The medical surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Device Description

The proposed device, Medical Surgical Mask is a three-layer, single-use, flat-pleated mask. The mask body is made of 25g/m2 PP non-woven cloth. The mask contains tie strings or ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Nylon and PU, and tie strings are made of Nylon. The nose clip which is made of Iron strip covered by polypropylene covering. The device is provided in sterile.

AI/ML Overview

The provided document (K202029) describes the substantial equivalence determination for a Medical Surgical Mask. It is a 510(k) premarket notification, which means the device is being compared to a legally marketed predicate device to establish substantial equivalence, rather than proving novel safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implied by the similarity comparison to the predicate device and the adherence to relevant ASTM and ISO standards for medical face masks. The "Performance" section within Table 1 provides the reported device performance, and the "Remark" column indicates how it compares to the predicate.

Performance Characteristic	Acceptance Criteria (Implied by Predicate and Standards)	Reported Device Performance (Medical Surgical Mask)	Remark (vs. Predicate)
Fluid resistance	Pass at 120 mmHg	Pass at 120 mmHg	Same
Particulate efficiency level	Average 99.74% at 0.1µm (Predicate's value)	Average 98.87%	Similar
Bacterial filtration level	Average 99.4% (Predicate's value)	Average 99.46%	Similar
Differential pressure	Average 2.7 mmH2O/cm² (Predicate's value)	Average 3.72 mmH2O/cm²	Similar
Flammability	Class 1	Class 1	Same
Cytotoxicity (Biocompatibility)	No Cytotoxicity	No Cytotoxicity	Same
Sensitization (Biocompatibility)	No Sensitization	No Sensitization	Same
Irritation (Biocompatibility)	No Irritation	No Irritation	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 non-clinical test (e.g., how many masks were tested for particulate efficiency). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

Sample size: Not explicitly stated for each test.
Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The sponsor is based in Beijing, China, so it's likely the testing was conducted there or by a certified lab, but this is not confirmed in the text. The tests are "non-clinical," implying they were laboratory-based rather than involving human subjects or real-world data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this submission. This is a 510(k) for a medical surgical mask, which relies on non-clinical performance testing against established standards and comparison to a predicate device, not on expert interpretation of medical images or clinical outcomes. Therefore, there are no "experts" establishing ground truth in the context of a typical AI/diagnostic device study.

4. Adjudication method for the test set

This information is not applicable. Since there are no human readers or expert interpretations involved in establishing ground truth for a medical mask's performance tests, there's no need for an adjudication method.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance to assess the AI's impact on their performance. This 510(k) is for a physical medical device (surgical mask) and does not involve AI or human interpretation in its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm-only performance study was not done. This is also relevant for AI/diagnostic devices. The medical surgical mask is a physical barrier device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by objective, standardized laboratory testing against specified ASTM and ISO standards for medical face masks. These standards define the methodologies and criteria for evaluating attributes like fluid resistance, particulate efficiency, bacterial filtration, differential pressure, flammability, and biocompatibility. The results are quantitative measurements or pass/fail determinations based on these established test procedures.

8. The sample size for the training set

Not Applicable. This device is a physical product (medical mask) and does not involve machine learning or AI models, so there is no "training set."

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for an AI/ML model, there is no ground truth to be established for it.

Summary

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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 16, 2020

Beijing Biosis Healing Biological Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co. Ltd P.O.Box 120-119 Shanghai, 200120 China

Re: K202029

Trade/Device Name: Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 15, 2020 Received: July 22, 2020

Dear Diana Hong:

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.

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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 and Part 809); 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

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Indications for Use

510(k) Number (if known) K202029

Device Name Medical Surgical Mask

Indications for Use (Describe)

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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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202029

1. Sponsor Identification

Beijing Biosis Healing Biological Technology Co., Ltd.

No.6 plant west, Valley No.1 Bio-medicine Industry Park, Daxing District, 102600, Beijing, China.

Contact Person: Ting Jiang Position: RA Director Tel: +86-10-6125 2660-816 Fax: +86-10-6125 2030 Email: jiangting@biosishealing.com

Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net

Date of Preparation: 12/16/2020

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1. Identification of Proposed Device
  Trade Name: Medical Surgical Mask Common Name: Surgical Mask Regulation Name: Surgical Apparel
1. Regulatory Information
  Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital
1. Identification of Predicate Device
  Manufacturer: V&Q Manufacturing Corporation 510(k) Number: K173062 Product Name: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
1. Indication for use:
  The medical surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
1. Device Description:
  The proposed device, Medical Surgical Mask is a three-layer, single-use, flat-pleated mask. The mask body is made of 25g/m2 PP non-woven cloth. The mask contains tie strings or ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Nylon and PU, and tie strings are made of Nylon. The nose clip which is made of Iron strip covered by polypropylene covering. The device is provided in sterile.

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1. Summary of Technological Characteristics

Table 1 Comparison of Medical Surgical Mask
ITEM	Proposed Device	Predicate Device	Remark
Product Code	K202029	K173062
	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indication for Use	The medical surgical maskis intended for single use byoperating room personneland other general healthcareworkers to protect bothpatients and healthcareworkers against transfer ofmicroorganisms, blood andbody fluids, and particulatematerials.	Non Woven Face Mask(Models: VQN0185W (earloop)and VQN0185B (ties)) isintended for single use byoperating room personnel andother general healthcare workersto protect both patients andhealthcare workers againsttransfer of microorganisms,blood and body fluids, andparticulate materials.	Same
Mask style	Flat pleated	Flat pleated	Same
Mask color	Blue	Blue	Same
Design feature	Earloop or tie-on	Earloop or tie-on	Same
Dimension (mm)	120mm×70mm145mm×90mm175mm×95mm	175mm×95mm	Different
ASTM F2100 Level	Level 2	Level 2	Same
Performance
Fluid resistance	Pass at 120mmHg	Pass at 120mmHg	Same
Particulate efficiencylevel	Average 98.87%	Average 99.74% at 0.1µm	Similar
Bacterial filtrationlevel	Average 99.46%	Average 99.4%	Similar
Differential pressure	Average 3.72mmH2O/cm2	Average 2.7mmH2O/cm2	Similar
Flammability	Class 1	Class 1	Same
Label/Labeling	Complied with 21 CFR part801	Complied with 21 CFR part 801	Same
Patient Contacting Material
ear strap	Nylon and PU	Urethane elastic fiber orspun-bond polypropylene	Different
nose clip	Iron strip covered by polypropylene covering	White aluminum strip covered by PP covering	Different
mask body	25g/m² PP non-woven cloth	Spun-bond polypropylene	Different
Biocompatibility
Cytotoxicity	No Cytotoxicity	No Cytotoxicity	Same
Sensitization	No Sensitization	No Sensitization	Same
Irritation	No Irritation	No Irritation	Same
Sterility	Sterile	Non-sterile	Different

Table 1 Comparison of Medical Surgical Mask

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1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
A ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials.(Sterility)
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
ア ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
A ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
ASTM F2101-2017 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Conclusion
  The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device.

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.