(298 days)
Pasture 60S Surgical Mask is a surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
Pasture 60S Surgical Mask is a flat pleated surgical mask. It is in 4 layers and composed of PP and Meltblown, also with elastic loops and nosepiece which is the combination of zinc wires and embedded polyester inside of layers.
The provided documents detail the 510(k) summary for the Pasture 60S Surgical Mask (K141875), comparing it to the predicate device, TIDI® Facemasks (K092580). The focus of this submission is on non-clinical performance testing for substantial equivalence, rather than a clinical study involving human readers or AI.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Predicate Acceptance Criteria (K092580) | Pasture 60S Surgical Mask Performance |
|---|---|---|
| Fluid Resistance Performance | Pass @ 80 mmHg | Pass @ 120 mmHg |
| Particulate Filtration Efficiency (%) | 99.6 | 99.4 |
| Bacterial Filtration Efficiency (%) | >99.9 | 99.76 |
| Differential Pressure (mmH₂O/cm²) | 3.4 | 3.33 |
| Flammability Class | Class 1 | Class 1 |
| Biocompatibility - Cytotoxicity | Not available | non-cytotoxic |
| Biocompatibility - Sensitization | Not available | non-sensitizing |
| Biocompatibility - Primary skin irritation | Not available | non-irritating |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability, Biocompatibility). These tests are typically performed on a statistically significant number of samples according to the relevant test standards.
The provenance of the data is indicated by the laboratories that conducted the tests:
- Biocompatibility test: SUPER LABORATORY SGS (TAIWAN) LTD
- Flammability test: Taiwan Textile Research Institute
- Synthetic Blood Penetration test: Taiwan Textile Research Institute
- Particulate Filtration Efficiency: Nelson Laboratories (a well-known US-based lab for such testing)
- Bacterial filtration efficiency: Taiwan Textile Research Institute
- Differential pressure testing: Taiwan Textile Research Institute
The data is retrospective, as it refers to tests conducted on the device for this 510(k) submission. The countries of origin for the testing are Taiwan (for most tests) and the USA (for Particulate Filtration Efficiency).
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. The device under review is a surgical mask, and the evaluation is based on objective, standardized physical and biological performance tests, not on interpretations or diagnoses by human experts.
4. Adjudication Method
This is not applicable. The performance tests yield objective numerical or categorical results (e.g., "Pass," "99.4%", "Class 1"), which do not require expert adjudication in the context of this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is relevant for diagnostic or interpretive devices where human readers evaluate cases with and without AI assistance. The Pasture 60S Surgical Mask is a physical barrier device, and its safety and effectiveness are assessed through laboratory performance tests, not human interpretation of medical images or data.
6. Standalone Performance Study (Algorithm Only)
No. This concept is applicable to software algorithms or AI systems operating independently. The Pasture 60S Surgical Mask is a physical device, and its "standalone performance" is demonstrated through the various laboratory tests listed.
7. Type of Ground Truth Used
The "ground truth" for the performance criteria is established by internationally recognized test standards and regulatory requirements for surgical masks, such as those related to fluid resistance (ASTM F1862), particulate filtration efficiency (ASTM F2299), bacterial filtration efficiency (ASTM F2101), differential pressure (MIL-M-36954C or EN 14683), flammability (16 CFR Part 1610), and biocompatibility (ISO 10993 series). The results of the laboratory tests are compared against these predetermined standards.
8. Sample Size for the Training Set
This is not applicable. The device is a physical product, not a machine learning model, hence there is no "training set."
9. How the Ground Truth for the Training Set was Established
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.