(124 days)
Not Found
No
The device description focuses on a physical collection and transport system for viral specimens, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a collection and transport system intended to preserve viral specimens for viral culture, not for directly treating a medical condition.
No
The device is intended to preserve and transport viral specimens for viral culture, not to diagnose a condition itself.
No
The device description clearly outlines physical components: a sterile peel pouch, a rayon-tipped swab, and a tube containing a polyurethane pad soaked in transport medium. This is a hardware device for specimen collection and transport.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device 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." This describes a product used in vitro (outside the body) to prepare a biological specimen for subsequent diagnostic testing.
- Device Description: The description details a system for collecting and transporting a clinical specimen (viral specimen) to a laboratory for testing. This is a key characteristic of IVD devices.
- Processing in a Laboratory: The intended use mentions that "Virocult specimens are processed using standard clinical laboratory operating procedures for viral and cell culture." This confirms the specimens are being prepared for analysis in a laboratory setting, which is where IVD tests are performed.
- Predicate Devices: The listed predicate devices (Becton Dickinson Viral Culturette™ and Copan Viral Transystem™) are also known IVD devices used for specimen collection and transport for viral testing. This further supports the classification of Virocult® as an IVD.
While the device itself doesn't perform the diagnostic test, it is an essential component in the process of performing an in vitro diagnostic test by ensuring the integrity of the specimen for subsequent analysis.
N/A
Intended Use / Indications for Use
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.
Product codes
LIO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth, nose, throat and skin
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)
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.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Transport |
| Device | |
| Product Code | LIO |
| FDA Device Regulation Number | |
| and Classification Name | Sec. 866.2900 Microbiological |
| Specimen collection and transport | |
| device |
3. Predicate Devices
| Becton Dickinson Viral Culturette™ | (K800832) |
|---|---|
| Copan Viral Transystem™ | (K001780) |
4. Device Description
1
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.
5. Intended Use
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.
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.
2
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.
3
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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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
5
Indications for Use
510(k) Number (if known): K082472
Device Name: Medical Wire & Equipment Virocult® Virus Collection and Transport System
Indications For Use:
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.
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