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UltraDrape UGPIV Barrier and Securement, a sterile, single-use disposable device, serves as a sterile, viral barrier when used in conjunction with ultrasound transducers to shield patients from the potential transfer of contaminants and biological risk agents that may be introduced during ultrasound scanning and needle-quided procedures. It also serves as a transparent dressing to protect and secure devices to the patient's skin when required. UltraDrape UGPIV Barrier and Securement is indicated for adults and pediatric patients. For use by healthcare professionals appropriately trained in ultrasound within healthcare settings utilizing ultrasound.

Device Description

UltraDrape UGPIV Barrier and Securement is a uniquely designed, sterile, dual-action barrier and securement dressing designed for use during Ultrasound-Guided Peripheral Intravenous (UGPIV) procedures. UltraDrape is 3.25"(8.25 cm) wide x 5.8" (14.72 cm) long. UltraDrape UGPIV Barrier and Securement is sterile, nonirritating, non-sensitizing and is not made with natural rubber latex. Ultrasound imaging is not impaired by use of UltraDrape UGPIV Barrier and Securement as it is intended. The ultrasound gel is applied to a removable Polyurethane film layer to prevent contamination of the injection site. Convenient adhesive strips on the release film provide added securement of tubing and catheter hub surround. The bifurcated, "stand-alone" design prevents gel from reaching the IV site while enabling seamless catheter insertion and securement. UltraDrape UGPIV Barrier and Securement is furnished in sterile condition, for single use patient/procedure use, disposable. UltraDrape UGPIV Barrier and Securement is used with commercially available ultrasound probes.

AI/ML Overview

The provided text describes a medical device called "UltraDrape UGPIV Barrier and Securement" and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria and a study that proves the device meets those criteria in the format requested.

The document discusses:

Device Description and Intended Use: The UltraDrape UGPIV Barrier and Securement is a sterile, single-use, disposable device for use with ultrasound transducers to shield patients from contaminants and biological risk agents during ultrasound scanning and needle-guided procedures. It also protects and secures devices to the patient's skin.
Comparison to a Predicate Device (K221278 - Hony Medical Co. Transducer Probe Covers): The text details similarities and differences in intended use and technological characteristics to argue for substantial equivalence.
Non-Clinical Tests Summary & Conclusions: It lists several tests that were completed according to FDA recognized consensus standards to determine substantial equivalence. These tests include:
- Viral Penetration (ASTM 1671 20 nm Rodent Protoparvovirus PB627-001-V2)
- Tear Resistance (ASTM D1004)
- Burst Strength (ASTM F1140/F1140M-13)
- Velocity Testing (Acoustic Measurements Report)
- Tensile Strength (STA-040 Stability Report Accelerated 2 year 60C Ultradrape, ASTM D5035-11)
- Ultrasound Image Quality and Artifact ("FTR-003 UltraDrape UGPIV Image Clarity and Artifact Report")

The document does not provide:

A table of specific acceptance criteria values and reported device performance values against those criteria for most of the tests. For "Viral Penetration," it mentions the device has "viral prevention against 20 nm or greater viruses" while the predicate has "viral prevention against 25 nm or greater viruses," which implies the device meets or exceeds a criterion of 20nm. For "Ultrasound Image Quality and Artifact," it states "UltraDrape® UGPIV has minimal impact on the acoustic output, imaging clarity, and presence of artifact," and "no measurable attenuation at the UltraDrape film does not impact the depth of image penetration or spatial resolution," but doesn't provide specific numerical criteria or results.
Sample sizes for the test set or data provenance (country, retrospective/prospective).
Number or qualifications of experts used to establish ground truth.
Adjudication method for the test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
Information about a standalone (algorithm only) performance study. (This device appears to be a physical barrier, not an algorithm, so this section is likely not applicable).
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set. (Again, likely not applicable as it's not an AI/algorithm-based device).
How the ground truth for the training set was established. (Not applicable).

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Viral Penetration: Block viruses of a certain size (e.g., 20nm or greater) (Based on ASTM F1671/F1671-M)	Viral prevention against 20 nm or greater viruses. (Stated the predicate has viral prevention against 25nm or greater, implying the UltraDrape meets/exceeds 20nm.)
Tear Resistance: Meet standards for tear resistance (Based on ASTM D1004)	Test performed ("Tear Resistance Result UltraDrape"). Specific numerical performance not provided.
Burst Strength: Meet standards for burst strength (Based on ASTM F1140/F1140M-13)	Test performed ("UltraDrape DDL Package Validation Report - Burst Strength"). Specific numerical performance not provided.
Velocity Testing: (Likely related to acoustic properties)	Test performed ("Acoustic Measurements Report"). Specific numerical performance not provided.
Tensile Strength: Meet standards for tensile strength (Based on ASTM D5035-11)	Test performed ("STA-040 Stability Report Accelerated 2 year 60C Ultradrape"). Specific numerical performance not provided.
Ultrasound Image Quality and Artifact: Minimal impact on acoustic output, imaging clarity, and no significant artifacts. (Based on FTR-003 UltraDrape UGPIV Image Clarity and Artifact Report)	Minimal impact on the acoustic output, imaging clarity, and presence of artifact during ultrasound procedures. No measurable attenuation at the UltraDrape film does not impact the depth of image penetration or spatial resolution in ultrasound-guided procedures. (Specific numerical criteria for "minimal impact" or "no measurable attenuation" not quantified.)
Sterility: Furnished in sterile condition (Implied by gamma radiation sterilization)	Provided in a sterile format (sterilized via gamma radiation).

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

Not specified in the provided text. The tests listed are non-clinical (material and performance characteristics) rather than clinical studies with patient data.

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

Not applicable/Not specified in the provided text, as this is a physical device and the tests conducted are non-clinical performance and material tests, not diagnostic accuracy studies requiring expert ground truth on patient data.

4. Adjudication method for the test set

Not applicable/Not specified.

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 device is not an AI/software product.

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

Not applicable. This device is not an AI/software product.

7. The type of ground truth used

For the listed non-clinical tests, the "ground truth" would be established by the standardized methods and measurements defined by the ASTM standards (e.g., direct measurement of tear strength, burst pressure, viral penetration, acoustic properties) rather than expert consensus, pathology, or outcomes data typically associated with diagnostic performance studies.