(195 days)
The Technoweb Sugical Mask is 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.
Technoweb Surgical Mask is a type of surgical mask covers the user's nose and mouth. And provides a physical barrier to fluids and particulate materials. Technoweb Surgical Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of three nonwoven layers; inner and outer cover web with middle different filter web sandwiched in between.
This document describes the FDA's substantial equivalence determination for the Technoweb Surgical Mask (K172500) to the predicate device, 3M VFlexTM Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S (K121069).
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Technoweb Surgical Mask are based on performance testing to demonstrate substantial equivalence to the predicate device. These criteria are primarily focused on the physical characteristics and protective capabilities of surgical masks.
| Acceptance Criteria Category | Specific Criteria/Tests (Technoweb Surgical Mask) | Reported Device Performance (Technoweb Surgical Mask) | Predicate Device (3M VFlexTM Model 1805/1805S) | Comparison |
|---|---|---|---|---|
| Fluid Resistance | ASTM F1862 | Fluid resistance at 12 mmHg. | YES (implies meeting a similar standard) | Similar |
| Material | Outer cover web: Polypropylene spunbond | |||
| Stiffener web: Polypropylene spunbond | ||||
| Filter web: Polypropylene | ||||
| Inner web: Polypropylene | ||||
| Nose-Clip: Aluminum | ||||
| Staple: Steel | ||||
| Headband: Nylon | All listed materials are used. | Outer cover web: Felt | ||
| Stiffener web: N/A | ||||
| Filter web: Felt | ||||
| Inner web: Felt | ||||
| Nose-Clip: Aluminum | ||||
| Staple: N/A | ||||
| Headband: Polyisoprene | ||||
| Nose foam: Plastic coating | Similar (some material differences noted but deemed acceptable for equivalence) | |||
| Design | Flat fold with ear loops | Flat fold with ear loops | Flat fold with Advanced Electrostatic Media (implied design feature aiding filtration) | Similar |
| Indications for Use | 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. | Meets this indication. | Same indication. | Same |
| Single Use | Yes | Yes | Yes | Same |
| Biocompatibility | Biocompatibility assessment performed on patient contact materials. | Passed (implied by conclusion of safety and equivalence). | (Not explicitly detailed for predicate, but assumed to meet safety standards) | Implied as similar by equivalence conclusion. |
| Safety and Performance (General) | Laboratory testing regarding characteristics was performed to verify safety and performance. | Passed (implied by conclusion of safety and equivalence). | (Not explicitly detailed for predicate, but assumed to meet safety standards) | Implied as similar by equivalence conclusion. |
| Dimensions | TM-R is 212mm(W), 74mm(H) and model TM-S is 177.8mm(W), 138 mm(H). | Reported dimensions. | (Not explicitly detailed for predicate in the table, but assumed to be comparable for "similar" rating) | Similar |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific details on the sample sizes used for the various performance tests (e.g., fluid resistance, material testing, biocompatibility). It generally states "Laboratory testing regarding characteristics was performed on Technoweb surgical mask." It also doesn't specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a submission for a medical device (surgical mask), the "ground truth" is typically established by recognized national or international standards and test methods (e.g., ASTM F1862 for fluid resistance). The document does not mention the use of human experts to establish "ground truth" for the performance characteristics of the mask in the same way one might for an AI diagnostic imaging device. Instead, the performance is measured against established scientific criteria.
4. Adjudication Method
Not applicable for this type of device and testing. Performance is measured objectively against predefined standards, not through expert adjudication of subjective assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical medical device (surgical mask), not an AI algorithm intended for diagnostic interpretation or human-in-the-loop assistance.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is not an algorithm. The "standalone performance" refers to the intrinsic physical and protective properties of the mask as tested against standards.
7. Type of Ground Truth Used
The ground truth used for evaluating the Technoweb Surgical Mask's performance is based on established industry standards and test methods, such as ASTM F1862 for fluid resistance, and general biocompatibility testing methodologies. These are objective, empirically defined criteria for surgical mask performance.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical 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.