Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of a respirator, with no mention of AI or ML.

Therapeutic

No.
The device description clearly states its purpose is to protect personnel from transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition. It is a protective device, not a therapeutic one.

Diagnostic

No

The device is an N95 Particulate Respirator, which is intended to protect healthcare workers from the transfer of microorganisms, body fluids, and particulate material. Its function is protective, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, multi-layered respirator with hardware components like straps and a nose-piece, and the performance studies focus on physical properties and filtration efficiency, not software functionality.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Intended Use: The intended use of the N95 Particulate Respirator is to protect the wearer from the transfer of microorganisms, body fluids, and particulate material. It is a barrier device worn externally.
Device Description: The description details the physical construction of a respirator, not a device that analyzes biological samples.
Performance Studies: The performance studies focus on the physical properties of the respirator (fluid resistance, flammability, filtration efficiency) and biocompatibility, not on the analysis of biological specimens.

The information provided clearly indicates that this device is a personal protective equipment (PPE) designed to filter airborne particles and fluids, not to perform diagnostic tests on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

MSH

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.

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 or other healthcare workers

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

Non-clinical performance data included biocompatibility testing (In Vitro Cytotoxicity, Skin Irritation, Skin Sensitization) and physical performance testing (Fluid resistance, Flammability, Particulate filtration efficiency (PFE), Bacterial filtration efficiency (BFE), Differential Pressure (Δ P)). The device was found to be non-cytotoxic, non-irritating, and non-sensitizing. It passed fluid resistance at 160 mmHg (ASTM F1862) and was classified as Class I for flammability (16 CFR 1610). The device is NIOSH certified (# TC-84A-7697) for PFE, BFE, and Differential Pressure.

Key Metrics

Not Found

Predicate Device(s)

K160271

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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

1

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

2

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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3

K172963

510(k) Summary

1. Submission Sponsor

Applicant Name	Master & Frank Enterprise Co., Ltd
Address	Banhu Industrial District, Huang Jiang,Dong Guan
City, Guang Dong Province, CHINA
Phone No.	+86-769-83361381
Fax No.	+86-769-83362026
Contact Person	Ms. Shuge Zhao
Email	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, Nanshan
District,
Shenzhen,
Guangdong,
P.R.China
Image	Image: logo
Post Code	518000
Phone No.	86-755-86069197
Contact Person	Mr. Field Fu; Ms. Jessie You
Email	Jessie@cefda.com; cefda13485@163.com

3. Device Identification

4

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.

5

Item	Proposed Device:	Predicate Device:	Comments
	Master-Frank N95
Particulate
respirator	N95 Particulate
Respirator and
Surgical Mask
510 (k)
number	K172963	K160271	None
Manufacturer	Master & Frank
Enterprise Co., Ltd	SAN-M PACKAGE
CO., LTD.	None
Common
name	N95 Surgical
Respirator	N95 Surgical
Respirator	Same
Classification
name	Surgical apparel	Surgical apparel	Same
Classification	II	II	Same
Product code	MSH	MSH	Same
Indications
for use	OTC:
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	OTC:
The N95 Particulate
Respirator and Surgical
Mask, Models TN01-11
and TN01-12 are
single-use, disposable
devices, provided
non-sterile, and are
intended to be worn by
operating room
personnel 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 + steel
wire	Polyethylene coated
steel wire	Same
Straps
(Headband)	Synthetic rubber	Polyurethane, not
made with natural
rubber latex	The allergy
reaction to
rubber has
been
mentioned
as a warning
in the
labeling, and
safety of the
materials
has been
proved by
biocompatibility testing.
Design
features	Manufactured by
ultrasonic bonding,
composed of four
layers of materials,
trapezoid-shaped
when flat-folded,
pouched-shaped
when worn,
single-use,
disposable respirator,
and nose-piece to
contour to the wearer.	Manufactured by
ultrasonic bonding,
composed of four
layers
of materials,
trapezoid-shaped when
flat-folded,
pouched-shaped when
worn, single-use,
disposable respirator,
and nose clamp to
contour 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

                                                                                                                                                                                                                                   |                                                                                                                                                                                              |

7. Substantial Equivalence Discussion

6

7

8

9

10

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:

11

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).