(129 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. This face mask is intended for use in infection control practices to reduce the potential exposure to blood fluids. This is a single-use, disposable device, provided non-sterile.
The medical surgical mask is designed and manufactured by Shenzhen Everwin Precision Technology Co, Ltd. It is non-sterile and for single use. It's a disposable device. The medical surgical mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elasticear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from steel wire.
The provided text describes a 510(k) premarket notification for a Medical Surgical Mask (K201991). This is a filing for a Class II medical device, specifically a surgical mask, and the data provided is for non-clinical performance testing rather than a study involving AI or human readers for diagnostic interpretation. Therefore, many of the requested points related to AI, human readers, ground truth establishment for AI training/testing, and MRMC studies are not applicable to this document.
However, I can extract information related to the acceptance criteria and the non-clinical performance tests conducted on the device.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria | Proposed Device Performance | Predicate Device Performance | Result |
|---|---|---|---|---|
| Biocompatibility | ||||
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Same |
| Sensitization | Non-sensitizing | Non-sensitizing | Non-sensitizing | Same |
| Skin Irritation | Non-irritating | Non-irritating | Non-irritating | Same |
| Performance Testing (ASTM F2100 Level 3) | ||||
| Flammability | Class I | Class I | Class I | Same |
| Bacterial Filtration Efficiency (BFE) | >=98% | >=98% | 98% | Same |
| Differential Pressure, mm H2O/cm2 | <6.0 H2O/cm2 mm | <6.0 H2O/cm2 mm | Pass at average 5.5 mm H2O/cm2 | Similar |
| Sub-Micron Particle Filtration Efficiency | >= 98% | >= 98% | Average 99.8% | Similar |
| Resistance to Penetration by Synthetic Blood (mmHg) | 29 out of 32 passes at 160mmHg | 29 out of 32 passes at 160mmHg | 29 out of 32 passes at 160mmHg | Same |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the non-clinical tests (e.g., how many masks were tested for BFE or flammability). It only provides the results for these tests. The data provenance is implied to be from the manufacturer's testing, based in China (Shenzhen Everwin Precision Technology Co., Ltd.). These are non-clinical lab tests, not human data, so "retrospective or prospective" doesn't strictly apply in the context of patient data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving human interpretation of medical images or patient data to establish ground truth. The "ground truth" for these tests is defined by the standardized testing methodologies (e.g., ASTM F2100 for mask performance, ISO 10993-1 for biocompatibility).
4. Adjudication method for the test set
Not applicable. This applies to cases where human experts might disagree on interpretation. For laboratory testing, the results are objectively measured according to established protocols.
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 pertains to a medical surgical mask and its physical performance and biocompatibility, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by the results of standardized laboratory testing (e.g., ASTM F2100 for performance, ISO 10993 for biocompatibility). These are objective measurements following validated protocols.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device that requires a training set.
In summary: The provided document details the non-clinical performance and biocompatibility testing of a medical surgical mask, demonstrating its substantial equivalence to a predicate device. It does not involve AI, human reader studies, or associated methodologies for AI device evaluation.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 23, 2020
Shenzhen Everwin Precision Technology Co., Ltd. % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Services Co. Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K201991
Trade/Device Name: Medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 10, 2020 Received: July 17, 2020
Dear Olivia Meng:
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-reporting-
combination-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 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 CAPT Elizabeth Claverie, M.S. 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) K201991
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. This face mask is intended for use in infection control practices to reduce the potential exposure to blood 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 K201991
1. SUBMITTER
Shenzhen Everwin Precision Technology Co., Ltd. Building 3, Third Industrial Zone, FuqiaoQiaotou, Fuyong town, Bao'an district, Shenzhen, China Phone: +86-13925511162 Fax: +86-755-27343466
| Primary Contact | Olivia Meng |
|---|---|
| Person: | Regulatory Affairs Manager |
| Guangzhou Osmunda Medical Device Technical Service | |
| Co., Ltd. | |
| Tel: (+86)-20-6231 6262 | |
| Fax: (+86) -20-8633 0253 | |
| Secondary Contact | Guoshun Shi |
| Person: | Quality System Senior Manager |
Shenzhen Everwin Precision Technology Co., Ltd. Phone: +86-13925511162 Fax: +86-755-27343466
November 23, 2020 Date prepared
-
- DEVICE
| Trade Name: | Medical Surgical Mask |
|---|---|
| Common name: | Surgical Mask |
| Model: | EWPT0005 |
| Classification name | Mask, Surgical |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | Class II |
| Product Code: | FXX |
- PREDICATEDEVICE
K160269, Surgical Face Masks (Ear loops and Tie-on)
4. DEVICE DESCRIPTION
The medical surgical mask is designed and manufactured by Shenzhen Everwin
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Precision Technology Co, Ltd. It is non-sterile and for single use. It's a disposable device. The medical surgical mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elasticear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from steel wire.
5. INDICATIONS 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. This face mask is 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.
| Comparison Item | Proposed device | Predicate device | Comparisonresult |
|---|---|---|---|
| 510k number | K201991 | K160269 | - |
| Intended Use | The medical surgical mask isintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids, andparticulate material. This facemask is intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This is asingle-use, disposable device,provided non-sterile. | The surgical face masks areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure to blood and bodyfluids. This is a single-use,disposable device,provided non-sterile. | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Design feature | Ear loop | Earloop or tie-on | Similar |
| Material of outerfacing layer | Polypropylene | Polypropylene | Same |
| Material ofmiddle layer | Melt blown polypropylene | Polypropylene meltblownandpolypropylene | Similar |
6. Summary of Technological Characteristics
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| spunbond | |||
|---|---|---|---|
| Material of innerfacing layer | Polypropylene | Polypropylene | Same |
| Nosepiece | Polypropylene coated steel wire | Polypropylene coatedsteel wire | Same |
| Attachment | Ear loops: Spandex and nylon | Ear loops: Polyester,polyurethane Side tapes:Polyester spunbond (earloops mask only) Tie tapes:Polypropylene spunbondorpolyester spunbond | Similar |
| Dimension(Length × Width) | 17.5 cm × 9.5 cm | 17.5 cm × 9.0 cm18.0 cm × 9.0 cm | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Single use | Yes | Yes | Same |
| ASTM F 2100level | Level 3 | Level 1Level 2Level 3 | Similar |
| Biocompatibility | Pass ISO 10993cytotoxicity, skinirritation and skin sensitivitytests | Pass ISO10993cytotoxicity, skinirritation and skinsensitivity tests | Same |
The subject device is the same as the predicate device in the intended use, material, ASTM F2100 level and biocompatibility, and similar in mask style, design feature and dimension. So the subject device is identical to the predicate device.
PERFORMANCE DATA 7.
7.1. Non-clinical test performed on the proposed device
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the medical surgical mask was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of
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medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:
| Item | AcceptanceCriteria | Proposeddevice | Predicatedevice | Result |
|---|---|---|---|---|
| Cytotoxicity | Under theconditions of thestudy, the subjectdevice was non-cytotoxic. | Under theconditions of thestudy, the subjectdevice was non-cytotoxic. | Under theconditions of thestudy, the subjectdevice was non-cytotoxic | Same |
| Sensitization | Under theconditions of thestudy, the subjectdevice wasnon-sensitizing | Under theconditions of thestudy, the subjectdevice was non-sensitizing. | Under theconditions of thestudy, the subjectdevice was non-sensitizing. | Same |
| Skin Irritation | Under theconditions of thestudy, the subjectdevice wasnon-irritating. | Under theconditions of thestudy, thesubject device wasnon-irritating. | Under theconditions of thestudy, the subjectdevice was non-irritating. | Same |
Performance testing
Performance testing was conducted on the medical surgical mask. All of the tested parameters met the predefined acceptance criteria.
| Item | Proposeddevice | Predicatedevice | AcceptanceCriteria | Result |
|---|---|---|---|---|
| Flammability | Class I | Class I | Class I | Same |
| BacterialFiltrationEfficiency | >=98% | 98% | >=98% | Same |
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| K201991 | ||||
|---|---|---|---|---|
| Item | Proposed device | Predicate device | Acceptance Criteria | Result |
| DifferentialPressure, mmH2O/cm2 | <6.0 H2O/cm2 mm | Pass at average5.5 mm H2O/cm2 | <6.0 H2O/cm2 mm | Similar |
| Sub-MicronParticleFiltrationEfficiency | >= 98% | Average 99.8% | >= 98% | Similar |
| Resistance toPenetrationby SyntheticBlood(mmHg) | 29 out of 32 atpasses160mmHg | 29 out of 32 passesat160mmHg | 29 out of 32 passesat 160mmHg | Same |
7.2. Clinical test conclusion
No clinical study is included in this submission.
8. CONCLUSION
8.1. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Surgical Face Mask (K160269).
§ 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.