(51 days)
Not Found
No
The device is a physical cover for an ultrasound transducer and the description focuses on its material properties and barrier function, with no mention of software, algorithms, or data processing.
No.
The device is a protective cover for ultrasound transducers, intended to prevent the transfer of microorganisms and maintain a sterile field, not to treat or diagnose a medical condition.
No.
The device is a protective cover for diagnostic ultrasound transducers, not a diagnostic device itself. Its purpose is to prevent the transfer of microorganisms and maintain a sterile field during ultrasound procedures.
No
The device is a physical cover made of polychloroprene (neoprene) synthetic rubber, designed to be placed over ultrasound transducers. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to provide a protective barrier for ultrasound transducers to prevent the transfer of microorganisms and maintain a sterile field. It facilitates the use of the transducer for diagnostic ultrasound procedures, but it does not perform a diagnostic test itself.
- Device Description: The device is a physical cover made of polychloroprene. It does not contain reagents, analyze biological samples, or produce a diagnostic result.
- Lack of Diagnostic Function: The description focuses on the physical properties of the cover (strength, elasticity, barrier properties) and its ability to allow ultrasound imaging without impairment. There is no mention of it analyzing any biological material or providing diagnostic information.
- Predicate Device: The predicate device is a "Latex Ultrasound Transducer Cover," which also serves a protective function, not a diagnostic one.
In summary, the CIVCO NeoFlex™ Ultrasound Transducer Cover is an accessory used with a diagnostic ultrasound device, but it is not a diagnostic device itself. It is a barrier device intended to improve hygiene and safety during ultrasound procedures.
N/A
Intended Use / Indications for Use
The NeoFlex™ Ultrasound Transducer Cover is a 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 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). NeoFlex™ is latex-free and therefore beneficial when treating a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitized. Transducer covers are furnished sterile & non-sterile; single use patient / procedure, disposable.
The intended use and indications for use place NeoFlex™ 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
JUN 2 1999
CIVCO
MEDICAL INSTRUMENTS
K991236 (5 pages)
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
(As required by 21 CFR 807.92)
NeoFlex™ Ultrasound Transducer Cover
A. General Information
| Submitter's Name: | CIVCO Medical Instruments Company, Inc. |
|---|---|
| Address: | 102 First Street South, Kalona, IA 52247 |
| Telephone No.: | phone (319) 656-4447 fax: (319) 656-4451 |
| Contact Person: | J. William Jones, Manager - Regulatory Affairs |
1937223 Establishment Reqistration Number: CIVCO Medical Instruments is registered as a medical device manufacturer.
| Device Trade: | NeoFlex™ Ultrasound Transducer Cover |
|---|---|
| Device Common: | Ultrasound Transducer Cover / Sheath / Drape |
| Device Classification Name: | Ultrasonic Diagnostic Transducer Accessories |
Classification: Classification Panel: Classification Procode: Class II under 21 CFR 892.1570 Radiology 90 ITX
Performance Standards: No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
B. Device Description
The NeoFlex™ Ultrasound Transducer Cover device provides a thin, conformal covering to fit various & specific ultrasound transducer geometries. Device is manufactured as a one-piece design that provides a covering that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another.
Cover material is polychloroprene (neoprene) synthetic rubber similar to that of nonlatex medical examination / surgical gloves. Type I natural latex allergy does not occur in response to polychloroprene synthetic rubber since the synthetic rubber does not contain the natural protein allergen residuals present in latex.
Page II - 1
CIVCO North America
02 First Street South Kalona, IA 52247-9589 USA Phone: 319.656.4447 Fax: 319.656.4451 www.civcomedical.com
Image /page/0/Picture/18 description: The image contains two logos. The logo on the left is a circle with the text "QUALITY ASSURED FIRM" around the top half of the circle. Inside the circle is the text "ISO 9001" with a checkmark below it. The text "SGS" is below the checkmark. The logo on the right is a square with a crown on top. Inside the square is a checkmark and the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES".
Image /page/0/Picture/19 description: The image is a black and white logo for a company that is quality assured. The logo is circular in shape, with the words "QUALITY ASSURED FIRM" written around the top half of the circle. The letters "EN" are written above the number "46001" in the center of the circle. A check mark is below the number, and the letters "SGS" are at the bottom of the circle.
IV CO Europe
Avenue Louise 65, box 11 1050 Brussels Belgium Phone: +32(02)535.7881 Fax: +32(02)535.7700 www.civcomedical.com
1
Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:
General Purpose NeoFlex™ Transducer Covers (sterile and non-sterile)
Endocavity NeoFlex™ Transducer Covers (sterile and non-sterile)
Surgi-Tip™ Intraoperative* Transducer Covers (sterile) *polyethylene cord cover w/ NeoFlex ™ tip
Covers are packaged in both sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Transducer covers are also combined with disposable needle guide devices into custom kits that CIVCO builds for ultrasound OEMs and end users.
C. Intended Use / Indications for Use
The NeoFlex™ Ultrasound Transducer Cover is a 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 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). NeoFlex™ is latex-free and therefore beneficial when treating a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitized. Transducer covers are furnished sterile & non-sterile; single use patient / procedure, disposable.
The intended use and indications for use place NeoFlex™ Ultrasound Transducer Covers in device body contact categories as follows:
- a) surface devices, intact skin / mucosal membranes / breached surfaces, limited contact duration (