(51 days)
Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle quided 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 NeoFlex™ Ultrasound Transducer Covers are furnished sterile & non-sterile: single use patient / procedure, disposable.
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.
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.
The provided document, a 510(k) summary for the NeoFlex™ Ultrasound Transducer Cover, describes the device's characteristics and its substantial equivalence to a legally marketed predicate device (CIVCO Latex Ultrasound Transducer Cover K970515). This document is a regulatory submission for device clearance, not a peer-reviewed study, and therefore the "study" referred to in the prompt is a series of tests conducted to demonstrate equivalence rather than a clinical trial with human subjects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Acceptance Criteria | Reported Device Performance (NeoFlex™ Ultrasound Transducer Cover) |
|---|---|
| Material Biocompatibility (non-toxic, non-sensitizing, non-irritating, non-hemolytic, non-pyrogenic, compliant with ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, FDA-GLP) | The NeoFlex™ polychloroprene material/cover device is demonstrated to be non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic. Type I natural latex allergy does not occur due to polychloroprene. Testing was in accordance with ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP). |
| Strength and Elastic Characteristics (adequate for intended use without tearing or pinholing during application/removal, scanning, or attaching/removing needle guide) | Strength and elastic characteristics of the polychloroprene material are effectively similar to that of latex and allow use without tearing or pinholing the cover: a) during application and removal from transducer, b) during scanning under intended uses, and c) when attaching/removing a disposable needle guide to the transducer bracket over the cover. The nominal thickness is .0065", same as the predicate. |
| Ultrasound Imaging Impairment (does not impair ultrasound imaging) | Ultrasound imaging is not impaired. |
| Microbial Migration Barrier Effectiveness (provides an effective barrier to the prevention of microbial migration) | NeoFlex™ polychloroprene transducer cover provides an effective barrier to the prevention of microbial migration. Tested under a protocol adapted from that used to evaluate barrier properties/resistance of surgical gloves and endoscope sheaths to penetration by bloodborne pathogens using viral penetration as a test system. Polychloroprene (neoprene) material is used for medical examination/surgical gloves. |
| Material Safety (polychloroprene materials meet recommended safe levels as specified in US FDA CFR, Title 21, Section 177.2600 and 182.5991, and USP Absorbable Dusting Powder; synthetic rubber does not contain natural protein allergen residuals present in latex) | Polychloroprene synthetic rubber materials used in compounding meet the recommended safe levels as specified in the US Food and Drugs Administration CFR, Title 21, Section 177.2600 and 182.5991. USP Absorbable Dusting Powder is used. The synthetic rubber does not contain the natural protein allergen residuals present in latex, addressing the benefit for Type I hypersensitivity or sensitized healthcare workers. |
| Sterility (when applicable, sterilization by 100% EtO method, validated ANSI/AAMI/ISO 11135, SAL 10-6) | Same as predicate. Sterilization (when applicable) by 100% EtO method; validated ANSI/AAMI/ISO 11135. SAL 10-6. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of covers, number of tests) for each specific test conducted to demonstrate performance. The provenance of the data is internal to CIVCO Medical Instruments Company, Inc., as these are tests performed by the manufacturer to support their 510(k) submission. The document implies these are prospective tests conducted specifically for the NeoFlex™ device. No country of origin for the data is specified beyond the manufacturer's location in Kalona, IA, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. The "ground truth" here is not established by human expert consensus on images or clinical cases, but rather by standardized laboratory testing methods and accepted regulatory guidelines for medical device materials and performance.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to resolving disagreements among multiple human readers in clinical studies. The tests described are laboratory-based and do not involve human reader adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document is for a medical device (an ultrasound transducer cover), not an AI algorithm or diagnostic imaging interpretation system. Therefore, there is no discussion of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study (in the context of an AI algorithm) was not done, as the device is not an AI algorithm. The performance described is the physical and biological characteristics of the transducer cover itself.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation is based on established laboratory testing standards and regulatory compliance criteria. This includes:
- Biocompatibility standards (e.g., ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, FDA-GLP)
- Material safety regulations (e.g., 21 CFR 177.2600 and 182.5991)
- Sterilization validation standards (e.g., ANSI/AAMI/ISO 11135)
- Performance characteristics evaluated against the known performance of the predicate device (e.g., strength, elasticity, barrier properties, non-impairment of ultrasound imaging). For instance, the microbial barrier test likely uses a quantifiable endpoint (e.g., absence of viral penetration), and strength tests would have specific breakage points or elongation metrics as acceptance criteria.
8. Sample Size for the Training Set
This is not applicable. The device is a physical product (ultrasound transducer cover), not a machine learning or AI model, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
§ 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.