(118 days)
Not Found
No
The device description and performance studies focus on material properties, filtration efficiency, and fluid resistance, with no mention of AI or ML.
No
The device is a respirator and surgical mask intended to protect against transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
The device, a surgical mask and respirator, is designed to filter microorganisms and particulate material, not to diagnose medical conditions.
No
The device description clearly outlines physical components such as multi-layered materials, an aluminum nose clip, steel staples, and elastic headbands, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "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." This describes a physical barrier and filtration device used on a person, not a test performed on a sample taken from the body.
- Device Description: The description details the physical components and materials of a mask/respirator. It focuses on its function as a filter and barrier.
- Performance Studies and Key Metrics: The performance studies and metrics listed (Particulate Filtration Efficiency, Fluid Resistance, Bacterial Filtration Efficiency, Flammability) are all related to the physical performance of the mask as a barrier and filter, not to the detection or measurement of substances in a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
In summary, the 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask is a personal protective equipment (PPE) designed to filter airborne particles and provide a fluid barrier, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MSH
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. *
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.
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
operating room personnel during surgical procedures
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)
Not Found
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing right, stacked on top of each other.
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
1
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
2
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)
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - K171116
| Sponsor Information | 3M Health Care
2500 Conway Ave
3M Center, Building 275-5W-06
St. Paul, MN 55144 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Linda Johnsen
Title: Regulatory Affairs Specialist
Phone Number: (651) 737-4376
Fax 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 and
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,
Model 1870 cleared under K063023. |
| Intended Use: | The 3MTM 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. |
4
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.
5
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 | ||
| 3MTM VFlex™ Health Care | |||
| Particulate Respirator and | |||
| Surgical Mask | |||
| Model 1804 | 510(K) Submission Device | ||
| 3MTM VFlex™ Health Care | |||
| Particulate Respirator and | |||
| Surgical Mask- Small | |||
| Model 1804S | Predicate Device | ||
| (K063023) | |||
| 3MTM Health Care | |||
| Particulate Respirator and | |||
| Surgical Mask, Model | |||
| 1870 | |||
| Intended | |||
| Use | 3MTM VFlex™ Health Care | ||
| Particulate Respirator and | |||
| Surgical Mask 1804 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. | 3MTM VFlex™ Health Care | ||
| Particulate Respirator and | |||
| Surgical Mask- Small 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. | This product meets CDC | ||
| guidelines for M. | |||
| tuberculosis exposure | |||
| control. As a respirator, it is | |||
| intended to help reduce | |||
| wearer exposure to certain | |||
| airborne particles, including | |||
| those generated by | |||
| electrocautery, laser | |||
| surgery, and other powered | |||
| medical instruments. As a | |||
| surgical mask, it is designed | |||
| to be fluid resistant to splash | |||
| and splatter of blood and | |||
| other infectious materials. | |||
| Materials | |||
| Outer Cover | |||
| Web | Polypropylene Spunbond | Polypropylene Spunbond | Polypropylene Spunbond |
| Stiffener | |||
| 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 | ||
| fold | Cone shape provided as flat | ||
| fold | Cone shaped provided as | ||
| 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 | |||
| NaCl Load | |||
| Test | ≤ 5.0% | ≤ 5.0% | ≤ 5.0% |
| Color | White | White | White |
| Length | 255mm | 235mm | 208mm |
| Headband | |||
| Length | 240mm | 220mm | 193mm |
| Performance Specifications | |||
| Particulate | |||
| Filtration | |||
| Efficiency | |||
| (PFE) | NIOSH Certification | ||
| N95 Classification | |||
| 1804 TC-84A-7789 | NIOSH Certification | ||
| N95 Classification | |||
| 1804S TC-84A-7790 | NIOSH Certification | ||
| N95 Classification | |||
| 84A-3884 | |||
| Differential | |||
| Pressure | |||
| Delta P | NIOSH Certification | ||
| N95 Classification | |||
| 1804 TC-84A-7789 | NIOSH Certification | ||
| N95 Classification | |||
| 1804S TC-84A-7790 | NIOSH Certification | ||
| N95 Classification | |||
| 84A-3884 | |||
| 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 |
-
| Class I | Class I | Class I |
| NIOSH Certification | | | |
| N95
Respirator | N95 Classification
1804 TC-84A-7789 | N95 Classification
1804S TC-84A-7790 | N95 Classification
84A-3884 |
| Biocompatibility | | | |
| ISO109331-1 | 3M™ VFlex™ Health Care
Particulate Respirator and
Surgical Mask (1804) has
been evaluated according to
guidelines established by ISO
10993-1:2009. 3M™ VFlex™
Health Care Particulate
Respirator and Surgical Mask | 3M™ VFlex™ Health Care
Particulate Respirator and
Surgical Mask -
Small (1804S) has been
evaluated according to
guidelines established by ISO
10993-1:2009. 3M™ VFlex™
Health Care Particulate | The material was determined
to have acceptable
biocompatibility for a
surface contacting device
with prolonged
(