(129 days)
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 Poly Ultrasound Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.
CIVCO Poly Ultrasound Transducer Cover - this device provides an efficient, 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. Materials are polyurethane (CIV-Flex™) and polyethylene extruded thermoplastic film.
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 Poly 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 the cover off the transducer in a reverse method from the application.
Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:
General Purpose CIV-Flex™ (polyurethane) Transducer Covers (sterile and non-sterile) General Purpose Polyethylene Transducer Covers (sterile and non-sterile) Accordion-folded Polyethylene Transducer Covers (sterile) Intraoperative Polyethylene Transducer Covers (sterile) Endocavity CIV-Flex™ (polyurethane) Transducer Covers (sterile and non-sterile) Surgi™ Intraoperative (polvethylene) Transducer Covers (sterile) Intraoperative (polyethylene) Cord and System Drapes (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. Poly transducer covers are also combined with disposable needle guide devices that CIVCO custom kits for ultrasound OEMs.
The provided document describes the K970513 (CIVCO Poly Ultrasound Transducer Cover) 510(k) summary, which outlines the device's characteristics and its substantial equivalence to a predicate device, K844472 (CIVCO's Scan Drape). The acceptance criteria and the study proving the device meets these criteria are primarily based on demonstrating equivalence in materials, manufacturing, safety (biocompatibility), and effectiveness (barrier properties) to a previously cleared device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria or quantifiable performance metrics in a table format. Instead, it relies on demonstrating equivalence to the predicate device and satisfactory results from specific tests.
| Acceptance Criteria Category | Description of Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Both subject and predicate devices provide a thin, conformal protective cover system for ultrasound transducer usage in body surface, endocavity, and intra-operative patient environments. Both help prevent microorganism, body fluid, and particulate material transfer, and maintain a sterile field where applicable. Both are disposable. | The CIVCO Poly Ultrasound Transducer Cover fulfills these intended uses and indications as described. It is equivalent to the predicate device in its application for diagnostic ultrasound across various body contact categories (surface, external communicating) and contact durations ( |
§ 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.