(113 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
The device is a surgical mask intended for protection from microorganisms and fluids, not for treating a disease or condition.
No
Explanation: The device is a surgical mask intended for protection against microorganisms, body fluids, and particulate material, not for diagnosing conditions or diseases.
No
The device description clearly outlines the physical components of a surgical mask (layers of material, tie strings/ear loops, nosepiece, optional face shield) and the performance studies focus on physical properties like filtration efficiency, fluid resistance, and flammability, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function.
- Device Description: The device is a physical mask made of various layers of material designed to filter air and block fluids.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or condition. IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, fluid resistance, breathability, flammability, biocompatibility) rather than diagnostic accuracy or analytical performance.
This device is a medical device, specifically a surgical or procedure mask, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask are composed of four-layers and are flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, green), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains tie strings or ear loops to secure the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask may also contain a face shield (FS) made from a polyethylene terephthalate film, which includes an antireflection strip. The face shield is adhered to the top edge of the mask to cover the upper part of the face. The mask is a single use, disposable device, provided non-sterile. This device is not made from Natural Rubber Latex.
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
healthcare personnel
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)
Nonclinical tests demonstrate that the subject devices (3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask) are as safe and effective, and perform as well as or better than the legally marketed predicate device K131879.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Particulate Filtration Efficiency (PFE): 32/32 Passed at ≥98% @ 0.1 micron ASTM F2299
Fluid Resistance: 32/32 Passed at 160mm Hg ASTM F1862
Bacterial Filtration Efficiency (BFE): 31/32 Passed at ≥98% ASTM F2101
Differential Pressure: 32/32 Passed at
§ 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of an eagle, while the text on the right is written in a bold, sans-serif font. The word "FDA" is in a blue box.
September 11, 2019
3M Health Care Angie Draper Sr. Regulatory Affairs Associate 3M Center, 2510 Conway Ave., Building 275-5W-06 St. Paul, Minnesota 55144
Re: K191355
Trade/Device Name: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 19, 2019 Received: August 20, 2019
Dear Angie Draper:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K191355
Device Name 3MTM High Fluid-Resistant Surgical Mask 3MTM High Fluid-Resistant Procedure Mask
Indications for Use (Describe)
The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
- 1835 3MTM High Fluid-Resistant Surgical Mask
- 1835FS 3M™ High Fluid-Resistant Surgical Mask with Face Shield
- 1840 3MTM High Fluid-Resistant Procedure Mask
- 1840FS 3M™ High Fluid-Resistant Procedure Mask with Face Shield
| Type of Use (Select one or both, as applicable) |
|---|
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary
K191355
| | 3M™ High Fluid-Resistant Surgical Mask
3M™ High Fluid-Resistant Procedure Mask |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor Information: | 3M Health Care
2510 Conway Ave
3M Center, Building 275-5W-06 St.
Paul, MN 55144 |
| Contact Person: | Angie Draper
Title: Sr. Regulatory Affairs Associate
Phone Number: (651) 733-1179
Fax Number: (651) 737-5320 email:
amdraper01@mmm.com |
| Date of Summary: | April 30, 2019 |
| Common Name: | Surgical Mask |
| Classification Name: | Surgical Apparel |
| Proprietary Name: | 3M™ High Fluid-Resistant Surgical Mask
3M™ High Fluid-Resistant Procedure Mask |
| Review Panel: | General and Plastic Surgery |
| Product Code: | FXX |
| Device Classification: | Class II per (21 CFR §878.4040) |
| Predicate Device: | Kimberly-Clark* KC300 Surgical Mask (K131879) |
| Intended Use: | The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High
Fluid-Resistant Procedure Mask is intended to be worn to protect both
the patient and healthcare personnel from transfer of microorganisms,
body fluids, and particulate material. These face masks are intended for
use in infection control practices to reduce potential exposure to blood
and body fluids. The face mask is single use, disposable device,
provided non-sterile. |
4
Available Model Numbers
| 1835 | 3M™ High Fluid-Resistant Surgical Mask |
|---|---|
| 1835FS | 3M™ High Fluid-Resistant Surgical Mask with Face Shield |
| 1840 | 3M™ High Fluid-Resistant Procedure Mask |
| 1845FS | 3M™ High Fluid-Resistant Procedure Mask with Face Shield |
Device Description:
The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask are composed of four-layers and are flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, green), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains tie strings or ear loops to secure the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask may also contain a face shield (FS) made from a polyethylene terephthalate film, which includes an antireflection strip. The face shield is adhered to the top edge of the mask to cover the upper part of the face. The mask is a single use, disposable device, provided non-sterile.
This device is not made from Natural Rubber Latex.
Technological Characteristics:
The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask are compared with the predicate device (KC300 Surgical Mask (K131879)). The results are shown below in the Technological Characteristics Comparison Table:
5
| Item(S) | Subject Device (K191355)
3M™ High Fluid-
Resistant Surgical Mask
ASTM Level 3 | Subject Device (K191355)
3M™ High Fluid-Resistant
Procedure Mask K191355
ASTM Level 3 | Predicate
Device(K131879)
KC300 Face Mask
ASTM Level 3 | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use/
Indications
for Use | 3M™ High Fluid- Resistant
Surgical Mask is intended
to be worn to protect both
the patient and healthcare
personnel from transfer of
microorganisms, body
fluids, and particulate
material. These face masks
are intended for use in
infection control practices
to reduce potential exposure
to blood and body fluids.
This is a single use,
disposable device, provided
non-sterile. | 3M™ High Fluid- Resistant
Procedure Mask is intended to
be worn to protect both the
patient and healthcare
personnel from transfer of
microorganisms, body fluids,
and particulate material.
These face masks are intended
for use in infection control
practices to reduce potential
exposure to blood and body
fluids. This is a single use,
disposable device, provided
non-sterile. | The Kimberly-Clark
KC300 Surgical Mask is
intended to be worn to
protect both the patient
and healthcare personnel
from transfer of
microorganisms, body
fluids, and particulate
material. These face
masks are intended for
use in infection control
practices to reduce the
potential exposure to
blood and body fluids.
This is a single use,
disposable device, | Same |
| | | Materials | | |
| Outer Cover
Web | Polypropylene Spunbond,
green | Polypropylene Spunbond,
green | Polyethylene/Polyester
with pink and blue ink
print | Different |
| Insertion | Polypropylene Spunbond,
white | Polypropylene Spunbond,
white | Unknown | Not known |
| Filter Web
(Middle) | Polypropylene Meltblown,
white | Polypropylene Meltblown,
white | Polypropylene Spunbond
and Polypropylene Melt-
blown | Different |
| Inner Cover
Web | Polypropylene Thermal-
bonded, white | Polypropylene Thermal-
bonded, white | Polyethylene/Polyester | Different |
| Nose Wire | Polyethylene Coated Steel
Wire | Polyethylene Coated Steel
Wire | Unknown | Not known |
| Edge wrap | Polypropylene Spunbond,
white or
Polyethylene
Terephthalate, white | Polypropylene Spunbond,
white or Polyethylene
Terephthalate, white | Polyester Spunlace or
Polypropylene Spunbond | Different |
| Ear Loops | Not Applicable | Spandex elastic cord
(polyurethane core with
polyethylene terephthalate
/nylon cover) | Polyester/Lycra Knitted | Different |
| Tie Strings | Polypropylene Spunbond,
White or Polyethylene
Terephthalate, white | Not Applicable | Polypropylene Spunbond | Different |
| | | Design Features | | |
| Colors | Green (Outer) | Green (Outer) | Multiple (Outer) | Different |
| Style | Flat - Pleated | Flat - Pleated | Flat - Pleated | Same |
6
| Multiple
| Layers | Yes | Yes | Yes | Same |
|---|---|---|---|---|
| Single Use | Yes | Yes | Yes | Same |
| Sterility | ||||
| Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Dimensions | ||||
| Length | 6.9" ± 0.2" | 6.9" ± 0.2" | 6.5" ± 0.75" | Different |
| Width | 3.5" ± 0.3" | 3.5" ± 0.3" | 4" ± 0.75" | Different |
| Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 3 | ||||
| Particulate | ||||
| Filtration | ||||
| Efficiency | ||||
| (PFE) | 32/32 Passed at ≥98% @ 0.1 | |||
| micron | ||||
| ASTM F2299 | 32/32 Passed at ≥98% @ 0.1 | |||
| micron | ||||
| ASTM F2299 | Pass at ≥98% @ 0.1 | |||
| micron | ||||
| ASTM F2299 | Same | |||
| Fluid | ||||
| Resistance | 32/32 Passed at 160mm Hg | |||
| ASTM F1862 | 32/32 Passed at 160mm Hg | |||
| ASTM F1862 | Fluid Resistant 160mm Hg | |||
| ASTM F1862 | Same | |||
| Bacterial | ||||
| Filtration | ||||
| Efficiency | ||||
| (BFE) | 31/32 Passed at ≥98% | |||
| ASTM F2101 | 31/32 Passed at ≥98% | |||
| ASTM F2101 | Pass at ≥98% | |||
| ASTM F2101 | Same | |||
| Differential | ||||
| Pressure | 32/32 Passed at Staphylococcus aureus | |||
| MIL-M- 36954C | Military Specification, Mask, Surgical, Disposable | |||
| 16 CFR Part 1610 | Standard for the Flammability of Clothing | |||
| ISO10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a | |||
| risk management process | ||||
| ISO10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | |||
| of medical devices | ||||
| ISO10993-10 | Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin |
7
Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject devices in 510(K) submission K191355, the 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask are as safe, as effective, and performs as well as or better than the legally marketed predicate device K131879.