MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE

K103805 · Medical Wire & Equipment Company (Bath), Ltd. · LIO · Jan 25, 2011 · Microbiology

Device Facts

• Record ID: K103805
• Device Name: MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
• Applicant: Medical Wire & Equipment Company (Bath), Ltd.
• Product Code: LIO · Microbiology
• Decision Date: Jan 25, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.2900
• Device Class: Class 1

Indications for Use

Medical Wire & Equipment Σ-Transwab (Sigma-Transwab ) Specimen Collection and Transport System is intended to preserve the viability and infectivity of microbiological specimens after their collection and during transport from the collection site to the testing laboratory. Σ-Transwab specimens are processed using standard clinical laboratory operating procedures for microbiological specimens.

Device Story

System consists of a sterile swab and a transport tube containing liquid Amies medium. Used by clinicians to collect microbiological specimens from patients. Swab is used to sample the site; then placed into the transport tube. Liquid medium preserves specimen viability and infectivity during transport to the laboratory. Once at the laboratory, specimens are processed using standard clinical procedures. Device facilitates safe transport of potentially infectious material, ensuring sample integrity for diagnostic testing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Consists of a swab and a transport tube containing liquid Amies medium. Designed for microbiological specimen collection and transport. Class I device under 21 CFR 866.2900.

Indications for Use

Indicated for the collection and transport of microbiological specimens to maintain viability and infectivity during transit to a clinical laboratory for analysis.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, rendered in a simple, abstract design.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

| Medical Wire & Equipment Co (Bath) LTD |
|----------------------------------------|
| c/o David Ellis |
| Director of Operations |
| Potley Lane |
| Corsham |
| Wilshire, SN 13 9RT |
| UK |

| | JAN 2 5 2011 |
|--|--------------|
|--|--------------|

| Re: | K103805 |
|--------------------|-------------------------------------------------------------------------------------------|
| Trade/Device Name: | Medical Wire & Equipment S-Transwab ^® (or Sigma-Transwab ^® ) Liquid |
| Regulation Number: | 21 CFR § 866.2900 |
| Regulation Name: | Microbiological specimen collection and transport device |
| Regulatory Class: | Class I |
| Product Code: | LIO, JTW |
| Dated: | December 22, 2010 |
| Received: | December 28, 2010 |

Dear Mr. Ellis:

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. 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 administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

{1}------------------------------------------------

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).

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97).

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Saly aut
Sally A. Harrist, M.Sc., Ph.D.

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: Medical Wire & Equipment Σ-Transwab® (or Sigma-Transwab®) Liquid Amies Collection and Transport Device

Indications for Use:

Medical Wire & Equipment Σ-Transwab (Sigma-Transwab ) Specimen Collection and Transport System is intended to preserve the viability and infectivity of microbiological specimens after their collection and during transport from the collection site to the testing laboratory. Σ-Transwab specimens are processed using standard clinical laboratory operating procedures for microbiological specimens.

Prescription Use _ X AND/OR Over-The-Counter Use .(Part 21 CFR 801 Subpart D) (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

Division sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103805