← Product Code [MSH](/submissions/SU/subpart-e%E2%80%94surgical-devices/MSH) · K121069 # 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK (K121069) _3M Company · MSH · Feb 11, 2013 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MSH/K121069 ## Device Facts - **Applicant:** 3M Company - **Product Code:** [MSH](/submissions/SU/subpart-e%E2%80%94surgical-devices/MSH.md) - **Decision Date:** Feb 11, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use 3M™ VFlex™Health Care Particulate Respirator and Surgical Mask 1805/1805S is 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. ## Device Story 3M VFlex 1805/1805S is N95 particulate respirator and surgical mask; designed for use by operating room personnel during surgical procedures. Device acts as physical barrier to reduce wearer exposure to airborne particles (e.g., from electrocautery or laser surgery) and provides fluid resistance against blood and infectious materials. Construction includes multi-layer polypropylene spunbond filter web, aluminum nose-clip, steel staples, and polyisoprene headbands. Device is flat-fold style; provides >95% filtration efficiency against non-oil aerosols and >99% bacterial filtration efficiency. Protects both patient and clinician by preventing transfer of microorganisms and body fluids. No natural rubber latex components. ## Clinical Evidence Bench testing only. Performance validated via NaCl load testing (<5.0%), bacterial filtration efficiency (>99% per ASTM F2101), fluid resistance (ASTM F1862), and flammability testing (16 CFR Part 1610). NIOSH N95 certification (84A-5469, 84A-5470) confirms filtration performance. ## Technological Characteristics N95 particulate respirator/surgical mask. Materials: multi-layer polypropylene spunbond, aluminum nose-clip, steel staples, polyisoprene headbands. Flat-fold form factor. Fluid resistance: 120 mmHg (ASTM F1862). Bacterial filtration efficiency: >99% (ASTM F2101). Filtration: >95% against non-oil aerosols (42 CFR 84). Flammability: Class I (16 CFR 1610). Latex-free. ## Regulatory 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](/device/K063023.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 3M Center, Bldg. 0275-05-W-06 St. Paul. MN 55144-1000 651 733 1110 # K121069 # 510(k) Summary ## FEB 1 1 2013 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c) February 11, 2013 Jizhong Jin, RAC 1805/1805S Class II MSH Surgical Respirator Surgical Apparel 21 CFR 878.4040 Tel: Fax: Regulatory Affairs Specialist 651-733-6655 651-737-5320 e-mail: jjin1@mmm.com 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Model Date Prepared: Applicant: 3M Health Care Building 275 - 5W - 06 3M Center St. Paul, MN 55144 Establishment registration number: 2110898 Official Correspondent: Trade/Proprietary Name: Common Name: Classification Name: Device Class: Requlation Number: Product Code: Predicate Device Name: 3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870 Description of Device: The 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1805/1805S is an N95 particulate respirator. Particulate respirators help reduce wearer exposure to certain airborne particles, including those generated by electrocautery, laser surgery and other powered medical instruments. This {1}------------------------------------------------ respirator has a filter efficiency level of at least 95% against particulate aerosols free of oil . 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. This respirator contains no components 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. * Meets ASTM Standard Test Method for Bacterial Filtration Efficiency F2101. Intended use: 3M™ VFlex™Health Care Particulate Respirator and Surgical Mask 1805/1805S is 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. Technological Characteristics: The 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S substantially equivalent to the 3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870. The product proposed under this premarket notification submission is composed of the same or similar components, has same or similar performance features, same intended use and indications for use as the predicate device. There are no new questions of safety or effectiveness. Table of Comparison of the 3M™ VFlex™Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S and the 3M Health Care Particulate Respirator and Surgical Mask, Model 1870 | Description | Predicate Device | Subject Device | |--------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | | 3M™ Health Care
Particulate Respirator
and Surgical Mask,
Model 1870 (K063023) | 3M™ VFlex™ Health
Care Particulate
Respirator and Surgical
Mask, Model
1805/1805S | | Intended Use | Surgical Mask/Respirator | Surgical Mask/Respirator | {2}------------------------------------------------ | Materials
Construction
Technology | | | |-----------------------------------------|---------------------------------------|---------------------------------------------------------------------------------| | Outside cover web | Multi-Layer
Polypropylene spunbond | Multi-Layer
Polypropylene spunbond | | Stiffener web | Polypropylene spunbond | NA | | Filter web | Polypropylene | Polypropylene | | Inner web | Polypropylene | Polypropylene | | Nose-Clip | Aluminum | Aluminum | | Staple | Steel | Steel | | Headband | Polyisoprene | Polyisoprene | | Nose foam | Polyurethane | NA | | Specifications and
Dimensions | | | | Audit of NaCl Load Test | <5.0% | <5.0% | | Dimensions | See appendix 1 | See appendix 2 | | Product style | Flat fold | Flat fold | | Design Features | | | | Fluid Resistance
(ASTM F1862) | Pass @ 160 mmHg | Pass @ 120 mmHg | | Flammability class
16 CFR Part 1610 | Class I | Class I | | NIOSH Certificate | N95 classification
84A-3884 | N95 classification
84A-5469 for model
1805
84A-5470 for model
1805S | The product proposed under this premarket notification submission is similar in design, is composed of the same or similar components and is manufactured under the same quality management system as the predicate device. The product under this premarket notification submission has the same or similar performance characteristics. They are both fluid resistant with the flammability of class I. They are also NIOSH certified with the same filtration efficiency. {3}------------------------------------------------ 3M Center, Bldg. 0275-05-W-06 St. Paul, MN 55144-1000 651 733 1110 Based on the product design, the components of the product, the performance characteristics of the product, 3M concluded that the product proposed under this premarket notification submission is substantially equivalent to the this product. There are no new questions of safety or effectiveness. ・ {4}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 11, 2013 Mr. Jizhong Jin. RAC Regulatory Affairs Specialist 3M Health Care 3M Center, Building 275 - 5W - 06 ST. PAUL MN 55144 Re: K121069 Trade/Device Name: 3MTM VFlex™ Health Care Particulate Respirator and Surgical Mask, Model 1805 & 1805S Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: January 21, 2013 Received: January 28, 2013 Dear Mr. Jin: 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. {5}------------------------------------------------ Page 2 - Mr. Jin 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, hor Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ K121069 #### Indications for Use Statement 4.0 # Indications for Use 510(k) Number (if known): K121069 Device Name: 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Model 1805 & 1805S Indications for Use: 3M™ VFlex™Health Care Particulate Respirator and Surgical Mask 1805/1805S is 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. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Elizabeth F. Claverie 2013.02.07 15:07:14 -05'00' (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: k121069 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MSH/K121069](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MSH/K121069) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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