(28 days)
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No
The summary describes a specimen collection and transport system, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is intended for the collection and transport of microbiological specimens, not for treating any medical condition.
No
Explanation: The device is a specimen collection and transport system, which acts as a precursor to diagnostic testing by preserving samples. It does not perform the diagnostic analysis itself.
No
The 510(k) summary describes a specimen collection and transport system, which is a physical device (swab and transport medium), not a software-only device.
Based on the provided information, the Medical Wire & Equipment Σ-Transwab (Sigma-Transwab) Specimen Collection and Transport System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device 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." This directly relates to the collection and preparation of biological specimens for in vitro (outside the body) diagnostic testing.
- Processing in a Clinical Laboratory: The specimens are processed using "standard clinical laboratory operating procedures for microbiological specimens." This confirms that the specimens collected with this device are intended for analysis in a laboratory setting, which is a key characteristic of IVD use.
While the document doesn't explicitly state "IVD," the intended use and the context of its use in a clinical laboratory for microbiological testing clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LIO, JTW
Device Description
Medical Wire & Equipment S-Transwab ® (or Sigma-Transwab ®) Liquid
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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
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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)
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Division sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103805