(83 days)
Not Found
No
The device description and performance studies focus on the physical filtration and fluid resistance properties of a surgical mask, with no mention of AI or ML.
No.
The mask is intended for infection control and barrier protection, not for treating or diagnosing a medical condition.
No
The device is described as a mask intended for infection control and protection from fluids, not for diagnosing medical conditions.
No
The device description clearly describes a physical mask with filter webs, tie strings, and a nose piece, indicating it is a hardware device, not software only.
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 by minimizing the spread of microorganisms from the wearer and reducing the wearer's exposure to blood and body fluids. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a physical mask designed to cover the nose and mouth. It does not describe any components or processes related to analyzing biological samples.
- Performance Studies and Key Metrics: The performance studies and metrics (BFE, PFE, fluid resistance, differential pressure) evaluate the physical properties and effectiveness of the mask as a barrier. They do not involve the analysis of biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This mask does not fit that description.
N/A
Intended Use / Indications for Use
The product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms. In addition, the device is intended to reduce potential exposure of the wearer to blood and body fluids.
Product codes
Not Found
Device Description
The 1830/1830FS is a flat, pleated, tie-on mask consisting of inner and outer cover webs with two different filter webs sandwiched in between. It covers the nose and mouth of the wearer, and is held in place by tie strings and a malleable plastic coated wire nose piece.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
P. 1
510(k) Summary
MAR 1 0 1997
MANUFACTURER:
3M Health Care 3M Center St. Paul, MN 55144-1000
REGULATORY AFFAIRS CONTACT:
Karen C. Maass Regulatory Affairs Specialist 3M Medical Markets Group 3M Center, Bldg. 275-3E-08 St. Paul, MN 551441-1000
TELEPHONE: (612) 736-1031
DATE SUMMARY PREPARED:
October 9, 1996
- DEVICE TRADE NAME: 3M 1830 Fluid Block Anti-Fog Tie-on Surgical Mask, 3M 1830FS Fluid Block Anti-Fog Tie-on Surgical Mask with Face Shield
COMMON OR USUAL NAME:
Surgical Mask
CLASSIFICATION: Surgical Apparel, Class II, 21 CFR 878.4040
3M 1818 Tie-on Surgical Mask and 3M 1818FS Tie-PREDICATE DEVICES: On Surgical Mask with Face Shield (K940707). Tecnol FluidShield(R) Surgical Masks (K913043).
- DEVICE DESCRIPTION The 1830/1830FS is a flat, pleated, tie-on mask consisting of inner and outer cover webs with two different filter webs sandwiched in between. It covers the nose and mouth of the wearer, and is held in place by tie strings and a malleable plastic coated wire nose piece.
- INTENDED USE: The product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms. In addition, the device is intended to reduce potential exposure of the wearer to blood and body fluids.
1
SUBSTANTIAL EQUIVALENCE:
The 3M 1830/1830FS masks are the same product as the 3M Surgical Masks with Face Shield (K940707), with an additional "fluid block" layer to improve the masks fluid resistance. The following characteristics of the 3M 1830/1830FS mask indicate this device is substantially equivalent to the predicate devices listed above.
-
- Intended use
-
- Bacterial filtration efficiency
-
- Fluid resistance
-
- Anti-Fog coated face shield (1830FS only)
-
- Anti-fog strip incorporated in the mask design to reduce fogging of glasses
-
- Soft, non-irritating inner surface
-
- Flat, pleated, tie-on design
-
- Special fluid resistant layer
-
- Target population
TESTING SUMMARY:
Standard biocompatibility testing in animals and humans (including Cytotoxicity-Agar-Overlay, Primary Skin Irritation, Ocular Irritation, Human Draize Sensitization, and 21-Day Cumulative Irritation) on the product and/or its components indicate that the 1830/1830FS mask is non-irritating and hypoallergenic and safe for its intended use.
The following tests support the 1830/1830FS mask as acceptable for its intended use:
| Mod. Greene & Vesley | >99% BFE |
|---|---|
| 0.1 Micron Latex Particle | |
| Challenge | >95% PFE |
| Fluid Resistance (Cup Test) | Resists a liquid volume |
65 ml for 120 hr. |
| Fluid Resistance (Nelson Test) | Resists liquid pressures
under various conditions,
i.e. 2cc synthetic blood at
120 mm Hg (2.3 psi)/1.5
inches/1 assault, and 2.3
cc synthetic blood at 300
mm Hg (5.8 psi)/18
inches/5 assaults. |
2
K965043
p-3
TESTING SUMMARY (continued):
Differential Pressure (Delta P)
1818/1818FS 80%.