Search Results

The FreeeScan® Ultrasound Transducer Covers are protective covers applied to ultrasound transducers. These covers are designed to provide a sterile barrier between the non-sterile TXD's (and instrument guide adapters in some cases) and the patient/healthcare worker. The covers are intended for use during both sterile and non-sterile procedures using sector, linear, intravaginal and rectal transducers.

The cover is latex-free and therefore beneficial in procedures with a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitive. The transducer covers are supplied sterile or non-sterile and intended for single-use.

Covers are packed in sterile or non-sterile "convenience" kits form for single patient/procedure, disposable use. Covers kits are supplied with needle guide devices, coupling gel packet, elastic bands, and tape.

The FreeeScan® Ultrasound Transducer Cover provides a thin, conformal covering to fit various ultrasound transducer geometries. The device is manufactured as a one-piece design that provides a covering to prevent the transmission of pathogens, as the ultrasound transducer is reused from one patient to another.

The cover material is Chloroprene (synthetic rubber), which is similar to the non-latex material used in medical examination gloves or surgical gloves. Type I natural latex allergy does not occur in response to Chloroprene since the synthetic rubber does not contain the natural protein allergen which is present in latex.

Various sizes and shapes of covers are offered in order to fit different transducer geometries. The following product models are currently included (other shapes are likely to be added):

• . FreeeScan® 1 - W:3.4 cm, L:45-244 cm (Drawing 5500-000002-1B)
• FreeeScan® 4 W:10 cm, L:45-244 cm (Drawing 5500-000003-1B) .
• FreeeScan® 6 W:9.5/11.5 cm, L:45-244 cm (Drawing 5500-000004-1B) .
• . FreeeScan® 8 - W:7.5 cm, L:45-244 cm (Drawing 5500-000005-1B)
• FreeeScan® 77 Ø:2.6 cm, L:30 cm (Drawing 5500-000016-1A) .
• FreeeScan® 84 Ø:3 cm, L:30 cm (Drawing 5500-000015-1A) .

All of these versions are composed of the same materials, they are made using the same processes and procedures, in the same facilities and on the same equipment.

The provided document is a 510(k) summary for the FreeeScan® Ultrasound Transducer Cover. This document focuses on demonstrating substantial equivalence to a predicate device (CIVCO Medical's NeoFlex™ Ultrasound Transducer Cover) rather than presenting a study with specific acceptance criteria and performance metrics for the device itself in the way one might expect for an AI algorithm or diagnostic tool.

The "acceptance criteria" here are essentially the demonstration that the FreeeScan® device is as safe and effective as the predicate device. The "study" is the comparison made against the predicate device based on various parameters.

Here's an analysis based on the structure provided in your request, but adapted to the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) summary, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device. The "reported device performance" is a comparison to the predicate's known characteristics.

Note: The FreeeScan® device states "Severely cytotoxic" for its safety testing. This appears to be a typo given the predicate is "Non-toxic" and the overall claim is substantial equivalence. It's highly probable it should read "Non-cytotoxic" to align with the safety profile required for such a device and the substantial equivalence claim.

2. Sample size used for the test set and the data provenance

This document describes a 510(k) submission based on substantial equivalence to an existing predicate device, not a novel diagnostic AI algorithm. Therefore, there isn't a "test set" in the sense of a dataset for an AI model.
The performance claims are based on:

• Physical characteristics of the FreeeScan® device compared to the predicate.
• Biocompatibility testing of the FreeeScan® device.
• Microbial barrier effectiveness testing of the FreeeScan® device.

The document does not specify a "sample size" for these comparisons or tests in the way one would for a clinical study with a patient cohort. The tests are performed on the device material/design itself.
Data Provenance: The biocompatibility and microbial barrier testing would have been performed by Ascendia MedTech AB or its contracted labs (e.g., for sterilization). The country of origin of the data is not explicitly stated beyond the company being based in Sweden. These tests are inherently prospective for the FreeeScan® device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device (ultrasound transducer cover), not an AI diagnostic tool requiring expert ground truth labeling of images or clinical cases. The "ground truth" for its safety and effectiveness is established through standardized laboratory testing (biocompatibility, barrier integrity, material properties) as per regulatory guidelines, and comparison to the predicate device.

4. Adjudication method for the test set

Not applicable, as no "test set" requiring adjudication by experts is described for this type of device submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-powered diagnostic device or an imaging study that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established by:

• Standardized laboratory testing: Biocompatibility tests (cytotoxicity, irritation, sensitization), microbial barrier penetration tests, and material property assessments (e.g., thickness). These tests follow recognized standards (e.g., ISO 10993, relevant FDA guidelines).
• Comparison to predicate device: Assuming the predicate device (NeoFlex™ Ultrasound Transducer Cover) has already demonstrated its safety and effectiveness through similar rigorous testing and clinical use.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an AI model.

Ask a specific question about this device