(95 days)
The Surgical Mask (Model: WK1701-02A, WK1701-03A and WK1701-04A) is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.
The Model WK1701-02A is Level 1 barrier as ASTM F2100 requirements.
The Model WK1701-03A is Level 2 barrier as ASTM F2100 requirements.
The Model WK1701-04A is Level 3 barrier as ASTM F2100 requirements.
The proposed device(s) includes 3 models, which are WK1701-02A, WK1701-03A and WK1701-04A. Three of them all are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
All three models of proposed device(s) share same materials and structure, they all are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.
The proposed device(s) of Level 1, Level 2 and Level 3 have the same material. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene coated galvanized iron wire.
The proposed device(s) is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with nylon and spandex.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
The provided document is a 510(k) Premarket Notification for a Surgical Mask, not a deep learning AI device. Therefore, the questions related to deep learning AI evaluation (such as sample size for training/test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable to this submission.
The document describes the acceptance criteria and the study that proves the device meets those criteria for Surgical Masks, based on non-clinical performance and biocompatibility testing.
Here's the information extracted from the document relevant to the acceptance criteria and device performance:
1. A table of acceptance criteria and the reported device performance
The document provides several tables detailing the performance characteristics and comparisons. The most direct representation of acceptance criteria and results for the proposed device is found in the "Non-Clinical Test Conclusion" section (pages 7-8).
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM F2101-19 (Bacterial Filtration Efficiency, BFE) | Verify the Bacterial Filtration Efficiency (BFE) performance of the subject device. | Level 1: ≥95%; | |
| Level 2: ≥98%; | |||
| Level 3: ≥98%; | WK1701-02A (Level 1): 99.9% | ||
| WK1701-03A (Level 2): 99.8 - 99.9% | |||
| WK1701-04A (Level 3): 99.8 - 99.9% | |||
| EN 14683-2019+AC:2019 Annex C (Differential Pressure) | Verify the Differential Pressure (Delta P) performance of the subject device. | Level 1: |
§ 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.