(308 days)
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.
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 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.
The provided text is a 510(k) summary for the 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S. It describes the device and claims substantial equivalence to a predicate device (3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870) rather than presenting a study to prove a device meets specific acceptance criteria based on novel performance.
Therefore, the information required for the requested output (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone studies, ground truth types, and training set information) is not applicable to this document as it details a substantial equivalence claim for regulatory clearance, not a performance study against predefined acceptance criteria for a novel device or AI algorithm.
The document focuses on comparing the new device's characteristics and performance to those of a previously cleared predicate device to assert that there are "no new questions of safety or effectiveness."
However, I can extract the comparison table that shows the specifications and performance characteristics of both the subject device and the predicate device, which implicitly defines the "acceptance criteria" in the context of substantial equivalence.
1. A table of acceptance criteria and the reported device performance
In the context of a 510(k) substantial equivalence claim, the "acceptance criteria" are implied by the performance characteristics of the predicate device. The new device is considered to "meet acceptance criteria" if its performance is substantially equivalent to the predicate device, such that there are no new questions of safety or effectiveness.
| Description | Predicate Device (3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870 (K063023)) | Subject Device (3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S) |
|---|---|---|
| Intended Use | Surgical Mask/Respirator | Surgical Mask/Respirator |
| 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 (not provided in this excerpt) | See appendix 2 (not provided in this excerpt) |
| 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 |
| Particulate Respirator Efficiency* | At least 95% against particulate aerosols free of oil (0.3 micron particles per U.S. 42 CFR 84) | At least 95% against particulate aerosols free of oil (0.3 micron particles per U.S. 42 CFR 84) |
| Bacterial Filtration Efficiency (BFE)** | > 99% (ASTM Standard Test Method for Bacterial Filtration Efficiency F2101) | > 99% (ASTM Standard Test Method for Bacterial Filtration Efficiency F2101) |
*This is a common performance standard for all N95 respirators, specified in the description but implied as a meeting criterion for both predicate and subject.
**This is a common performance standard for surgical masks, specified in the description but implied as a meeting criterion for both predicate and subject.
Key conclusions from the document:
- The subject device (3M™ VFlex™ 1805/1805S) is substantially equivalent to the predicate device (3M™ 1870).
- Both devices are fluid resistant (though at different pressure levels: predicate at 160 mmHg, subject at 120 mmHg), classified as Class I for flammability, and NIOSH certified with N95 filtration efficiency.
- The differences in materials ("Stiffener web" and "Nose foam" present in predicate but "NA" for subject) and fluid resistance pressure threshold did not raise new questions of safety or effectiveness in the FDA's determination.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a 510(k) summary for substantial equivalence, not a report of a clinical or performance study with a test set of data in the AI/medical device sense. The "tests" mentioned are standard industry tests for mask performance (e.g., NaCl load test, fluid resistance, flammability, NIOSH certification), which are typically done on samples of the manufactured product. Specific sample sizes for these manufacturing quality/performance tests are not detailed in this regulatory summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts for a test set is described, as this is not an AI/diagnostic device performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (respirator/surgical mask), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth, in the context of AI or diagnostic device evaluation, is not relevant here. The "truth" for this device relates to meeting physical and performance specifications for filtration, fluid resistance, and flammability, tested by established laboratory methods.
8. The sample size for the training set
Not applicable. No training set is involved as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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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 CareParticulate Respiratorand Surgical Mask,Model 1870 (K063023) | 3M™ VFlex™ HealthCare ParticulateRespirator and SurgicalMask, Model1805/1805S | |
| Intended Use | Surgical Mask/Respirator | Surgical Mask/Respirator |
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| MaterialsConstructionTechnology | ||
|---|---|---|
| Outside cover web | Multi-LayerPolypropylene spunbond | Multi-LayerPolypropylene 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 andDimensions | ||
| 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 class16 CFR Part 1610 | Class I | Class I |
| NIOSH Certificate | N95 classification84A-3884 | N95 classification84A-5469 for model180584A-5470 for model1805S |
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.
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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.
・
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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.
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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
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Indications for Use Statement 4.0
Indications for Use
510(k) Number (if known):
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
§ 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.