MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is intended for the collection and transport of upper respiratory clinical specimens, contaming respiratory viruses, from the collection site to the testing laboratory.

MedSchenker Smart Transport Medium (STM15-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.

Device Description

The MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System ("MedSchenker STM") aids in the collection and safe transportation of biological samples that will be tested for viruses. MedSchenker Smart Transport Medium (STM15-A/STM30-A/SCS30-A) System provides a universal transport medium for viruses. MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System includes a universal transporting medium that is room temperature stable, which can sustain infectivity of a plurality of clinically important viruses during transit to the testing laboratory. The formulation of the STM includes protein for stabilization, antimicrobial agents to minimize bacterial and fungal contamination, and a buffer to maintain a neutral pH.

The MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is provided in labeled, screw-cap tubes designed for transport of the clinical sample. MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is also supplied as a sample collection kit that contains one screw-cap tube of STM-RT (room-temperature stable) medium and a peel pouch that contains a sterile specimen-collection swab.

AI/ML Overview

The document provided describes the MedSchenker Smart Transport Medium (STM) System, a device intended for the collection and transport of upper respiratory clinical specimens containing respiratory viruses. The acceptance criteria and the study that proves the device meets these criteria are detailed, primarily through a viral recovery study.

Here's an analysis of the provided information, structured to answer your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

While explicit "acceptance criteria" for viral recovery (e.g., minimum percentage recovery) are not presented as a quantitative threshold in the document, the implied acceptance criterion is that the MedSchenker STM System demonstrates sufficient recovery and viability of relevant viruses over specified time periods and temperatures to support its intended use for specimen transport. The study aims to show that the viral load does not drop below a critical level that would compromise subsequent testing.

The "Performance Data" section details the reported device performance.

Acceptance Criteria (Implied)	Reported Device Performance
Maintain viability of HSV-1 in STM for transport.	HSV-1: At 4-8°C, TCID50/mL ranged from 4.77 x 10^5 (0h) to 3.32 x 10^5 (72h), with max reduction of -32.89% at 48h. At 20-25°C, TCID50/mL ranged from 4.28 x 10^5 (0h) to 2.71 x 10^5 (72h), with max reduction of -36.57% at 72h. Recovery in all replicates demonstrated at 72 hours.
Maintain viability of HSV-2 in STM for transport.	HSV-2: At 4-8°C, TCID50/mL ranged from 1.49 x 10^5 (0h) to 7.56 x 10^4 (72h), with max reduction of -49.24% at 72h. At 20-25°C, TCID50/mL ranged from 1.52 x 10^5 (0h) to 8.13 x 10^4 (72h), with max reduction of -46.55% at 72h. Recovery in all replicates demonstrated at 72 hours.
Maintain viability of Adenovirus in STM for transport.	Adenovirus: At 4-8°C, TCID50/mL ranged from 1.11 x 10^5 (0h) to 7.87 x 10^4 (72h), with max reduction of -29.33% at 72h. At 20-25°C, TCID50/mL ranged from 1.03 x 10^5 (0h) to 5.97 x 10^4 (72h), with max reduction of -41.77% at 72h. Recovery in all replicates demonstrated at 72 hours.
Maintain viability of VZV in STM for transport.	VZV: At 4-8°C, TCID50/mL ranged from 1.23 x 10^6 (0h) to 4.33 x 10^5 (24h), with reduction of -64.85% at 24h. At 20-25°C, TCID50/mL ranged from 1.08 x 10^6 (0h) to 1.43 x 10^6 (24h), with an increase of +32.13% at 24h. Recovery in all replicates demonstrated at 24 hours.
Maintain viability of Influenza A in STM for transport.	Influenza A: At 4-8°C, TCID50/mL ranged from 7.11 x 10^6 (0h) to 5.79 x 10^6 (24h), with reduction of -18.57% at 24h. At 20-25°C, TCID50/mL ranged from 5.52 x 10^6 (0h) to 2.21 x 10^6 (24h), with reduction of -60.00% at 24h. Recovery in all replicates demonstrated at 24 hours.
Support transport of specimens for mycoplasma testing.	Not Supported: "Data was insufficient to support use of this medium for transport of specimens for mycoplasma testing." This indicates a clear failure to meet an implied acceptance criterion for mycoplasma.
Overall conclusion of viral recovery for intended use species.	"The MedSchenker STM demonstrated the recovery of HSV-1, HSV-2, and Adenovirus in all replicates at tested incubation times and storage conditions. These data support the transportation of HSV-1, HSV-2, and Adenovirus in MedSchenker STM at refrigerated (4-8°C) or room temperature (20-25°C) for up to 72 hours. The MedSchenker STM also demonstrated the recovery of VZV and Flu A in all replicates at refrigerated (4-8°C) or room temperature (20-25°C), up to 24 hours." This statement represents the device meeting the overall implied acceptance criteria for the specified viruses and transport durations.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- For each viral strain (HSV-1, HSV-2, Adenovirus, VZV, Flu A), "three replicates" of inoculated swabs were tested.
- These replicates were tested across two temperatures (4-8°C and 20-25°C) and multiple time points (0, 24, 48, 72 hours for HSV-1, HSV-2, Adenovirus; 0, 24 hours for Flu A and VZV).
- Each time point was assessed using "3 lots of media."
- Therefore, the total number of individual tests (replicates x temperatures x time points x lots) is substantial for each virus. For HSV-1, for example: 3 replicates x 2 temperatures x 4 time points x 3 lots = 72 tests.
- The "negative nasopharyngeal clinical matrix" was used to prepare the viral samples, indicating the use of a relevant biological sample type.
Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given it is a premarket notification for an FDA submission, the data would typically be generated in a controlled laboratory setting, likely in the US or an equivalent regulatory region, and would be considered prospective for the purpose of demonstrating device performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of study does not rely on expert consensus for "ground truth" in the way an AI diagnostic imaging study would. The ground truth here is the measured viral viability (TCID50/mL) determined through laboratory assays (MTT assay and observation of cytopathic effects on host cell monolayers). This is an objective, quantitative measurement rather than an interpretive one requiring expert adjudicated consensus. Therefore, the concept of "number of experts" or their qualifications for establishing ground truth is not applicable in this context. The validity of the ground truth relies on the rigor of the laboratory procedures and controls.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpreters (e.g., radiologists) are making subjective judgments, and a consensus needs to be reached for the ground truth. As noted in point 3, this study involves objective laboratory measurements of viral viability (TCID50/mL) and cytopathic effects (CPE). There is no "adjudication" in the sense of reconciling differing expert opinions. The method involves conducting replicates and ensuring consistent results across those replicates and media lots.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance (e.g., radiologists interpreting images). The MedSchenker STM System is a transport medium, not an AI diagnostic tool, and therefore, an MRMC study is not relevant to its performance evaluation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is framed for AI algorithms. Interpreting it for this device: the "standalone" performance here refers to the inherent ability of the transport medium to maintain viral viability under specified conditions, without intervention or modification based on human interpretation or real-time adjustment. The viral recovery studies (as described in section 7, "Performance Data") are precisely this: a "standalone" evaluation of the transport medium's performance in preserving viral integrity. The results (TCID50/mL and percent change) are direct measures of the medium's efficacy.

7. The Type of Ground Truth Used

The ground truth used was quantitative viral viability measurements expressed as Tissue Culture Infectious Dose 50% per milliliter (TCID50/mL) and qualitative assessment of cytopathic effects (CPE) on host cell monolayers. This is a direct measure of the infectious viral particles remaining viable in the transport medium over time compared to the initial concentration. This is an objective, laboratory-based "outcomes data" rather than expert consensus or pathology in the traditional sense from clinical samples.

8. The Sample Size for the Training Set

This question is relevant for AI/machine learning models. The MedSchenker STM system is a physical transport medium, not a software algorithm that undergoes "training." Therefore, there is no "training set" in the context of this device.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for a physical transport medium, this question is not applicable. The device's performance is driven by its chemical composition and physical properties, which are validated through the performance studies described, not learned from data.

Summary

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May 3, 2023

MedSchenker, Inc. % Rhonda Alexander Sr. Consultant, Regulatory Strategy IUVO Consulting, LLC PO Box 56436 Virginia Beach, Virginia 23456

Re: K212743

Trade/Device Name: MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System Regulation Number: 21 CFR 866.2390 Regulation Name: Transport culture medium Regulatory Class: Class I, reserved Product Code: JSM Dated: December 16, 2022 Received: December 19, 2022

Dear Rhonda Alexander:

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.

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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 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 -S

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) K212743

Device Name

MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System

Indications for Use (Describe)

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

Date Prepared: April 25, 2023

1. SUBMITTER

MedSchenker Inc. 10 Industrial Ave Suite 4 Mahwah NJ. 07430 USA Tel: +1 201 458 9835 E-mail: info@medschenker.com Website: www.medschenker.com

Contact Person: Dr. Rhonda Alexander Sr. Consultant, Regulatory Strategy IUVO Consulting, LLC PO Box 56436 Virginia Beach, VA 23456 Tel: +1-757-582-4337 Email: ralexander(@juvoconsulting.com Website: www.iuvoconsulting.com

2. DEVICE

Name of Device:	MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
Classification Name:	Culture Media, Non-Propagating Transport
Regulatory Class:	Class I
Product Code:	JSM
Regulation:	21 CFR 866.2390

3. PREDICATE DEVICE

Copan Universal Transport Medium (UTM-RT) System (K042970) Manufacturer: Copan Diagnostics Inc.

4. DEVICE DESCRIPTION

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contains one screw-cap tube of STM-RT (room-temperature stable) medium and a peel pouch that contains a sterile specimen-collection swab.

. 1 screw-cap tube containing 1.5mL/2.0mL/3mL of transport medium
One sterile specimen-collection swab ●

Configurations to be marketed:

SKU	STM Tube Description	Pack size
STM15-A	1.5 mL Screw cap with Tube	50 Qty
STM20-A	2.0 mL Screw cap with Tube	50 Qty
STM30-A	3.0 mL Screw cap with Tube	50 Qty
SCS30-A	3.0 mL Screw cap with Tube +Nasopharyngeal CavSwab Swabs	50 Qty

5. INDICATIONS FOR USE

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.

6. SUMMARY OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject and predicate devices have the following similarities and differences:

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Device & Predicate Device(s):	Subject: K212743	Predicate: K042970
Device Trade Name	MedSchenker Smart TransportMedium (STM15-A/STM20-A/STM30-A/SCS30-A) System	Copan Universal Transport Medium(UTM-RT) System
General Device CharacteristicSimilarities
Intended Use/Indications For Use	MedSchenker Smart TransportMedium (STM15-A/STM20-A/STM30-A/SCS30-A) System isintended for the collection andtransport of upper respiratory clinicalspecimens, containing respiratoryviruses, from the collection site to thetesting laboratory. MedSchenker SmartTransport Medium (STM15-A/STM20-A/STM30-A/SCS30-A)System is a culture-based medium thatcan be processed using standardclinical laboratory operatingprocedures for the recovery ofinfectious viral particles.	Copan Universal Transport Medium(UTM-RT) System is intended for thecollection and transport of clinicalspecimens containing viruses,chlamydiae, mycoplasma orureaplasma from the collection site tothe testing laboratory. UTM-RT can beprocessed using standard clinicallaboratory operating procedures forviral, chlamydial, mycoplasma andureaplasma culture.
Media formulation	Amphotericin BBovine Serum AlbuminHank's Balanced Salt SolutionVancomycinColistinGelatinHEPESL-cysteineL-glutamic acidPhenol RedSucrose	Same
Container for medium	Plastic, conical bottom	Same
Product configuration	Medium Tubes; Kit with MediumTubes andSwab Option	Same
Storage Temperature	2 - 25℃ (refrigerated and roomtemperature)	Same
Shelf Life	12 months	Same
Single Use	Yes	Same
General Device CharacteristicDifferences
Microorganisms Supported	Viruses:Influenza A (H1N1)Type 5 AdenovirusHerpes Simplex 1Herpes Simplex 2Varicella-Zoster Virus	Viruses:AdenovirusCytomegalovirus (CMV)Echovirus Type 30 (Echo 30)Herpes Simplex Virus Type 1 (HSV1)HSV2Influenza AParainfluenza Type 3Respiratory Syncytial Virus (RSV)Varicella Zoster Virus (VZV)Chlamydiae:Chlamydia pneumoniae Strain CM-1Chlamydia trachomatis Type 1 Strain
		Mycoplasma:Mycoplasma hominisMycoplasma pneumoniaeUreaplasma:Ureaplasma urealyticum
pH Stability	7.3 ± 0.5 maintained up to 12 months	7.3 ± 0.2 maintained up to 12 months
Swab material	Nylon tip with break point	Polyester

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7. PERFORMANCE DATA

The following performance study data were provided in support of the substantial equivalence determination.

Viral recovery studies. Strains of HSV-1, HSV-2, VZV, Flu A, and Adenovirus were used for transport media validation. Each viral strain was mixed with negative nasopharyngeal clinical matrix, followed by a 1:2 dilution with 0.85% saline to obtain diluted viral samples for testing. CavSwabs were used to soak up 100 uL of each concentration of viruses in three replicates. Three replicates of the inoculated swabs were then transferred into tubes with the MedSchenker STM, one swab per tube, and incubated at room temperature (20-25°C) or refrigerated (4-8°C) for 0, 24, 48, and 72 hours for HSV-1, HSV-2, and Adenovirus, and for 0 and 24 hours for Flu A and VZV. Each time point was assessed using 3 lots of media. After each time point, the swabs were centrifuged and then removed from the transport media tube and a 50 uL aliquot of the test suspension was seeded onto the appropriate host cell monolaver and incubated at 37℃ (5% CO2) for 3-5 days. Viral viability was assessed via cytopathic effects (CPE) using the MTT assay. The table below shows the summary and recovery of the 1:2 dilution of each viral strain at the indicated times and temperatures. Viral recovery is represented as TCID50 mL and percent change over time.

		4-8°C		20-25°C
Viral strains	Duration(hours)	TCID50/mL	Percent change (%)(-ve indicates reduction)	TCID50/mL	Percent change (%)(-ve indicates reduction)
HSV-1	0	4.77 x 105	0	4.28 x 105	0
	24	4.18 x 105	-12.40	2.87 x 105	-32.91
	48	3.20 x 105	-32.89	4.09 x 105	-4.47
	72	3.32 x 105	-30.30	2.71 x 105	-36.57
HSV-2	0	1.49 x 105	0	1.52 x 105	0
	24	1.45 x 105	-2.88	1.24 x 105	-18.60
	48	1.54 x 105	+3.78	1.26 x 105	-14.35
	72	7.56 x 104	-49.24	8.13 x 104	-46.55
Adenovirus	0	1.11 x 105	0	1.03 x 105	0
	24	9.95 x 104	-10.72	1.00 x 105	-2.57
	48	9.26 x 104	-16.89	8.76 x 104	-14.62
	72	7.87 x 104	-29.33	5.97 x 104	-41.77
VZV	0	1.23 x 106	0	1.08 x 106	0
	24	4.33 x 105	-64.85	1.43 x 106	+32.13

Summary of recovered viral viability at 4-25°C

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Influenza A	0	7.11 x 106	0	5.52 x 106	0
		24	5.79 x 106	-18.57	2.21 x 106

Conclusion of the culture-based viral recovery study: The MedSchenker STM demonstrated the recovery of HSV-1, HSV-2, and Adenovirus in all replicates at tested incubation times and storage conditions. These data support the transportation of HSV-1, HSV-2, and Adenovirus in MedSchenker STM at refrigerated (4-8°C) or room temperature (20-25°C) for up to 72 hours.

The MedSchenker STM also demonstrated the recovery of VZV and Flu A in all replicates at refrigerated (4-8°C) or room temperature (20-25°C), up to 24 hours.

The MedSchenker STM was also evaluated for mycoplasma viability at different incubation times and temperatures. Data was insufficient to support use of this medium for transport of specimens for mycoplasma testing

8. CONCLUSION

Based on the indications for use, technological characteristics, safety, and performance testing, the subject device, the MedSchenker Smart Transport Medium (STM15-A/STM30-A/SCS30-A) System, meets the requirements that are considered essential for its intended use and supports a decision of substantial equivalence to a legally marketed device.

Regulation Number and Section

§ 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).