(266 days)
Medical Surgical 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.
Medical Surgical Masks are disposable medical masks and are made of mask body, nose clips and mask belt by ultrasonic heat sealing. The mask body is divided into three layers: inner, middle and outer layers, the inner and outer layers are Non-woven fabrics and middle layer is polypropylene melt blown cloth, nose piece is made of galvanized iron wire covered plastic materials. The mask belt is made of spandex. The mask style is flat pleated.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided FDA 510(k) summary for the "Medical Surgical Mask":
The document does not describe a clinical study in the traditional sense for evaluating the device's performance with human patients or AI assistance. Instead, it describes non-clinical performance testing (bench testing) to demonstrate that the device meets established safety and performance standards for surgical masks.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Passing Standard) | Reported Device Performance (Subject Device Tested) | Result |
|---|---|---|
| Flammability | ||
| Class 1 (16 CFR 1610) | Class 1 | Pass |
| Delta Pressure | ||
| < 5.0 mmH₂O/cm² (EN 14683:2019) | 3.4 mmH₂O/cm² | Pass |
| Fluid Resistance | ||
| 120 mmHg (level 2) (ASTM F1862) | 32 out of 32 pass at 120 mmHg (level 2) | Pass |
| Bacterial Filtration Efficacy | ||
| ≥ 98 % (ASTM F2101) | 99.80 % | Pass |
| Particulate Filtration Efficacy | ||
| ≥ 98 % (ASTM F2299) | 98.69 % | Pass |
| Biocompatibility | ||
| Not a primary skin irritant (ISO 10993-10: 2010) | Passes (not a primary skin irritant) | Pass |
| Not a primary skin sensitizer (ISO 10993-10: 2010) | Passes (not a primary skin sensitizer) | Pass |
| Not cytotoxic (ISO 10993-5: 2019) | Passes (not cytotoxic) | Pass |
The study described is a series of non-clinical, bench-top tests conducted to demonstrate that the Medical Surgical Mask meets industry standards for safety and performance.
Additional Information Not Applicable to This Device
The questions related to AI studies, multi-reader multi-case studies, and specific human expert qualifications for ground truth are not applicable to this 510(k) submission for a Medical Surgical Mask, as it is a medical device subject to bench testing for physical and biological characteristics, not an AI-powered diagnostic or assistive tool.
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Sample size used for the test set and the data provenance:
- Sample Size: The document specifies "32 out of 32 pass" for fluid resistance, indicating a sample size of 32 masks for that particular test. For other tests like flammability, delta pressure, bacterial filtration, particulate filtration, and biocompatibility, specific sample sizes are not explicitly stated in this summary, but are typically defined by the referenced ASTM and ISO standards for such tests.
- Data Provenance: The origin of the data is from non-clinical laboratory testing (bench testing) performed on the "subject device." The location of the testing facility is not specified, but the applicant company is located in Hangzhou, China. These are laboratory results, not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a medical surgical mask, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM, ISO, CFR) for performance and safety characteristics. These standards have defined methodologies and acceptance criteria. Experts are involved in setting these standards and performing the tests, but it's not and "expert consensus" in the way it would be for an AI diagnostic.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 are used for human interpretation of medical images or data where a consensus is needed among experts. For the physical and biological performance tests of a surgical mask, the results are objectively measured according to standardized protocols, thus no expert adjudication in this sense is required.
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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:
- No. This is not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI-powered device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on pre-defined, objective performance metrics and safety thresholds established by regulatory bodies and consensus standards (ASTM F2100, EN 14683, 16 CFR 1610, ISO 10993). It is not derived from clinical outcomes, pathology, or expert consensus on a diagnostic interpretation.
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The sample size for the training set:
- Not Applicable. This device is not an AI/ML algorithm that requires training data.
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How the ground truth for the training set was established:
- Not Applicable. This device is not an AI/ML algorithm.
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March 15, 2021
Hangzhou Mycode Bio-Medicine Co., Ltd. Alice Gong Manager Floor 4, Building No. 4, No. 2 Xiyuansi Road, Xihu District Hangzhou, Zhejiang 310030 China
Re: K201698
Trade/Device Name: Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 5, 2021 Received: February 10, 2021
Dear Alice Gong:
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 Ryan Ortega Ph. D Acting 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)
Device Name Medical Surgical Mask
Indications for Use (Describe)
Medical Surgical 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.
| 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 K201698
| 1.0 Submitter: | |
|---|---|
| Submitter's name: | Hangzhou Mycode Bio-Medicine Co., Ltd. |
| Submitter's address: | Floor 4, Building No. 4, No. 2 Xiyuansi Road, Xihu District,Hangzhou, China |
| Phone number: | 86-571-87329869 |
| Name of contact person: | Ms. Alice Gong |
| Summary PreparationDate: | Feb. 5, 2021 |
| Summary Revision: | Rev. 2 |
| 2.0 Name of the Device | |
| Proprietary/Trade name: | Medical Surgical Mask |
| Common Name: | Surgical Mask |
| 510(k) Number: | K201698 |
| Classification Name: | Mask, Surgical |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 878.4040 |
| Product Code: | FXX |
| 3.0 Predicate device | |
| Device Name: | SURGICAL FACE MASK |
| Company name: | Wuhan Dymex Healthcare Co., Ltd |
| 510(K) Number: | K182515 |
4.0 Device Description
Medical Surgical Masks are disposable medical masks and are made of mask body, nose clips and mask belt by ultrasonic heat sealing. The mask body is divided into three layers: inner, middle and outer layers, the inner and outer layers are Non-woven fabrics and middle layer is polypropylene melt blown cloth, nose piece is made of galvanized iron wire covered plastic materials. The mask belt is made of spandex. The mask style is flat pleated.
5.0 Indications for Use
Medical Surgical 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.
6.0 Summary of the Technological Characteristics of the Device:
Provided below is a comparison of the subject device to the predicate device.
| DeviceCharacteristic | Subject Device | Predicate Device | Comparison(Same,similar,different) |
|---|---|---|---|
| Product name | Medical Surgical Mask | SURGICAL FACE MASK | N/A |
| 510(K) No. | K201698 | K182515 | N/A |
| Product Owner | Hangzhou Mycode Bio-Medicine Co., Ltd. | Wuhan Dymex Healthcare Co., Ltd | N/A |
| Product Code | FXX | FXX | Same |
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| Regulation | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
|---|---|---|---|
| Class | Class II | Class II | Same |
| Indications for Use | Medical Surgical Masks are intended to beworn to protect both the patient andhealthcare personnel from transfer ofmicroorganisms, body fluids and particulatematerial. These face masks are intended foruse in infection control practices to reducethe potential exposure to blood and bodyfluids. This is a single use, disposabledevice(s), provided non-sterile. | The Surgical Face Masks are intended to beworn to protect both the patient andhealthcare personnel from transfer ofmicroorganisms, body fluids and particulatematerial. These face masks are intended foruse in infection control practices to reducethe potential exposure to blood and bodyfluids. This is a single use, disposabledevice(s), provided non-sterile. | Same |
| Color | White | Yellow | Different |
| Single Use | Single Use, Disposable | Single Use, Disposable | Same |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Dimensions-Length | 17.5cm±5% | 17.5cm±0.2cm | Similar |
| Dimensions-Width | 9.5cm±5% | 9.5cm±0.2cm | Similar |
| Ear loops | Yes, Spandex | Yes, Spandex | Similar |
| ParticulateFiltrationEfficiency(ASTM F2299) | 98.69 % | 99.7% | Similar |
| Fluid resistance(ASTM F1862) | 32 out 32 passat 120 mmHg (level 2) | 32 out of 32 pass at 120mmHg | Same |
| Bacterial Filtrationefficiency(ASTM F2101) | 99.80 % | 99.9% | Similar |
| Flammability(16 CFR 1610) | Class 1 | Class 1 | Same |
| Delta-Pressure(EN14683:2019) | 3.4 mmH2O/cm² | 4.0mmH2O/cm² | Similar |
| BiocompatibilityCytotoxicity (ISO10993-5:2019)Skin Irritation(ISO 10993-10:2010)Skin sensitization | All items passed | All items passed | Same |
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7.0 Summary of f Non-Clinical Performance Data:
The following bench testing was conducted to demonstrate that the subject device met the acceptance criteria for the relevant standard for this device.
| Summary of Non-clinical Testing | |||
|---|---|---|---|
| Name of the standardCharacteristic tested | Subject device tested perASTM F-2100 | Passing Standardacceptance criteria | Result |
| Flammability(16 CFR 1610) | Class 1 | Class 1 | Pass |
| Delta Pressure(EN 14683:2019) | $3.4 \text{ mmH}_2\text{O/cm}^2$ | $< 5.0 \text{ mmH}_2\text{O/cm}^2$ | Pass |
| Fluid Resistance(Provide the number ofmasks that pass thetest)(ASTM F1862) | 32 out 32 passat 120 mmHg level 2 | 120 mmHg (level 2) | Pass |
| Bacterial filtrationefficacy(ASTM F2101) | 99.80 % | ≥ 98 % | Pass |
| Particulate filtrationefficacy(ASTM F2299) | 98.69 % | ≥ 98 % | Pass |
| Biocompatibility | Primary Skin Irritation in rabbitsISO 10993-10: 2010 | PassesUnder the conditions of the study, thesubject device is not a primary skin irritant. | Passes |
| Dermal sensitization in the guinea pigISO 10993-10: 2010 | PassesUnder the conditions of the study, thesubject device is not a primary skin sensitizer. | Passes | |
| In vitro cytotoxicity accordance withISO 10993-5: 2019 | PassesUnder the conditions of the study, thesubject device is not cytotoxic | Passes |
8.0 Clinical Performance Data:
Clinical data was not needed for the subject device.
9.0 Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K201698, the Medical Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182515
§ 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.