Medical Wire & Equipment Virocult® Virus Collection and Transport System is intended to preserve the viability and infectivity of viral specimens for viral culture after their collection and during transport from the collection site to the testing laboratory. Virocult specimens are processed using standard clinical laboratory operating procedures for viral and cell culture.

Device Description

Each Virocult® device comprises a sterile peel pouch containing a rayon- tipped swab used to collect the sample and a tube containing an open cell polyurethane pad soaked with Virocult® virus transport medium. After sampling, the swab applicator is placed inside the tube, where the bud is bathed with the liquid from the foam pad.

Virocult® medium consists of a phosphate-buffered balanced salt solution, glucose, lactalbumin hydrolysate to stabilise the virus particles, and antibiotics to inhibit the growth of other microorganisms that may be present in the clinical specimen.

The rayon- tipped swab will suit most general applications such as mouth, nose, throat and skin.

To use Virocult®, the sterile peel pouch is opened, and the cap removed from the transport tube. The applicator swab is removed from the pouch and used to collect the clinical specimen. During specimen collection, the applicator should only fouch the area where the infection is suspected.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medical Wire Virocult® Virus Collection and Transport System:

Based on the provided 510(k) summary, the device is a virus collection and transport system, not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study designs associated with AI medical devices (like those involving expert adjudication, multi-reader multi-case studies, or AI standalone performance) are not applicable to this submission.

The "acceptance criteria" for a device like this would primarily revolve around its ability to preserve viral viability and infectivity, its stability over time, and its pH, recovery, and toxicity characteristics as a transport medium. The study done proves its performance against these criteria.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
CLSI (NCCLS) M40-A Compliance	Simulating transport at 4°C	Tests were done to simulate transport at 4°C and at 23°C for swabs within date and swabs 2 months beyond expiry. The submission implies compliance without giving specific performance metrics against a defined standard (e.g., "X% viral recovery").
	Simulating transport at 23°C	Tests were done to simulate transport at 4°C and at 23°C for swabs within date and swabs 2 months beyond expiry. The submission implies compliance without giving specific performance metrics against a defined standard (e.g., "X% viral recovery").
Expiration Date Support	12-month shelf life validation	Stability studies were performed to support a 12-month expiration date.
	Recovery testing	Demonstrated stability over its 12-month shelf life.
	pH testing	Demonstrated stability over its 12-month shelf life.
	Toxicity testing	Demonstrated stability over its 12-month shelf life.
	Visual inspection	Demonstrated stability over its 12-month shelf life.

Study Details

Given this is a 510(k) for a physical medical device (transport medium), the study details differ significantly from those for AI/Software as a Medical Device (SaMD).

Sample sizes used for the test set and the data provenance:
- The document does not specify exact sample sizes (e.g., number of swabs, number of viral strains, number of tests conducted) for the performance testing. It generally states that "Tests were done to simulate transport" and "Stability studies were performed."
- Data Provenance: The studies were conducted by the manufacturer, Medical Wire & Equipment Company (Bath) Ltd., as part of their 510(k) submission. The country of origin for the testing would presumably be the UK, where the company is based. The studies appear to be laboratory-based performance evaluations rather than clinical trials with patient data, so they are prospective in the sense of being planned experiments.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device used to collect and transport biological samples, not an AI system making diagnostic interpretations. "Ground truth" in this context would be defined by the known initial viral concentration in the samples used for testing, and the known conditions (temperature, time) that the samples were subjected to. These would be laboratory-controlled parameters, not expert-adjudicated diagnoses.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication of diagnostic outcomes is involved. The evaluation relies on laboratory measurements of viral viability/recovery.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical collection and transport device, not an AI system or an AI-assisted diagnostic tool. There are no "human readers" (e.g., radiologists, pathologists) whose performance would be improved by this device in a diagnostic context, nor is there any AI involved.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the performance testing (viral recovery, stability), the ground truth is primarily established through laboratory standards and controls. This would involve:
  - Known initial concentrations of specific viruses (reference strains).
  - Standardized methods for viral culture and quantification (e.g., plaque assays, PCR measurement of viral load) to determine recovery rates after transport.
  - Measurement against established benchmarks for acceptable viral viability post-transport (likely derived from CLSI guidelines or internal validation against predicate devices).
The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/machine learning model that requires a "training set."
How the ground truth for the training set was established:
- Not Applicable. As there is no AI or machine learning model, there is no "training set" or ground truth for it. The product's formulation and specifications are based on scientific principles of viral preservation and chemical stability, not trained data.

Summary

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510(k) Summary for Medical Wire Virocult® Virus Collection and 8.0 Transport System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is: K082472.

1. Submitter	Medical Wire & Equipment Company (Bath) Ltd.,
	Leafield Industrial Estate,
	Corsham,
	Wiltshire,
	SN13 9RT
	United Kingdom
Contact person	David Ellis
Telephone	+441225810361

Date prepared 28 July 2008

2. Device Name

Proprietary Name	Medical Wire & Equipment Virocult®
Common / Usual Name	Virus Collection and TransportDevice
Product Code	LIO
FDA Device Regulation Numberand Classification Name	Sec. 866.2900 MicrobiologicalSpecimen collection and transportdevice

3. Predicate Devices

Becton Dickinson Viral Culturette™	(K800832)
Copan Viral Transystem™	(K001780)

4. Device Description

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The rayon- tipped swab will suit most general applications such as mouth, nose, throat and skin.

5. Intended Use

6. Technological characteristics and substantial equivalence

Medical Wire & Equipment's Virocult® products are substantially equivalent in design, intended use, and overall function to other FDA approved commercially distributed products used for the collection and transport of viruses. Specifically Virocult® products are equivalent to the Becton Dickinson Viral Culturette (K800832), and the the Copan Viral Transystem (K001780).

Medical Wire & Equipment's Virocult® device, and the substantially equivalent products are all sterile, single use devices intended for use in the collection, transport, and preservation of microbial specimens for culture. The candidate and predicate devices are equivalent in design and function in that single applicators are used for collection of the specimen and the swab applicator is then inserted into a tube containing medium for transport and preservation. Both Virocult®, and the predicate devices are offered in collection kit formats with specimen collection swabs.

7.0 Performance testing

Virocult® virus transport swabs have been tested in accordance with CLSI (NCCLS) 'Quality Control of Microbiological Transport Systems'; Approved Standard M40-A. Tests were done to simulate transport at 40C and at 23 ℃. The tests were performed both on swabs within date, and swabs which had gone 2 months beyond their expiry date.

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Stability studies were performed on Medical Wire & Equipment's Virocult® products to support performance for a 12-month expiration date. Recovery testing, pH testing, toxicity testing and visual inspection were performed which demonstrated the stability of Medical Wire & Equipment's Virocult® over its 12 month shelf life.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Douglas Shedden Technical & Development Manager Medical Wire & Equipment Company (Bath) Ltd. Potley Lane, Corsham Wiltshire, SN13 9RT United Kingdom

DEC 3 0 2008

Re: K082472 Trade/Device Name: VIROCULT® Viral Specimen Transport Device Regulation Number: 21 CFR 866.2900 Regulation Name: Microbiological specimen collection and transport device Regulatory Class: Class I Product Code: LIO Dated: December 8, 2008 Received: December 10, 2008

Dear Mr. Shedden:

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 predicated and casines marketed in interstate commerce prior to May 28, 1976, the enactment date af 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, morket 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 either class II (Special Controls) or class III (PMA), 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 administeried 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); and good manufacturing practice requirements, as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

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 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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally attayma

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 (if known): K082472

Device Name: Medical Wire & Equipment Virocult® Virus Collection and Transport System

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Uke Schuf
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082472

Regulation Number and Section

§ 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.