(160 days)
The SpectraShield 9500 Surgical N95 Respirator is a single use, disposable, surgical N95 respirator, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the outer layer of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.
No clinical studies have been conducted comparing the ability of an untreated surgical N95 respirator and the SpectraShield model 9500 surgical N95 respirator to protect the wearer from infection, and the antibacterial treatment cannot effect pathogens that are inhaled around the edges of the respirator.
The SpectraShield 9500 Surgical N95 respirator is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.
The SpectraShield model 9500 Surgical Mask is a molded shape surgical mask composed of 4 layers of material, molded to form the mask. A 2-ply meitblown polypropylene middle layer is sandwiched by inner and outer layers of 100% polyester nonwoven fabric. The inner and outside layers of polyester nonwoven fabric include fibers that have been embedded with an antibacterial agent to provide antibacterial performance. The mask has 2 latex-free non-allergenic elastic straps and an aluminum nose strip.
The SpectraShield 9500 Surgical N95 Respirator, as described in K120244, demonstrates its performance through a series of laboratory-based tests comparing it to a predicate device (K090414). The primary goal of this 510(k) submission was to amend the Intended Use Statement of the SpectraShield 9500 Surgical N95 Respirator to include "tested for continuous use up to 8 hours," based on existing bioefficacy data showing sustained performance.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by meeting or exceeding the performance of the predicate device (K090414) in various standardized tests. The new device is essentially the same as the predicate, with the requested change being an update to the Intended Use Statement.
| Test | Acceptance Criteria (Predicate Device K090414) | Reported Device Performance (New Device) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | Pass: Fluid Resistant @ 160mm Hg | Pass: Fluid Resistant @ 160mm Hg |
| Particulate Filtration Efficiency (ASTM F2299) | Pass: 99.87% at 0.1 microns | Pass: 99.87% at 0.1 microns |
| Differential Pressure (Mil M36954C) | Pass: 4.3mm H2O/cm2 | Pass: 4.3mm H2O/cm2 |
| Bacterial Filtration Efficiency (ASTM F2101) | Pass: 99.9% | Pass: 99.9% |
| Flammability (Class 16CFR 1610) | Class 1 | Class 1 |
| Cytotoxicity (ISO 10993-10) | Pass: USP reactivity score = 4.40 log10 reduction - 1 hour, H. influenzae: > 6.20 log10 reduction - 1 hour, MRSA: > 4.83 log10 reduction - 1 hour (To Inoculums measured, >10^6) | S. pyogenes: > 4.40 log10 reduction - 1 hour, H. influenzae: > 6.20 log10 reduction - 1 hour, MRSA: > 4.83 log10 reduction - 1 hour (To Inoculums measured, >10^6) |
| BioEfficacy (after repeated exposures to perspiration over 12 hours) | S. pyogenes: > 4.25 log10 reduction - 1 hour, H. influenzae: > 4.18 log10 reduction - 1 hour, MRSA: > 4.11 log10 reduction - 1 hour (To Inoculums measured, >10^6) | S. pyogenes: > 4.25 log10 reduction - 1 hour, H. influenzae: > 4.18 log10 reduction - 1 hour, MRSA: > 4.11 log10 reduction - 1 hour (To Inoculums measured, >10^6) |
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state the sample sizes used for each specific test in the "test set" in terms of number of masks. Instead, it references standardized ASTM, Mil, ISO, and USP test methods, which typically define their own sample size requirements. The data provenance is described as "in vitro (laboratory) tests," indicating that the tests were conducted in a controlled lab environment. There is no information about country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
This type of submission (510(k) for a surgical mask with an amended intended use) relies on objective, repeatable physical and biological performance tests, not human expert interpretation of results for ground truth. Therefore, there were no "experts" in the traditional sense (e.g., radiologists) used to establish ground truth for a test set. The ground truth for performance measures (e.g., filtration efficiency, bacterial kill) is based on the results of the specified laboratory tests performed according to recognized standards.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is described or applicable, as the evaluation of this device is based on quantifiable laboratory test results against predefined standards, not on subjective human assessments that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There was no MRMC comparative effectiveness study done. The device is a surgical mask, and its performance is evaluated through material science and microbiology testing rather than clinical interpretation by human readers. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" is not applicable.
6. Standalone Performance (Algorithm Only)
A standalone performance evaluation was conducted for various physical and biological parameters of the mask. The "algorithm only" concept does not apply here as the device is a physical product (a mask), not an AI algorithm. The performance metrics presented in the table above represent the standalone performance of the device without human-in-the-loop for the core functionalities tested.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's performance is based on objective laboratory test results according to established national and international standards (e.g., ASTM, Mil, ISO, USP). For bioefficacy, the ground truth is the measured bacterial reduction percentage based on controlled in vitro bacterial challenges. No pathology or outcomes data is mentioned in this summary for establishing ground truth.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI, as this device submission is for a physical medical device. The tests performed are part of a product validation rather than an AI model development.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of this traditional medical device submission, the concept of establishing ground truth for a training set is not applicable.
§ 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.