(142 days)
This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
The Fluid Resistant Eyeshield Masks are constructed of a light weight spunbonded polyolefin or cellulosic outer facing, a meltblown polyolefin filter media, and a light weight spunbonded polyolefin or cellulosic inner facing. The three layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The bodies have either light weight polyolefin or cellulosic nonwoven material sonically welded or otherwise attached to both sides of the body (ties on the surgeons tie masks) or polyolefin/elastic earloops sonically welded or otherwise attached to both sides of the body. The masks have a malleable aluminum wire encapsulated in the facing to form the mask to fit the nose. An optical quality eyeshield is attached to the mask by ultrasonic welding.
This 510(k) summary describes a Fluid Resistant Eyeshield Mask and its equivalence to existing predicate devices. The "acceptance criteria" here refers to the performance standards that demonstrate the new device is as safe and effective as the predicate devices. The "study" refers to the testing conducted to show this equivalence.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to predicate devices and the performance of those devices. The document does not explicitly state numerical "acceptance criteria" but rather presents test results for both the new device and a predicate device (Tecnol Fluid Resistant Mask) to show similar or better performance. The 3M predicate device is only listed, not elaborated on in the test results.
| Performance Metric | Implied Acceptance Criteria (Based on Tecnol Predicate) | American Threshold Device Performance |
|---|---|---|
| Water Resistance (Impact Penetration Test) | ≤ 49.33% average blotter weight increase (Tecnol, Study 1) | 2.64% (Study 1), 9.15% (Study 2) |
| ≤ 2.99% average blotter weight increase (Tecnol, Study 2) | ||
| Differential Pressure (Breathability) | Average around 1.99 - 2.68 (Tecnol, Study 1 & 2) | 2.19 (Study 1), 2.54 (Study 2) |
| Latex Particle Challenge (Filtration Efficiency) | No explicit numbers for Tecnol are given for particle challenge, but the claim "filter particles at an average efficiency of greater than 95% when tested at both 1.0 micron and 0.1 micron particle sizes" from the device description implies this is the target. | Polyolefin Inner Facing: |
- 1.0 micron: 99.3%
- 0.1 micron: 98.4%
Cellulosic Inner Facing: - 1.0 micron: 99.2%
- 0.1 micron: 99.2% |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each specific test (e.g., how many masks were tested for water resistance, differential pressure, or particle challenge).
The data provenance is from Nelson Laboratories SOPs, which suggests these were laboratory-based tests. There is no information provided about the country of origin of the data or whether it was retrospective or prospective in the context of clinical use. These are material science tests, not clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This is a medical device focused on material properties and physical performance, not diagnostic accuracy where expert ground truth establishment is typically required. The "ground truth" for these tests comes from standardized laboratory procedures and instrument readings.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments. These tests are objective, quantitative laboratory measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not an imaging or diagnostic device that would typically involve a multi-reader multi-case study. The evaluation focuses on the physical performance of the mask.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This is not an algorithm or AI-driven device.
7. The Type of Ground Truth Used
The "ground truth" for these tests is the quantitative measurement obtained through standardized laboratory procedures:
- Water Resistance: Measured by the percentage increase in blotter weight after water exposure.
- Differential Pressure: Measured pressure drop across the material.
- Latex Particle Challenge: Measured filtration efficiency of particles at specified micron sizes.
8. The Sample Size for the Training Set
N/A. There is no "training set" in the context of material performance testing for this type of device.
9. How the Ground Truth for the Training Set Was Established
N/A. No training set is 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.