(142 days)
No
The device description and performance studies focus on material properties and physical filtration, with no mention of AI or ML.
No
The device is described as a mask and eyeshield intended for infection control by minimizing contamination from exhaled microorganisms and reducing exposure to blood and body fluids, which are preventative rather than therapeutic uses.
No
This device is a fluid-resistant eyeshield mask intended for infection control by minimizing contamination from exhaled microorganisms and reducing exposure to blood and body fluids, not for diagnosing medical conditions.
No
The device description clearly outlines the physical components of a mask with an eyeshield, including materials like polyolefin, cellulosic, meltblown polyolefin filter media, aluminum wire, and an optical quality eyeshield. The performance studies also focus on physical properties like water resistance, differential pressure, and particle filtration efficiency, which are characteristic of a physical medical device. There is no mention of software as a component or function of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on infection control practices by minimizing the spread of microorganisms from the wearer and reducing exposure to blood and body fluids. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details the physical construction of a mask with an eyeshield. It does not mention any components or mechanisms for analyzing biological samples.
- Performance Studies: The performance studies evaluate physical properties like water resistance, breathability (differential pressure), and particle filtration efficiency. These are relevant to the barrier function of the mask, not to diagnostic accuracy.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, this device is a personal protective equipment (PPE) designed for infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MASK, SURGICAL
Device Description
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.
All of the materials used in the construction of the masks are being used in other currently marketed devices, such as our regular surgical mask, 510 (k) #K801036.
These masks filter particles at an average efficiency of greater than 95% when tested at both 1.0 micron and 0.1 micron particle sizes. The breathability of the masks (measured by the pressure drop across the mask) averages no more than 5.0 mm of water.
All of the materials used in the construction of the mask are used in other currently marketed devices, these include:
-American Threshold Surgical Mask 510(k) #K801036
-Tecnol Surgical Mask 510(k) #K874608
-3M Surgical Mask 510(k) #K910110
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was submitted to determine substantial equivalence and device claims, including:
- Water Resistance, Impact Penetration Test (Nelson Laboratories SOP#MBG/037): This procedure measures the resistance of materials to water penetration under contact with sprayed water.
- Results: American Threshold Fluid Resistant Mask had an average increase in blotter weight of 2.64% in the first study and 9.15% in the second. Tecnol Fluid Resistant Mask had an average increase of 49.33% in the first study and 2.99% in the second.
- Differential Pressure, Delta P Test (Nelson Laboratories SOP#ARO/006): This test determines the air exchange differential of porous materials, which is important for breathability.
- Results: American Threshold Fluid Resistant Mask's average Differential Pressure was 2.19 in the first study and 2.54 in the second. Tecnol Fluid Resistant Mask's average Differential Pressure was 1.99 in the first study and 2.68 in the second.
- Latex Particle Challenge (Nelson Laboratories SOP#ARO/011): This procedure evaluates non-viable particle retention or filtration efficiency of barrier materials.
- Results:
- Polyolefin Inner Facing: 1.0 micron particle size = 99.3% filtration efficiency; 0.1 micron particle size = 98.4% filtration efficiency.
- Cellulosic Inner Facing: 1.0 micron particle size = 99.2% filtration efficiency; 0.1 micron particle size = 99.2% filtration efficiency.
- Results:
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Filtration efficiency for 1.0 micron particle size = 99.3% (Polyolefin Inner Facing); 99.2% (Cellulosic Inner Facing)
- Filtration efficiency for 0.1 micron particle size = 98.4% (Polyolefin Inner Facing); 99.2% (Cellulosic Inner Facing)
- Breathability (pressure drop across the mask) averages no more than 5.0 mm of water.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510 (k) SUMMARY
APR 2 5 199
Submitted by: American Threshold Industries 240 Sardis Road Enka, N.C. 28828
Contact Person: Frances Mayhew, Quality Assurance Manager
Date of Submission: Original - December 4, 1995
Device Name: Fluid Resistant Eyeshield Mask Classification Name: MASK, SURGICAL
-
Tecnol Fluid Resistant Surgical Mask, 510 (k) #K874608, dated Predicate Device(s): December 2, 1987.
-
3M Fluid Resistant Mask, 510 (k) #K910110, dated March 20, 1991
Device Description:
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.
All of the materials used in the construction of the masks are being used in other currently marketed devices, such as our regular surgical mask, 510 (k) #K801036.
These masks filter particles at an average efficiency of greater than 95% when tested at both 1.0 micron and 0.1 micron particle sizes. The breathability of the masks (measured by the pressure drop across the mask) averages no more than 5.0 mm of water.
All of the materials used in the construction of the mask are used in other currently marketed devices, these include:
-American Threshold Surgical Mask 510(k) #K801036
1
Statement of Intended Use:
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.
Testing Submitted to Determine Substantial Equivalence and Device Claims:
- Water Resistance, Impact Penetration Test, Nelson Laboratories SOP#MBG/037 1. -This procedure is designed to measure the resistance of materials to water penetration under contact with sprayed water. This test was performed to demonstrate substantial equivalence.
-
- Differential Pressure, Delta P Test, Nelson Laboratories SOP#ARO/006 - The differential pressure test determines the air exchange differential of porous materials and is important for determining the breathability of surgical face masks. This test was performed to demonstrate substantial equivalence.
- Latex Particle Challenge, Nelson Laboratories SOP#ARO/011 3. -This procedure provides for evaluation of non-viable particle retention or filtration efficiency of barrier materials. This test was performed to substantiate device claims.
Conclusions Drawn from the Results of the Above Testing:
ﻣﺴﻪ
- l . Water Resistance, Impact Penetration Test Results:
American Threshold Fluid Resistant Mask: -Average per-cent increase in blotter weight = 2.64% increase in the first study and 9.15% in the second.
Tecnol Fluid Resistant Mask: -Average per-cent increase in blotter weight = 49.33% increase in the first study and 2.99% in the second.
-
- Differential Pressure, Delta P Test Results:
American Threshold Fluid Resistant Mask: -Differential Pressure average was 2.19 in the first study and 2.54 in the second.
- Differential Pressure, Delta P Test Results:
Tecnol Fluid Resistant Mask: -Differential Pressure average was 1.99 in the first study and 2.68 in the second.
2
Latex Particle Challenge Test Results: 3.
American Threshold Fluid Resistant Mask: (with or without eyeshield)
-Average filtration efficiency for Polyolefin Inner Facing:
1.0 micron particle size = 99.3% filtration efficiency 0.1 micron particle size = 98.4% filtration efficiency
-Average filtration efficiency for Cellulosic Inner Facing:
1.0 micron particle size = 99.2% filtration efficiency
- 0.1 micron particle size = 99.2% filtration efficiency
Based on the above test results American Threshold Industries considers their fluid resistant mask to be substantially equivalent to the other fluid resistant masks currently on the market.