(190 days)
The N95 Particulate Respirator (MF01) is single-use, disposable device, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
The N95 particulate respirator (Model MF-01) is NIOSH certified (TC-84A-7697), pouched-shaped respirators when worn. The flat-folded respirator is composed of four layers-inner layer, filter (2 layers) and outer layer. The four layers are combined via ultrasonically welded. The respirator also contains a nose-piece enclosed in a binding tape welding the top edge to conform to the contours of the face. The respirator contains straps to secure the respirator in place on the wearer. The respirator is offered in white. The respirator is provided non-sterile and for single use only.
This document is a 510(k) Premarket Notification for a Master-Frank N95 Particulate Respirator. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of diagnostic AI. Thus, much of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types for AI models) is not applicable or present in this document.
However, I can extract the acceptance criteria and reported device performance from the "Non-Clinical Performance Data" and "Performance testing" sections, which are focused on the physical performance and biocompatibility of the respirator.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Standard / Requirement | Reported Device Performance (Master-Frank N95 Particulate Respirator Model MF-01) | Satisfies Criteria |
|---|---|---|---|
| Biocompatibility | |||
| In Vitro Cytotoxicity | ISO 10993-5 (Non-cytotoxic) | Non-cytotoxic | Yes |
| Skin Irritation | ISO 10993-10 (Non-irritating) | Non-irritating | Yes |
| Skin Sensitization | ISO 10993-10 (Non-sensitizing) | Non-sensitizing | Yes |
| Physical Performance | |||
| Fluid Resistance | ASTM F1862 (Pass at 160 mmHg) | Pass at 160 mmHg | Yes |
| Flammability | 16 CFR 1610 (Class 1) | Class 1 | Yes |
| Particulate Filtration Efficiency (PFE) | NIOSH Certification (TC-84A-7697, N95 standard) | NIOSH Certified (TC-84A-7697) | Yes |
| Bacterial Filtration Efficiency (BFE) | NIOSH Certification (TC-84A-7697, N95 standard) | NIOSH Certified (TC-84A-7697) | Yes |
| Differential Pressure (ΔP) | NIOSH Certification (TC-84A-7697, N95 standard) | NIOSH Certified (TC-84A-7697) | Yes |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each of the biocompatibility and physical performance tests. It refers to established standards (e.g., ISO 10993, ASTM F1862, 16 CFR 1610, NIOSH certification), which would have their own specified sample sizes. The data provenance is from tests conducted on the Master-Frank N95 Particulate Respirator (Model MF-01) by accredited labs for NIOSH certification and other standards. The document doesn't specify the country of origin of the testing data itself, but the manufacturer is based in China. The data is prospective as it pertains to the device being submitted for clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of this device clearance. The "ground truth" for these tests is defined by the objective measurement criteria within the specified international standards and NIOSH certification protocols. These tests are conducted by trained technicians in certified laboratories, following stringent procedures rather than subjective expert interpretation.
4. Adjudication method for the test set
Not applicable. The tests performed are objective, quantitative measurements following standardized protocols (e.g., measuring filter efficiency, fluid penetration, flame spread). There is no "adjudication" in the sense of reconciling differing expert opinions. The results are either "pass" or "fail" against defined thresholds.
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 document is for the clearance of an N95 particulate respirator, not an AI-powered diagnostic device. Therefore, no MRMC study involving human readers or AI assistance was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical respirator, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance claims of the N95 respirator is based on objective, standardized physical and biocompatibility testing criteria. Examples include:
- Physical Measurements: Filtration efficiency (% of particles filtered), differential pressure (airflow resistance), fluid penetration (absence of synthetic blood penetration at a given pressure), and flame spread time.
- Biocompatibility Assessments: Observational and analytical results from in vitro cytotoxicity assays, irritation tests (e.g., skin irritation), and sensitization tests (e.g., skin sensitization) performed according to ISO 10993 standards.
These are verifiable, objective measures against international standards and regulatory requirements.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/machine learning device. The device is a physical product designed and manufactured to meet specific performance standards.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for a training set does not apply here. The device's performance is established through direct physical and biological testing against predefined standards.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.
April 4, 2018
Master & Frank Enterprise Co., Ltd % Field Fu Official Correspondent Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, gd755 Cn
Re: K172963
Trade/Device Name: Master-Frank N95 Particulate Respirator Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: MSH Dated: March 5, 2018 Received: March 13, 2018
Dear Field Fu:
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 Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
For Tina Kiang, Ph.D. 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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Indications for Use
510(k) Number (if known) K172963
Device Name
Master-Frank N95 Particulate Respirator
Indications for Use (Describe)
The N95 Particulate Respirator (MF01) is single-use, disposable device, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect and operating room personnel from the 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K172963
510(k) Summary
1. Submission Sponsor
| Applicant Name | Master & Frank Enterprise Co., Ltd |
|---|---|
| Address | Banhu Industrial District, Huang Jiang,Dong GuanCity, Guang Dong Province, CHINA |
| Phone No. | +86-769-83361381 |
| Fax No. | +86-769-83362026 |
| Contact Person | Ms. Shuge Zhao |
| zhaosg.dg@master-frank.cn | |
| Date Prepared | 04/03/2018 |
2. Submission correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | Room 1122, No.55 Shizhou Middle Road, NanshanDistrict,Shenzhen,Guangdong,P.R.China |
| Image | Image: logo |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Mr. Field Fu; Ms. Jessie You |
| Jessie@cefda.com; cefda13485@163.com |
3. Device Identification
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| Trade / Proprietary Name | Master-Frank N95 Particulate respirator |
|---|---|
| Common / Usual Name | N95 Surgical Respirator |
| Classification Name | Surgical apparel |
| Classification Regulation | 21 CFR 878.4040 |
| Product Code | MSH |
| Classification Panel | General Hospital |
4. Legally Marketed Predicate Devices
| Trade Name N95 Particulate Respirator and Surgical Mask | ||
|---|---|---|
| 510(k) Number K160271 | ||
| Product Code MSH | ||
| Manufacturer | San-M Package Co., Ltd. |
5. Device Description
The N95 particulate respirator (Model MF-01) is NIOSH certified (TC-84A-7697), pouched-shaped respirators when worn. The flat-folded respirator is composed of four layers-inner layer, filter (2 layers) and outer layer. The four layers are combined via ultrasonically welded. The respirator also contains a nose-piece enclosed in a binding tape welding the top edge to conform to the contours of the face. The respirator contains straps to secure the respirator in place on the wearer. The respirator is offered in white. The respirator is provided non-sterile and for single use only.
6. Indications for Use Statement
The N95 Particulate Respirator (MF01) is single-use, disposable device, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
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| Item | Proposed Device: | Predicate Device: | Comments |
|---|---|---|---|
| Master-Frank N95Particulaterespirator | N95 ParticulateRespirator andSurgical Mask | ||
| 510 (k)number | K172963 | K160271 | None |
| Manufacturer | Master & FrankEnterprise Co., Ltd | SAN-M PACKAGECO., LTD. | None |
| Commonname | N95 SurgicalRespirator | N95 SurgicalRespirator | Same |
| Classificationname | Surgical apparel | Surgical apparel | Same |
| Classification | II | II | Same |
| Product code | MSH | MSH | Same |
| Indicationsfor use | OTC:The N95 ParticulateRespirator (MF01) issingle-use,disposable device,provided non-sterile,and are intended tobe worn by operatingroom personnel orother healthcareworkers to protect | OTC:The N95 ParticulateRespirator and SurgicalMask, Models TN01-11and TN01-12 aresingle-use, disposabledevices, providednon-sterile, and areintended to be worn byoperating roompersonnel or other | Same |
| both the patient and | healthcare workers to | ||
| operating room | protect both the patient | ||
| personnel from the | and operating room | ||
| transfer of | personnel from the | ||
| microorganisms, body | transfer of | ||
| fluids, and particulate | microorganisms, body | ||
| material. | fluids, and particulate | ||
| material. | |||
| Materials | |||
| Outer material | Polypropylene | Polypropylene | Same |
| spunbond non-woven | spunbond | ||
| fabric | |||
| Inner material | Polypropylene | Polypropylene and | All of the |
| spunbond non-woven | polyethylene | materials | |
| fabric | are common | ||
| fabric | |||
| material for | |||
| making a | |||
| respirator. | |||
| Safety of the | |||
| materials | |||
| has been | |||
| proved by | |||
| biocompatibi | |||
| lity testing. | |||
| Filter media | Two layers of | Two layers of | Same |
| melt-blown | polypropylene | ||
| polypropylene fabric | meltblown | ||
| Nose-piece(Nose clamp) | Polyethylene + steelwire | Polyethylene coatedsteel wire | Same |
| Straps(Headband) | Synthetic rubber | Polyurethane, notmade with naturalrubber latex | The allergyreaction torubber hasbeenmentionedas a warningin thelabeling, andsafety of thematerialshas beenproved bybiocompatibility testing. |
| Designfeatures | Manufactured byultrasonic bonding,composed of fourlayers of materials,trapezoid-shapedwhen flat-folded,pouched-shapedwhen worn,single-use,disposable respirator,and nose-piece tocontour to the wearer. | Manufactured byultrasonic bonding,composed of fourlayersof materials,trapezoid-shaped whenflat-folded,pouched-shaped whenworn, single-use,disposable respirator,and nose clamp tocontour to the wearer. | Same |
| Specification | MF-01 | TN01-12 (Small):A | Similar |
| s and | The upper side length | Length: 205 ± 5 mm | (Size of |
| dimensions | of trapezoid: 98mm | Width: 75 ± 5 mm | MF-01 is |
| The bottom side | Band length: 205 ± 5 | similar with | |
| length of trapezoid: | mm | Medium) | |
| 240mm | TN01-11> | ||
| Width: 90mm | (Medium): | ||
| Straps: | Length: 240 ± 5 mm | ||
| Length: 580mm | Width: 75 ± 5 mm | ||
| Width: 5mm | Band length: 240 ± 5 | ||
| mm | |||
| Mask style | Flat-folded, Pouch | Flat-folded, Pouch | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Biocompatibi | The biocompatibility | Referenced ISO | Same |
| lity | testing items were | 10993-1 to determine | |
| determined in | standard tests required | ||
| accordance with the | for surface devices | ||
| FDA guidance | with limited contact ([] | ||
| "Use of International | 24 hours), contacting | ||
| Standard ISO | intact skin: | ||
| 10993-1" and ISO | Cytotoxicity (ISOA | ||
| 10993-1, the product | 10993-5): the | ||
| is surface device with | device was | ||
| limited contact (within | non-cytotoxic; | ||
| 24 hours) and | Irritation (ISOA | ||
| contacting intact skin: | 10993-10): the | ||
| Cytotoxicity (ISOA | device was | ||
| 10993-5): the | non-irritating; | ||
| device was | Sensitization (ISO | ||
| non-cytotoxic; | 10993-10): the | ||
| Irritation (ISO | device was | ||
| 10993-10): the | non-sensitizing. | ||
| device was | |||
| non-irritating; | |||
| Sensitization | |||
| (ISO 10993-10): | |||
| the device was | |||
| non-sensitizing. | |||
| Performance | |||
| testing | |||
| Fluid | Pass at 160 mmHg | Pass at 160 mmHg | Same |
| resistance | (ASTM F1862) | (ASTM F1862) | Same |
| Flammability | Class 1 (16 CFR | Class 1 (16 CFR | Same |
| 1610) | 1610) | Same | |
| Particulate | NIOSH Certification # | NIOSH Certification | Same |
| filtration | TC-84A-7697 | #TC 84A-3348 | Same |
| efficiency | (includes TN01-11 & | Same | |
| (PFE) | TN01-12) | Same | |
| Bacterialfiltrationefficiency(BFE) | NIOSH Certification # | NIOSH Certification | Same |
| TC-84A-7697 | #TC 84A-3348(includes TN01-11 &TN01-12) | ||
| DifferentialPressure ( $\triangle$ P) | NIOSH Certification # | NIOSH Certification | Same |
| TC-84A-7697 | #TC 84A-3348(includes TN01-11 &TN01-12) |
7. Substantial Equivalence Discussion
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8. Non-Clinical Performance Data
8.1 Biocompatibility testing
The N95 particulate respirators have been subjected to biocompatibility studies to demonstrate the safety of device. The biocompatibility studies are in accordance with ISO10993:
- A In Vitro Cytotoxicity (ISO 10993-5): the device was non-cytotoxic;
-
Skin Irritation (ISO 10993-10): the device was non-irritating;
-
Skin Sensitization (ISO 10993-10): the device was non-sensitizing.
There is no additional safety risk for the products when compared with the predicate device (N95 Particulate Respirator and Surgical Mask).
8.2 Physical performance testing
The N95 particulate respirator (Model MF-01) is NIOSH certified (TC-84A-7697). The performance testing was determined from the guidance "Surgical Masks – Premarket Notification (510k) Submissions" to demonstrate the effectiveness of device:
- A Fluid resistance:
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Pass at 160 mmHg (ASTM F1862)
A Flammability:
Class I (16 CFR 1610)
-
NIOSH Certification # TC-84A-7697 to address the following:
- Particulate filtration efficiency (PFE) .
- . Bacterial filtration efficiency (BFE)
- . Differential Pressure (Δ P)
The N95 particulate respirator (Model MF-01) passed tests performed by NIOSH.
9. Conclusion
The Indications for Use, materials, design features, specifications and technological
characteristics for N95 particulate respirators are similar to the predicate device
(K160271). The non-clinical performance testing demonstrates that the Master-Frank N95
Particulate Respirator is as safe, as effective, and performs as well as the legally
marketed predicate device (K160271).
§ 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.