(159 days)
Not Found
No
The summary describes a physical respirator with filtration and fluid resistance properties, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a respirator designed to minimize exposure to airborne particles and fluids, which is a protective function rather than a therapeutic one aimed at treating or curing a medical condition.
No
The device description clearly states it is a respirator designed to minimize wearer exposure to airborne particles and is not used to diagnose any medical condition.
No
The device description clearly describes a physical, molded respirator with components like a semi-rigid innershell, filter media, coverweb, headbands, and a noseclip. The performance studies focus on physical properties like filtration efficiency, fluid resistance, and face fit, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device designed to protect the wearer from airborne particles and fluid splash. This is a personal protective equipment (PPE) function, not a diagnostic function.
- Device Description: The description details a respirator that covers the nose and mouth, focusing on physical barriers and filtration. This aligns with PPE, not diagnostic testing.
- Performance Studies: The performance studies focus on filtration efficiency, fluid resistance, face fit, and ease of breathing. These are all relevant to the protective function of a respirator, not to the detection or measurement of substances in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
The device is a respirator intended for personal protection, not for performing diagnostic tests in vitro.
N/A
Intended Use / Indications for Use
Meets the CDC guidelines for TB exposure control Has a filter efficiency level of 95% or greater against particulate aerosols free of oil (Type N95 respirator) Minimizes wearer exposure to certain airborne particles in a size range of 0.1 to 10.0 microns, such as those generated by electrocautery, laser, and other powered medical instruments Designed to be fluid resistant to splash and spatter of blood and body fluids and other potentially hazardous biomaterials Provides greater than 99% Bacterial Filtration Efficiency* to exhaled wearer generated microorganisms (*as determined by the modified Greene and Vesley test method)
Product codes
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Device Description
The 3M 1860 is a molded, cup-shaped respirator, consisting of a semi-rigid innershell, filter media, and a coverweb. It covers the nose and mouth of the wearer, and is held snugly in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable aluminum noseclip.
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
Not Found
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 particles having a count median diameter of 0.055 to 0.095 microns, and an aerodynamic diameter of 0.3 microns; at no time can the filtration efficiency drop below 95%.
Fluid Resistance: subject device samples were challenged with 100 ml ±1 ml for up to 24 hours; no fluid penetration was observed.
Multiple Sized Particles Penetration Test: subject device samples were challenged with particles of multiple sizes, having an aerodynamic diameter range of 0.1µm to 10.1 µm; the filter efficiency level was greater than 99%.
Bacterial Filtration Efficiency: subject device samples were tested using the modified Greene and Vesley procedure; filtration efficiency was greater than 99%
Face Fit: subject device samples were tested using a qualitative fit test; face seal leakage was less than 10%
Ease of Breathing: subject device samples met the requirements of the NIOSH airflow resistance test which requires initial resistance (inhalation) to be less than 35mmH2O.
CONCLUSION: the results of these nonclinical tests, when compared with data available and/or claims made on the predicate devices, demonstrate that the subject device is as safe and effective as the predicate devices. and performs as well as the predicate devices.
Key Metrics
Filtration Efficiency: Greater than 95%
Multiple Sized Particles Penetration: Greater than 99% filter efficiency
Bacterial Filtration Efficiency: Greater than 99%
Face Fit: Face seal leakage less than 10%
Ease of Breathing: Initial resistance (inhalation) less than 35mmH2O
Predicate Device(s)
3M Model 1812 surgical mask, Tecnol DMR2010 respirator and Lazer™ Surgical Mask
Reference Device(s)
Not Found
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.
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Attachment 3, Page 1 of 2
Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letters 'K' and 'g', followed by the numbers '5', '5', '3', '8', and '2'. The characters are written in black ink on a white background, and the handwriting style appears somewhat casual.
Attachment 3 510(k) Summary
МДУ
| (1) | Submitter: | Minnesota Mining and Manufacturing Company (3M)
Occupational Health and Environmental Safety Division
3M Center, Building 260-3A-07
St. Paul, Minnesota 55144-1000 |
|-----|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Dorothea von Busch |
| | Phone Number: | 612-737-8838 |
| | Date Prepared: | February 28, 1996 |
| (2) | Device Name/
Trade Name: | 3M™ Model 1860 Health Care N95 Particulate Respirator and
Surgical Mask |
| | Common Name: | Surgical Mask
Also sometimes referred to as a Particulate Respirator |
| | Classification
Name: | Surgical Apparel, as described in 21 CFR 878.4040 |
| (3) | Predicate Device(s): | 3M Model 1812 surgical mask; Tecnol DMR2010 respirator and
Lazer™ Surgical Mask |
| (4) | Device Description: | The 3M 1860 is a molded, cup-shaped respirator, consisting of a
semi-rigid innershell, filter media, and a coverweb. It covers the
nose and mouth of the wearer, and is held snugly in place with two
synthetic elastic headbands, conforming to the curvature of the
wearer's nose with a malleable aluminum noseclip. |
| (5) | Intended Use: | Meets the CDC guidelines for TB exposure control Has a filter efficiency level of 95% or greater against particulate aerosols free of oil (Type N95 respirator) Minimizes wearer exposure to certain airborne particles in a size range of 0.1 to 10.0 microns, such as those generated by electrocautery, laser, and other powered medical instruments Designed to be fluid resistant to splash and spatter of blood and body fluids and other potentially hazardous biomaterials Provides greater than 99% Bacterial Filtration Efficiency* to exhaled wearer generated microorganisms (*as determined by the modified Greene and Vesley test method) |
| (6) | Technological
Characteristics
Comparison: | No new technological characteristics are used in the 1860 |
| (7) | Performance Data Summary: | Filtration Efficiency: subject device samples met the NIOSH required sodium chloride test, with particles having a count median diameter of 0.055 to 0.095 microns, and an aerodynamic diameter of 0.3 microns; at no time can the filtration efficiency drop below 95%.
Fluid Resistance: subject device samples were challenged with 100 ml ±1 ml for up to 24 hours; no fluid penetration was observed.
Multiple Sized Particles Penetration Test: subject device samples were challenged with particles of multiple sizes, having an aerodynamic diameter range of 0.1µm to 10.1 µm; the filter efficiency level was greater than 99%.
Bacterial Filtration Efficiency: subject device samples were tested using the modified Greene and Vesley procedure; filtration efficiency was greater than 99%
Face Fit: subject device samples were tested using a qualitative fit test; face seal leakage was less than 10%
Ease of Breathing: subject device samples met the requirements of the NIOSH airflow resistance test which requires initial resistance (inhalation) to be less than 35mmH2O.
CONCLUSION: the results of these nonclinical tests, when compared with data available and/or claims made on the predicate devices, demonstrate that the subject device is as safe and effective as the predicate devices. and performs as well as the predicate devices. |
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