(129 days)
Not Found
No
The device is a passive physical barrier (a latex cover) for ultrasound transducers and does not involve any data processing or algorithmic functions.
No.
The device is a protective cover for diagnostic ultrasound transducers, intended to prevent the transfer of microorganisms and maintain a sterile field. It does not provide any therapeutic benefit or treat any medical condition.
No
Explanation: This device is a protective cover for diagnostic ultrasound transducers. Its purpose is to prevent the transfer of microorganisms and maintain a sterile field, not to perform a diagnostic function itself.
No
The device is a physical latex cover for ultrasound transducers, not a software program.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to cover an ultrasound transducer during diagnostic ultrasound procedures performed on the patient's body (body surface, endocavity, intra-operative). It does not analyze samples taken from the patient.
- The device's function is a physical barrier. Its primary purpose is to prevent the transfer of microorganisms, body fluids, and particulate material between the transducer and the patient/healthcare worker. It facilitates the diagnostic procedure but is not directly involved in the in vitro analysis of biological samples.
- The performance studies focus on barrier properties and biocompatibility. These are relevant to a device that comes into contact with the patient and is intended to prevent contamination, not to a device that performs diagnostic tests on biological samples.
Therefore, this device is a medical device used in conjunction with an ultrasound system for diagnostic imaging, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Latex Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.
The intended use and indications for use place CIVCO Latex Ultrasound 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
K9 70515
Image /page/0/Picture/1 description: The image contains the text 'B2 of B4'. The text is written in a simple, sans-serif font. The letters and numbers are clearly legible against the white background.
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Solutions for Ultrasound
JUN 20 1997
510 (k) SUMMARY_______________________________________________________________________________________________________________________________________________________________
CIVCO Latex Ultrasound Transducer Cover
Date Summary Prepared: 30 January 1997
This summary of the safety and effectiveness information upon which the substantial equivalence determination is based is being submitted in accordance with the requirements of SMDA 1990.
Submitter's Name: Address: Telephone No.: Contact Person:
CIVCO Medical Instruments Company, Inc. 102 First Street South, Kalona, IA 52247 (319) 656-4447 fax: (319) 656-4451 J. William Jones, Manager - Regulatory Affairs
Establishment Registration Number: 1937223 CIVCO Medical Instruments is registered as a medical device manufacturer.
Device Trade / Proprietary Name: Device Common / Usual Name: Device Classification Name:
Classification: Classification Panel: Classification Procode: CIVCO Latex Ultrasound Transducer Cover Ultrasound Transducer Cover / Sheath / Drape Ultrasonic Diagnostic Transducer Accessories
Class II under 21 CFR 892.1570 90 Radiology ITX
Description of Predicate Device(s): The CIVCO Latex Ultrasound Transducer Cover is equivalent to CIVCO's currently, legally marketed Latex Ultrasound Sheath, 510(k) reference number K895614.
ORIGINALS ARE CODED RED
sheet 1 of 3
102 First Street South • Kalona, IA 52247 USA Phone: 319/656-4447 • Fax: 319/656-4451 E-mail: info@civcomedical.com
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B3 of B4 510 (k) SUMMARY con't.
Description of Subject Device Submitted for Premarket Notification: Latex Ultrasound Transducer Cover - this device provides an efficient, thin, conformal covering to fit various & specific ultrasound transducer geometries. Devices are manufactured as a one-piece design that provides a covering that helps prevent the transmission of pathogens from one patient to another. Covers are beaded and rolled for easy application to the transducer. Cover materials are dipmolded Natural Rubber Latex similar to that of patient / surgical gloves.
Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required - the sterile or non-sterile Latex Ultrasound Transducer Cover is utilized by applying sterile transmission, coupling, or lubricating gel onto the transducer face or into closed end of cover, inserting ultrasound transducer into closed end of cover and unrolling cover over length of the transducer as desired, and securing open end of cover with bands as necessary. The removal process is accomplished by pulling or unrolling the cover off the transducer in a reverse method from the application, resulting in the cover being turned inside out.
Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:
General Purpose Latex Transducer Covers (sterile and non-sterile) PROcovers™ Endocavity Latex Transducer Covers (sterile and non-sterile) Endocavity Latex Transducer Covers (sterile and non-sterile) Bulk Packaged Endocavity Latex Transducer Covers (non-sterile) Endocavity Accessories - non-sterile latex fingercots Transesophageal Echocardiography (TEE) Covers (sterile)
Covers are packaged in both sterile and non-sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Latex transducer covers are also combined with disposable needle guide devices that CIVCO custom kits for ultrasound OEMs.
Intended Uses / Indications for Use: Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Latex Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.
The intended use and indications for use place CIVCO Latex Ultrasound Transducer Covers in device body contact categories as follows:
- a) surface devices, intact skin / mucosal membranes / breached surfaces, limited contact duration (