(119 days)
Not Found
No
The device description and intended use describe a physical surgical mask with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No
The device is a surgical mask intended for infection control and protection from fluid transfer, not for treating or preventing a disease or condition in a patient.
No
The provided text explicitly states that the device's intended use is to "protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material" and for "infection control practices," not for diagnosing any medical condition.
No
The device description clearly outlines a physical product (surgical mask) made of specific materials and having a physical design, indicating it is a hardware 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 patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical construction of a surgical mask, designed to be worn on the face. It does not describe any components or processes related to analyzing biological samples.
- 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 be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical mask does not fit that description.
N/A
Intended Use / Indications for Use
The 3M™ High Performance Surgical Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face mask(s) are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device(s) and provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The 3M™ High Performance Surgical Mask has a duckbill design consisting of three layers that are comprised of an (polypropylene spunbond) inner and outer cover web and (polypropylene melt blown) filter web. The mask has ties to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. They may be produced with or without a face shield. This is a single use, disposable device, provided non-sterile.
This device is not made with 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)
The conclusions drawn from the nonclinical tests demonstrate that the 3M™ High Performance Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device K143287.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized caduceus. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 11, 2019
3M Health Care Kristin Totushek Advanced Regulatory Affairs Specialist 3M Health Care 2510 Conway Ave. Building 275-5W-06 St. Paul, MN 55144
Re: K180874
Trade/Device Name: 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: June 14, 2018 Received: June 20, 2018
Dear Kristin Totushek:
This letter corrects our substantially equivalent letter of July 31, 2018.
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.
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray Iii III -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180874
Device Name
3MTM High Performance Surgical Mask
Indications for Use (Describe)
The 3M™ High Performance Surgical Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face mask(s) are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device(s) and provided non-sterile.
3MTM High Performance Surgical Mask - 1838R 3M™ High Performance Surgical Mask with Face Shield - 1838FSG
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
3M™ High Performance Surgical Mask
| Sponsor Information: | 3M Health Care
2510 Conway Ave
3M Center, Building 275-5W-06
St. Paul, MN 55144 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristin Totushek, RAC
Title: Advanced Regulatory Affairs Specialist
(651) 736-6117
ktotushek@mmm.com |
| Date of Summary: | July 30, 2018 |
| Proprietary Name: | 3MTM High Performance Surgical Mask |
| Common Name: | Surgical Mask |
| Classification Name: | Surgical Apparel |
| Review Panel: | General and Plastic Surgery |
| Product Code: | FXX |
| Device Classification: | Class II per (21 CFR §878.4040) |
| Predicate Device: | Fluidshield* Surgical Mask with Expanded Chamber
(K143287) |
| Intended Use: | The 3M™ High Performance Surgical Mask is intended to be
worn to protect both patient and healthcare personnel from
transfer of microorganisms, body fluids, and particulate material.
These face mask(s) are intended for use in infection control
practices to reduce potential exposure to blood and body fluids.
This is a single use, disposable device(s) and provided non-
sterile. |
4
Model Numbers: 3MTM High Performance Surgical Mask 1838R 1838FSG 3MTM High Performance Surgical Mask with Face Shield
Device Description:
The 3M™ High Performance Surgical Mask has a duckbill design consisting of three layers that are comprised of an (polypropylene spunbond) inner and outer cover web and (polypropylene melt blown) filter web. The mask has ties to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. They may be produced with or without a face shield. This is a single use, disposable device, provided non-sterile.
This device is not made with Natural Rubber Latex.
Technological Characteristics:
The 3M™ High Performance Surgical Mask is substantially equivalent to the current Fluidshield* Surgical Mask with Expanded Chamber (K143287) as these products conform with ASTM F2100 standard and meet Level 2 performance specifications. Both the submission and predicate products address, "Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification 510(K) submissions. Issued March 5, 2004".
Comparison to Predicate Device:
The 3M™ High Performance Surgical Mask, the subject of this submission, is substantially equivalent to the Fluidshield* Surgical Mask with Expanded Chamber cleared under K143287. The submission and predicate devices claim Level 2 in accordance with ASTM F2100 product standard.
5
| Feature | K180874
3M™ High Performance
Surgical Mask
1838R | K180874
3M™ High Performance
Surgical Mask with Face
Shield
1838FSG | Predicate Device
Halyard Heath, Inc.
Fluidshield* Surgical
Mask with Expanded
Chamber
K143287 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | 3M™ High Performance
Surgical Mask is intended
to be worn to protect 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(s), provided non-
sterile. | 3M™ High Performance
Surgical Mask is intended
to be worn to protect 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(s), provided non-
sterile. | The Expanded Chamber
Surgical Face Mask is
intended to be worn to
protect 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(s),
provided non-sterile. |
| Materials | | | |
| Outer Cover
Web | Polypropylene Spunbond,
(w Print) – Upper Top Half
Polypropylene Spunbond,
White – Lower Bottom
Half | Polypropylene Spunbond,
(w Print) – Upper Top Half
Polypropylene Spunbond,
White – Lower Bottom
Half | Polypropylene Spunbond
(w Print) – Upper Top
Half
Polypropylene
Spunbond, White –
Lower Bottom Half |
| Middle
Web/Filter | Polypropylene Melt Blown | Polypropylene Melt Blown | Polypropylene Spunbond
and Polypropylene Melt
Blown |
| Inner Cover
Web | Polypropylene Spunbond | Polypropylene Spunbond | Polypropylene/Polyester |
| Tie Strings | Polypropylene Spunbond
or
PolyethyleneTerephthalate | Polypropylene Spunbond
or
PolyethyleneTerephthalate | Polyester Spunbond or
Polypropylene Spunbond |
| Top and
Bottom
Binding | Polypropylene Spunbond | Polypropylene Spunbond | Polypropylene Spunbond |
| Nose Piece | Polyethylene coated steel
wire | Polyethylene coated steel
wire | Wire (Material
Unknown) |
| Feature | K180874
3M™ High Performance
Surgical Mask
1838R | K180874
3M™ High Performance
Surgical Mask with Face
Shield
1838FSG | Predicate Device
Halyard Heath, Inc.
Fluidshield* Surgical
Mask with Expanded
Chamber
K143287 |
| Design Features | | | |
| Color | Blue - Outer Cover Web
(Upper) White - Outer
Cover Web (Lower) | Blue - Outer Cover Web
(Upper) White - Outer
Cover Web (Lower) | Variety |
| Face Shield | No | Yes | Yes |
| Mask Design | | | |
| Style | Duckbill | Duckbill | Duckbill |
| Single Use | Yes | Yes | Yes |
| Sterility | | | |
| Sterile | Non-sterile | Non-sterile | Non-sterile |
| Specifications and Dimensions | | | |
| Length | $187 mm \pm 4 mm$ | $187 mm \pm 4 mm$ | $8.3" \pm 0.4"$ |
| Width | $107 mm \pm 6 mm$ | $107 mm \pm 6 mm$ | $7.5" \pm 0.11"$ |
| Technological Characteristics | | | |
| | Product Performance Specifications Per ASTM F2100 - Meets ASTM Level 2 | | |
| Fluid | ASTM F1862 | ASTM F1862 | ASTM F1862 |
| Particulate | ASTM F2299 | ASTM F2299 | ASTM F2299 |
| Bacterial | ASTM F2101 | ASTM F2101 | ASTM F2101 |
| Differential | MIL-M36954C | MIL-M36954C | MIL-M36954C |
| Flammability | 16 CFR 1610 | 16 CFR 1610 | 16 CFR 1610 |
| Biocompatibility | | | |
| Results | Biocompatible, Non-
cytotoxic, Non- irritating,
Non-Sensitizing | Biocompatible, Non-
cytotoxic, Non-irritating,
Non-Sensitizing | Biocompatible, Non-
cytotoxic, Non-
irritating, Non-
Sensitizing |
6
7
| ASTM F2100 | Standard Specification for Performance of Materials Used in Medical Face Masks |
|---|---|
| ASTM F1862 | Standard Test Method for Resistance of Medical Face Masks to Penetration by |
| Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) | |
| ASTM F2299 | Standard Test Method for Determining the Initial Efficiency of Materials Used in |
| Medical Face Masks to Penetration by Particulates Using Latex Spheres | |
| ASTM F2101 | Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of |
| Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus | |
| aureus | |
| MIL-M- | |
| 36954C | MIL-M36954C - Military Specification, Surgical Mask, Disposable - Differential |
| Pressure (Delta P) | |
| 16 CFR Part | |
| 1610 | Standard for the Flammability of Clothing Textiles |
| 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 |
| ISO10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin |
| sensitization |
The following standards have been met for the 3M™ High Performance Surgical Mask.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the 3M™ High Performance Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device K143287.