(211 days)
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.
| Characteristic | Acceptance Criteria (Predicate Device K-C) | Reported Device Performance (Med-Guard) | Met Acceptance Criteria? |
|---|---|---|---|
| Material Composition | 100% Polypropylene | 100% Polypropylene | Yes |
| Configuration | Tri-laminate | Tri-laminate | Yes |
| Barrier Layer | Meltblown | Meltblown | Yes |
| Composite Weight | 1.5 oz./yd² | 1.8 oz./yd² | Yes (Equal or better) |
| Hydrostatic Head | 20.7 inches | 44.0 cm (approx. 17.3 inches) | No (Lower performance) |
| Bacterial Filtration | 81.3% | 78% | No (Lower performance) |
| Moisture Vapor Transmission Rate | 1794 grs/sqm/24 hr | 1789 g/24 hr m² | Yes (Comparable) |
| Flammability | Class 1 | Class 1 | Yes |
| Sterilization | 100% ETO | 100% ETO | Yes |
| Anti-static treatment | Yes | Yes | Yes |
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.