respiratory viruses, from the collection site to the testing laboratory." It also mentions it's intended to be used with "standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles." This clearly indicates its role in the diagnostic process.
- Device Description: The description details a "Non-Propagating Transport Medium Device designed to facilitate the secure collection and transportation of biological samples for diagnosing viral infections." The purpose is to maintain the viability of viruses for subsequent diagnostic testing.
- Performance Studies: The performance studies focus on "Viral Recovery Study Results" and "Reagent Stability Study Results," which are relevant to ensuring the device functions correctly for its intended diagnostic purpose (maintaining viral viability for testing).
- Key Metrics: The key metrics measured are related to "Percent reduction in virus infectivity," which directly impacts the ability to accurately diagnose viral infections using the collected sample.
- Predicate Device: The predicate device listed (K212743; MedSchenker Smart Transport Medium) is also a viral transport medium, which are typically classified as IVDs.
While the device itself doesn't perform the final diagnostic test, it is an essential component in the in vitro diagnostic process by enabling the proper collection and transport of the sample to the laboratory where the diagnostic testing will be performed. It is designed to maintain the integrity of the sample for subsequent in vitro analysis.
N/A
Intended Use / Indications for Use
The Avantik VTM is intended for the collection and transport of upper respiratory clinical specimens containing respiratory viruses, from the collection site to the testing laboratory. The collection system is a culture-based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles.
Product codes
JSM
Device Description
The Avantik VTM is a Non-Propagating Transport Medium Device designed to facilitate the secure collection and transportation of biological samples for diagnosing viral infections. The device contains a transport medium that maintains the viability and infectivity of clinically significant viruses en route to testing laboratories.
The device can be stored between 2 - 25°C for up to 12 months and is only for use by Health Care Professionals. Upon collection, samples should be immediately placed in the transport tube to maintain optimal conditions. It is recommended to refrigerate the samples between 2 - 8°C or store them on wet ice to maintain a temperature of 2 - 8°C during transit. Post-collection, the specimen can be transported at 2 - 25°C and should be processed within 48 hours.
The transport system allows for specimen collection, maintenance through a buffered medium, and contains a pH indicator. The liquid medium consists of a mixture of Hank's balanced salt solution, BSA (Bovine Serum Albumin), L-cysteine, Gelatin, Sucrose, L-glutamic acid, HEPES, Vancomycin, Amphotericin B, Colistin, and Phenol Red. The liquid medium inhibits the growth of competing bacteria and fungus, is non-toxic to mammalian host cells, and supports viral viability during transportation. The device includes a conical polypropylene vial filled with 3 ml of culture medium, secured with a high-density polyethylene screw-on cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper respiratory
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Care Professionals
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)
Reagent Stability Study Results
Shelf-life was determined using the data from real-time aged, stability testing of the finished product at documented intervals. Testing was also performed on lots returning from the simulated distribution per ASTM D4169-16/D4332 testing to determine whether the product maintains acceptable stability under known, stressed shipping conditions. Selected lot samples were assessed by visual inspection, weight, pH, and contamination checks to determine whether lots remained stable at each timepoint. All samples from all testing conditions gave passing results for all acceptance criteria. The shelf-life of the product was determined to be 12 months from the date of manufacture, based on the data provided.
Viral Recovery Study Results
Performance of the subject device was evaluated in culture-based viral recovery studies in accordance with CLSI M40-A2. Three viral strains were evaluated: influenza A, RSV, and Human Coronavirus NL63 at different incubation times and storage temperatures. Virus viability was then determined after storing in virus transport media for 0 and 48 h at 4°C and a controlled room temperature of 22°C. Three lots of the candidate device were evaluated to validate performance over shelf-life. Percentages of reduction in virus infectivity following storage in VTM compared to Time 0 are shown in the table below. The device demonstrated recovery of influenza A. RSV, and Human Coronavirus NL63 at refrigerated or room temperature up to 48 hours.
Key results (Percent Reduction in Virus Infectivity After 48 Hours):
Lot 1 @ 4°C: Influenza A: 21.97 ± 3.64, RSV: 59.26 ± 5.90, hCoV: -23.55 ± 7.85
Lot 2 @ 4°C: Influenza A: 9.52 ± 6.79, RSV: 55.24 ± 3.13, hCoV: 1.50 ± 5.21
Lot 3 @ 4°C: Influenza A: 7.06 ± 1.14, RSV: 65.27 ± 4.02, hCoV: -18.26 ± 3.99
Lot 1 @ 22°C: Influenza A: -9.89 ± 5.86, RSV: 76.18 ± 3.50, hCoV: 4.84 ± 3.25
Lot 2 @ 22°C: Influenza A: 6.13 ± 2.04, RSV: 75.85 ± 2.85, hCoV: 21.06 ± 1.55
Lot 3 @ 22°C: Influenza A: 11.70 ± 3.15, RSV: 70.16 ± 1.22, hCoV: -1.92 ± 3.86
In support of the viral recovery study, the cytotoxicity profile of virus transport media was assessed as well. The results demonstrate that the medium is non-toxic to mammalian host cells.
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
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 15, 2024
Hanchang Medic Co., Ltd. (Han Chang Medic) Hyunsoo Shin Official Correspondent 10, Wolsan-ro 201beon-gil, Eumbong-myeon Asan-Si. Chungcheognam-Do 14501 Korea. South
Re: K233449
Trade/Device Name: Avantik VTM Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I, reserved Product Code: JSM Dated: June 10, 2024 Received: June 10, 2024
Dear Hyunsoo Shin:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233449
Device Name Avantik VTM
Indications for Use (Describe)
The Avantik VTM is intended for the collection and transport of upper respiratory clinical specimens containing respiratory viruses, from the collection site to the testing laboratory. The collection system is a culture-based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
This summary of 510(k) substantial equivalence information is submitted in accordance with the requirements of 21 CFR §807.92:
| I. SUBMITTER: | HanChang Medic Co. Ltd. (HAN CHANG MEDIC) |
|---|---|
| Address: | 10, Wolsan-ro 201beon-gil, Eumbong-myeon, Asan-si, |
| Chungcheongnam-do, Republic of Korea | |
| Tel: | +82-41-547-8805 |
| Fax: | N/A |
| Contact Person: | Shin, Hyunsoo |
| Date Prepared: | JUL-8-2024 |
| II. DEVICE | |
|---|---|
| Device Trade Name: | Avantik VTM |
| Classification Name: | CULTURE MEDIA, NON-PROPAGATING TRANSPORT |
| Regulation: | 21 CFR §866.2390 |
| Regulatory Class: | Class I |
| Device Panel: | MICROBIOLOGY |
| Product Classification Code: | JSM |
| III. PREDICATE DEVICE | |
|---|---|
| Predicate Manufacturer: | Medschenker, Inc. |
| Predicate Trade Name: | MedSchenker Smart Transport Medium |
| (STM15-A/STM20A/STM30-A/SCS30-A) System | |
| Predicate 510(k): | K212743 |
IV. DEVICE DESCRIPTION
The Avantik VTM is a Non-Propagating Transport Medium Device designed to facilitate the secure collection and transportation of biological samples for diagnosing viral infections. The device contains a transport medium that maintains the viability and infectivity of clinically significant viruses en route to testing laboratories.
The device can be stored between 2 - 25°C for up to 12 months and is only for use by Health Care Professionals. Upon collection, samples should be immediately placed in the transport tube to maintain optimal conditions. It is recommended to refrigerate the samples between 2 - 8°C or store them on wet ice to maintain a temperature of 2 - 8°C during transit. Post-collection, the specimen can be transported at 2 - 25°C and should be processed within 48 hours.
The transport system allows for specimen collection, maintenance through a buffered medium, and contains a pH indicator. The liquid medium consists of a mixture of Hank's balanced salt
4
solution, BSA (Bovine Serum Albumin), L-cysteine, Gelatin, Sucrose, L-glutamic acid, HEPES, Vancomycin, Amphotericin B, Colistin, and Phenol Red. The liquid medium inhibits the growth of competing bacteria and fungus, is non-toxic to mammalian host cells, and supports viral viability during transportation. The device includes a conical polypropylene vial filled with 3 ml of culture medium, secured with a high-density polyethylene screw-on cap.
V. INTENDED USE
The Avantik VTM is intended for the collection and transport of upper respiratory clinical specimens containing respiratory viruses, from the collection site to the testing laboratory. The collection system is a culture-based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles.
COMPARISON WITH THE PREDICATE DEVCE VI.
The subject and predicate devices have the following similarities and differences:
| Device & Predicate
| Device(s): | Subject Device: K233449 | Predicate Device: K212743 |
|---|---|---|
| Device Trade Name | Avantik VTM | MedSchenker Smart |
| Transport Medium (STM15- | ||
| A/STM20-A/STM30- | ||
| A/SCS30-A) System | ||
| General Device Characteristic | ||
| Similarities | ||
| Intended Use/Indications | ||
| For Use | The Avantik VTM is intended for the | |
| collection and transport of upper | ||
| respiratory clinical specimens | ||
| containing respiratory viruses, from the | ||
| collection site to the testing laboratory. | ||
| The collection system is a culture- | ||
| based media that is intended to be used | ||
| with standard laboratory examination, | ||
| culture or with other assays that utilize | ||
| stable recovery of infectious viral | ||
| particles. | MedSchenker Smart Transport | |
| Medium (STM15- | ||
| A/STM20-A/STM30-A/SCS30-A) | ||
| System is | ||
| intended for the collection and | ||
| transport of upper | ||
| respiratory clinical specimens, | ||
| containing respiratory viruses, from | ||
| the collection site to the testing | ||
| laboratory. MedSchenker Smart | ||
| Transport Medium (STM15- | ||
| A/STM20-A/STM30-A/SCS30-A) | ||
| System is a culture-based medium | ||
| that can be | ||
| processed using standard clinical | ||
| laboratory operating procedures for | ||
| the recovery of infectious viral | ||
| particles. | ||
| Product Code and | ||
| Classification | JSM, Class I | Same |
| Media Formulation | Amphotericin B Bovine Serum Albumin Hank's Balanced Salt Solution Vancomycin Colistin Gelatin HEPES L-cysteine L-glutamic acid Phenol Red Sucrose | Same |
| Container for medium | Plastic, conical bottom | Same |
| Storage Temperature | 2 - 25°C (refrigerated and room temperature) | Same |
| Shelf Life | 12 months | Same |
| pH Stability | 7.3 ± 0.5 maintained up to 12 months | Same |
| Single Use | Yes | Same |
| General Device | ||
| Characteristic Differences | ||
| Supported Viruses | Validated Viruses: | |
| Influenza A (H3N2) | ||
| RSV | ||
| Human Coronavirus | Validated Viruses: | |
| Influenza A (H1N1) | ||
| Type 5 Adenovirus | ||
| Herpes Simplex 1 | ||
| Herpes Simplex 2 | ||
| Varicella-Zoster Virus | ||
| Swab Material | Not Applicable | Nylon tip with breakpoint |
| Product Configuration | Medium Tubes | Medium Tubes; Kit with |
| Medium Tubes and | ||
| Swab Option | ||
| Sample Stability | 48 hours | 72 hours for HSV-1, HSV-2, and |
| Adenovirus | ||
| 24 hours for IFA and VZV |
5
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Reagent Stability Study Results
Shelf-life was determined using the data from real-time aged, stability testing of the finished
6
product at documented intervals. Testing was also performed on lots returning from the simulated distribution per ASTM D4169-16/D4332 testing to determine whether the product maintains acceptable stability under known, stressed shipping conditions. Selected lot samples were assessed by visual inspection, weight, pH, and contamination checks to determine whether lots remained stable at each timepoint. All samples from all testing conditions gave passing results for all acceptance criteria. The shelf-life of the product was determined to be 12 months from the date of manufacture, based on the data provided.
Viral Recovery Study Results
Performance of the subject device was evaluated in culture-based viral recovery studies in accordance with CLSI M40-A2. Three viral strains were evaluated: influenza A, RSV, and Human Coronavirus NL63 at different incubation times and storage temperatures. Virus viability was then determined after storing in virus transport media for 0 and 48 h at 4°C and a controlled room temperature of 22°C. Three lots of the candidate device were evaluated to validate performance over shelf-life. Percentages of reduction in virus infectivity following storage in VTM compared to Time 0 are shown in the table below. The device demonstrated recovery of influenza A. RSV, and Human Coronavirus NL63 at refrigerated or room temperature up to 48 hours.
| Samples | Temperature | Percent reduction in virus
infectivity relative to 0h | | |
|---------|-------------|----------------------------------------------------------|--------------|---------------|
| | | Influenza A | RSV | hCoV |
| Lot 1 | 4°C | 21.97 ± 3.64 | 59.26 ± 5.90 | -23.55 ± 7.85 |
| Lot 2 | 4°C | 9.52 ± 6.79 | 55.24 ± 3.13 | 1.50 ± 5.21 |
| Lot 3 | 4°C | 7.06 ± 1.14 | 65.27 ± 4.02 | -18.26 ± 3.99 |
| Lot 1 | 22°C | -9.89 ± 5.86 | 76.18 ± 3.50 | 4.84 ± 3.25 |
| Lot 2 | 22°C | 6.13 ± 2.04 | 75.85 ± 2.85 | 21.06 ± 1.55 |
| Lot 3 | 22°C | 11.70 ± 3.15 | 70.16 ± 1.22 | -1.92 ± 3.86 |
Table 1. Percent Reduction in Virus Infectivity After 48 Hours
In support of the viral recovery study, the cytotoxicity profile of virus transport media was assessed as well. The results demonstrate that the medium is non-toxic to mammalian host cells.
VIII. CONCLUSIONS
Based on the indications for use, technological characteristics, safety, and performance testing, the subject device, Avantik VTM, meets the requirements that are considered essential for its intended use and supports a decision of substantial equivalence to a legally marketed device.