(58 days)
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.
| CHARACTERISTIC | Acceptance Criteria (Predicate: PRO/VENT GOWN) | Reported Device Performance (PRO/VENT TE) |
|---|---|---|
| Material Composition | 100% Polypropylene | 100% Polypropylene |
| Fabric Configuration | Trilaminate | Trilaminate |
| Barrier Layer | Microporous Film | Microporous Film |
| Composite Weight | 2.1 oz/square yard | 2.1 oz/square yard |
| Hydrostatic Head | 43 inches | 43 inches |
| Bacterial Filtration | 99.9% | 99.9% |
| Moisture Vapor Transmission Rate | 1385 g/sqm/24hr | 1385 g/sqm/24hr |
| Flammability | Class 1 | Class 1 |
| Synthetic Blood/Viral Resistance | Pass | Pass |
| Sterility Assurance Level (SAL) | 10⁻⁶ (typical for medical devices) | 10⁻⁶ |
| Ethylene Oxide Residues | < 25 ppm (FDA limits) | < 25 ppm |
| Ethylene Chlorohydrin Residues | < 50 ppm (FDA limits) | < 50 ppm |
| Ethylene Glycol Residues | < 250 ppm (FDA limits) | < 250 ppm |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The performance data is presented as generic characteristics of the material rather than results from a specific "test set" in the context of individual units. It's likely these are properties of the material itself.
- Data Provenance: Not specified. It represents the inherent properties of the material and product design as characterized by laboratory tests.
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 physical product, and "ground truth" is established through standardized material testing, not expert consensus on interpretations.
4. Adjudication method for the test set
Not applicable. Material properties are measured objectively.
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/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used
The "ground truth" for the performance characteristics is derived from standardized material testing and laboratory measurements (e.g., ASTM or ISO standards for hydrostatic head, bacterial filtration, flammability, synthetic blood resistance) and sterilization validation protocols (e.g., overkill method for ETO sterilization and residue testing).
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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NOV 20 1996
510(k) Summary (K963809)
Submitter: Kappler USA, 70 Grimes Drive, Guntersville, AL 35976
Prepared: September 20, 1996
Contact: Philip C. Mann
Device Name: Totally Encapsulated (TE) Surgical Gown/Hood Proprietary Name: COOL-ZONE Classification Name: Gown, Surgical
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.
Gown and Hood
The surgical gown and hood are similar in design and composition to the Kappler Pro/Vent Surgical Gown identified in premarket notification #K932694.
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.
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 technological characteristics of the Kappler Pro/Vent Surgical Gown and the Pro/Vent TE Gown or Hood are identical. The non-clinical performance data is summarized below.
The gown and hood may be used with air supplied cooling systems.
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| CHARACTERISTIC | PRO/VENT GOWN | PRO/VENT TE |
|---|---|---|
| Material Composition | 100% Polypropylene | 100% Polypropylene |
| Fabric Configuration | Trilaminate | Trilaminate |
| Barrier Layer | Microporous Film | Microporous Film |
| Composite Weight | 2.1 oz/square yard | 2.1 oz/square yard |
| Hydrostatic Head | 43 inches | 43 inches |
| Bacterial Filtration | 99.9% | 99.9% |
| Moisture VaporTransmission Rate | 1385 g/sqm/24hr | 1385 g/sqm/24hr |
| Flammability | Class 1 | Class 1 |
| Synthetic Blood/Viral Resistance | Pass | Pass |
Sterility
The sterilization method is Ethylene Oxide (ETO). The method used to validate the sterilization cycle is overkill. The sterility assurance level (SAL) for the device will be 10 *. The packaging for the sterile device is the same type as the predicate device.
The maximum levels of residues of ethylene oxide were less than 25 ppm, for ethylene chlorohydrin were less than 50 ppm and for ethylene glycol were less than 250 ppm from the sterilization process and are below allowable FDA limits.
§ 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.