(34 days)
The Kimberly-Clark* MicroCool* Breathable High Performance Surgical Gowns, are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The MicroCool* Breathable High Performance Surgical Gowns meet the Level 4 requirements of the AAMI Liquid Barrier classifications.
The Kimberly-Clark* MicroCool* Breathable High Performance Surqical Gowns, are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
The MicroCool* Breathable High Performance Surgical Gowns are manufactured from a breathable, repellent, non-woven, polypropylene fabric. The fabric is a three-layer lamination that resists tearing and penetration by liquids. The gown is constructed from a spunbond/film/spunbond/meltblown/spunbond (SFSMS) design. The film layer is a multi-layer polypropylenebased, breathable film. A C6 fluorochemical treatment is added to the film to retard penetration by low surface tension fluids. A polyolefin hot melt adhesive is used to laminate the facing layers. to the film layer to complete the composite.
Here's a breakdown of the acceptance criteria and study information for the Kimberly-Clark MicroCool Breathable High Performance Surgical Gown, based on the provided text:
Important Note: This document describes the "substantial equivalence" of the device to a predicate device, meaning it meets the same standards. It doesn't detail a study comparing performance against human readers or a standalone algorithm, as it's a physical device, not an AI/software product. Therefore, sections related to AI/MRMC studies, number of experts, and training data provenance are not applicable and will be marked as such.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| AAMI Liquid Barrier Level 4 requirements as per ANSI/AAMI PB70: 2003 ("Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities"). | The MicroCool* Breathable High Performance Surgical Gown meets the Level 4 requirements of the AAMI Liquid Barrier classifications. |
| Resistance to penetration by blood-borne pathogens using Phi-X174 bacteriophage penetration as a test system, as per ASTM1671:2003 ("Standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens"). | The MicroCool* Breathable High Performance Surgical Gown meets the requirements of ASTM1671:2003. |
| Flame Resistant Class 1 as per CPSC 1610. | The MicroCool* Breathable High Performance Surgical Gown meets the requirements of Flame Resistant CPSC 1610 Class 1. |
| Biocompatibility requirements for surface devices with limited contact with breached or compromised surfaces, as per ISO 10993. | The MicroCool* Breathable High Performance Surgical Gown has been tested in compliance with the biocompatibility requirements of ISO 10993. All results of testing met acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text for each specific test. The text indicates "testing" was done in compliance with the listed standards. These standards typically define minimum sample sizes for material testing.
- Data Provenance: Not explicitly stated. This is a physical product test, so "country of origin of the data" or "retrospective/prospective" study design in the context of data collection for AI is not directly applicable. The data would derive from laboratory testing of the gown materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable: This is a physical device subject to standardized material performance testing, not a diagnostic device requiring expert interpretation of results. The "ground truth" is established by the defined parameters and methods within the referenced ASTM, AAMI, CPSC, and ISO standards.
4. Adjudication Method for the Test Set
- Not Applicable: As this involves standardized material testing, there is no "adjudication method" in the sense of reconciling multiple expert opinions on a diagnostic outcome. The results of the tests are objectively measured against the criteria established by the standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No: This is a physical surgical gown. An MRMC study is relevant to diagnostic or interpretation devices, typically involving human readers (e.g., radiologists) and an AI system. This device does not involve such a comparative effectiveness study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This device is a physical product, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
- Standardized Test Results/Compliance with Performance Standards: The "ground truth" is defined by the objective performance criteria and methodologies outlined in the referenced national and international standards (ANSI/AAMI PB70:2003, ASTM1671:2003, CPSC 1610, ISO 10993). The device's materials are tested against these established benchmarks.
8. The Sample Size for the Training Set
- Not Applicable: This is a physical device and does not involve AI or machine learning, therefore there is no "training set" in this context. The product design is based on material science and engineering, not data training.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set for this physical device, this question is not relevant.
§ 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.