(189 days)
The 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 mask 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, provided non-sterile.
The proposed devices are single use, three-layer, flat masks with ear loops and nose piece. The Surgical Face Masks are 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 proposed device, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene with steel wire. The colorants used for mask are Copper phthalocyanine, Titanium dioxide and Polyethylene. The proposed devices are sold non-sterile and are intended to be single use, disposable devices. The proposed device including two models, WXDKZ0001 and WXDKZ0006, the difference is the color of the outer layer.
The provided text is a 510(k) summary for a Surgical Face Mask and focuses on demonstrating substantial equivalence to a predicate device based on non-clinical bench testing and biocompatibility assessments, not on studies involving AI/ML models or human readers.
Therefore, I cannot extract the information required by your prompt regarding acceptance criteria and studies proving an AI/ML device's performance, as the document describes a traditional medical device (face mask).
The prompt's questions pertain to:
- AI/ML model acceptance criteria and performance.
- Sample sizes for test and training sets (implying data used for model development/validation).
- Expert ground truth establishment and adjudication (relevant for medical imaging AI).
- MRMC studies (relevant for AI-assisted human performance).
- Standalone AI performance.
- Type of ground truth (pathology, outcomes data, etc.).
None of these concepts are discussed in the provided text, which details the physical and material characteristics, intended use, and performance standards (e.g., fluid resistance, filtration efficiency, flammability, biocompatibility) of a surgical face mask.
The document explicitly states:
- "No clinical tests were performed" (Section 9).
- The tests mentioned are "Bench testing" and "Biocompatibility testing" of the physical mask.
To accurately answer your request, you would need a document describing the regulatory submission for an AI/ML-driven medical device.
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March 10, 2021
Wanxinda (Guangzhou) Technology Product Co., Ltd % Joyce No Last Name Provided Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518100 China
Re: K202548
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 13, 2020 Received: September 2, 2020
Dear Joyce No Last Name Provided:
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 (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 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 Ryan Ortega, PhD 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) K202548
Device Name Surgical Face Mask
Indications for Use (Describe)
The 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 mask 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, 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
Submission Number: K202548
Date of Summary revised: March 10, 2021
1. Submission Sponsor
| Applicant Name | Wanxinda(Guangzhou)Technology ProductCo., Ltd. |
|---|---|
| Address | Ling Xi Road, Accessory Section 2, AutomobileZone,Huadu District, Guangzhou, Guangdong,China. |
| Contact person | Zeng Xueping |
| Phone | 86-020-61816666 |
2. Submission correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | 1713A, 17th Floor, Block A, Zhongguan TimesSquare, Nanshan District, Shenzhen |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Joyce Yang |
| joyce@cefda.com |
3. Device Identification
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Surgical Face Mask |
| Model: | WXDKZ0001, WXDKZ0006 |
| Classification name: | Mask, Surgical |
| Review Panel: | Surgical Apparel |
| Product Code: | FXX |
| Common name: | Surgical face mask |
| Device Class: | II |
| Regulation Number: | 878.4040 |
4. Legally Marketed Predicate Device
| Trade Name | Surgical Face Mask |
|---|---|
| Regulation number | 878.4040 |
| Regulation class | II |
| Regulation name | Surgical Apparel |
| 510(k) Number | K133070 |
| Product Code | FXX |
| Manufacturer | BH Medical Products Co.,Ltd. |
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Device Description 5.
The proposed devices are single use, three-layer, flat masks with ear loops and nose piece. The Surgical Face Masks are 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 proposed device, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene with steel wire.
The colorants used for mask are Copper phthalocyanine, Titanium dioxide and Polyethylene. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
The proposed device including two models, WXDKZ0001 and WXDKZ0006, the difference is the color of the outer layer.
| Model | Color | Performance Level |
|---|---|---|
| WXDKZ0001 | White | Level 2 |
| WXDKZ0006 | Blue | Level 2 |
6. Intended Use/ Indications for Use
The 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 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, provided non-sterile.
7. Summary of Technological Characteristics
| Comparisonitem | Subject Device(K202548) | Predicate Device(K133070) | Comments |
|---|---|---|---|
| ProductCode | FXX | FXX | Same |
| RegulationNumber | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classification | Class II | Class II | Same |
| OTC use | Yes | Yes | Same |
| Intendeduse &Indications for Use | The Surgical Face Masks areintended to be worn to protect boththe patient and healthcare | The Disposable SurgicalMasks are intended to beworn to protect both the | Same |
| Comparisonitem | Subject Device(K202548) | Predicate Device(K133070) | Comments |
| personnel from transfer of | patient and healthcare | ||
| microorganisms, body fluids and | personnel from transfer of | ||
| particulate material. These mask | microorganisms, body | ||
| are intended for use in infection | fluids and particulate | ||
| control practices to reduce the | material. These face mask | ||
| potential exposure to blood and | are intended for use in | ||
| body fluids. This is a single | infection control practices | ||
| use ,disposable device, provided | to reduce the potential | ||
| non-sterile. | exposure to blood and body | ||
| Designfeature | Ear-loop | Ear-loop, Tie-on | Same |
| Usage | Single use | Single use | Same |
| Color | White, Blue | Blue, Green | Different(Issue 1) |
| Size | Width:175mm±5% | Width:6.5"+/-0.25"Length:3.5"+/-0.25"4.2"+/-0.25" | Same |
| Length: 95mm±5% | |||
| The length of nose piece: 100mm±5mm | |||
| The length of ear loop: 190mm±5mm | |||
| Sterile | Non-sterile | Non-sterile | Same |
| Material | Outer layer: polypropylene non-woven | Outer layer: Spun-bondpolypropylene | Same |
| Middle layer: Melt blown fabric | Middle layer: Melt blownpolypropylene | Same | |
| Inner layer: polypropylene non-woven | Inner layer:Spun-bondpolypropylene | Same | |
| Nose piece: PP+Steel wire | Nose piece: Aluminum wire | Different(Issue 2) | |
| Ear-loops: Spandex | Ear-loops:Polyester | Different(Issue 3) | |
| Comparisonitem | Subject Device(K202548) | Predicate Device(K133070) | Comments |
| ASTM F2100 Level | Level 2 | Level 1, Level 2, Level 3 | Same |
| FluidResistancePerformanceASTM F1862-13 | 32 out of 32 pass at 120mmHg | Level 1: 32 out of 32 passat 80mmHgLevel 2: 32 out of 32 passat 120mmHgLevel 3: 32 out of 32 passat 160mmHg | Same |
| ParticulateFiltrationEfficiencyASTM F2299 | 99.8% | Level 1: > 95%Level 2: > 98%Level 3: > 98% | Same |
| BacterialFiltrationEfficiencyASTM F2101 | 99.8% | Level 1: >95%Level 2: > 98%Level 3: > 98% | Same |
| DifferentialPressure(Delta P) EN14683:2019+AC : 2019 | 4.0 mm H2O/cm² | Level 1: < 5 mm H2O/cm²Level 2: < 6 mmH2O/cm²Level 3: < 6 mm H2O/cm² | Same |
| Flammability16CFR 1610 | Class 1 | Class 1 | Same |
| Cytotoxicity | Under the conditions of the studythe subject device was found non-cytotoxic | Under the conditions of thestudy the subject devicewas found non-cytotoxic | Same |
| Irritation | Under the conditions of the studythe subject device was found non-irritating | Under the conditions of thestudy the subject devicewas found non- irritating | Same |
| Sensitization | Under the conditions of the studythe subject device was found non-sensitizing | Under the conditions of thestudy the subject devicewas found non-sensitizing | Same |
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Issue 1: The color master batch of proposed device outer layer is different from the predicate device. This difference will not affect the performance of the mask. Moreover, the proposed product has been tested for biocompatibility and has no potential toxicity or irritation.
lssue 2: The nose piece of the proposed device is made polypropylene with steel wire, which of the predicate device is made by Malleable aluminum wire. The Nose piece is between the inner and outer layers of the mask, which does not contact with the human body directly when used. Moreover, the whole product has been tested for biocompatibility, and the test results confirm that they have good biocompatibility, so their differences will not cause new safety risks.
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lssue 3: The Ear-loops of the proposed device are made by spandex, which of the predicate device is made by polyester. The major chemical composition of the spandex is segmented polyurethane-urea, which is similar to polyester. In addition, the proposed devices have been tested for biocompatibility, and the test results confirm that they have good biocompatibility, so their differences will not cause new safety risks.
8. Non-clinical Testing
Surgical Face Mask conforms to the following standards:
ASTM F 2100-19, Standard Specification for Performance of Materials Use in Medical Face Masks.
ISO 10993-1:2018, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process.
Bench testing
The bench testing of Surgical Face Mask include the following tests:
*Fluid Resistance Performance
*Particulate Filtration Efficiency
*Bacterial Filtration Efficiency
*Differential Pressure
*Flammability
Biocompatibility testing
The biocompatibility evaluations were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as recognized by FDA. The tests of Surgical Face Mask include the following tests:
- Cytotoxicity
-
- Sensitization
-
- Irritation
9. Brief discussion of clinical tests
No clinical tests were performed.
10. Conclusions
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(K) submission K202548, the Surgical Face Mask is as safe, effective, and performs as well as or better than the legally marketed predicate device cleared under K133070.
§ 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.