(219 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No.
The device's intended use is for protection and infection control, not for treating or rehabilitating a medical condition or disease.
No
The device is a surgical face mask, which is intended to protect individuals from the transfer of microorganisms and fluids. Its purpose is protective, not diagnostic.
No
The device description clearly outlines physical components (spun-bond polypropylene, melt blown polypropylene filter, elastic ear loops, ties, polyethylene, iron) and the performance studies are focused on physical properties and biocompatibility, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The device is a physical barrier (a mask) designed to be worn externally. It does not interact with biological samples or perform any tests on them.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, fluid resistance, flammability) and its biocompatibility (cytotoxicity, irritation, sensitization). These are relevant to a barrier device, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This surgical face mask does not fit that description.
N/A
Intended Use / Indications for Use
The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, YX011, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The model of proposed device, YX121, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene and iron.
The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
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
healthcare personnel
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)
Bench testing for Surgical Face Mask included: Fluid Resistance Performance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability. Biocompatibility testing included: Cytotoxicity, Sensitization, Irritation. The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
March 10, 2021
Hunan EEXI Technology & Service Co., Ltd. % Joyce Yang Consultant Shenzhen Joyantech Consulting Co.,Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518100 China
Re: K202161
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 16, 2021 Received: February 8, 2021
Dear Joyce Yang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202161
Device Name Surgical Face Mask
Indications for Use (Describe)
The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
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)
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 K202161
This summary of 510(K) safety and effectiveness information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1. Submission Sponsor
| Applicant Name | Hunan EEXI Technology & Service Co.,Ltd. |
|---|---|
| Address | No. 6 North of Pingtou Road, Liuyang Hi-tech |
| Industrial Development Zone, Hunan China. | |
| Contact person | Zhang Xianliang |
| Phone | +0086-15874115252 |
Submission correspondent 2.
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | 1713A, 17th Floor, Block A, Zhongguan Times |
| Square, Nanshan District, Shenzhen | |
| Post Code | 518000 |
| Phone No. | +86-755-86069197 |
| Contact Person | Joyce Yang |
| joyce@cefda.com |
3. Devices Identification
| Type of 510(k) submission | Traditional |
|---|---|
| Trade Name | Surgical Face Mask |
| Model | YX011, YX121 |
| Classification name | Mask, Surgical |
| Review Panel | Surgical Apparel |
| Product Code | FXX |
| Device Class | II |
| Regulation Number | 878.4040 |
4
| 4. Legally Marketed Predicate Devices | |
|---|---|
| Trade Name | Disposable Surgical Face Mask |
| Regulation number | 878.4040 |
| Regulation class | II |
| Regulation name | Surgical Apparel |
| 510(k) Number | K153496 |
| Product Code | FXX |
| Manufacturer | Xiantao Rayxin Medical Products Co.,Ltd. |
-----
Device Description 5.
The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, YX011, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The model of proposed device, YX121, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene and iron.
The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
6. Intended Use/ Indications for Use
The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
7. Technological characteristics of the subject device compared to the predicate device
7.1 Predicate Device Information:
| 510(K) No.: | K153496 |
|---|---|
| Common name: | Disposable Surgical Face Mask |
| Classification name: | Mask, Surgical |
5
Production regulation: 21 CFR § 878.4040 Product code: FXX
Panel: Surgical Apparel
7.2 Comparison to predicate device:
| Comparison
item | Subject Device
(K202161) | Predicate Device
(K153496) | Comments |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Applicant | Hunan EEXI Technology &
Service Co.,Ltd. | Xiantao Rayxin Medical
Products Co.,Ltd. | |
| Product
name | Surgical Face Mask | Disposable Surgical Face
Mask | Similar |
| Product
Code | FXX | FXX | Same |
| Regulation
Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classificatio
n | Class II | Class II | Same |
| OTC use | Yes | Yes | Same |
| Intended
use &
Indication
s for Use | The Surgical Face Masks
are intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids and particulate
material. These masks are
intended for use in infection
control practices to reduce
the potential exposure to
blood and body fluids. This is
a single use, disposable
device, provided non-sterile. | The Disposable Surgical
Masks are intended to be
worn to protect both the
patient and healthcare
personnel from transfer of
microorganisms, body
fluids and particulate
material. These face
masks are intended for
use in infection control
practices to reduce the
potential exposure to
blood and body fluids.
This is a single
use, disposable device,
provided non-sterile. | Same |
| Design
feature | Ear-loop, Tie-on | Ear-loop, Tie-on | Same |
| Usage | Single use | Single use | Same |
| Color | Blue | Blue | Same |
| Size | (175±10) mm×(95±10)mm | (17.5±1) cm×(9.5±1)cm | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Material | Outer layer: Spun-bond
polypropylene | Outer layer: Spun-bond
polypropylene | Same |
| | Middle layer: Melt blown
polypropylene filter | Middle layer: Melt blown
polypropylene filter | Same |
| | Inner layer: Spun-bond
polypropylene | Inner layer:Spun-bond
polypropylene | Same |
| | Nose piece: polyethylene
and iron | Nose piece:Malleable
aluminum wire | Similar |
| | Ear-loops: Elastic fiber | Ear-loops:Polyester | Similar |
| | Tie-on:Spun-bond
polypropylene | Tie-on:Spun-bond
polypropylene | Same |
| ASTM F
2100 Level | Level 3 | Level 2 | Similar |
| Fluid
Resistance
Performance
ASTM F
1862-13 | Meet the ASTM F2100
Requirements for Level 3
Classification | Meet the ASTM F2100
Requirements for Level 2
Classification | Similar |
| Particulate
Filtration
Efficiency
ASTM F
2299 | Meet the ASTM F2100
Requirements for Level 3
Classification | Meet the ASTM F2100
Requirements for Level 2
Classification | Similar |
| Bacterial
Filtration
Efficiency
ASTM F
2101 | Meet the ASTM F2100
Requirements for Level 3
Classification | Meet the ASTM F2100
Requirements for Level 2
Classification | Similar |
| Differential
Pressure
(Delta P) EN
14683:2019+
AC:2019 | Meet the ASTM F2100
Requirements for Level 3
Classification | Meet the ASTM F2100
Requirements for Level 2
Classification | Similar |
| Flammability
16CFR 1610 | Class 1 | Class 1 | Same |
| Cytotoxicity | Comply with ISO 10993-5
Non cytotoxic | Comply with ISO 10993-5
Non cytotoxic | Same |
| Irritation | Comply with ISO 10993-10
Non irritating | Comply with ISO 10993-10
Non irritating | Same |
| Sensitization | Comply with ISO 10993-10
Non sensitizing | Comply with ISO 10993-10
Non sensitizing | Same |
6
7
Non-clinical Testing 8.
Surgical Face Mask conforms to the following standards:
- ASTM F 2100-19, Standard Specification for Performance of Materials Use in . Medical Face Masks.
- ISO 10993-1:2018, Biological Evaluation Of Medical Devices Part 1: ● Evaluation And Testing Within A Risk Management Process.
Bench testing
The bench testing of Surgical Face Mask include the following tests:
- *Fluid Resistance Performance
- *Particulate Filtration Efficiency
- *Bacterial Filtration Efficiency
- *Differential Pressure
- *Flammability
Biocompatibility testing
The biocompatibility evaluations were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as recognized by FDA. The tests of Surgical Face Mask include the following tests:
-
- Cytotoxicity
-
- Sensitization
-
- Irritation
9. Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.