(56 days)
The Disposable Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The Disposable Face Mask is single use, three-layer, flat-pleated mask with ear loops and nose clip. The inner and outer layers of the mask are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene. The ear loops are held in place over the users' mouth and nose by two elastic ear straps. The ear loops are made of spandex and nylon. The nose clip is a malleable iron wire covered by polyethylene. Users can adjust the nose clip according to the shape of the nose and fix the mask on the bridge of the nose to prevent the mask from falling off. The Disposable Face Mask is blue and provided non-sterile.
The document describes the non-clinical tests performed on the Disposable Face Mask (K210815) to demonstrate its safety and effectiveness, and its substantial equivalence to the predicate device (K202211).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| No. | Performance Test | Acceptance Criteria | Reported Device Performance (Average) |
|---|---|---|---|
| 1 | Bacterial Filtration (BFE) | Level 2: >98% | Lot 1: 99.40%, Lot 2: 99.45%, Lot 3: 99.46% (All >98%) |
| 2 | Differential Pressure | Level 2: 98% | Lot 1: 99.50%, Lot 2: 99.46%, Lot 3: 99.47% (All >98%) |
| 5 | Resistance to Penetration | Level 2: 120 mmHg | Pass at 120 mmHg (All lots) |
| Biocompatibility | |||
| In Vitro Cytotoxicity Test | No Cytotoxicity Observed | Passed: No Cytotoxicity Observed | |
| Skin Sensitization Test | No Skin Sensitization Observed | Passed: No Skin Sensitization Observed | |
| Skin Irritation Test | No Skin Irritation Observed | Passed: No Skin Irritation Observed |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for performance tests: 32 samples per lot for 3 non-consecutive lots (total 96 samples for each performance test).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It refers to "Non-Clinical Test Conclusion," implying laboratory testing rather than human subject studies. Given the manufacturer's location in China (Biobase Scientific (Shandong) Co., Ltd.), it's highly probable the testing was conducted in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable (N/A): This study involves non-clinical laboratory testing of a physical device (face mask) against established performance standards, not diagnostic or interpretive tasks requiring human expert ground truth.
4. Adjudication Method for the Test Set
- Not Applicable (N/A): This study does not involve human adjudication for ground truth. It relies on objective laboratory measurements against defined performance criteria.
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 (N/A): This document describes the testing of a medical device (face mask), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A): This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Objective Laboratory Measurements: The "ground truth" for the device's performance is established through quantitative measurements obtained from standardized laboratory tests (e.g., Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration, Flammability, Resistance to Penetration, and Biocompatibility tests) according to recognized international and national standards (ASTM, EN, ISO, CFR).
8. The Sample Size for the Training Set
- Not Applicable (N/A): This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable (N/A): There is no training set for a physical medical device.
§ 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.