(184 days)
Jian Yu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask is a single use, disposable device provided non-sterile.
The JianYu surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (spunbond polypropylene, blue), filter layer (meltblown polypropylene, white), and inner layer (spunbond polypropylene, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical mask is a single use, disposable device, provided non-sterile.
The manufacturer, Jiangsu JianYu Health Medical Co., Ltd., submitted a 510(k) premarket notification (K201754) for their JianYu Surgical Mask. The device is classified as a Class II surgical apparel under regulation 21 CFR 878.4040. The predicate device is the "Surgical Face Mask (EL30000)" cleared under K160269.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the JianYu Surgical Mask are based on the ASTM F2100-19 Level 3 standard for medical face mask performance. The reported performance of the device is compared against these criteria, as well as against the predicate device (K160269).
| Performance Metric | Acceptance Criteria (ASTM F2100-19 Level 3) | Reported Device Performance (JianYu Surgical Mask) | Predicate Device (K160269) Performance | Comparison to Predicate |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥98% (ASTM F2101) | Passed at ≥99.9% (ASTM F2101) | Passed at ≥99% (ASTM F2101) | Same |
| Differential Pressure | <6.0 mmH₂O/cm² (EN14683:2019 Annex C) | Passed at <6.0 mmH₂O/cm² (EN14683:2019 Annex C) | 2.5 mmH₂O/cm² (MIL-M-36954C) | Similar |
| Particulate Filtration Efficiency (PFE) | ≥98% (ASTM F2299) | Passed at ≥98% (ASTM F2299) | Passed at 99.7% (ASTM F2299) | Similar |
| Resistance to Penetration by Synthetic Blood | 160 mmHg (ASTM F1862) | Passed at 160 mmHg (ASTM F1862) | Passed at 160 mmHg (ASTM F1862) | Same |
| Flammability | Class 1 (16 CFR PART 1610) | Class 1 (16 CFR PART 1610) | Class 1 (16 CFR PART 1610) | Same |
| Cytotoxicity | No potential cytotoxicity (AAMI/ANSI/ISO 10993-5:2009) | No potential cytotoxicity | Passed acceptance criteria (ISO 10993) | Same |
| Irritation and Skin Sensitization | No significant irritation or sensitization (AAMI/ANSI/ISO 10993-10:2010) | No significant irritation or sensitization | Passed acceptance criteria (ISO 10993) | Same |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual performance test (BFE, differential pressure, PFE, synthetic blood penetration, flammability, cytotoxicity, irritation, and sensitization). However, the tests were conducted according to established international and national standards (ASTM, EN, ISO, 16 CFR), which typically outline the required sample sizes and methodologies for ensuring statistical validity.
The data provenance is from non-clinical performance testing conducted by the manufacturer or a designated testing facility, following the mentioned standards. There is no information provided regarding the country of origin of the data beyond the manufacturer's location in China. The testing is assumed to be prospective in nature, as it aims to demonstrate the device's performance against predefined criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This submission is for a medical device (surgical mask) that is evaluated based on non-clinical performance testing against established standards, not through interpretation of complex medical cases requiring expert radiologists or other medical specialists to establish ground truth. Therefore, no medical experts were used to establish ground truth in the context of diagnostic performance. The "ground truth" for the device's performance is determined by the objective measurements and pass/fail criteria defined within the specified testing standards. The experts involved would be laboratory technicians and engineers qualified to conduct these specific tests and interpret the results according to the standards.
4. Adjudication method for the test set
As the evaluation is based on objective non-clinical performance tests against pre-defined criteria in standards, an adjudication method (like 2+1, 3+1) is not applicable. The results of each test are compared directly to the specified acceptance criteria of the relevant standard.
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
No MRMC comparative effectiveness study was done. This device is a surgical mask, not an AI-assisted diagnostic or therapeutic device. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a passive physical barrier (surgical mask) and does not involve any algorithms or software that would perform in a standalone or human-in-the-loop capacity.
7. The type of ground truth used
The ground truth used is based on objective measurements and pass/fail criteria defined in recognized consensus standards for medical face masks. These include:
- Bacterial Filtration Efficiency (BFE): Measured according to ASTM F2101-19.
- Differential Pressure: Measured according to EN14683: 2019 Annex C.
- Particulate Filtration Efficiency (PFE): Measured according to ASTM F2299-17.
- Resistance to Penetration by Synthetic Blood: Measured according to F1862/F1862M-17.
- Flammability: Measured according to 16 CFR PART 1610.
- Biocompatibility (Cytotoxicity, Irritation, Sensitization): Evaluated according to AAMI/ANSI/ISO 10993-5:2009 and AAMI/ANSI/ISO 10993-10:2010.
8. The sample size for the training set
Not applicable. Surgical masks are not data-driven systems that require a "training set." The device's performance is determined by its physical characteristics and material properties, which are evaluated through standardized laboratory tests.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this type of device, no ground truth was established for a training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.
December 30, 2020
Jiangsu JianYu Health Medical Co., Ltd. Andy Shu Regulatory Affairs Specialist No. 88 Longxi Avenue, Zhulin Town, Jintan District Changzhou, Jiangsu 213241 China
Re: K201754
Trade/Device Name: JianYu Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 16, 2020 Received: December 29, 2020
Dear Andy Shu:
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.
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)
Device Name
JianYu Surgical Mask
Indications for Use (Describe)
Jian Yu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask 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
(as requested by 21 CFR 807.92)
| 510K Number: | K201754 |
|---|---|
| Submitter / 510(k) owner: | Jiangsu JianYu Health Medical Co., Ltd.Address: No. 88 Longxi Avenue, Zhulin Town, Jintan District,Changzhou City, Jiangsu, CN 213241Tel: +86-519-82445588Fax: +86-519-82442788 |
| Contact Person: | Andy ShuRegulatory Affairs SpecialistE-mail: andy_smiths@sina.com |
| Date of preparation: | June 15th, 2020 |
| Proposed device: | |
| Trade Name: | JianYu Surgical Mask |
| Common/Classification Name: | Surgical Mask Regulation |
| Name: | Surgical Apparel |
| Product Code: | FXX |
| Review Panel: | General Hospital |
| Device Class: | Class II |
| Regulation Number: | 878.4040 |
| Legally Marketed Predicate Device: | |
| Trade Name: | Surgical Face Mask (EL30000) |
| 510(k) Number: | K160269 |
| Submitter of 510(k)/holder: | SAN-M PACKAGE CO., LTD. |
Device Description:
The JianYu surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (spunbond polypropylene, blue), filter layer (meltblown polypropylene, white), and inner layer (spunbond polypropylene, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical mask is a single use, disposable device, provided non-sterile.
Intended Use:
JianYu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask is a single use, disposable device provided non-sterile.
{4}------------------------------------------------
Comparison of Technological Characteristics between the subject and predicate devices:
JianYu Surgical mask has the same technological characteristics as the predicate device. The design, material, form, fit, function and method of operation are similar.
| Element ofComparison | Subject DeviceK201754 | Predicate DeviceK160269 | Comparison |
|---|---|---|---|
| Indications forUse | JianYu surgical mask is intended tobe worn to protect both patients andhealthcare workers from transfer ofmicroorganisms, body fluids, andparticulate material. The surgicalmask is intended for use in infectioncontrol practices to reduce thepotential exposure to blood and bodyfluids. The JianYu surgical mask is asingle use, disposable deviceprovided non-sterile. | The surgical face masks areintended to be worn to protect boththe patient and healthcare personnelfrom transfer of microorganisms,body fluids, and particulate material.These face masks are intended foruse in infection control practices toreduce the potential exposure toblood and body fluids. This is asingle-use, disposable device,provided non-sterile. | Same |
| MaterialComposition | Three-layer mask constructed of:Outer layer: spunbond polypropyleneFilter layer: meltblown polypropyleneInner layer: spunbond polypropyleneEar loops: spandexNose clip: malleable aluminumwire/PVC | Outer layer: PolypropyleneFilter media:1. Polypropylene spunbond2. Polypropylene meltblown Innerlayer: PolypropyleneEar loop: Polyester, polyurethaneNose lamps: Polyethylene coatedsteel wire | Similar |
| Dimension | Length: 175±5mm, Width: 95±5mm | Length: 175±5mm, Width: 90±3mm | Similar |
| Mask style | Flat-pleated | Flat-pleated | Same |
| Design feature | Ear loops | Ear loops | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single use; Disposable | Single use; Disposable | Same |
| Color | Blue | White or blue | Same |
| Biocompatibility | The surgical mask was tested withfollowing standards:• AAMI /ANSI/ ISO10993-5:2009,Under the testing conditions, thesubject surgical mask did not showpotential cytotoxicity• AAMI /ANSI/ ISO10993-10:2010,Under the testing conditions, thesubject surgical mask did not causesignificant irritation or sensitizationreaction to the test animals | The surgical mask was tested inaccordance with ISO10993 andpassed acceptancecriteria. | Same |
{5}------------------------------------------------
| Product performance specification per ASTM F2100-19 meets Level 3 | ||||
|---|---|---|---|---|
| Bacterialfiltrationefficiency(BFE) | Passed at ≥99.9% ASTM F2101 | Passed at ≥99% ASTM F2101 | Same | |
| Differentialpressure | Passed at <6.0 mmH2O/cm²EN14683:2019 Annex C | Passed at 2.5 mmH2O/cm² MIL-M-36954C | Similar | |
| Particulate filtrationefficiency (PFE) | Passed at ≥98% ASTM F2299 | Passed at 99.7% ASTM F2299 | ||
| Resistance topenetration bysynthetic blood | Passed at 160mmHg ASTM F1862 | Passed at 160mmHg ASTM F1862 | ||
| Flammability | Class 1, 16CFR PART 1610 | Class 1, 16CFR PART 1610 |
Summary of Non-Clinical Performance Testing
Performance tests have been conducted on Surgical mask per ASTM F2100-19, and all testing results met ASTM F2100-19 Level 3 acceptance criteria. Detailed testing conducted as below:
- Bacterial filtration efficiency (BFE) •
- Differential pressure
- Particulate filtration efficiency (PFE) •
- Resistance to penetration by synthetic blood •
- Flammability •
Testing standards
| Standards No. | Standards Title |
|---|---|
| ASTM F2100-19 | Standard Specification for Performance of Materials Used inMedical Face Masks |
| ASTM F2101-19 | Standard Test Method for Evaluating the Bacteria Filtration Efficiency (BFE)of Medical Face Mask Materials, Using aBiological Aerosol of Staphylococcus Aureus |
| EN14683: 2019 | Medical Fask Masks—Requirements and Test Methods |
| ASTM F2299-17 | Standard Test Method for Determining the Initial Efficiency ofMaterials Used in Medical Face Masks to Penetration byParticulates Using Latex Spheres |
| F1862/F1862M-17 | Standard Test Method for Resistance of Medical Face Masks to Penetrationby Synthetic Blood (Horizontal Projection of FixedVolume at a Known Velocity) |
| 16CFR PART 1610 | Standard for the Flammability of Clothing Textiles |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process |
| AAMI /ANSI/ ISO10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization |
| AAMI /ANSI/ ISO10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity |
{6}------------------------------------------------
Summary of Clinical Performance Testing
Not applicable.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K201754, the JianYu Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160269.
§ 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.