(141 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
Explanation: This device is a surgical mask intended for protection against microorganisms and body fluids. It does not treat or cure any medical condition, which is characteristic of a therapeutic device.
No
Explanation: The device is a surgical mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. It is used for infection control and does not perform any diagnostic function.
No
The device description clearly outlines a physical product (surgical masks) made of materials like polypropylene and metal, and the performance studies focus on physical properties and biological compatibility, 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 clearly states the masks are for protecting against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose piece) and its materials. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, flammability, biocompatibility). These are relevant to a physical barrier device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Single-use Surgical Masks (Model:FE2311) are intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Product codes
FXX
Device Description
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The proposed device(s) 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, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of metal core plastic. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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)
Non clinical tests were conducted and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 05, 2004.
Standards:
- ASTM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face Masks.
- ASTM F1862-13, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity).
- ASTM F2299-03, Stand Test Method For Determining The Initial Efficiency Of Materials Used In Medical Face Masks To Penetration By Particulates Using Latex Spheres.
- 16 CFR 1610, Standard For The Flammability Of Clothing Textiles.
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices – Part 10: Tests For Irritation And Skin Sensitization.
Key results:
- Fluid Resistance Performance: 32 out of 32 Pass at 160 mmHg (ASTM F1862)
- Particulate Filtration Efficiency: Pass at 99.67% (ASTM F2299)
- Bacterial Filtration Efficiency: Pass at 99.95% (ASTM F2100)
- Differential Pressure: 5.62 mmH20/cm² (ASTM F2100)
- Flammability: Class 1 (16 CFR 1610)
- Cytotoxicity: Under the conditions of the study, not cytotoxicity effect
- Irritation: Under the conditions of the study, not an irritant
- Sensitization: Under the conditions of the study, not a sensitizer
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 26, 2020
BYD Precision Manufacturer Co.Ltd. % Annie Zhang Regulatory Affairs Nova Clinical Solutions, Inc. 6792 Solterra Vista Pkwy San Diego, California 92130
Re: K200923
Trade/Device Name: Single-use Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 6, 2020 Received: April 7, 2020
Dear Annie Zhang:
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.
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
1
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 (QS) 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 mediation-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,
For CAPT Elizabeth Claverie, M.S. 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) K200923
Device Name Single-Use Surgical Masks (Model:FE2311)
Indications for Use (Describe)
The Single-use Surgical Masks (Model:FE2311) are intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
This is a single use, disposable device(s), provided non-sterile.
| 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
K200923
510(k) Summary
August 26, 2020
A. 510(k) Submitter:
BYD Precision Manufacturer Co.Ltd. No.3001 Baohe Road, Baolong Industrial Area, Longgang Shenzhen, Guangdong, 518116, CHINA
B. Submitter Contact:
Yubo Guan 86-755-89888888-68765 Guan.yubo@byd.com
Designated Submission Correspondent:
Annie Zhang 617-595-3484 annie.zhang@huanuoclinical.com
C. Device Trade Name: Single-use Surgical Mask Model: FE2311
Device Classification: Class II, Surgical Face Mask (21 CFR 878.4040)
Product Code: FXX
D. Predicate:
K153496 Disposable Surgical Face Mask Xiantao Rayxin Medical Products Co.,Ltd.
E. Intended Use/Indications for Use:
The Single-use Surgical Masks (Model: FE2311) 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.
4
This is a single use, disposable device(s), provided non-sterile.
F. Device Description:
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.
The proposed device(s) 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, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of metal core plastic. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
G. Technological Characteristics:
The Single-use Surgical Mask is compared with the predicate device Disposable Surgical Face Mask (K153496) . The product characteristics are shown below in the Comparison Tables:
| Item(s) | Subject Device | Predicate Device (K153496) | Comparison |
|---|---|---|---|
| Intended | |||
| Use/Indications for | |||
| Use | The Single-use Surgical | ||
| Masks (Model:FE2311) 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(s), | |||
| provided non-sterile. | The Disposable 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 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(s), provided non-sterile. | Same | ||
| Type | Ear loop, Flat Pleated, 3 | ||
| layers | Ear Loops and Tie-On, Flat | ||
| Pleated, 3 layers | Difference | ||
| Materials Outer | |||
| Layer | Spun-bond | ||
| polypropylene | Spun-bond polypropylene | Same |
Table 1: General Comparison Table
5
| | Middle
Layer | Melt blown
polypropylene filter | Melt blown polypropylene
filter | Same |
|--------------------|-----------------|------------------------------------|------------------------------------|------------|
| | Inner
Layer | Spun-bond
polypropylene | Spun-bond polypropylene | Same |
| | Nose
Piece | Metal Core Plastic | Malleable aluminum wire | Difference |
| | Ear
Loops | Polyester | Polyester | Same |
| Color | | Blue | Blue | Same |
| Dimension (Width) | | 17.5 cm +/- 0.4 cm | 17.5 cm +/- 1 cm | Difference |
| Dimension (Length) | | 9.5 cm +/- 0.4 cm | 9.5 cm +/- 1 cm | Same |
| OTC Use | | Yes | Yes | Same |
| Single Use | | Yes | Yes | Same |
| Sterile | | No | No | Same |
| ASTM F2100 Level | | Level 3 | Level 2 | Difference |
H. Non-Clinical Test
Non clinical tests were conducted and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 05, 2004.
Standards:
- . ASTM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face Masks.
- . ASTM F1862-13, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity).
- . ASTM F2299-03, Stand Test Method For Determining The Initial Efficiency Of Materials Used In Medical Face Masks To Penetration By Particulates Using Latex Spheres.
- 16 CFR 1610, Standard For The Flammability Of Clothing Textiles.
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices Part 5: Tests For In Vitro ● Cytotoxicity
- . ISO 10993-10: 2010 Biological Evaluation Of Medical Devices – Part 10: Tests For Irritation And Skin Sensitization.
| Item(s) | Subject Device | Predicate Device (K153496) | Comparison |
|---|---|---|---|
| Fluid Resistance | |||
| Performance | 32 out of 32 Pass at | ||
| 160 mmHg | |||
| (ASTM F1862) | 32 out of 32 pass at 120 | ||
| mmHg | |||
| (ASTM F1862) | Difference | ||
| Particulate Filtration | |||
| Efficiency | Pass at 99.67% | ||
| (ASTM F2299) | 98.46% | ||
| (ASTM F2299) | Difference |
Table 2: Performance Characteristic Comparison Table
6
| Bacterial Filtration
Efficiency | Pass at 99.95%
(ASTM F2100) | 98.7%
(ASTM F2101) | Difference |
|------------------------------------|--------------------------------|---------------------------------|------------|
| Differential Pressure | 5.62 mmH20/cm²
(ASTM F2100) | 4.2 mmH20/cm²
(MIL-M-36954C) | Difference |
| Flammability | Class 1
(16 CFR 1610) | Class 1
(16 CFR 1610) | Same |
Table 3: Biocompatibility Comparison Table
| Item(s) | Subject Device | Predicate Device
(K153496) | Comparison |
|---------------|---------------------------------------------------------------|-------------------------------|------------|
| Cytotoxicity | Under the conditions of the
study, not cytotoxicity effect | Comply with ISO
10993-5 | Same |
| Irritation | Under the conditions of the
study, not an irritant | Comply with ISO
10993-10 | Same |
| Sensitization | Under the conditions of the
study, not a sensitizer | | |
Clinical Test l.
No clinical study is included in this submission.
J. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device, the Disposable Surgical FaceMask (K153496) manufactured by Xiantao Rayxin Medical Products Co.,Ltd.