(49 days)
The device 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.
Barrier® N95 Particulate Respirators. Models #4273 are NIOSH certified (TC-84A-4350), trapezoid shaped respirators. Barrier® N95 Particulate Respirators, Models #4273 consists of a flat folded disposable face mask that is a piece of three layered non-woven fabric folded in two. An aluminum filament is enclosed in a binding tape welding the top edge, which forms a conformable nose clamp for the purpose of shaping the mask to the contours of the face. It features elastic head bands, ultrasonically welded, to secure the masks in place for the wearer.
Here's a breakdown of the acceptance criteria and the study information for the Barrier® N95 Particulate Respirators, Models #4272 and #4273, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by various standards and NIOSH certifications. The document states that the device "meets the requirements" of these standards and certifications.
| Characteristic | Acceptance Criteria (Reference Standard/Certification) | Reported Device Performance |
|---|---|---|
| Fluid Resistance | ASTM F1862 | Pass |
| Particulate Filtration Efficiency | NIOSH Certification Number: TC 84A-4350 | Meets NIOSH Certification (TC 84A-4350) |
| Bacterial Filtration Efficiency | NIOSH Certification Number: TC 84A-4350 | Meets NIOSH Certification (TC 84A-4350) |
| Differential Pressure | NIOSH Certification Number: TC 84A-4350 | Meets NIOSH Certification (TC 84A-4350) |
| Flammability | 16 CFR 1610 Standard for Flammability of Clothing Textiles | Pass |
| Cytotoxicity | (Implied: Not cytotoxic, assessed against relevant biological reactivity standards) | Not cytotoxic |
| Irritation | (Implied: Not irritating, assessed against relevant biological reactivity standards) | Not irritating |
| Delayed-Type Hypersensitivity | (Implied: No potential for sensitization, assessed against relevant biological reactivity standards) | Does not display any potential for sensitization |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for each characteristic. It refers to meeting the requirements of established standards and NIOSH certifications. For example, for Fluid Resistance, it states it meets ASTM F1862, which would have its own defined sample sizes for testing. The data provenance is not explicitly mentioned as a specific "country of origin" for testing, but given the applicant is a US LLC and the submission is to the FDA, it is likely that testing adhered to US regulations or internationally recognized standards. The study appears to be retrospective in the sense that it relies on existing standardized tests and certifications rather than a new prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The "ground truth" for the performance characteristics is established by the methods, parameters, and pass/fail criteria defined within the referenced standards (e.g., ASTM F1862, NIOSH TC 84A-4350, 16 CFR 1610). These standards are developed by expert committees, but the specific number and qualifications of individuals involved in the testing that led to these results are not detailed here.
4. Adjudication Method for the Test Set
This information is not applicable in the context of this submission. The "adjudication method" usually refers to how discrepancies are resolved when multiple human readers interpret data, often in medical imaging studies. Here, the performance is measured against objective technical standards which typically have clear pass/fail criteria, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data was required." The clearance is based on substantial equivalence to a predicate device, supported by technical performance testing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the device is a physical N95 respirator, not an algorithm or AI system. The performance evaluated is that of the physical product itself.
7. The Type of Ground Truth Used
The ground truth used is primarily objective technical standards and certifications. These include:
- ASTM F1862 (for Fluid Resistance)
- NIOSH Certification Number (TC 84A-4350 for filtration efficiency and differential pressure)
- 16 CFR 1610 Standard for Flammability of Clothing Textiles
- Implied biological reactivity testing standards (for cytotoxicity, irritation, sensitization).
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not an AI or machine learning model 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 this device.
§ 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.