(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 Latex Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.
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.
The provided text describes the 510(k) summary for the CIVCO Latex Ultrasound Transducer Cover. While it details the device's features, intended use, and comparison to a predicate device, it does not present a typical acceptance criteria table with reported device performance in a quantitative manner as would be found in a clinical study for an AI/ML device.
This document is for a medical device (ultrasound transducer cover), not an AI/ML diagnostic tool, and therefore the types of studies and acceptance criteria are different. The evaluation focuses on physical properties, biocompatibility, and barrier effectiveness rather than diagnostic performance metrics like sensitivity, specificity, or AUC.
Here's a breakdown of the information provided, framed as closely as possible to your request, but acknowledging the difference in device type:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of a table of diagnostic performance metrics, the document describes performance in terms of safety, effectiveness, and material properties.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance | Study Type/Reference |
|---|---|---|---|
| Biocompatibility | Acute systemic toxicity | Non-toxic | ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, FDA-GLP; conducted on sterilized, finished devices |
| Irritation | Non-irritating | ||
| Sensitization | Non-sensitizing | ||
| Hemolysis | Non-hemolytic | ||
| Material mediated pyrogen | Non-pyrogenic | ||
| Physical/Mechanical Properties | Material strength and elasticity | Adequate to allow use without tearing or pinholing (during application/removal, scanning, attaching/removing needle guide) | Claims based on 7 years of predicate device use; likely internal testing/engineering validation. |
| Barrier Properties | Resistance to penetration by bloodborne pathogens (viral penetration) | Effective barrier to prevention of microbial migration | Independent laboratory testing, protocol adapted from surgeons' glove evaluation using viral penetration as a test system. |
| Material Composition | Natural Rubber Latex; conformity to US FDA CFR, Title 21, Section 177.2600 | Conforms | Material specifications. |
| Manufacturing Standards | Manufactured under FDA-CGMP under 21 CFR, Part 820 | Compliant | Manufacturing process documentation. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility: The specific sample size for biocompatibility testing is not explicitly stated, but it was conducted on "sterilized (where applicable), finished devices." The provenance would be the manufactured devices themselves.
- Barrier Properties: The sample size for the independent laboratory testing of barrier properties is not specified. The provenance would be the manufactured devices.
- Given this is a physical device, concepts like "test set" and "data provenance" (e.g., country of origin, retrospective/prospective clinical data) are not directly applicable in the same way they would be for an AI/ML algorithm. The "test set" here refers to the actual manufactured devices undergoing physical and biological evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable for this type of device. "Ground truth" for an ultrasound transducer cover involves objective physical, chemical, and biological measurements, not expert interpretation of diagnostic images. The "experts" involved would be laboratory scientists or engineers conducting the tests, whose qualifications are implied by the nature of the tests (e.g., microbiology, toxicology).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in diagnostic image interpretation. The tests described (biocompatibility, barrier properties) yield objective results that do not typically require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is not designed to assist human readers in diagnostic interpretation. Therefore, there's no MRMC study or an effect size for human readers improving with AI vs. without AI assistance. The "effectiveness" here refers to the physical and biological function of the cover itself.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on objective, standardized laboratory measurements and compliance with regulatory standards:
- Biocompatibility: Results from standardized biological tests (e.g., acute systemic toxicity, irritation, sensitization, hemolysis, pyrogenicity) following ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, and FDA-GLP.
- Barrier Properties: Results from independent laboratory testing using viral penetration as a test system.
- Material Composition: Chemical analysis confirming conformity to CFR standards.
- Physical Properties: Engineering measurements and functional testing (e.g., resistance to tearing).
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model for this device.
§ 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.