3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1804/1804S is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Device Description

The 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S are provided as a flat-folded Surgical N95 Respirator composed of multi layers of materials consisting of polypropylene spunbond (inner web), polypropylene (filter web), polypropylene spunbond (outer web). The product contains an aluminum nose clip within the layers of the top edge of the product to conform to the contours of the face. In addition, the product contains two steel staples used to secure the two polyisoprene elastic headbands (not made with natural rubber latex) to the product and the headbands are to secure the product in place on the wearer. The products are provided only in white and provided in two sizes one being small.

The 3MM VFlex™ Health Care Particulate Respirator and Surgical Mask, 1804/1804S is an particulate respirator. Particulate respirators help reduce the wearer exposure to certain airborne particles. including those generated by electrocautery, laser surgery and other powered medical instruments. This respirator has a filter efficiency level of at least 95% against particulate aerosols free of oilt. As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials and meets >99% bacterial filtration efficiency (BFE) ±. It is cleared to be worn in surgery. It can fit a wide range of face sizes. CDC guidelines state N95 respirators may be used for M. tuberculosis. *

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device: 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S. The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870).

The provided text describes the device, its intended use, and a comparison to a predicate device based on various features and performance specifications. However, this document does not describe a study involving an AI/Machine Learning device, human readers, or image analysis for medical diagnosis. It details the acceptance criteria and performance data for a physical product, specifically a surgical mask/respirator.

Therefore, many of the questions regarding AI/ML study design (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training) are not applicable to this type of device submission.

Here's a breakdown of the information that is relevant to the provided text, structured as requested where possible:

Acceptance Criteria and Device Performance for a Surgical Mask/Respirator:

Acceptance Criteria (Performance Specification)	Target/Standard	Reported Device Performance (3M™ VFlex™ 1804/1804S)	Predicate Device Performance (3M™ 1870)
Particulate Filtration Efficiency (PFE)	NIOSH Certification N95 Classification	NIOSH Certification N95 Classification	NIOSH Certification N95 Classification
Differential Pressure (Delta P)	NIOSH Certification N95 Classification	NIOSH Certification N95 Classification	NIOSH Certification N95 Classification
Fluid Resistance (ASTM F1862)	Pass 80 mmHg	Pass 80 mmHg	Pass 160 mmHg
Bacterial Filtration Efficiency (BFE) (ASTM F2101)	≥ 99 (%)	≥ 99 (%)	≥ 99 (%)
Flammability (CFR 16 1610)	Class I	Class I	Class I
NIOSH Certification	N95 Classification	N95 Classification (TC-84A-7789 for 1804, TC-84A-7790 for 1804S)	N95 Classification (84A-3884)
Biocompatibility (ISO 10993-1)	Acceptable for surface contacting device with prolonged (< 30 days) contact	Evaluated per ISO 10993-1, non-irritating and non-sensitizing. Cytotoxicity reports ranged from non-cytotoxic to moderately cytotoxic, deemed to have no increased health risk.	Material determined to have acceptable biocompatibility for a surface contacting device with prolonged (< 30 days) contact.
Audit of NaCl Load Test	≤ 5.0% (for "Specifications and Dimensions" table, seems to refer to filter penetration)	≤ 5.0%	≤ 5.0%

Study Proving Device Meets Acceptance Criteria:

The document describes pre-market testing and comparison to a predicate device, not a "study" in the typical sense of a clinical trial or AI model validation. The "proof" relies on adherence to recognized standards and certifications.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "sample size" in the context of subject recruitment. The tests are conducted on manufactured products. The number of masks/respirators tested for each performance metric (e.g., fluid resistance, BFE, PFE, flammability) is not specified in this summary, but would adhere to the sample size requirements defined by the respective ASTM, NIOSH, or CFR standards.
- Data Provenance: The tests are standard performance evaluations for the device, likely conducted by the manufacturer (3M Health Care) or certified laboratories. The information does not specify the country of origin of testing, nor does it distinguish between retrospective or prospective data generation, as it pertains to product performance testing rather than patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context refers to the defined performance standards (e.g., ASTM F1862 for fluid resistance) and the physical properties of the device, measured by laboratory equipment, rather than expert interpretation of medical images or clinical outcomes.
Adjudication method:
- Not applicable, as there are no human interpretations or disagreements that require adjudication. Performance metrics are objectively measured against established standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is a physical product (respirator/mask), not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical product.
The type of ground truth used:
- The "ground truth" for this device's performance is based on recognized industry standards and laboratory test methods (e.g., NIOSH certification for PFE and differential pressure, ASTM F1862 for fluid resistance, ASTM F2101 for BFE, 16 CFR 1610 for flammability, and ISO 10993-1 for biocompatibility). These standards define the acceptable range or threshold for a product to be considered effective and safe for its intended use.
The sample size for the training set:
- Not applicable. This is not an AI/Machine Learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 10, 2017

3M Health Care Linda Johnsen Regulatory Affairs Specialist 3M Center, 2510 Conway Ave., Building 275-5W-06 St. Paul, Minnesota 55144

Re: K171116

Trade/Device Name: 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: MSH Dated: July 12, 2017 Received: July 13, 2017

Dear Linda Johnsen:

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. 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 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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tara A. Ryan -S 2017.08.10 13:27:51 -04'00'

for Lori Wiggins 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171116

Device Name

3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary - K171116

Sponsor Information	3M Health Care2500 Conway Ave3M Center, Building 275-5W-06St. Paul, MN 55144
Contact Person	Linda JohnsenTitle: Regulatory Affairs SpecialistPhone Number: (651) 737-4376Fax Number: (651) 737-5320
Date of Summary	August 9, 2017
Common Name	Surgical N95 Respirator
Classification Name	Surgical Apparel
Proprietary Name	3MTM VFlex™ Health Care Particulate Respirator andSurgical Mask, Models 1804/1804S
Review Panel	General Hospital
Product Code	MSH
Device Classification	Class II per 21 CFR §878.4040
Predicate Device	3MTM Health Care Particulate Respirator and Surgical Mask,Model 1870 cleared under K063023.
Intended Use:	The 3MTM VFlex™ Health Care Particulate Respirator andSurgical Mask 1804/1804S is intended to be worn by operatingroom personnel during surgical procedures to protect both thesurgical patient and operating room personnel from transfer ofmicroorganisms, body fluids, and particulate material.

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Device Description:

The 3MM VFlex™ Health Care Particulate Respirator and Surgical Mask, 1804/1804S is an ખેતે ર

particulate respirator. Particulate respirators help reduce the wearer exposure to certain airborne particles. including those generated by electrocautery, laser surgery and other powered medical instruments. This respirator has a filter efficiency level of at least 95% against particulate aerosols

free of oilt. As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials and meets >99% bacterial filtration efficiency (BFE) ±. It is cleared to be worn in surgery. It can fit a wide range of face sizes. CDC guidelines state N95 respirators may be used for M. tuberculosis. *

Not made from natural rubber latex.

Tested against 0.3 micron particles (mass median aerodynamic diameter) per U.S. 42 CFR 84.
Meets ASTM Fluid Resistant Challenge F1862 80 mmHg.

± Meets ASTM Standard Test Method for Bacterial Filtration Efficiency F2101.

Centers for Disease Control and Prevention. 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings.

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Comparison Table:

A comparison between the proposed submission devices and predicate device is shown in the table below for the purpose of demonstrating equivalence as to efficacy and safety.

	Table 1 Comparison Table
Feature	510(K) Submission Device3MTM VFlex™ Health CareParticulate Respirator andSurgical MaskModel 1804	510(K) Submission Device3MTM VFlex™ Health CareParticulate Respirator andSurgical Mask- SmallModel 1804S	Predicate Device(K063023)3MTM Health CareParticulate Respirator andSurgical Mask, Model1870
IntendedUse	3MTM VFlex™ Health CareParticulate Respirator andSurgical Mask 1804 isintended to be worn byoperating room personnelduring surgical procedures toprotect both the surgicalpatient and operating roompersonnel from transfer ofmicroorganisms, body fluids,and particulate material.	3MTM VFlex™ Health CareParticulate Respirator andSurgical Mask- Small 1804S isintended to be worn byoperating room personnelduring surgical procedures toprotect both the surgical patientand operating room personnelfrom transfer ofmicroorganisms, body fluids,and particulate material.	This product meets CDCguidelines for M.tuberculosis exposurecontrol. As a respirator, it isintended to help reducewearer exposure to certainairborne particles, includingthose generated byelectrocautery, lasersurgery, and other poweredmedical instruments. As asurgical mask, it is designedto be fluid resistant to splashand splatter of blood andother infectious materials.
Materials
Outer CoverWeb	Polypropylene Spunbond	Polypropylene Spunbond	Polypropylene Spunbond
StiffenerWeb	N/A	N/A	Polypropylene Spunbond
Filter Web	Polypropylene	Polypropylene	Polypropylene
Inner Web	Polypropylene Spunbond	Polypropylene Spunbond	Polypropylene Spunbond
Nose-Clip	Aluminum	Aluminum	Aluminum
Staple	Steel	Steel	Steel
Headband	Polyisoprene	Polyisoprene	Polyisoprene
Nose Foam	N/A	N/A	Polyurethane
Surgical N95 Respirator Style
Fold	Cone shape provided as flatfold	Cone shape provided as flatfold	Cone shaped provided asflat fold
Layers	Multi	Multi	Multi
Design Feature
Headband	Polyisoprene rubber elastic band	Polyisoprene rubber elastic band	Polyisoprene rubber elastic band
Sterility
	Non Sterile Single Use	Non Sterile Single Use	Non Sterile Single Use
Specifications and Dimensions
Audit ofNaCl LoadTest	≤ 5.0%	≤ 5.0%	≤ 5.0%
Color	White	White	White
Length	255mm	235mm	208mm
HeadbandLength	240mm	220mm	193mm
Performance Specifications
ParticulateFiltrationEfficiency(PFE)	NIOSH CertificationN95 Classification1804 TC-84A-7789	NIOSH CertificationN95 Classification1804S TC-84A-7790	NIOSH CertificationN95 Classification84A-3884
DifferentialPressureDelta P	NIOSH CertificationN95 Classification1804 TC-84A-7789	NIOSH CertificationN95 Classification1804S TC-84A-7790	NIOSH CertificationN95 Classification84A-3884
FluidResistance(ASTMF1862)	Pass 80 mmHg	Pass 80 mmHg	Pass 160 mmHg
BacterialFiltrationEfficiency(BFE)(ASTMF2101)	≥ 99 (%)	≥ 99 (%)	≥ 99 (%)
Flammability(CFR 161610)	Class I	Class I	Class I
NIOSH Certification
N95Respirator	N95 Classification1804 TC-84A-7789	N95 Classification1804S TC-84A-7790	N95 Classification84A-3884
Biocompatibility
ISO109331-1	3M™ VFlex™ Health CareParticulate Respirator andSurgical Mask (1804) hasbeen evaluated according toguidelines established by ISO10993-1:2009. 3M™ VFlex™Health Care ParticulateRespirator and Surgical Mask	3M™ VFlex™ Health CareParticulate Respirator andSurgical Mask -Small (1804S) has beenevaluated according toguidelines established by ISO10993-1:2009. 3M™ VFlex™Health Care Particulate	The material was determinedto have acceptablebiocompatibility for asurface contacting devicewith prolonged(< 30 days) contact.

(1804) is categorized as a	Respirator and Surgical Mask
surface device having	- Small (1804S) is categorized
prolonged (< 30 days) contact	as a surface device having
with intact skin. As such, the	prolonged (< 30 days) contact
guidance suggests that	with intact skin. As such, the
cytotoxicity, irritation and	guidance suggests that
sensitization testing be	cytotoxicity, irritation and
performed. 3M™ VFlex™	sensitization testing be
Health Care Particulate	performed. 3M™ VFlex™
Respirator and Surgical Mask	Health Care Particulate
(1804) as to risk of adverse	Respirator and Surgical Mask
reactions is low for under the	- Small (1804S) as to risk of
conditions of study the device	adverse reactions is low for
is non-irritating and non-	under the conditions of study
sensitizing. Results for	the device is non-irritating
cytotoxicity ranged from non-	and non-sensitizing. Results
cytotoxic to moderately	for cytotoxicity ranged from
cytotoxic. Cytotoxicity is	non-cytotoxic to moderately
defined by ISO 10993-5 as a	cytotoxic. Cytotoxicity is
screening test, and on the	defined by ISO 10993-5 as a
basis of the totality of the data	screening test, and on the
there is no increased health	basis of the totality of the data
risk based on these results.	there is no increased health
	risk based on these results.

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Technological Characteristics:

The technological characteristics of the submission device is substantially equivalent to the predicate device for they are N95 NIOSH-certified respirators and have undergone testing according to recognized standards ASTM F1862, ASTM F2101 and flammability testing in accordance with 16 CFR 1610. Their materials are determined to have acceptable biocompatibility for a surface contacting device with prolonged (< 30 days) contact in accordance with ISO10993-1.

Conclusion:

The proposed submission devices 3MTM VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S are similar in design, intended use, technological characteristics and components as the predicate 3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870. The submission and predicate devices are N95 NIOSHcertified respirators.

The biocompatibility testing and toxicology assessment supports the 3MTM VFlexTM Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S being biocompatible as the predicate 3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870.

Based on the above, the proposed submission devices 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask. Models 1804/1804S is substantially equivalent to the predicate 3MTM Health Care Particulate Respirator and Surgical Mask, Model 1870.

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.