Search Results

The gown is intended to protect the wearer from blood and other body fluids encountered during surgery

This surgical gown is similar in design and composition to the Kimberly Clark gown identified in a pre-market notification #K781682. The Kappler Med-Guard surgical gown is constructed from a tri-layer composite material which is a 100% polypropylene. The specific arrangement is spunbonded polypropylene/meltblown polypropylene film/spunbonded polypropylene. The fabric is treated with an anti-static agent.

The provided text describes a 510(k) summary for the Kappler Med-Guard Surgical Gown, focusing on its substantial equivalence to a predicate device (Kimberly Clark gown #K781682). The submission primarily relies on non-clinical testing to demonstrate performance and clinical testing to address the safety of an anti-static treatment. There is no information provided about AI or machine learning algorithms, therefore the questions related to AI-specific studies are not applicable.

Here's the breakdown of the acceptance criteria and the studies performed, based on the provided text:

Acceptance Criteria and Device Performance for Kappler Med-Guard Surgical Gown

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance characteristics of the predicate device (Kimberly-Clark surgical gown). The Kappler Med-Guard surgical gown aims to meet or exceed these characteristics to demonstrate substantial equivalence.

Note on "Met Acceptance Criteria?": While some Med-Guard performance values (Hydrostatic Head, Bacterial Filtration) are numerically lower than the predicate, the FDA ultimately made a "substantially equivalent" determination. This suggests that these differences were deemed acceptable and did not raise new questions of safety or effectiveness. For example, a lower Hydrostatic Head might indicate less resistance to water, and lower bacterial filtration might mean slightly less protection. However, a slight variation within a functional range might still be considered equivalent for the intended use. The text doesn't provide the specific thresholds for "acceptable" values, only the comparison to the predicate.

2. Sample Size Used for the Test Set and the Data Provenance

Non-clinical testing: The text does not specify the exact sample sizes (number of gowns or material samples) for each non-clinical test (e.g., Hydrostatic Pressure Resistance, Bacterial Filtration Efficiency). It only states that "the individual test data sheets identify the samples as 'Blue Hawk'".
Clinical testing: The text does not specify the sample size (number of subjects or samples) for the clinical tests (Acute Systemic Toxicity, Cytotoxicity, Delayed Contact Sensitization Study).
Data provenance: Not specified, but given the nature of the tests (material properties, biological safety), they would be conducted in a laboratory setting, likely in the US, and are inherently prospective in nature.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable in the context of device performance testing. The "ground truth" here is the empirically measured physical and biological properties of the material and the device, as determined by standardized test methods (e.g., ASTM, MIL, NFPA). These are objective measurements rather than subjective expert opinion.
For the clinical testing, North American Science Associates, Inc. (NAmSA) established the protocol and evaluated the results, concluding no concerns. This suggests experts at NAmSA were involved, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. This relates to objective measurements from standard tests, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not relevant for a surgical gown. The submission evaluates the physical, barrier, and comfort characteristics, and the safety of anti-static treatment, not diagnostic accuracy requiring human reader interpretation.

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

No. This is not relevant for a surgical gown. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used

• Non-clinical testing: Objective, empirically measured physical and biological properties of the gown material, determined by adherence to established test standards (e.g., ASTM D 751, SOP/ARO/007F.1/MIL-M-36954C, ASTM E 96, NFPA 702, ASTM D 5733).
• Clinical testing: Results from standardized biological assays (Acute Systemic Toxicity, Cytotoxicity, Delayed Contact Sensitization Study) to assess biocompatibility and safety related to the anti-static treatment.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this device does not involve machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "training set" as this device does not involve machine learning or AI.

Ask a specific question about this device

The TE Gown is intended to provide the wearer an increased level of blood and other body fluid protection during certain surgical procedures that result in excessive blood exposures by providing total encapsulation.

The COOL-ZONE System is either a gown or hood that are similar to the Kappler Pro/Vent Surgical Gown which was the subject of Premarket Notification #K932694. The fabric in the COOL-20NE gown and hood is identical to the fabric in the Pro/Vent Surgical Gown. The Pro/Vent TE Gown and Hood are constructed from the same fabric as the predicate device. The design of the gown differs in that the gament provides totally encapsulated protection to the wearer. Total encapsulation means total coverage of the entire upper body, thus providing greater protection than conventional surgical apparel.. The TE Gown utilizes a mylar face shield for visibility. A zipper is located in the back of the garment. The TE Hood provides the same level of face and head protection, but does not extend down as far on the body. It will typically be worn with another surgical gown.

This document is a 510(k) Summary for a medical device (surgical gown/hood) and does not describe an AI/ML powered device. Therefore, most of the requested information regarding AI-specific evaluation criteria, such as "Multi Reader Multi Case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only) performance," "sample size for the training set," or "adjudication method for the test set," is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device based on material composition, design, and non-clinical performance characteristics.

Here's an attempt to extract relevant information given the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device (Kappler Pro/Vent Surgical Gown). The device ("PRO/VENT TE") is considered to meet acceptance criteria if its characteristics are "identical" or equivalent to the predicate.

Ask a specific question about this device