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.

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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a surgical mask, which outlines its substantial equivalence to a predicate device based on performance specifications and safety. It is not a study proving device meeting acceptance criteria in the context of an AI/ML medical device. Therefore, I cannot generate the requested table and information as this document pertains to a physical medical device (surgical mask), not an AI/ML software device.

Key reasons why the request cannot be fulfilled based on the provided text:

Device Type: The document is about a physical medical device (surgical mask), not a software-based AI/ML device.
Acceptance Criteria for AI/ML: The acceptance criteria for AI/ML devices typically involve metrics like sensitivity, specificity, AUC, F1-score, etc., and are evaluated against a ground truth established by experts. The criteria here are based on ASTM standards for surgical mask performance (e.g., fluid resistance, particulate filtration, bacterial filtration, flammability).
Study Design: The document references "nonclinical tests" demonstrating equivalence to a predicate device based on performance specifications. This is not a description of a clinical study or a standalone AI/ML performance study as requested.
Ground Truth, Sample Sizes, Experts, Adjudication: These concepts are relevant to studies evaluating diagnostic or predictive performance of AI/ML algorithms and are not applicable to the documentation of a surgical mask following ASTM standards.
MRMC Comparative Effectiveness Study: Such studies compare human performance with and without AI assistance, which is not relevant for a surgical mask.

Therefore, the requested information (table of acceptance criteria with AI/ML performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study details, standalone performance, and ground truth types) cannot be extracted or inferred from the provided document.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K180874

Device Name

3MTM High Performance Surgical Mask

Indications for Use (Describe)

3MTM High Performance Surgical Mask - 1838R 3M™ High Performance Surgical Mask with Face Shield - 1838FSG

Type of Use (Select one or both , as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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3M™ High Performance Surgical Mask

K180874

Sponsor Information:	3M Health Care2510 Conway Ave3M Center, Building 275-5W-06St. Paul, MN 55144
Contact Person:	Kristin Totushek, RACTitle: Advanced Regulatory Affairs Specialist(651) 736-6117ktotushek@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 beworn to protect both patient and healthcare personnel fromtransfer of microorganisms, body fluids, and particulate material.These face mask(s) are intended for use in infection controlpractices to reduce potential exposure to blood and body fluids.This is a single use, disposable device(s) and provided non-sterile.

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Model Numbers: 3MTM High Performance Surgical Mask 1838R 1838FSG 3MTM High Performance Surgical Mask with Face Shield

Device Description:

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.

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Feature	K1808743M™ High PerformanceSurgical Mask1838R	K1808743M™ High PerformanceSurgical Mask with FaceShield1838FSG	Predicate DeviceHalyard Heath, Inc.Fluidshield* SurgicalMask with ExpandedChamberK143287
IntendedUse	3M™ High PerformanceSurgical Mask is intendedto be worn to protect thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids, and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids. This is asingle use, disposabledevice(s), provided non-sterile.	3M™ High PerformanceSurgical Mask is intendedto be worn to protect thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids, and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids. This is asingle use, disposabledevice(s), provided non-sterile.	The Expanded ChamberSurgical Face Mask isintended to be worn toprotect the patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided non-sterile.
Materials
Outer CoverWeb	Polypropylene Spunbond,(w Print) – Upper Top HalfPolypropylene Spunbond,White – Lower BottomHalf	Polypropylene Spunbond,(w Print) – Upper Top HalfPolypropylene Spunbond,White – Lower BottomHalf	Polypropylene Spunbond(w Print) – Upper TopHalfPolypropyleneSpunbond, White –Lower Bottom Half
MiddleWeb/Filter	Polypropylene Melt Blown	Polypropylene Melt Blown	Polypropylene Spunbondand Polypropylene MeltBlown
Inner CoverWeb	Polypropylene Spunbond	Polypropylene Spunbond	Polypropylene/Polyester
Tie Strings	Polypropylene SpunbondorPolyethyleneTerephthalate	Polypropylene SpunbondorPolyethyleneTerephthalate	Polyester Spunbond orPolypropylene Spunbond
Top andBottomBinding	Polypropylene Spunbond	Polypropylene Spunbond	Polypropylene Spunbond
Nose Piece	Polyethylene coated steelwire	Polyethylene coated steelwire	Wire (MaterialUnknown)
Feature	K1808743M™ High PerformanceSurgical Mask1838R	K1808743M™ High PerformanceSurgical Mask with FaceShield1838FSG	Predicate DeviceHalyard Heath, Inc.Fluidshield* SurgicalMask with ExpandedChamberK143287
Design Features
Color	Blue - Outer Cover Web(Upper) White - OuterCover Web (Lower)	Blue - Outer Cover Web(Upper) White - OuterCover 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

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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 bySynthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
ASTM F2299	Standard Test Method for Determining the Initial Efficiency of Materials Used inMedical Face Masks to Penetration by Particulates Using Latex Spheres
ASTM F2101	Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) ofMedical Face Mask Materials, Using a Biological Aerosol of Staphylococcusaureus
MIL-M-36954C	MIL-M36954C - Military Specification, Surgical Mask, Disposable - DifferentialPressure (Delta P)
16 CFR Part1610	Standard for the Flammability of Clothing Textiles
ISO10993-1	Biological evaluation of medical devices - Part 1: Evaluation and testing withina 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 skinsensitization

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.

Regulation Number and Section

§ 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.