(116 days)
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile. Serial number: ZZ-YYKZ-01, size 175x95mm, Blue ZZ-YYKZ-02, size 145x95mm, Blue ZZ-YYKZ-03.size 175x95mm, Black ZZ-YYKZ-04, size 145x95mm, Black
The proposed device, Surgical Mask is a three-layer, plane bandage type mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The proposed device includes masks in two colors and two sizes, as shown in Table 1. The device is single use and provided sterile.
This document is a 510(k) Summary for a Surgical Mask, submitted to the FDA. It details the non-clinical testing performed to demonstrate that the proposed device is substantially equivalent to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Purpose (from document) | Acceptance Criteria (per ASTM F2100-19) | Reported Device Performance (Blue Mask) | Reported Device Performance (Black Mask) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Verify the fluid resistance of the proposed device can meet the requirements for Level 1 specified in ASTM F2100-19. | Pass at 80 mmHg | 96 out of 96 pass at 80 mmHg | 96 out of 96 pass at 80 mmHg |
| Bacterial filtration efficiency (BFE) (ASTM F2101) | Verify the bacterial filtration efficiency of the proposed device can meet the requirements for Level 1 specified in ASTM F2100-19. | ≥95% | Passed at 99.60% | Passed at 99.61% |
| Particulate filtration efficiency (PFE) (ASTM F2299) | Verify the particulate filtration efficiency of the proposed device can meet the requirements for Level 1 specified in ASTM F2100-19. | ≥95% | Passed at 99.14% | Passed at 99.14% |
| Differential pressure (EN 14683) | Verify the differential pressure of the proposed device can meet the requirements for Level 1 specified in ASTM F2100-19. | ) | Verify the bacterial endotoxin of the proposed device can meet the requirements of USP . | Bacterial Endotoxin Levels were below the level of 20 EU/device. |
| Package Integrity (ASTM F series) | Verify the package integrity of the proposed device can meet the requirements of ASTM F1886 / F1886M-16, ASTM F88/F88M-15, ASTM F1929-15. | There should be no channel on the package and no damage on device. The maximum seal strength should be no less than 2.0N/15mm. There should be no dye penetration on the package. | Pass | Pass (implied, as results are for "the device") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for performance tests: For Fluid Resistance, Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Differential Pressure, and Flammability, the sample size was "three lots, 32 per lot" for a total of 96 samples per test.
- Data Provenance: The tests were conducted by the submitting company, Guangdong Zhizhen Biological Medical Co., Ltd, which is based in China. The document does not specify if the data is retrospective or prospective, but based on the nature of device testing for 510(k) clearance, it is typically prospective for the purpose of demonstrating performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document describes non-clinical laboratory testing (e.g., physical properties, filtration efficiency, biocompatibility). It does not involve "experts" establishing ground truth in the sense of medical diagnosis or interpretation of images. The "ground truth" is established by adherence to standardized test methods (e.g., ASTM, ISO, EN standards) and their predefined acceptance criteria. Thus, the expertise lies in the accredited laboratories and personnel performing these specific, standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as the study involves standardized laboratory testing against specific criteria, not human interpretation or adjudication of cases.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for AI/imaging devices, not for a surgical mask.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. The device is a physical surgical mask, not an algorithm. The performance tests are for the physical properties of the mask (e.g., filtration, fluid resistance).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these tests is defined by established international standards and regulations (e.g., ASTM F2100-19, ISO 10993 series, EN 14683, 16 CFR 1610, USP ). The performance of the device is measured against the quantitative and qualitative acceptance criteria specified in these standards.
8. The sample size for the training set
- This is not applicable. The submission describes non-clinical testing of a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- This is not applicable, as there is no training set for a physical device like a surgical mask.
§ 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.