(127 days)
The Tiger SFM0001 surgical mask is intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
The Tiger surgical mask SFM0001 (colors: blue) is flat pleated by 3-ply masks with outer layer and inner layers (spunbonded polypropylene) that sanwich a meltbown polypropylene filter material; Ear-loops are made of urethane elastic fiber for free elastic loops. The nose piece is white aluminum strip with PP covering. All of the materials used in the construction of the Tiger flat surgical Masks are being used in currently marketed devices (see predicate information). All items are nosterilize and only for single use.
This submission describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Tiger Surgical Mask SFM0001.
The study is a series of non-clinical bench tests performed by accredited laboratories to demonstrate substantial equivalence to predicate devices.
1. A table of acceptance criteria and the reported device performance:
| Performance Characteristics | Test method | Acceptance criteria/result (Tiger Surgical Mask SFM0001) | Predicate K061716 results | Predicate K022256 results |
|---|---|---|---|---|
| Fluid resistance | ASTM 1862 | 31 of 32 Pass at 120mmHg | 29 of 32 pass | No visual penetration |
| Particulate Filtration Efficiency | ASTM F2299 | >99.9% at 2.7µm | 2.0 microns | 98.5% at 0.1 microns |
| Bacterial Filtration Efficiency | ASTM F2101 | 99.86% | 99.6% | 97.9% |
| Flammability Class | 16CFR 1610 | 1 | 1 | 2 |
| Delta-P | Mil M36954C | 3.78 | 2.6 | 1.8 |
| Biocompatibility | ISO10993-1 | Cytotoxicity: no cytotoxic potential | N/A | N/A |
| Sensitization: negligible | N/A | N/A | ||
| Irritation: No reactions | N/A | N/A |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance (ASTM F1862): 32 samples were tested. The data provenance is from Nelson Laboratories.
- Particulate Filtration Efficiency (ASTM F2299): Specific sample size not explicitly stated in the provided text, but testing was performed by Nelson Laboratories.
- Bacterial Filtration Efficiency (ASTM F2101): Specific sample size not explicitly stated in the provided text, but testing was performed by Nelson Laboratories.
- Flammability Class (16CFR 1610): Specific sample size not explicitly stated, but testing was performed by Nelson Laboratories.
- Delta-P (Mil M36954C): Specific sample size not explicitly stated, but testing was performed by Nelson Laboratories.
- Biocompatibility (ISO 10993-1): Specific sample sizes for cytotoxicity, sensitization, and irritation tests are not explicitly stated, but tests were performed by Toxikon Corporation.
The data provenance is retrospective as these are non-clinical bench tests of an already manufactured device, and the testing was conducted by independent laboratories (Nelson Laboratories and Toxikon Corporation). The country of origin for the device manufacturer is China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a non-clinical bench study on device performance characteristics, not a diagnostic or clinical study requiring expert consensus for ground truth. The "ground truth" is based on the objective measurements and established standards of the specified ASTM, CFR, and ISO test methods. The laboratories performing these tests are accredited and their expertise lies in conducting these specific performance evaluations.
4. Adjudication method for the test set:
Not applicable. This is not a clinical study involving subjective interpretation or multiple reviewers. The results are based on objective measurements according to standardized test protocols.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a study for a surgical mask, not an AI-powered diagnostic device, and therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device (surgical mask), not an algorithm.
7. The type of ground truth used:
The ground truth used for this study is based on objective measurements from standardized test methods. For example:
- Fluid resistance is measured by the number of passes at a specific blood pressure.
- Filtration efficiencies are measured as percentages of particles/bacteria blocked.
- Flammability is categorized into classes.
- Biocompatibility is assessed against established criteria for cytotoxicity, sensitization, and irritation.
8. The sample size for the training set:
Not applicable. There is no "training set" for physical device performance testing of this nature. The tests are directly evaluating the product's performance against pre-defined standards.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
§ 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.