(205 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
A therapeutic device is intended to treat a condition or disease, while this device, a surgical mask, is intended to protect healthcare personnel from the transfer of microorganisms and body fluids.
No
The device is a surgical mask intended for protection and filtration, not for diagnosis of any condition.
No
The device description clearly outlines a physical, multi-layer mask with ear loops and a nose piece, made of materials like polypropylene and polyethylene wire. The performance studies also focus on physical properties and filtration, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease, monitoring a condition, or screening for a risk.
- Device Function: The Medical Surgical Mask described here is a physical barrier worn on the face. Its function is to filter air and prevent the transfer of microorganisms, body fluids, and particulate material between people or from the environment to the wearer. It does not analyze any biological samples from the user.
- Intended Use: The intended use clearly states it's for protection and infection control by being worn on the face. It doesn't mention any analysis of biological specimens.
- Device Description: The description details the physical construction of the mask, not any components for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, breathability, fluid resistance) and its biocompatibility when in contact with skin. They do not involve testing the mask's ability to analyze biological samples.
In summary, the Medical Surgical Mask is a personal protective equipment (PPE) device, not an IVD.
N/A
Intended Use / 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. 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.
Product codes
FXX
Device Description
The Medical Surgical Mask is a single use, three-layer, flat-pleated style surgical mask with ear loops and nose piece. The mask is 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 surgical masks is held over the user's mouth and nose via earloops made of nylon with spandex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The medical surgical mask includes blue colorant, Shining Blue R603. The medical surgical mask is sold non-sterile and is intended to be single use, and disposable.
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)
Non-Clinical Test Conclusion:
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
Performance Testing:
- Synthetic Blood Penetration Resistance (ASTM F1862): No penetration at 160 mmHg (Pass)
- Particulate Filtration Efficiency (ASTM F2299): Particle filtration efficiency at 0.1 micron (%) >98 % (Pass)
- Bacterial Filtration Efficiency (ASTM F2101): >98 % (Pass)
- Differential Pressure (Delta P) EN 14683:2019+AC:2019 Annex C: Differential pressure 98 %
- Bacterial Filtration Efficiency >98 %
- Differential pressure
§ 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). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 8, 2021
Sichuan Pharmaceutical. Inc. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K210813
Trade/Device Name: Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 25, 2021 Received: September 9, 2021
Dear Boyle Wang:
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 mediation-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 Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control And Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210813
Device Name Medical Surgical Mask
Indications for Use (Describe)
The Medical Surgical Mask is 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 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) | Over-The-Counter Use (21 CER 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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3
510(k) Summary
(K210813)
This summary is submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Sichuan Pharmaceutical,Inc. |
|---|---|
| Address: | Sichuan Pharmaceutical.Inc No. 18 Baiye Road, |
| Hi-Tech West Zone, Chengdu, Sichuan Province, | |
| China. | |
| Contact: | Yunrui Zhang |
| Tel: | 86-13678040510 |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Address: | Shanghai Truthful Information Technology Co., Ltd. |
| Room 1801, No. 161 East Lu Jiazui Rd., Pudong | |
| Shanghai, 200120 China | |
| Tel: | +86-21-50313932 |
| Email: | info@truthful.com.cn |
Date of Preparation: Oct.8,2021
2.0 Device Information
| Trade name: | Medical Surgical Mask |
|---|---|
| Common name: | Surgical Face Mask |
| Classification name: | Surgical Face Mask |
| Production code: | FXX |
| Regulation number: | 21CFR 878.4040 |
| Classification: | Class II |
| Review Panel: | Surgical Apparel |
3.0 Predicate Device Information
| Manufacturer: | DemeTECH Corporation. |
|---|---|
| Device: | DemeMASK Surgical Mask |
| 510(k) number: | K201479 |
4.0 Device Description
4
The Medical Surgical Mask is a single use, three-layer, flat-pleated style surgical mask with ear loops and nose piece. The mask is 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 surgical masks is held over the user's mouth and nose via earloops made of nylon with spandex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The medical surgical mask includes blue colorant, Shining Blue R603. The medical surgical mask is sold non-sterile and is intended to be single use, and disposable.
5.0 Indication for Use Statement
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. 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.
| Item | Subject Device
K210813 | Predicate Device
K201479 | Comparison | |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|------------|
| Product Name | Medical Surgical Mask | DemeMASK Surgical Mask | -- | |
| Product Code | FXX | FXX | Same | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Class | II | II | Same | |
| Intended Use&
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. 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), | The Disposable 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 face masks are intended for use in infection control practices to reduce the potential exposure to | Same | |
| | | | | |
| | | provided non-sterile. | blood and body fluids.
This is a single use,
disposable device
provided non-sterile. | |
| Design features | | Ear Loops, 3 layers | Ear Loops, 3 layers | Same |
| Mask Styles | | Flat pleated | Flat pleated | Same |
| Material | Outer
facing
layer | Spun-bond
polypropylene | Spun-bond
polypropylene | Same |
| | Middle
layer | Melt blown
polypropylene filter | Melt blown
polypropylene filter | Same |
| | Inner
Facing
layer | Spun-bond
polypropylene | Spun-bond
polypropylene | Same |
| | Nose
piece | Malleable polyethylene
wire | Galvanized wire with
coated polyethylene | *Different |
| | Ear
loops | Nylon and spandex | Nylon and spandex | Same |
| Color | | Blue | Blue | Same |
| Dimension
(Length) | | 17.5 cm +/- 0.2 cm | 17.5 cm +/- 1cm | *Different |
| Dimension
(Width) | | 9.5 cm +/- 0.2 cm | 9.5 cm +/- 1cm | ent |
| OTC use | | Yes | Yes | Same |
| Sterility | | Non-Sterile | Non-Sterile | Same |
| Single Use | | Yes | Yes | Same |
| Sterile | | No | No | Same |
| ASTM F2100
Level | | Level 3 | Level 3 | Same |
| Biocompatibility
ISO 10993-5/
ISO 10993-10 | | Non-cytotoxic,
non-sensitizing, and
non-irrtating | Non-cytotoxic,
non-sensitizing, and
non-irrtating | Same |
6.0 Comparison to the Predicate Device
5
- Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials. The difference in the materials does not raise additional questions for safety and effectiveness.
7.0 Non-Clinical Test Conclusion
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
6
| Test | Subject Device | Predicate Device | Results |
|---|---|---|---|
| Synthetic | |||
| Blood | |||
| Penetration | |||
| Resistance | |||
| ASTM F1862 | No penetration | ||
| at 160 mmHg | No penetration at | ||
| 160 mmHg | Pass | ||
| Particulate | |||
| Filtration | |||
| Efficiency | |||
| ASTM F2299 | Particle filtration | ||
| efficiency at 0.1 | |||
| micron | |||
| (%) >98 % | Particle filtration | ||
| efficiency at 0.1 | |||
| micron (%) >98 % | Pass | ||
| Bacterial | |||
| Filtration | |||
| Efficiency | |||
| ASTM F2101 | >98 % | >98 % | Pass |
| Differential | |||
| Pressure | |||
| (Delta P) | |||
| EN | |||
| 14683:2019+AC:2019 | |||
| Annex C | Differential | ||
| pressure ≤ 6.0 | |||
| mmH2O/cm² | Differential | ||
| pressure ≤ 6.0 | |||
| mmH2O/cm² | Pass | ||
| Flammability | |||
| 16 CFR 1610 | Class 1 | Class 1 | Pass |
Table 2 - Performance Testing
Table 3 - Biocompatibility Testing
| Item | Subject Device | Result |
|---|---|---|
| Cytotoxicity | ||
| ISO 10993-5 | Under the conditions of the study, the device is non-cytotoxic. | Pass |
| Irritation | ||
| ISO 10993-10 | Under the conditions of the study, the device is non-irritating. | Pass |
| Sensitization | ||
| ISO 10993-10 | Under the conditions of the study, the device is non-sensitizing | Pass |
8.0 Clinical Test Conclusion
No clinical study is included in this submission.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device in K201479.