(746 days)
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No
The summary describes a transducer cover and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a "Transducer Cover," which suggests it is an accessory for a transducer, likely to maintain hygiene or protect the transducer. It does not inherently perform a therapeutic action on a patient.
No
The device description "EVERYTIME™ Transducer Cover" suggests it is an accessory used for hygiene or protection for a transducer, not a device that itself diagnoses medical conditions.
No
The device description "EVERYTIME™ Transducer Cover" clearly indicates a physical component, not a software-only device.
Based on the provided information, it is highly unlikely that the EVERYTIME™ Transducer Cover is an IVD (In Vitro Diagnostic) device.
Here's why:
- Lack of IVD Characteristics: The description only mentions "Transducer Cover." IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. A transducer cover is a physical barrier used during imaging procedures, not for analyzing biological samples.
- Missing Information: The provided text lacks any information typically associated with IVD devices, such as:
- Intended Use related to analyzing specimens.
- Mention of biological samples or assays.
- Performance metrics relevant to diagnostic testing (sensitivity, specificity, etc.).
Conclusion:
The EVERYTIME™ Transducer Cover appears to be an accessory used with medical imaging equipment (likely ultrasound transducers) to maintain hygiene and prevent contamination. This function does not align with the definition of an In Vitro Diagnostic device.
No
Explanation: The provided clearance letter does not contain any information or mention of a Predetermined Change Control Plan (PCCP). For a device to be a PCCP authorized device, the clearance letter would explicitly state this authorization and the details of the PCCP.
Intended Use / Indications for Use
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Product codes
90 ITX
Device Description
EVERYTIME™ Transducer Cover
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a simple, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 1997
Ms. Gina Azarik Market Manager AMEDIC AB Turebergsvagen 5 191 47 SOLLENTUNA SWEDEN
Re: K955893
EVERYTIME™ Transducer Cover Dated: September 29, 1997 Received: October 1, 1997 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Ms. Azarik:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject io such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivaliation assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Kilian Ym
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health