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

K171116 · 3M Healthcare · MSH · Aug 10, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171116
• Device Name: 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S
• Applicant: 3M Healthcare
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Aug 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

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 Story

Flat-folded surgical N95 respirator; multi-layer construction (polypropylene spunbond/filter web); aluminum nose clip; steel staples; polyisoprene elastic headbands. Used in operating rooms by surgical personnel. Functions as physical barrier; filters ≥95% of airborne particles (0.3 micron); provides ≥99% bacterial filtration efficiency (BFE); fluid resistant to 80 mmHg (ASTM F1862). Protects wearer and patient from microorganisms, body fluids, and particulates. Non-sterile, single-use.

Clinical Evidence

Bench testing only. Performance validated via NIOSH N95 certification (TC-84A-7789/7790), ASTM F1862 fluid resistance (80 mmHg), ASTM F2101 bacterial filtration efficiency (≥99%), and 16 CFR 1610 flammability (Class I). Biocompatibility evaluated per ISO 10993-1; materials determined non-irritating and non-sensitizing.

Technological Characteristics

Multi-layer polypropylene construction; aluminum nose clip; steel staples; polyisoprene headbands. NIOSH N95 certified; fluid resistance 80 mmHg (ASTM F1862); BFE ≥99% (ASTM F2101); flammability Class I (16 CFR 1610). Biocompatibility per ISO 10993-1. Non-sterile, single-use, flat-fold form factor.

Indications for Use

Indicated for operating room personnel during surgical procedures to protect patient and personnel from transfer of microorganisms, body fluids, and particulate material. Suitable for use as a particulate respirator to reduce exposure to airborne particles, including those from electrocautery, laser surgery, and powered medical instruments. Meets CDC guidelines for M. tuberculosis exposure control.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870 (K063023)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> 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 Care<br>2500 Conway Ave<br>3M Center, Building 275-5W-06<br>St. Paul, MN 55144 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Linda Johnsen<br>Title: Regulatory Affairs Specialist<br>Phone Number: [phone]<br>Fax Number: [phone] |
| Date of Summary | August 9, 2017 |
| Common Name | Surgical N95 Respirator |
| Classification Name | Surgical Apparel |
| Proprietary Name | 3MTM VFlex™ Health Care Particulate Respirator and<br>Surgical 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,<br>Model 1870 cleared under K063023. |
| Intended Use: | The 3MTM VFlex™ Health Care Particulate Respirator and<br>Surgical Mask 1804/1804S is intended to be worn by operating<br>room personnel during surgical procedures to protect both the<br>surgical patient and operating room personnel from transfer of<br>microorganisms, body fluids, and particulate material. |

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# 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 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 Device<br>3MTM VFlex™ Health Care<br>Particulate Respirator and<br>Surgical Mask<br>Model 1804 | 510(K) Submission Device<br>3MTM VFlex™ Health Care<br>Particulate Respirator and<br>Surgical Mask- Small<br>Model 1804S | Predicate Device<br>(K063023)<br>3MTM Health Care<br>Particulate Respirator and<br>Surgical Mask, Model<br>1870 |
| Intended<br>Use | 3MTM VFlex™ Health Care<br>Particulate Respirator and<br>Surgical Mask 1804 is<br>intended to be worn by<br>operating room personnel<br>during surgical procedures to<br>protect both the surgical<br>patient and operating room<br>personnel from transfer of<br>microorganisms, body fluids,<br>and particulate material. | 3MTM VFlex™ Health Care<br>Particulate Respirator and<br>Surgical Mask- Small 1804S is<br>intended to be worn by<br>operating room personnel<br>during surgical procedures to<br>protect both the surgical patient<br>and operating room personnel<br>from transfer of<br>microorganisms, body fluids,<br>and particulate material. | This product meets CDC<br>guidelines for M.<br>tuberculosis exposure<br>control. As a respirator, it is<br>intended to help reduce<br>wearer exposure to certain<br>airborne particles, including<br>those generated by<br>electrocautery, laser<br>surgery, and other powered<br>medical instruments. As a<br>surgical mask, it is designed<br>to be fluid resistant to splash<br>and splatter of blood and<br>other infectious materials. |
| Materials | | | |
| Outer Cover<br>Web | Polypropylene Spunbond | Polypropylene Spunbond | Polypropylene Spunbond |
| Stiffener<br>Web | 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 flat<br>fold | Cone shape provided as flat<br>fold | Cone shaped provided as<br>flat 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 of<br>NaCl Load<br>Test | ≤ 5.0% | ≤ 5.0% | ≤ 5.0% |
| Color | White | White | White |
| Length | 255mm | 235mm | 208mm |
| Headband<br>Length | 240mm | 220mm | 193mm |
| Performance Specifications | | | |
| Particulate<br>Filtration<br>Efficiency<br>(PFE) | NIOSH Certification<br>N95 Classification<br>1804 TC-84A-7789 | NIOSH Certification<br>N95 Classification<br>1804S TC-84A-7790 | NIOSH Certification<br>N95 Classification<br>84A-3884 |
| Differential<br>Pressure<br>Delta P | NIOSH Certification<br>N95 Classification<br>1804 TC-84A-7789 | NIOSH Certification<br>N95 Classification<br>1804S TC-84A-7790 | NIOSH Certification<br>N95 Classification<br>84A-3884 |
| Fluid<br>Resistance<br>(ASTM<br>F1862) | Pass 80 mmHg | Pass 80 mmHg | Pass 160 mmHg |
| Bacterial<br>Filtration<br>Efficiency<br>(BFE)<br>(ASTM<br>F2101) | ≥ 99 (%) | ≥ 99 (%) | ≥ 99 (%) |
| Flammability<br>(CFR 16<br>1610) | Class I | Class I | Class I |
| NIOSH Certification | | | |
| N95<br>Respirator | N95 Classification<br>1804 TC-84A-7789 | N95 Classification<br>1804S TC-84A-7790 | N95 Classification<br>84A-3884 |
| Biocompatibility | | | |
| ISO109331-1 | 3M™ VFlex™ Health Care<br>Particulate Respirator and<br>Surgical Mask (1804) has<br>been evaluated according to<br>guidelines established by ISO<br>10993-1:2009. 3M™ VFlex™<br>Health Care Particulate<br>Respirator and Surgical Mask | 3M™ VFlex™ Health Care<br>Particulate Respirator and<br>Surgical Mask -<br>Small (1804S) has been<br>evaluated according to<br>guidelines established by ISO<br>10993-1:2009. 3M™ VFlex™<br>Health Care Particulate | The material was determined<br>to have acceptable<br>biocompatibility for a<br>surface contacting device<br>with prolonged<br>(< 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 | |…