(111 days)
Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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 Surgical Mask is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Polypropylene+Galvanized-iron dual core. The Surgical Mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document, a 510(k) summary for a Surgical Mask (K212344), outlines the non-clinical tests conducted to demonstrate the device's substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| No. | Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Sensitization Test) | Assess possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Sensitization Test: provided grades less than 1, otherwise sensitization. | All grades are 0. All animals were survived and no abnormal signs were observed during the study. (Pass) |
| 2 | ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Irritation Test) | Assess possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Irritation Test: If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe. | The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition. (Pass) |
| 3 | ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | Describe test methods to assess the in vitro cytotoxicity of medical devices. | The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to 10 N | Average Lot 1: Left: 14.3 N, Right: 14.4N; Average Lot 2: Left: 14.1 N, Right: 14.7N; Average Lot 3: Left: 14.6 N, Right: 13.9N. (Pass) |
| 10 | Product dimensions | Evaluate the product dimensions | Length: 17.5cm ± 0.5cm; Width: 9.5cm ± 0.5cm | Average Lot 1: (Length): 17.7 cm, (Width): 9.8 cm; Average Lot 2: (Length): 17.8 cm, (Width): 9.6 cm; Average Lot 3: (Length): 17.4 cm, (Width): 9.6 cm. (Pass) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Lot 1," "Lot 2," and "Lot 3" for several tests (BFE, Differential Pressure, PFE, Synthetic Blood Penetration, Tensile Strength, Product Dimensions). This implies that a sample of masks from at least three different manufacturing lots was used for testing. However, the precise number of individual masks from each lot for each specific test is not explicitly stated, except for the "Resistance to penetration by synthetic blood" test, which used 32 test articles per lot.
The data provenance is from non-clinical testing performed on the device itself, rather than human subject data. The testing was conducted to conform to international standards such as ASTM, EN, and ISO, and potentially US regulations (16 CFR Part 1610(a)). There is no information about the country of origin of the data beyond the manufacturer being in China. The data is prospective in the sense that it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
These are non-clinical hardware performance tests. No human experts or ground truth establishment by experts were involved in the traditional sense of clinical studies. The "ground truth" for these tests is defined by the objective, quantitative criteria established in the referenced international standards (ASTM, EN, ISO). The results are based on laboratory measurements and observations performed by accredited testing facilities.
4. Adjudication Method for the Test Set:
Not applicable. As these are non-clinical performance tests, there is no need for an adjudication method by human experts. The results are directly compared to the established numerical acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states: "No clinical study implemented for the Surgical Mask." Therefore, no MRMC study was conducted, and no effect size for human readers with or without AI assistance is reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
Not applicable. This device is a physical product (a surgical mask), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical tests is based on defined performance standards and specifications from recognized organizations (e.g., ASTM, EN, ISO) and regulatory bodies (e.g., 16 CFR). For example, for Bacterial Filtration Efficiency, the ground truth is "≥98% filtration." For Biocompatibility, it's defined by specific cellular viability percentages or irritation indices.
8. Sample Size for the Training Set:
Not applicable. As this is a physical medical device and not an AI/ML algorithm requiring training data, 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 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.