(258 days)
The "Disposable Medical Surgical Mask" is intended to be worn to protect both the patient on the from the transfer of microorganisms, body fluids and particulate material. The face 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, provided nonsterile.
The "Disposable Medical Surgical Mask" is single use, without face shield, Flat Pleated type, utilizing ear loops for wearing, and it has a Nose clip design for fitting the facemask around the nose. The "Disposable Medical Surgical Mask" is manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The ear loop is made of Knited nylon and spandex. The nose clip contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of Synthetic iron wire, PP and PE. The "Disposable Medical Surgical Mask" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
The provided text describes a submission for a Disposable Medical Surgical Mask seeking FDA clearance (K210348) by demonstrating substantial equivalence to a predicate device (K202463).
Here's the analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document includes two tables that effectively serve this purpose, one for general performance and another for biocompatibility.
Performance Test Results:
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| BFE (Bacterial Filtration Efficiency) | ASTM F2101-19 | ≥98% | Accepted (≥98%) |
| PFE (Particulate Filtration Efficiency) | ASTM F2299-03(2017) | ≥98% | Accepted (≥98%) |
| Differential Pressure | EN 14683:2019+AC (2019)(E), Annex C | 10% occurs in three or more animals, the test article did not meet the requirements. (2) If slight signs are observed, and no more than one animal showed gross symptoms or died, repeat with ten animals. If all ten animals show no meaningful biological reactivity, the test article met the requirements. | Under the condition of the test, the test article was found to be non-systemic toxicity. |
2. Sample size used for the test set and the data provenance
- Sample Size: For performance testing (BFE, PFE, Differential Pressure, Synthetic Blood Penetration Resistance, Flammability), the testing was performed using 3 nonconsecutive lots of 32 samples per lot.
- Data Provenance: Not explicitly stated regarding country of origin or specific lab accreditation, but the tests were "conducted below testing" for the proposed device, suggesting the tests were specifically performed for this submission. The lack of further detail on provenance beyond "Proposed Device" suggests these are new tests conducted for the submission. The classification and purpose indicate these are likely laboratory tests rather than human clinical data. The submission is from Weihai Dishang Medical Technology Co., Ltd in Weihai, Shandong, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for surgical masks is established by objective measurements based on specified ASTM and ISO standards (e.g., filtration efficiency, differential pressure). There are no human experts "establishing ground truth" in the way radiologists establish ground truth for medical images. The acceptance criteria themselves serve as the ground truth.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, primarily in imaging studies where multiple readers interpret cases and disagreements need to be resolved. For objective laboratory tests like those performed on a surgical mask, there is no subjective interpretation requiring an adjudication process.
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
This information is not applicable. This is a submission for a physical medical device (surgical mask), not an AI-powered diagnostic tool, therefore no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for this device is based on established objective laboratory test results that meet internationally recognized standards (ASTM, EN, ISO) for performance and biocompatibility. These standards define the acceptable range for parameters like filtration efficiency, pressure differential, and biological reactions.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of testing a physical medical device like a surgical mask. These are direct performance and safety evaluations.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set involved.
§ 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.