(302 days)
Surgical Mask (Procedure Mask) (Models: OH02-01 (Bandage)) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are 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 proposed Surgical Mask (Procedure Mask) body is a multi-layer construction of a Spun- bond polypropylene outer layer, meltblown middle layer and Spun-bond polypropylene inner layer. Nose clip is made of Aluminum plastic wire. There are two models of the proposed Surgical Mask (Procedure Mask), OH02-01 and OH02-01(Bandage). The main difference between each model is their wearing method, i.e. mask band part. For OH02-01 model, mask band part is made of non-woven fabric ear loops. For OH02-01(Bandage) model, mask band part is made of non-woven fabric ties. However, the raw materials of the two models devices are exactly the same. And have been tested according to ASTM F2100-19 Standard Specification For Performance Of Materials Used In Medical Face Masks. Surgical Mask (Procedure Mask) is a single use, disposable medical device that will be provided in non-sterile packaging configurations.
The provided document is a 510(k) Pre-market Notification for a Surgical Mask (Procedure Mask). It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.
Crucially, this document is for a physical medical device (a surgical mask), not an AI/software medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets acceptance criteria" in the context of an AI/software medical device (e.g., using a test set, ground truth established by experts, MRMC studies) do not apply here.
Instead, the "acceptance criteria" for a surgical mask relate to its physical performance characteristics and biocompatibility, as defined by recognized standards (e.g., ASTM F2100-19, ISO 10993). The "study" proving the device meets these criteria involves laboratory testing of physical samples.
Here's the information extracted from the document, re-interpreting the "acceptance criteria" for a physical medical device:
1. Acceptance Criteria and Reported Device Performance
The device is a surgical mask, and its performance is evaluated against the ASTM F2100-19 standard for materials used in medical face masks, which defines levels of protection based on specific physical tests. The reported device performance is based on fulfilling the requirements for "Level 3".
| Item (Performance Requirement) | Acceptance Criteria (ASTM F2100-19 Level 3) | Reported Device Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862) | Fluid resistant claimed at 160 mm Hg | 32 out of 32 Pass at 160 mmHg (Average of 3 lots with 32 samples per lot) |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | ≥ 98% (for 0.1 µm polystyrene latex spheres) | Pass at 99.12% (Average of 3 lots with 32 samples per lot) |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | ≥ 98% | Pass at 99.79% (Average of 3 lots with 32 samples per lot) |
| Differential Pressure (Delta P) (MILM-36954C) |
§ 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.