(10 days)
The Handan N95 Particulate Respirators and Surgical Masks HY8510, HY9810 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.
Handan HY8510 N95 particulate respirators and surgical mask is constructed from a polypropylene spunbond used in the inner and outer cover. The polypropylene melt blown filter media and polyester filter fabric are layered between the inner and outer cover. The head strap is made of polyester elastic(for single head strap) which is circled to the mask. The inside nosepiece is a PU foam.
Handan HY9810 N95 particulate respirators and surgical mask is constructed from a polypropylene spunbond used in the outer cover, polyester filter fabric used in the inner cover. The polypropylene melt blown filter media is layered between the inner and out cover. The head straps are made of polyester elastic(for double headband) which is welded to the mask. The inside nosepiece is a PU foam.
Both items are no - sterilized and only for single use.
Acceptance Criteria and Study for Handan N95 Particulate Respirators and Surgical Masks (HY8510 & HY9810)
The provided document describes the Handan N95 Particulate Respirators and Surgical Masks (HY8510 & HY9810) and their substantial equivalence to predicate devices, rather than a standalone AI/algorithm-based device requiring detailed performance metrics typical of AI/ML studies. Therefore, the information provided below is adapted to reflect the nature of the submitted 510(k) summary for a medical device that relies on established material and physical property testing.
The acceptance criteria for the Handan N95 Particulate Respirators and Surgical Masks are based on established NIOSH (National Institute for Occupational Safety and Health) standards for N95 respirators and flammability standards. The study demonstrates that the device meets these criteria through non-clinical bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Acceptance Criteria | Reported Device Performance |
|---|---|
| NIOSH Standards | |
| Exhalation Resistance | Met relevant requirements |
| Inhalation Resistance | Met relevant requirements |
| Sodium Chloride (NaCl) | Met relevant requirements |
| Flammability Standard | |
| 16 CFR 1610 Class I | Complied (Class I) |
| Biocompatibility | |
| ISO 10993 | Met relevant requirements |
Note: The document explicitly states, "It is our conclusion that performance testing meet all relevant requirements of the aforementioned test standard."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (Exhalation Resistance, Inhalation Resistance, NaCl, Flammability, Biocompatibility). These are non-clinical bench tests performed on physical samples of the manufactured respirators. The data provenance is from the manufacturer's internal testing or contracted laboratories, performed for the purpose of demonstrating compliance with the specified standards. The nature of these tests is prospective for the device being submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable in the context of this device and study. The ground truth for these tests is established by objective, standardized measurement protocols defined by NIOSH and other regulatory bodies (e.g., 16 CFR 1610, ISO 10993). The "experts" involved would be technicians and engineers qualified in performing these specific tests accurately according to the established methodologies, rather than clinical experts establishing a ground truth based on medical interpretations.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are not applicable here. The tests involve objective measurements against predefined thresholds. The results are either compliant or non-compliant, based on the measured values falling within the acceptable ranges specified by the standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices that assist human readers in tasks like image interpretation. The Handan N95 respirators are physical devices whose performance is evaluated through material and physical property testing, not through human reader interpretation.
6. Standalone Performance Study
Yes, a standalone performance was done in the sense that the device's performance was evaluated independently against established standards through a series of bench tests. The algorithm, in this context, is the physical design and material composition of the respirator itself. The device (respirator) was tested on its own to demonstrate its intrinsic performance characteristics, without direct human-in-the-loop assistance for its primary function (filtration, resistance, etc.).
7. Type of Ground Truth Used
The ground truth used is based on objective, quantitative measurements against pre-defined regulatory and industry standards. For example:
- NIOSH standards: Specify acceptable levels of inhalation and exhalation resistance, and filtration efficiency for particulate matter (e.g., NaCl aerosol).
- 16 CFR 1610: Defines flammability performance classes based on burn time.
- ISO 10993: Defines biocompatibility requirements through various tests (e.g., cytotoxicity, irritation, sensitization).
8. Sample Size for the Training Set
This concept is not applicable to the evaluation of this device. The Handan N95 respirators are physical products, not AI/ML algorithms. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process of the respirators would be analogous to the development phase, but not a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a training set and its ground truth is not applicable for this type of medical device submission. The design and engineering of the respirators would be guided by the requirements of the standards (NIOSH, ISO, etc.), and the performance is then verified through the mandated non-clinical tests.
§ 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.