(183 days)
Not Found
No
The device is a protective cover for ultrasound transducers and does not perform any analytical or processing functions that would require AI/ML.
No.
The device is a protective cover for an ultrasound transducer, intended to prevent the transfer of microorganisms and bodily fluids, not to directly treat a medical condition.
No
Explanation: The device is a protective cover for an ultrasound transducer, not the transducer itself. Its function is to prevent pathogen transmission and does not perform any diagnostic imaging or analysis.
No
The device description clearly states it is a "protective cover" made of material (PU) and is a physical product intended to be placed over an ultrasound transducer. It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Protective cover placed over diagnostic ultrasound transducer/ probe/scanhead instruments." Its primary function is to prevent the transfer of microorganisms and body fluids during ultrasound procedures.
- Mechanism of Action: The device acts as a physical barrier. It does not analyze or test samples taken from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections. This device does not perform such tests.
The device is a medical device used in conjunction with a diagnostic ultrasound system, but it is not itself a diagnostic device.
N/A
Intended Use / Indications for Use
Protective cover placed over diagnostic ultrasound transducer/probe/scanhead instruments. The cover allows use of the transducer in scanning procedures for body surface, endocavity, and intra-operative diagnostic ultra-sound, while helping to prevent transfer of microorganisms, body-fluids, and material to the patient and healthcare worker during reuse of the transducer.
Ultra-Cover® PU-transducer covers are furnished sterile; single use patient/procedure, disposable.
The intended use and indications for use place Ultra-Cover® PU-transducer covers in device body contact categories as follows:
- a) surface devices, intact skin/mucosal membranes/ breached surfaces, limited contact duration . (
§ 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 text "SEP 23 1998". The text is written in a simple, handwritten font. The letters and numbers are all clearly legible. The date is likely a stamp or handwritten note on a document.
International Medical
Poly-urethane Ultrasound Transducer Cover 510 (k) SUMMARY
Date Summary Prepared: 2 october 1997
Submitter's Name: Address Telephone No: Contact Person:
International Medical Products BV Gerritsenweg 5, 7202 BP, Zutphen, Holland (+31)(0575)596500 fax: (+31)(0575)519639 H.G te Winkel, Product-Manager
Establishment Registration Number:
Device Trade/ Proprietary Name: Device Common/ Usual Name: Device Classification Name:
Ultra-Cover® PU-transducer cover Ultrasound Transducer Cover/ Sheath/Drape Ultrasonic Diagnostic Transducer Accessories
Classification: Classification Panel: Classification Procode: Class II under 21 CFR 892.1570 90 Radiology ITX
Description of Predicate device(s): The Ultra-Cover ® PU transducer cover is equivalent to Civco Medical Instruments legally marketed Poly Ultrasound Transducer Cover, 510(k) reference number K970513
8030461
1
International Medical
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Description of Subiect Device Submitted for Premarket Notification: Ultra-Cover® PUtransducer covers provides an efficient, conformal covering to fit various & specific ultrasound transducer geometries. The cover helps prevent the transmission of pathogens from one patient to another.
Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required transmission gel onto the transducer face or into open end of cover, inserting ultrasound transducer into closed end of cover. The removal process is a reverse method from the application.
Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries.
Covers are packaged in both sterile and non-sterile procedure kit form for single patient/procedure, disposable use.
Product categories/models include:
General Purpose Ultra-Cover® PU-transducer covers (sterile and non sterile) Intraoperative Ultra-Cover® PU-kits (sterile)
Intended use/ Indications for use: Protective cover placed over diagnostic ultrasound transducer/ probe/scanhead instruments.The cover allows use of the transducer in scanning procedures for body surface, endocavity, and intra-operative diagnostic ultra-sound, while helping to prevent transfer of microorganisms, body-fluids, and material to the patient and healthcare worker during reuse of the transducer.
Ultra-Cover® PU-transducer covers are furnished sterile; single use patient/procedure, disposable.
The intended use and indications for use place Ultra-Cover® PU-transducer covers in device body contact categories as follows:
- a) surface devices, intact skin/mucosal membranes/ breached surfaces, limited contact duration . (