(97 days)
The Cufitec Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids and has an anti-influenza agent (active ingredient: Cul at 0.5% wt. concentration) on the outer and inner mask layers.
The Cufitec Surgical Mask inactivates 99.90% of the following influenza viruses on five minutes contact with the surface of the facemask in laboratory (in vitro) tests against the following influenza viruses:
Influenza A/H1N1: A/WS/33, A/Virginia/ATCC2/2009; Influenza A/H3N2: A/Kitakyusyu/159/93, A/Udorn/307/72, A/Hong Kong/8/68, A/Victoria/210/09, A/Virginia/ ATCC6/2012; Influenza B: B/Lee/40, B/Taiwan/2/62; under tested contact conditions.
Correlations between in vitro testing results and any clinical event has not been tested.
The Cufitec® Surgical Mask is a single-use, disposable device, provided non-sterile, and is intended to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids, and particulates and has an added anti-influenza agent which inactivates specific pathogens under specified contact conditions. The mask is comprised of four layers of materials: rayon layers with added anti-influenza coating (outer and inner layers) and polypropylene layers (two middle layers). All of the construction materials used in this device are commonly used in the construction of surgical facemasks used in current legally marketed devices. The inner and outer layers are coated with an anti-influenza agent (CuI, 0.5% wt.), which inactivates influenza viruses under tested contact conditions using the same mechanism of action. Masks are held in place on the wearer with ear loops (polyurethane and nylon) and contains a malleable polyethylene nosepiece strip to conform to the wearer's face.
This document describes the premarket notification for the Cufitec Surgical Mask (K182766), a Class II medical device. While it explicitly states that no clinical testing was required or performed (Section 6, Table on Performance Testing, row "Clinical Testing" states "Not applicable. Same – clinical testing is not required to support the subject device."), it details extensive non-clinical performance and antiviral testing to demonstrate substantial equivalence to its predicate device.
Therefore, the requested information regarding "human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," and the "ground truth used (expert consensus, pathology, outcomes data, etc.)" for AI validation is not applicable to this specific submission, as it concerns a physical surgical mask and not an AI/algorithm-based device.
However, I can extract information related to the acceptance criteria and study proving the physical device meets these criteria, focusing on the non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Bench Testing | Fluid Resistance | Met ASTM F1862 standard (Specific pressure not detailed but implied by standard). | Results met all acceptance criteria per ASTM standards. |
| Bacterial Filtration Efficiency (BFE) | Met ASTM F2101 standard (Specific efficiency not detailed but implied by standard). | Results met all acceptance criteria per ASTM standards. | |
| Particulate Filtration Efficiency (PFE) | Met ASTM F2299 standard (Specific efficiency not detailed but implied by standard). | Results met all acceptance criteria per ASTM standards. | |
| Delta Pressure | Met MIL-M-36945C standard (Specific pressure differential not detailed but implied by standard). | Results met all acceptance criteria per MIL standards. | |
| Flammability | Met Class 1, 16 CFR Part 1610. | Results met Class 1, 16 CFR Part 1610. | |
| Antiviral Testing | Antiviral Efficacy (A/H1N1, A/H3N2, B strains) | ≥ 99.99% reduction (≥4 log kill) of influenza viruses at 5 minutes' contact for both "fresh" and "aged" test articles. | Achieved 99.99% reduction of the viruses at 5 minutes' contact across all tested strains and conditions (fresh and aged masks, after simulated breathing, and repeated exposure). |
| Limit of Quantitation (LOQ) of active ingredient | LOQ of CuI on the mask to be determined (specific numerical criterion for acceptable LOQ not explicitly stated as a pass/fail but as a value determined). | LOQ was determined to be 0.048 µg/cm². | |
| Neutralization Validation | Neutralizer (SCDLP) must effectively neutralize the antiviral effect of eluted antiviral agent. | Neutralizer effectively neutralized the antiviral effect of eluted antiviral agent. | |
| Determination of Resistant Strains | Identify the most resistant strains (no specific numerical acceptance criteria, but an outcome of the test). | The three most resistant strains were identified as Influenza A (H3N2): A/Kitakyusyu/159/93, A/HongKong/8/68, and A/Udorn/307/72. | |
| Simulated Breathing Test (Antiviral Efficacy) | ≥ 99.99% reduction of influenza viruses at 5 minutes' contact after simulated breathing, for "fresh" and "aged" articles, against the most resistant strains and selected H1N1 and B strains. | All test articles met the acceptance criteria of achieving 99.99% reduction of the virus at 5 minutes' contact after simulated breathing test. | |
| Repeated Exposure Testing (Antiviral Efficacy) | ≥ 99.99% reduction of influenza viruses at 5 minutes' contact after repeated exposure, for "fresh" and "aged" articles, against 5 subtypes. | All test articles met the acceptance criteria of achieving 99.99% reduction of the virus at 5 minutes' contact after simulated breathing test (likely a typo, should probably refer to repeated exposure instead of simulated breathing test here based on the test name). | |
| Uniform Distribution Validation | Concentration of active ingredient (CuI) on the surgical mask must be sufficiently higher than the minimum effective concentration in both "fresh" and "aged" mask samples. | The concentration of CuI was sufficiently higher than the minimum effective concentration in both "fresh" and "aged" mask samples. | |
| Minimum Effective Concentration Testing | The minimum concentration of CuI on the mask must be sufficiently higher than the minimum effective concentration required for 99.99% reduction of influenza viruses at 5 minutes contact. | The minimum concentration of CuI on the mask is sufficiently higher than the minimum effective concentration required for 99.99% reduction of influenza viruses at 5 minutes contact. | |
| Biocompatibility Testing | Sensitization | Met ISO 10993-10 standard. | Results met ISO 10993-10 standard. |
| Irritation | Met ISO 10993-10 standard. | Results met ISO 10993-10 standard. | |
| Ocular Irritation | Met ISO 10993-10 standard. | Results met ISO 10993-10 standard. | |
| Chemical Characterization | Met ISO 10993-18 standard; Chemical characterization must support the biological safety of the device (implying no harmful releases or extracts). | The test included analysis of solids released into airflow and extracts by saline and hexane. The results support the biological safety of the device. Results met ISO 10993-18 standard. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of masks or viral samples) used for each non-clinical performance and antiviral test. It mentions "test articles" and "samples" but not the quantity for each specific test.
- Data Provenance: The tests are explicitly described as "laboratory (in vitro) tests." The submitter is NBC Meshtec Inc. based in Tokyo, Japan, and the official US correspondent is Globizz Corporation in Gardena, California. It can be inferred that the testing was conducted in a laboratory setting, likely either in Japan or a contracted lab. The data is retrospective in the context of the submission, as the tests were completed and results reported prior to the FDA review.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable as the submission pertains to a physical medical device (surgical mask) and its non-clinical performance characteristics, not an AI/algorithm-based diagnostic device requiring human expert ground truth.
4. Adjudication Method for the Test Set
Not applicable for a physical device's non-clinical performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No clinical or human-reader studies were conducted for this device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Standardized laboratory protocols and measurements: Adherence to ASTM, ISO, and MIL standards for physical performance (fluid resistance, filtration, flammability).
- Validated laboratory assays: For antiviral efficacy, the "ground truth" is the empirically measured viral reduction (log kill) under controlled in vitro conditions, with specific viral strains and contact times. This is based on established microbiological testing methods.
- Chemical and biological characterization: For biocompatibility and active ingredient concentration, the "ground truth" is based on analytical chemistry and toxicology principles, confirmed by tests like ISO 10993 series.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for this product would be the iterative design and manufacturing process of the mask itself, involving material selection and coating application, which is not quantified as a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no "training set" in the AI/ML sense. The product's development would have been guided by engineering and materials science principles, aiming to meet the performance criteria established by relevant standards and the intended antiviral claims.
§ 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.