(230 days)
Phyziofit Medical Surgical Masks are intended to be worn to protect 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 a single use, disposable device(s), provided non-sterile.
The proposed device(s) are Blue color (colorant: Pigment blue 15:3/CAS No. 147-14-8), and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose clips design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the outer layer is made of polypropylene non-woven fabric, the middle layer is made of melt blown non-woven fabric and the inner layer is made of absorbent nonwoven fabric.
The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clips contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PP plastic material.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and the study conducted for the Phyziofit Medical Surgical Mask (K201868).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Test Method | Acceptance Criteria | Reported Device Performance (Average) | Result |
|---|---|---|---|---|
| Differential Pressure | EN 14683:2019+AC: 2019 (E), Annex C | < 5.0 mm H2O/cm² | 3.4 mm H2O/cm² (32/32) | Pass |
| Fluid Resistance | ASTM F1862/F1862M-17 | No Penetration at 80 mm Hg | No Penetration at 80 mm Hg (32/32) | Pass |
| Particulate Filtration Efficiency | ASTM F2299-03 (2017) | ≥95% | 98% (32/32) | Pass |
| Flammability | 16 CFR Part 1610 | Class I | Class I (32/32) | Pass |
| Bacterial Filtration Efficiency | ASTM F2101-19 | ≥95% | 99.9% (32/32) | Pass |
| Biocompatibility (Cytotoxicity) | ISO 10993-5:2009 | Non-Cytotoxic | Non-cytotoxic | Pass |
| Biocompatibility (Skin Irritation) | ISO 10993-10:2010 | Non-Irritating | Non-irritating | Pass |
| Biocompatibility (Skin Sensitization) | ISO 10993-10:2010 | Non-Sensitizing | Non-sensitizing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
For the performance tests (Differential Pressure, Fluid Resistance, Particulate Filtration Efficiency, Flammability, Bacterial Filtration Efficiency), a sample size of 32 units was used for each test (indicated by "(32/32)").
The provenance of the data is non-clinical bench testing. The country of origin for the data is not explicitly stated, but the submission is from Wellpower Sporting Goods Co., Ltd. in China. The testing itself is explicitly described as "bench testing".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study did not involve human experts establishing ground truth. The acceptance criteria were based on established industry standards and test methods for medical surgical masks.
4. Adjudication Method for the Test Set
This information is not applicable. The study involved objective bench tests with predefined acceptance criteria. There was no need for adjudication as the results were quantitative measurements against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed to demonstrate that the subject mask is substantially equivalent to the predicate. Therefore, determination of substantial equivalence is not based on an assessment of clinical performance data."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The device is a physical medical surgical mask, not an AI algorithm or software. The "standalone" performance here refers to the mask's inherent physical and biological characteristics when tested against established standards.
7. The Type of Ground Truth Used
The ground truth used for this study was based on established scientific and regulatory standards and test methods for medical surgical masks (e.g., EN, ASTM, ISO, CFR standards). These standards define the acceptable performance limits for the various properties of a surgical mask.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical product and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there was no training set for an algorithm.
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February 22, 2021
Wellpower Sporting Goods Co., Ltd % Mar Liu Regulatory Affairs Manager Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 2012#, Gebu commercial building, Hongxing community Songgang street Shenzhen, Guangdong 518105 China
Re: K201868
Trade/Device Name: Phyziofit Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 24, 2021 Received: February 1, 2021
Dear Mar 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.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201868
Device Name Phyziofit Medical Surgical Mask
Indications for Use (Describe)
Phyziofit Medical Surgical Masks are intended to be worn to protect 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 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 Wellpower Sporting Goods Co., Ltd. Phyziofit Medical Surgical Mask K201868
1.0 Submitter:
Submitter's name : Submitter's address :
Phone number : Fax number : Name of contact person: Summary Preparation Date: Wellpower Sporting Goods Co., Ltd. No.12. Xinglong New Street, Quantang Industrial Zone, Liaobu Town, Dongguan City, Guangdong Province, 523425 China +86 13829158242 NA Carol Tseng Feb. 20th 2021
| 2.0 | Consultant Firm | Shenzhen Reanny Medical Devices Management Consulting Co., Ltd |
|---|---|---|
| Contact name | Reanny Wang | |
| Company address | Room 1813, Honghaigebu Business Building, Hongxing CommunitySonggang Street, Baoan District, Shenzhen | |
| Telephone number | +86-755-27391220/86-15389012257 | |
| Contact email | counselor7@reanny.com |
counselor / @reanny.com
3.0 Name of the Device
| Proprietary/Trade name: | Phyziofit Medical Surgical Mask |
|---|---|
| Common Name: | Mask, Surgical |
| 510(k) Number | K201868 |
| Classification Name: | Mask, Surgical |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 878.4040 |
| Product Code: | FXX |
4.0 Predicate device
| Device Name: | Surgical Face Masks (Ear loops and Tie-on) |
|---|---|
| Company name: | San-M Package Co., Ltd. |
| 510(K) Number: | K160269 |
5.0 Device Description:
The proposed device(s) are Blue color (colorant: Pigment blue 15:3/CAS No. 147-14-8), and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose clips design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the outer layer is made of polypropylene non-woven fabric, the middle layer is made of melt blown non-woven fabric and the inner layer is made of absorbent nonwoven fabric.
The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clips contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PP plastic material.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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6.0 Indications for Use:
Phyziofit Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel form 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.
7.0 Technological Characteristics Comparison:
Predicate Device Proposed Device Comparison (Same. Device Similar, Level 1 Level 1 Level 2 Level 3 Characteristic Different) Product name Surgical Face Masks (Ear Phyziofit Medical Surgical Mask N/A loops and Tie-on) K160269 K201868 510(K) No. N/A Product Owner San-M Package Co., Ltd. Wellpower Sporting Goods Co., N/A Ltd. Product Code FXX FXX Same Regulation 21 CFR 878.4040 21 CFR 878.4040 Same Class 11 11 Same The surgical face masks are Phyziofit Medical Surgical Indications for Similar Masks are intended to be worn intended to be worn to protect Use to protect both the patient and both the patient and healthcare personnel from transfer of healthcare personnel from microorganisms, body fluids, transfer of microorganisms. and particulate material. These body fluids and particulate face masks are intended for use material. These face masks are in infection control practices to intended for use in infection control practices to reduce the reduce the potential exposure to blood and body fluids. This potential exposure to blood and
body fluids. This is a single use, is a single-use, disposable device, provided non-sterile. disposable device(s), provided non-sterile. Level I Face Mask Models:# EL 10000, EL 10010, TO 10000, TÓ 10010
Level 2 Face Mask Models:# EL 20000, EL 20010, TO
20000, TO 20010, TO 20010
Level 3 Face Mask Models:# EL 30000, EL 300 I 0, TO 30000. TÓ 300 10 Color White or Blue Blue Similar Single Use, Disposable Single Use Single Use, Disposable Same Sterile Non-Sterile Non-Sterile Same Similar Materials Outer Material: Polypropylene Outer Layer: polypropylene non-Inner Material: Polypropylene woven fabric Filter Media: Polypropylene Middle layer: melt blown non-Spunbond and Polypropylene woven fabric Meltblown Inner layer: absorbent nonwoven
Comparative Table
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| Nose Clamp: Polyethylenecoatedsteel wireEar loops: Polyester, polyurethane | fabricNose Clips: PP plastic materialEar loops: Nylon + spandex | ||
|---|---|---|---|
| Design features | Colors: white or blueFlat-pleated | Colors: blueFlat-pleated | Similar |
| Dimensions-Length | $90\pm 3mm$ | $9.5cm \pm 1cm$ | Similar |
| Dimensions -Palm Width | $175 \pm 5mm$ | $17.5cm \pm 1cm$ | Similar |
| ParticulateFiltrationEfficiency( ASTM F2299-03 (2017)) | Pass at 99.6% | Pass at 98% | Similar |
| Fluid resistance( ASTMF1862/F1862M-17) | Pass at 80 mmHg | Pass at 80 mmHg | Same |
| BacterialFiltrationEfficiency( ASTM F2101-19) | Pass at >98% | Pass at >98% | Same |
| Flammability(16 CFR1610) | Class 1 | Class 1 | Same |
| DifferentialPressure (EN14683:2019+AC: 2019 (E)) | Pass at $2.0mmH_2O/cm^2$ | Pass at $3.4 mmH_2O/cm^2$ | Similar |
| BiocompatibilityCytotoxicity(ISO10993-5) | Under the conditions of thestudy, the subject deviceextract was determined to benon-cytotoxic. | Under the conditions of thestudy, the subject device extractwas determined to be non-cytotoxic. | Similar |
| Skin Irritation(ISO10993-10) | Under the conditions of thestudy, the subject device non-polar and polar extracts weredetermined to be non-irritating. | Under the conditions of thestudy, the subject device non-polar and polar extracts weredetermined to be non-irritating. | |
| Skinsensitization(ISO10993-10) | Under the conditions of thestudy, the subject device non-polar and polar extracts weredetermined to be non-sensitizing. | Under the conditions of thestudy, the subject device non-polar and polar extracts weredetermined to be non-sensitizing. |
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8.0 Summary of Non-Clinical Performance Data
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device, Surgical Face Masks (Ear loops and Tie-on) manufactured by San-M Package Co., Ltd.The subject device Phyziofit Medical Surgical Mask met the acceptance criteria as established by the Standard testing methods utilized as applicable. No new safety or efficacy concerns were raised during testing:
| Bench Testing | ||||
|---|---|---|---|---|
| Test Performed | Test Method | AcceptanceCriteria | Average | Results |
| DifferentialPressure | EN14683:2019+AC: 2019 (Ε),Annex C | < 5.0mmH2O/cm² | 3.4 mm H2O/cm²(32/32) | Pass |
| Fluid resistance | ASTMF1862/F1862M-17 | No Penetration at80 mm Hg | No Penetration at80 mm Hg(32/32) | Pass |
| ParticulateFiltrationEfficiency | ASTM F2299-03(2017) | ≥95% | 98% (32/32) | Pass |
| Flammability | 16 CFR Part1610 | Class I | Class I (32/32) | Pass |
| BacterialFiltrationEfficiency | ASTM F2101-19 | ≥95% | 99.9% (32/32) | Pass |
| BiocompatibilitycytotoxicityTest | ISO 10993-5:2009 | Non-Cytotoxic | Under theconditions of thestudy, the subjectdevice extractwas determinedto be noncytotoxic | Pass |
| BiocompatibilitySkin irritation | ISO 10993-10:2010 | Non-Irritating | Under theconditions of thestudy, the subjectdevice non-polarand polarextracts weredetermined tobe non-irritating. | Pass |
| BiocompatibilitySkinSensitization | ISO 10993-10:2010 | Non-Sensitizing. | Under theconditions of thestudy, the subjectdevice non-polarand polarextracts weredetermined tobe non-sensitizing. | Pass |
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9.0 Summary of Clinical Performance Data:
Clinical data was not needed to demonstrate that the subject mask is substantially equivalent to the predicate. Therefore, determination of substantial equivalence is not based on an assessment of clinical performance data.
10.0 Conclusion:
The subject product has the same intended use and principle of operation, similar performance specifications as predicate device. The difference between Phyziofit Medical Surgical Mask and predicate device have been analyzed and demonstrates that the difference does not raise any new safety or effectiveness concerns.
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed 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.