(83 days)
Gerson Isolair APR Type N95 Model 2735 Respirator
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No
The description focuses on the physical components and performance characteristics of a respirator, with no mention of AI or ML.
No
The device is described as a respirator designed to protect the wearer from particulate aerosols and fluid splash, not to treat a disease or condition. While it has a protective function against exposure, it does not fit the definition of a therapeutic device.
No
The device is described as a respirator designed to protect the wearer from particulate aerosols and fluid splashes, not to diagnose a medical condition.
No
The device description clearly outlines physical components (nonwoven interfacing, filter media, fluid barrier film, headbands, nosepiece) and performance studies relate to physical properties (filtration efficiency, fluid resistance, face fit, ease of breathing). This is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided description clearly states that this device is a respirator designed to cover the nose and mouth and filter airborne particles. It is a personal protective equipment (PPE) device.
- Intended Use: The intended use is for TB exposure control and providing a filter efficiency level of 95% against solid particulate aerosols. This is a protective function, not a diagnostic one.
- Performance Studies: The performance studies focus on filtration efficiency, fluid resistance, face fit, and ease of breathing – all characteristics of a respiratory protective device, not a diagnostic test.
The device's function is to protect the wearer from inhaling harmful particles, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Meets the CDC guidelines for TB exposure control. Has a filter efficiency level of 95% against solid particulate aerosols free of oil (Type N95 respirator). Designed to be fluid resistant to splash and spatter of blood and body fluids.
Product codes
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Device Description
Respirator consisting of nonwoven inter facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer, and is held in place with two synthetic clastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Nose and mouth
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Filtration Efficiency: Subject device samples met the NIOSH required sodium chloride test with 0.3 micron particles. At no time can the filtration efficiency drop below 95%.
Fluid Resistance: Subject device samples were challenged with 2cc of synthetic blood at a speed simulating release of blood from an artery. No fluid penetration was observed.
Face Fit: Subject device samples were tested using a qualitative fit test.
Ease of Breathing: Subject device samples met the requirements of the NIOSH airflow resistance test which requires initial resistance (inhalation) to be less than 35mm H2O.
Key Metrics
Not Found
Predicate Device(s)
Gerson Isolair APR Type N95 Model 2735 Respirator
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
:
Tecnol Medical Products, Inc. 510(k) Premarket Notification J (6) I Land Ret News Respirator and Surgical Mask with FluidShield® Protection
APR 3 0 1997
Tab H
1 of 2
510(k) SUMMARY
12:18
| (1) Submitter: | Tecnol Medical Products, Inc. 7201 Industrial Park Blvd. Fort Worth, TX 76180 |
|---|---|
| Prepared By: | Ruth L. Jones |
| Date Submitted: | March 24, 1997 |
| (2) Device Name/ Trade Name: | Tecnol PFR95 TM Particulate Filter Respirator and Surgical Mask FluidShield ® Protection |
| Common Name: | Surgical Mask Also sometimes referred to as a particulate respirator. |
Classification Name: Surgical Apparel, as described in 21 CFR 878.4040
- Gerson Isolair APR Type N95 Model 2735 Respirator (3) Predicate Device: and Surgical Mask .
- Respirator consisting of nonwoven inter facing, filter Device Description: (4) media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer, and is held in place with two synthetic clastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece.
- Intended Use: Meets the CDC guidelines for TB exposure control. (2) Has a filter efficiency level of 95% against solid particulate aerosols free of oil (Type N95 respirator). Designed to be fluid resistant to splash and spatter of blood and body fluids.
- No new technological characteristics are used in the (6) Technological PFR95TM mask. Characteristics Comparison:
1
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Techol Medical Products, Inc. 510(k) Premarket Notification
From Particulate Filter Respirator and Surgical Mask with FluidShield® Protection
Tab H 2 of 2
Performance Data: (7)
Filtration Efficiency: Subject device samples met the NIOSH required sodium chloride test with 0.3 micron particles. At no time can the filtration efficiency drop below 95%.
Fluid Resistance: Subject device samples were challenged with 2cc of synthetic blood at a speed simulating release of blood from an artery. No fluid penetration was observed.
Face Fit: Subject device samples were tested using a qualitative fit test.
Ease of Breathing: Subject device samples met the requirements of the NIOSH airflow resistance test which requires initial resistance (inhalation) to be less than 35mm H2O.
CONCLUSION: The results of these nonclinical tests, when compared with data available and/or claims made on the predicate device, demonstrate that the subject device is as safe and effective as the predicate device, and performs as well as the predicate device.
f\p&510(k)/pfi-tabh3.doc