(88 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 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 proposed devices are three-layer, flat pleated masks. A Surgical Face Mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric. The model of proposed device, ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are knitted elastic loops (made of polyester and spandex). The nose piece is in the layers of face mask to allow the user to fit the face mask around their nose, which is a steel wire with polyethylene covering. The proposed devices are provided non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) Premarket Notification for a Surgical Face Mask. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing, rather than a clinical study establishing efficacy with defined acceptance criteria for AI/ML performance.
Therefore, the information requested in the prompt regarding AI/ML device acceptance criteria, study design (test set, ground truth, experts, MRMC studies), and training set details cannot be found in this document. This document is for a physical medical device (surgical face mask) and not an AI/ML powered device.
However, I can provide the acceptance criteria and study information for the physical properties and biocompatibility of the surgical face mask, which are the main performance aspects evaluated in this 510(k) submission.
Here's the information based on the document provided, re-interpreting "acceptance criteria" and "study" in the context of a physical device:
Acceptance Criteria and Study for the Surgical Face Mask (Physical Device)
The device being evaluated is a Surgical Face Mask, for which the performance is assessed based on physical properties and biocompatibility, specified by recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Standard & Level) | Reported Device Performance |
|---|---|---|
| Fluid Resistance | Meet ASTM F1862 (Pass) | Pass |
| Particulate Filtration Efficiency (PFE) | Meet ASTM F2299 (Pass) | Pass |
| Bacterial Filtration Efficiency (BFE) | Meet ASTM F2101 (Pass) | Pass |
| Differential Pressure (Delta P) | Meet EN 14683 Annex C (method specified in ASTM F2100-19) (Pass) | Pass |
| Flammability | Class 1 (16 CFR Part 1610) | Class 1 |
| In Vitro Cytotoxicity | Non-cytotoxic (ISO 10993-5) | Non-cytotoxic |
| Skin Irritation | Non-irritating (ISO 10993-10) | Non-irritating |
| Skin Sensitization | Non-sensitizing (ISO 10993-10) | Non-sensitizing |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the numerical sample size for each performance test (e.g., how many masks were tested for BFE). It generally states that "the following performance tests have been conducted to demonstrate the effectiveness of device."
- Data Provenance: The tests were conducted on the "proposed device" (Guangdong Winsun Personal Care Products Co.,Ltd's Surgical Face Mask). The location where the testing was performed is not specified, but the applicant and contact persons are based in China. The data is retrospective in the sense that it was collected prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the "ground truth" for a physical device like a surgical mask is established by validated laboratory test methods performed according to international standards (e.g., ASTM, EN, ISO, CFR). It does not involve human expert consensus or adjudication in the way an AI/ML diagnostic device's ground truth would. The "experts" are the qualified laboratory personnel performing the standardized tests.
4. Adjudication method for the test set
- Not applicable. Performance is determined directly by objective measurements from standardized tests, not by human adjudication of interpretations.
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 document is for a physical medical device (surgical face mask), not an AI/ML product. Therefore, no MRMC study, human readers, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device's performance is defined by established international and national standards for physical and chemical properties (e.g., ASTM F2100-19, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR Part 1610, ISO 10993-5/10). Compliance with these standards through laboratory testing serves as the basis for demonstrating performance and safety.
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. As there is no training set for a physical device, no ground truth was established in this context.
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April 2, 2021
Guangdong Winsun Personal Care Products Co.,Ltd % Grace Liu Consultant Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K210023
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 28, 2020 Received: January 4, 2021
Dear Grace Liu:
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 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 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) K210023
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 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
1. Contact Details
1.1 Applicant information
| Applicant Name | Guangdong Winsun Personal Care Products Co.,Ltd |
|---|---|
| Address | No.1 Guangxing Road, Xiqiao Sci-Tec Industrial Park, XiqiaoTown, Nanhai District, Foshan City, Guangdong Province,P.R.China |
| Contact person | Dong Pingping |
| Phone No. | +86-139 2990 4428 |
| dongpingping@gdwinsun.cn | |
| Date Prepared | 2020-12-12 |
1.2 Submission Correspondent
| Shenzhen Joyantech Consulting Co., Ltd1713A, 17th Floor, Block A, Zhongguan Times Square,Nanshan District, Shenzhen, Guangdong Province, China | |
|---|---|
| 卓远天成 | |
| Phone No. | +86-755-86069197 |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | grace@cefda.com; field@cefda.com |
| Website | http://www.cefda.com |
2. Device Information
| Trade name | Surgical Face Mask |
|---|---|
| Common name | Surgical Face Mask |
| Model | YS0002 |
| Classification name | Mask, Surgical |
| Review Panel | General Hospital |
| Product code | FXX |
| Device Class | II |
| Regulation No. | 21 CFR 878.4040 |
3. Legally Marketed Predicate Device
| Trade Name | Surgical Face Mask, Ear Loops, Model101B, 101G, 136B, 136G, 137B, 137G |
|---|---|
| ------------ | ---------------------------------------------------------------------------- |
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| Surgical Face Mask, Tie-on, Model145B, 145G, 143B, 143G, 138B, 138G, 142B, 142G, 151B,151G | |
|---|---|
| 510(k) Number | K133070 |
| Product Code | FXX |
| Manufacturer | BH Medical Products Co., Ltd. |
4. Device Description
The proposed devices are three-layer, flat pleated masks. A Surgical Face Mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric.
The model of proposed device, ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are knitted elastic loops (made of polyester and spandex).
The nose piece is in the layers of face mask to allow the user to fit the face mask around their nose, which is a steel wire with polyethylene covering.
The proposed devices are provided non-sterile and are intended to be single use, disposable devices.
5. Intended Use/Indication 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(s), provided non-sterile.
6. Substantial Equivalence Comparison
| Comparisonitem | Proposed Device | Predicate Device (K133070) | Comment |
|---|---|---|---|
| Manufacturer | Guangdong Winsun PersonalCare Products Co., Ltd | BH Medical Products Co., Ltd. | None |
| Product name | Surgical Face Mask | Surgical Face Mask, Ear Loops,Model101B, 101G, 136B, 136G, 137B,137GSurgical Face Mask, Tie-on, Model145B, 145G, 143B, 143G, 138B,138G, 142B, 142G, 151B, 151G | None |
| Product Code | FXX | FXX | Same |
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| RegulationNumber | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same | ||
|---|---|---|---|---|---|
| Classification | Class II | Class II | Same | ||
| OTC use | Yes | Yes | Same | ||
| Indications forUse | The Surgical Face Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material. Thesemasks are intended for use ininfection control practices toreduce the potential exposureto blood and body fluids. Thisis a single use ,disposabledevice(s), provided non-sterile. | The surgical face masks areintended to be worn to protect boththe patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. Thesefacemasks are intended for use ininfection control practices to reducethe potential exposure to blood andbody fluids. This is a single use,disposable device(s), provided nonsterile. | Same | ||
| Design feature | Ear-loop | Ear-loop/Tie-on | Similar | ||
| Mask style | 3 flat pleated | 3 flat pleated | Same | ||
| Single use | Yes | Yes | Same | ||
| Color | Blue | Blue, Green | Similar | ||
| Specificationsanddimensions | $(17.5±1)cm×(9.5±0.5)cm$$(6.9" ±0.39") × (3.7" ±0.20")$ | $(6.8"±0.25")×(3.5"±0.25")$$(6.8"±0.25")×(4.2"±0.25")$ | Similar | ||
| Sterility | Non-sterile | Non-sterile | Same | ||
| Materials | Outerlayer | Spunbond Polypropylene | Spunbond Polypropylene | Same | |
| Middlelayer | Meltblown Polypropylene | Meltblown Polypropylene | Same | ||
| Innerlayer | Spunbond Polypropylene | Spunbond Polypropylene | Same | ||
| Nosepiece | Steel wire with polyethylenecovering | Aluminum wire | Different(Issue 1) | ||
| Earloop | Polyester and spandex | Polyester | Different(Issue 2) | ||
| ASTM F2100Level | Level 1 | Level 2 | Level 3 | Same | |
| FluidResistance | Meet ASTM F1862 | Meet ASTM F1862-07 | Same | ||
| Particulate | Meet ASTM F2299 | Meet ASTM F2299-03 | Same |
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| FiltrationEfficiency | |||
|---|---|---|---|
| BacterialFiltrationEfficiency | Meet ASTM F2101 | Meet ASTM F2101-07 | Same |
| DifferentialPressure(Delta P) | Meet EN 14683 | Meet MIL-M-36954C | Different(Issue 3) |
| Flammability(16CFR 1610) | Class 1 | Class 1 | Same |
| Biocompatibilityy | Non-cytotoxic, non-sensitizing,non-irritating | Non-cytotoxic, Non-sensitizer,non-irritant | Same |
lssue 1 and Issue 2: The differences in the materials do not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials.
lssue 3: The Differential Pressure test of the proposed device was conducted in accordance with the method specified in EN 14683:2019, Annex C that is the test method specified in ASTM F2100-19. ASTM F2100-19 is the recognized consensus standard [Rec# 6-425] which is the standard specification for performance of materials used in medical face masks. And the Differential Pressure performance of the proposed device meets the requirement of ASTM F2100-19.
7. Non-clinical Testing
7.1 Physical performance testing
The performances of Surgical Face Mask conform to ASTM F 2100-19 and the following performance tests have been conducted to demonstrate the effectiveness of device.
-
Bacterial filtration efficiency (BFE): pass (ASTM F2101)
- A Particulate filtration efficiency (PFE): pass (ASTM F2299)
- A Differential pressure (Delta-P): pass (EN 14683)
- Fluid Resistance: pass (ASTM F1862) A
-
Flammability: Class 1 (16 CFR Part 1610)
7.2 Biocompatibility testing
Surgical Face Mask has been subjected to biocompatibility studies to demonstrate the safety according to ISO 10993-1, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process". The following tests have been conducted.
- A In Vitro Cytotoxicity (ISO 10993-5): non-cytotoxic;
-
Skin Irritation (ISO 10993-10): non-irritating;
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Skin Sensitization (ISO 10993-10): non-sensitizing. >
There is no additional safety risk for the proposed device when compared with the predicate device.
8. Clinical testing
Clinical testing was not performed for the proposed device.
9. Conclusion
Indications for Use, material, design feature, specifications and technological characteristics for the proposed device are similar to the predicate device (K133070). The non-clinical performance testing demonstrates that the proposed device is substantially equivalent to the legally marketed predicate device (K133070). Therefore, the results show that it is Substantially Equivalent (SE) between the proposed device and the predicate 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.