(166 days)
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 surgical 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 single use, flat-pleated masks that are provided in blue. The Medical Surgical Mask is available in two types, which are Level 3 based on ASTM F2100-19. The inner and outer layers of the mask are made of polypropylene non-woven fabric, the middle layer is made of polypropylene meltblown fabric, and the nose clip is made of polypropylene and iron wire. Users can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops are made of spandex. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the mask. This is a single use, disposable device(s), provided non-sterile.
The provided document is a 510(k) premarket notification for a Medical Surgical Mask. It details the device's characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device.
However, the request asks for information regarding an AI/Software as a Medical Device (SaMD) study, specifically about acceptance criteria, ground truth establishment, sample sizes for training and testing, expert qualifications, and potential MRMC studies.
The provided document is NOT for an AI/SaMD device. It is for a physical medical device (a surgical mask) and therefore does not contain any of the information requested about AI/SaMD acceptance criteria or study methodologies.
Therefore, I cannot fulfill the request using the provided text. The document discusses:
- Acceptance Criteria (for a physical surgical mask): These are performance standards like Bacterial Filtration Efficiency (BFE), Differential Pressure, Sub-micron Particulate Filtration Efficiency, Resistance to Penetration by Synthetic Blood, and Flame Spread, as well as Biocompatibility.
- Device Performance: The document states "Passed" for all the listed performance tests against the specified acceptance criteria for Level 2 and Level 3 masks.
- Study That Proves the Device Meets Acceptance Criteria: This is the "Non-Clinical Test Conclusion" section (pages 4-5), where various physical and biological tests were performed according to recognized standards (e.g., ASTM F2101, EN14683, ASTM F1862, 16CFR Part 1610, ISO 10993).
To explicitly address the numbered points in the prompt based on the provided document (even though it's not an AI/SaMD):
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A table of acceptance criteria and the reported device performance:
Performance Testing Purpose Acceptance Criteria for Level 2 Barrier Acceptance Criteria for Level 3 Barrier Result Bacterial Filtration Efficiency ASTM F2101 Measure bacterial filtration efficiency ≥98% ≥98% Passed Differential Pressure (mm H2O/cm2) Determine breathability of a mask <6.0 H2O/cm² <6.0 H2O/cm² Passed Sub-micron Particulate Filtration Efficiency ASTM F2299/F2299M-03 Measure initial particle filtration efficiency ≥98% ≥98% Passed Resistance to Penetration by Synthetic Blood ASTM F1862/F1862M-2017 Evaluate the resistance to penetration by impact of small volume of synthetic blood 120 mmHg 160 mmHg Passed Flame spread 16CFR Part 1610-2008 Response of materials to heat and flame Class I Class I Passed Biocompatibility Acceptance Criteria and Results:
Biocompatibility Evaluation Biological Effect Standard Results Cytotoxicity ISO 10993-5 Not cytotoxic Sensitization ISO 10993-10 Non sensitizing Irritation ISO 10993-10 Negligibly irritating -
Sample sizes used for the test set and the data provenance: The document does not specify the sample sizes used for each of the non-clinical tests (e.g., how many masks were tested for BFE). It also does not specify the country of origin of the data or whether the testing was retrospective or prospective, though it implicitly describes a prospective testing process for compliance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable to the type of device. The "ground truth" for a surgical mask's performance is established by standardized test methodologies and equipment, not human expert consensus.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical performance testing of a physical device.
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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 device is not an AI/SaMD, so no MRMC study or AI assistance is relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI/SaMD.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is determined by adherence to established, quantitative non-clinical testing standards and their respective measurement methods. For biocompatibility, it's based on biological responses in standardized in-vitro and in-vivo tests according to ISO 10993.
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The sample size for the training set: Not applicable. There is no AI/ML model for this physical device that would require a "training set."
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How the ground truth for the training set was established: Not applicable.
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January 4, 2022
Wepon Medical Technology Co., Ltd. Yongxian Sun Manager Representative West side of North Baizhang Road, Chengdong Street Wenling, Zhejiang 317500 China
Re: K212299
Trade/Device Name: Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 21, 2021 Received: December 2, 2022
Dear Yongxian Sun:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 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, PhD 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) K212299
Device Name Medical Surgical Mask
Indications for Use (Describe)
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 surgical 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 CFR 801 Subpart C) |
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510(k) Summary K212299
I Submitter
- Device submitter: Wepon Medical Technology Co., Ltd. West side of North Baizhang Road, Chengdong Street, Wenling City, Zhejiang Province, China
- Contact person: Yongxian Sun Management Representative Phone: +86 13586268021 E-mail: syx@wepon.cc
II Proposed Device
| 510(k) Number: | K212299 |
|---|---|
| Trade/Device Name: | Medical Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Name: | Surgical Apparel |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel: | General Hospital |
III Predicate Devices
| 510(k) Number: | K210030 |
|---|---|
| Trade/Device Name: | Medical Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Name: | Surgical Apparel |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer: | Tianjin Aoshang Outdoor Equipment Co., Ltd. |
IV Device description
The Medical Surgical Mask is single use, flat-pleated masks that are provided in blue. The Medical Surgical Mask is available in two types, which are Level 3 based on ASTM F2100-19.
The inner and outer layers of the mask are made of polypropylene non-woven fabric, the middle layer is made of polypropylene meltblown fabric, and the nose clip is made of polypropylene and iron wire. Users can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops are made of spandex. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the mask.
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This is a single use, disposable device(s), provided non-sterile.
V Indication for use
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 surgical 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.
VI Non-Clinical Test Conclusion
The Medical Surgical Mask was tested in accordance with the tests recommended in the FDA guidance document, Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submission issued March of 2004. Based upon the guidance document the following testing has been performed.
| Performance Testing | ||||
|---|---|---|---|---|
| Test Methodology | Purpose | Acceptance Criteria forLevel 2 Barrier | Acceptance Criteria forLevel 3 Barrier | Result |
| Bacterial FiltrationEfficiency ASTMF2101 | Measure bacterialfiltration efficiency | ≥98% | ≥98% | Passed |
| Differential Pressure(mm H2O/cm2)EN14683:2019 Annex C | Determinebreathability of amask | <6.0 H2O/cm² | <6.0 H2O/cm² | Passed |
| Sub-micron ParticulateFiltration EfficiencyASTM F2299/F2299M-03 | Measure initialparticlefiltration efficiency | ≥98% | ≥98% | Passed |
| Resistance toPenetration by SyntheticBlood ASTM F1862/F1862M-2017 | Evaluate theresistance topenetration byimpact of smallvolume of syntheticblood | 120 mmHg | 160 mmHg | Passed |
| Flame spread 16CFRPart 1610-2008 | Response ofmaterials to heat andflame | Class I | Class I | Passed |
Biocompatibility Testing
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The biocompatibility evaluation for the Medical Surgical Mask was conducted in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The Medical Surgical Mask is classified as a surface contacting device. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2018 Annex A.
| Biocompatibility Evaluation | ||||
|---|---|---|---|---|
| Biological Effect | Standard | Results | ||
| 1 | Cytotoxicity | ISO 10993-5 | Not cytotoxic | Passed |
| 2 | Sensitization | ISO 10993-10 | Non sensitizing | Passed |
| 3 | Irritation | ISO 10993-10 | Negligibly irritating | Passed |
VII Clinical Test Conclusion
No clinical study is included in this submission.
VIII Summary of Technological characteristics
Table 1 Comparison of Medical Surgical Mask
| Item | Subject device | Predicate device(K210030) | Discussion | |
|---|---|---|---|---|
| Product name | Medical Surgical Mask | Medical Surgical Mask | NA | |
| Product Code | FXX | FXX | identical | |
| Intended use | The Medical Surgical Mask isintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material. Thesesurgical masks are intendedfor use in infection controlpractices to reduce thepotential exposure to bloodand body fluids. This is asingle use, disposabledevice(s), providednon-sterile. | The Medical Surgical Masksare intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These surgical masksare intended for use ininfection control practices toreduce the potential exposureto blood and body fluids. Thisis a single use, disposabledevice(s), provided non-sterile. | identical | |
| Mask style | Flat-pleated | Flat-pleated | identical | |
| ASTM F2100 Level | Level 2 and Level 3 | Level 2 and Level 3 | identical | |
| Design feature | Level 2: Ear loop | Level 2: Ear loop | identical | |
| Level 3: Ear loop | Level 3: Ear loop and Tie-on | |||
| Color | Blue | Blue | identical | |
| Dimension | 17.5cmx9.5cm | 17.5cmx9.5cm | identical | |
| Sterility | Non-Sterile | Non-Sterile | identical | |
| Use | Single Use, Disposable | Single Use, Disposable | identical | |
| Particulatefiltrationefficiency | Level 2 and Level 3: average 99.96% | Level 2 mask: average 99.71%Level 3 mask: average 99.93% | different | |
| Bacterial filtrationefficiency | Level 2 and Level 3: average99.9% | Level 2 mask: average 99.7%Level 3 mask: average 99.9% | different | |
| Differential pressure | Level 2 and Level 3: average$2.8 mmH_2O/cm_2$ | Level 2 mask: average$2.8mmH_2O/cm_2$ | different | |
| Level 3 mask: average 4.0 | ||||
| $mmH_2O/cm_2$ | ||||
| EN 14683 | ||||
| Flammability | Class 1 | Class 1 | identical | |
| Fluid resistance | Level 2: Pass at 120mmHgLevel 3: Pass at 160mmHg | Level 2: Pass at 120mmHgLevel 3: Pass at 160mmHg | identical | |
| Label/Labeling | Complied with 21 CFR part801 | Complied with 21 CFR part801 | identical | |
| Patient Contacting Material | Outer facinglayer | polypropylene non-wovenfabric | Spunbond Polypropylene | Different |
| Middle layer | polypropylene meltblownfabric | Meltblown PolypropyleneFilter | ||
| Inner facinglayer | polypropylene non-wovenfabric | Spunbond Polypropylene | ||
| Nose clip | polypropylene and iron wire | PE and Iron | ||
| Ear loops | spandex | Spandex | ||
| Biocompatibility | ISO 10993-5 and ISO10993-10;Under the conditions of thestudy, the proposed deviceextract was determined to benon-cytotoxic, non-sensitizing,and non-irritating. | |||
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Different - Particulate filtration efficiency
The test result for particulate filtration efficiency for the proposed device is different from the two predicate devices. However, the test result for the proposed device can meet the requirements of level 2 mask and Level 3 mask. Thus, this difference will not affect the safety and effectiveness between the
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proposed device and the two predicate devices.
Different - Bacterial filtration efficiency
The test result for bacterial filtration efficiency for the proposed device is different from the two predicate devices. However, the test result for the proposed device can meet the requirements of level 2 mask and Level 3 mask. Thus, this difference will not affect the safety and effectiveness between the proposed device and the two predicate devices.
Different - Differential pressure
The test result for differential pressure for the proposed device is different from the two predicate devices. However, the test result for the proposed device can meet the requirements of level 3 mask based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness between the proposed device and the two predicate devices.
Different - Patient Contacting Material
The patient contacting material for the proposed device is different from the two predicate devices. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect. Thus, this difference will not affectiveness between the proposed device and the two predicate devices.
IX Conclusion
The proposed device has the same the intended use as the predicate device. It presents similar technological characteristics as the predicate device including the performance parameters and biocompatibility. The non-clinical testing demonstrates that the device is as effective and performs as well as the legally marketed device.
§ 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.