(230 days)
Not Found
No
The description details a standard surgical mask with no mention of AI or ML capabilities.
No.
The device description and intended use clearly state that it is a medical surgical mask for protection against transfer of microorganisms and fluids, intended for infection control, not for treating any medical condition or disease.
No
Explanation: The document describes a medical surgical mask, which is a protective barrier device. Its intended use is to protect healthcare personnel from the transfer of microorganisms and body fluids. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly outlines physical components like fabric layers, ear loops, and a nose clip, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of a face mask, not a device designed to analyze biological samples or provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of any components or functions related to analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic results.
- Performance Metrics: The performance metrics listed (Differential Pressure, Fluid resistance, Filtration Efficiency, Flammability, Biocompatibility) are all related to the physical and protective properties of a mask, not diagnostic accuracy.
- Predicate Device: The predicate device is also a surgical face mask, further indicating the device's classification as a protective barrier, not a diagnostic tool.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
FXX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Differential Pressure: EN 14683:2019+AC: 2019 (E), Annex C; Acceptance Criteria:
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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.
1
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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3
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 Community | |
| Songgang 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.
4
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
5
| | Nose Clamp: Polyethylene
coated
steel wire
Ear loops: Polyester, polyurethane | fabric
Nose Clips: PP plastic material
Ear loops: Nylon + spandex | |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------|
| Design features | Colors: white or blue
Flat-pleated | Colors: blue
Flat-pleated | Similar |
| Dimensions-
Length | $90\pm 3mm$ | $9.5cm \pm 1cm$ | Similar |
| Dimensions -
Palm Width | $175 \pm 5mm$ | $17.5cm \pm 1cm$ | Similar |
| Particulate
Filtration
Efficiency
( ASTM F2299-
03 (2017)) | Pass at 99.6% | Pass at 98% | Similar |
| Fluid resistance
( ASTM
F1862/F1862M-
17) | Pass at 80 mmHg | Pass at 80 mmHg | Same |
| Bacterial
Filtration
Efficiency
( ASTM F2101-
19) | Pass at >98% | Pass at >98% | Same |
| Flammability
(16 CFR1610) | Class 1 | Class 1 | Same |
| Differential
Pressure (EN
14683:2019+AC
: 2019 (E)) | Pass at $2.0mmH_2O/cm^2$ | Pass at $3.4 mmH_2O/cm^2$ | Similar |
| Biocompatibility
Cytotoxicity
(ISO10993-5) | Under the conditions of the
study, the subject device
extract was determined to be
non-cytotoxic. | Under the conditions of the
study, the subject device extract
was determined to be non-
cytotoxic. | Similar |
| Skin Irritation
(ISO10993-10) | Under the conditions of the
study, the subject device non-
polar and polar extracts were
determined to be non-irritating. | Under the conditions of the
study, the subject device non-
polar and polar extracts were
determined to be non-irritating. | |
| Skin
sensitization
(ISO10993-10) | Under the conditions of the
study, the subject device non-
polar and polar extracts were
determined to be non-
sensitizing. | Under the conditions of the
study, the subject device non-
polar and polar extracts were
determined to be non-
sensitizing. | |
6
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 | Acceptance | ||
| Criteria | Average | Results | ||
| Differential | ||||
| Pressure | EN | |||
| 14683:2019+AC | ||||
| : 2019 (Ε), | ||||
| Annex C |