(205 days)
The Medical Surgical Mask is intended to be worn to protect 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 Medical Surgical Mask is a single use, three-layer, flat-pleated style surgical mask with ear loops and nose piece. The mask is 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 surgical masks is held over the user's mouth and nose via earloops made of nylon with spandex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The medical surgical mask includes blue colorant, Shining Blue R603. The medical surgical mask is sold non-sterile and is intended to be single use, and disposable.
This is a medical device submission for a "Medical Surgical Mask" (K210813). The document describes non-clinical performance testing against established standards and a predicate device.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| Synthetic Blood Penetration Resistance | No penetration at 160 mmHg | No penetration at 160 mmHg | Pass |
| Particulate Filtration Efficiency (0.1 µm) | >98 % | >98 % | Pass |
| Bacterial Filtration Efficiency | >98 % | >98 % | Pass |
| Differential Pressure (Delta P) | ≤ 6.0 mmH2O/cm² | ≤ 6.0 mmH2O/cm² | Pass |
| Flammability | Class 1 | Class 1 | Pass |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic | Pass |
| Irritation (ISO 10993-10) | Non-irritating | Non-irritating | Pass |
| Sensitization (ISO 10993-10) | Non-sensitizing | Non-sensitizing | Pass |
The acceptance criteria for the subject device are explicitly stated as meeting or exceeding the performance of the predicate device (DemeMASK Surgical Mask, K201479) and conforming to relevant standards (ASTM F1862, ASTM F2299, ASTM F2101, EN 14683:2019+AC:2019, 16 CFR 1610, ISO 10993-5, ISO 10993-10).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each performance test. The data provenance is not specified, but the manufacturing company (Sichuan Pharmaceutical, Inc.) is based in China. The testing was conducted as part of a premarket notification for the FDA, making it a prospective study relative to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is a physical device (surgical mask), not an AI/software device. Therefore, the concept of "experts establishing ground truth" in the context of image interpretation or diagnosis is not applicable. The performance is measured objectively against established physical and biological standards using laboratory testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for physical device performance testing. The results are obtained through standardized laboratory procedures, not expert adjudication of subjective assessments.
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
Not applicable. This is a physical medical device (surgical mask), not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this physical device, the "ground truth" is defined by the established performance standards (e.g., ASTM F1862 for synthetic blood penetration, ASTM F2299 for particulate filtration efficiency, ISO 10993 for biocompatibility). The device's performance is measured against these objective, quantitative criteria.
8. The sample size for the training set
Not applicable. This is a physical device, and there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned or implied for this physical device.
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October 8, 2021
Sichuan Pharmaceutical. Inc. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K210813
Trade/Device Name: Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 25, 2021 Received: September 9, 2021
Dear Boyle Wang:
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); 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 Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control And Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210813
Device Name Medical Surgical Mask
Indications for Use (Describe)
The Medical Surgical Mask is intended to be worn to protect 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.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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510(k) Summary
(K210813)
This summary is submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Sichuan Pharmaceutical,Inc. |
|---|---|
| Address: | Sichuan Pharmaceutical.Inc No. 18 Baiye Road,Hi-Tech West Zone, Chengdu, Sichuan Province,China. |
| Contact: | Yunrui Zhang |
| Tel: | 86-13678040510 |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Address: | Shanghai Truthful Information Technology Co., Ltd.Room 1801, No. 161 East Lu Jiazui Rd., PudongShanghai, 200120 China |
| Tel: | +86-21-50313932 |
| Email: | info@truthful.com.cn |
Date of Preparation: Oct.8,2021
2.0 Device Information
| Trade name: | Medical Surgical Mask |
|---|---|
| Common name: | Surgical Face Mask |
| Classification name: | Surgical Face Mask |
| Production code: | FXX |
| Regulation number: | 21CFR 878.4040 |
| Classification: | Class II |
| Review Panel: | Surgical Apparel |
3.0 Predicate Device Information
| Manufacturer: | DemeTECH Corporation. |
|---|---|
| Device: | DemeMASK Surgical Mask |
| 510(k) number: | K201479 |
4.0 Device Description
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The Medical Surgical Mask is a single use, three-layer, flat-pleated style surgical mask with ear loops and nose piece. The mask is 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 surgical masks is held over the user's mouth and nose via earloops made of nylon with spandex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The medical surgical mask includes blue colorant, Shining Blue R603. The medical surgical mask is sold non-sterile and is intended to be single use, and disposable.
5.0 Indication for Use Statement
The Medical Surgical Mask is 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.
| Item | Subject DeviceK210813 | Predicate DeviceK201479 | Comparison | |
|---|---|---|---|---|
| Product Name | Medical Surgical Mask | DemeMASK Surgical Mask | -- | |
| Product Code | FXX | FXX | Same | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Class | II | II | Same | |
| Intended Use&Indications foruse | The Medical Surgical Mask is 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), | 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 | Same | |
| provided non-sterile. | blood and body fluids.This is a single use,disposable deviceprovided non-sterile. | |||
| Design features | Ear Loops, 3 layers | Ear Loops, 3 layers | Same | |
| Mask Styles | Flat pleated | Flat pleated | Same | |
| Material | Outerfacinglayer | Spun-bondpolypropylene | Spun-bondpolypropylene | Same |
| Middlelayer | Melt blownpolypropylene filter | Melt blownpolypropylene filter | Same | |
| InnerFacinglayer | Spun-bondpolypropylene | Spun-bondpolypropylene | Same | |
| Nosepiece | Malleable polyethylenewire | Galvanized wire withcoated polyethylene | *Different | |
| Earloops | Nylon and spandex | Nylon and spandex | Same | |
| Color | Blue | Blue | Same | |
| Dimension(Length) | 17.5 cm +/- 0.2 cm | 17.5 cm +/- 1cm | *Different | |
| Dimension(Width) | 9.5 cm +/- 0.2 cm | 9.5 cm +/- 1cm | ent | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Single Use | Yes | Yes | Same | |
| Sterile | No | No | Same | |
| ASTM F2100Level | Level 3 | Level 3 | Same | |
| BiocompatibilityISO 10993-5/ISO 10993-10 | Non-cytotoxic,non-sensitizing, andnon-irrtating | Non-cytotoxic,non-sensitizing, andnon-irrtating | Same |
6.0 Comparison to the Predicate Device
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- Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials. The difference in the materials does not raise additional questions for safety and effectiveness.
7.0 Non-Clinical Test Conclusion
The proposed device was tested 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 5, 2004.
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| Test | Subject Device | Predicate Device | Results |
|---|---|---|---|
| SyntheticBloodPenetrationResistanceASTM F1862 | No penetrationat 160 mmHg | No penetration at160 mmHg | Pass |
| ParticulateFiltrationEfficiencyASTM F2299 | Particle filtrationefficiency at 0.1micron(%) >98 % | Particle filtrationefficiency at 0.1micron (%) >98 % | Pass |
| BacterialFiltrationEfficiencyASTM F2101 | >98 % | >98 % | Pass |
| DifferentialPressure(Delta P)EN14683:2019+AC:2019Annex C | Differentialpressure ≤ 6.0mmH2O/cm² | Differentialpressure ≤ 6.0mmH2O/cm² | Pass |
| Flammability16 CFR 1610 | Class 1 | Class 1 | Pass |
Table 2 - Performance Testing
Table 3 - Biocompatibility Testing
| Item | Subject Device | Result |
|---|---|---|
| CytotoxicityISO 10993-5 | Under the conditions of the study, the device is non-cytotoxic. | Pass |
| IrritationISO 10993-10 | Under the conditions of the study, the device is non-irritating. | Pass |
| SensitizationISO 10993-10 | Under the conditions of the study, the device is non-sensitizing | Pass |
8.0 Clinical Test Conclusion
No clinical study is included in this submission.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device in K201479.
§ 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.