(97 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration efficiency of a disposable medical mask, with no mention of AI or ML.
No
Explanation: The device is a medical mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, primarily for infection control. It is not designed to treat a disease, injury, or other medical condition.
No
The device is a medical mask designed to protect against the transfer of microorganisms, body fluids, and particulate material. Its intended use focuses on infection control and physical barrier protection rather than the detection, diagnosis, or monitoring of a disease or condition.
No
The device description clearly outlines a physical, three-layer mask made of nonwoven fabrics, a nose piece, and ear loops. The performance studies focus on material properties and filtration efficiency, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a disposable medical mask. Its function is to create a physical barrier to protect against the transfer of microorganisms, body fluids, and particulate material. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states its purpose is for protection and infection control by being worn over the mouth and nose. This is a physical barrier function, not a diagnostic one.
The information provided about performance testing (filtration efficiency, pressure, etc.) relates to the mask's ability to filter and provide a barrier, which are relevant metrics for a medical mask, not an IVD.
N/A
Intended Use / Indications for Use
The disposable medical 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 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 (comma separated list FDA assigned to the subject device)
FXX
Device Description
The proposed device is a three-layer, flat pleated mask. Each 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 made of spandex and nylon, not made from natural rubber latex.
The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is a iron wire with polypropylene covering.
The proposed device is provided non-sterile and is intended to be a 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)
Non-clinical Testing:
Biocompatibility testing:
- In Vitro Cytotoxicity (ISO 10993-5): the device was non-cytotoxic;
- Skin Irritation (ISO 10993-10): the device was non-irritating;
- Skin Sensitization (ISO 10993-10): the device was non-sensitizing.
Performance testing - Bench (according to "ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks" Level 3 (AQL=4.0%)):
- Fluid Resistance (ASTM F1862): 96/96 samples passed at 160 mmHg. (32 Samples each from 3 non-consecutive lots)
- Bacterial filtration efficiency (BFE) (ASTM F2101): 96/96 samples passed with an average of 99.9%. (32 Samples each from 3 non-consecutive lots)
- Particulate filtration efficiency (PFE) (ASTM F2299): 96/96 samples passed with an average of 99.8% (at 0.1 micron). (32 Samples each from 3 non-consecutive lots)
- Differential pressure (Delta-P) (EN 14683): 96/96 samples passed at = 98%
Particulate 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.
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April 11, 2021
Diasia Biomedical Technology 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: K210018
Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 16, 2021 Received: March 23, 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.
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 -S
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210018
Device Name Disposal Medical Mask
Indications for Use (Describe)
The disposable medical 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 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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3
510(k) Summary
K210018
1. Contact Details
1.1 Applicant information
| Applicant Name | Diasia Biomedical Technology Co., Ltd. |
|---|---|
| Address | 2F/3F301/4F (Building A) & 2F (Building B), Fuxinlin |
| Industrial Park, Hangcheng Industrial Zone, Taoyuan, | |
| Xixiang, Bao'an District, Shenzhen, Guangdong, China | |
| Contact person | Jason Luo |
| Phone No. | +86 150 1299 9080 |
| luojinxin@diasia.com.cn | |
| Date Prepared | 2021-04-05 |
1.2 Submission Correspondent
| Image: logo | Shenzhen Joyantech Consulting Co., Ltd
1713A, 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 | Disposable Medical Mask |
|---|---|
| Common name | Surgical Face Mask |
| Model | TP175x94 |
| Classification | II |
| Classification name | Mask, Surgical |
| Product code | FXX |
| Regulation No. | 21 CFR 878.4040 |
3. Legally Marketed Predicate Device
| Trade Name | DemeMASK Surgical Mask |
|---|---|
| 510(k) Number | K201479 |
| Product Code | FXX |
| Manufacturer | DemeTECH Corporation |
4. Device Description
4
The proposed device is a three-layer, flat pleated mask. Each 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 made of spandex and nylon, not made from natural rubber latex.
The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is a iron wire with polypropylene covering.
The proposed device is provided non-sterile and is intended to be a single use, disposable device.
5. Intended Use/Indication for Use
The disposable medical 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.
| Table 1 Substantial Equivalence Comparison | |||
|---|---|---|---|
| Item | Proposed Device | ||
| (K210018) | Predicate Device | ||
| (K201479) | Comment | ||
| Product name | Disposable Medical Mask | DemeMASK Surgical Mask | None |
| Manufacturer | Diasia Biomedical | ||
| Technology Co., Ltd. | DemeTECH Corporation | None | |
| Product Code | FXX | FXX | Same |
| Regulation Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classification | Class II | Class II | Same |
| OTC use | Yes | Yes | Same |
| ASTM Level (ASTM | |||
| F2100-19) | Level 3 | Level 3 | Same |
| Indications for use | The disposable medical | ||
| 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 | The Disposal 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 | ||
| blood and body fluids. This is | |||
| a single use, disposable | |||
| device(s), provided | |||
| non-sterile. | blood and body fluids. This is | ||
| a single use, disposable | |||
| device provided non-sterile. | |||
| Design feature | Ear-loop | Ear-loop | Same |
| Mask style | Flat Pleated | Flat Pleated | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Specifications and | |||
| Dimensions | Length: 17.5cm±0.5cm | ||
| Width: 9.4cm ±0.5cm | Length: 17.5cm±1cm | ||
| Width: 9.5cm±1cm | Similar | ||
| Sterility | Non-Sterile | Non-Sterile | Same |
| Materials | |||
| Outer layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle layer | Meltblown polypropylene | ||
| filter | Meltblown polypropylene | ||
| filter | Same | ||
| Inner layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Nose piece | Iron wire with polypropylene | ||
| covering | Galvanized wire coated with | ||
| polyethylene | Different | ||
| (Issue 1) | |||
| Ear loop | Spandex and Nylon - Not | ||
| made from natural rubber | |||
| latex | Spandex and Nylon - Not | ||
| made from natural rubber | |||
| latex | Same | ||
| Performance | |||
| Fluid Resistance | |||
| ASTM F1862 | Pass at 160 mmHg | Pass at 160 mmHg | Same |
| Bacterial Filtration | |||
| Efficiency | |||
| ASTM F2101 | Pass at ≥99% | Pass at ≥99% | Same |
| Particulate Filtration | |||
| Efficiency | |||
| ASTM F2299 | Pass at ≥99% | Pass at ≥99% | Same |
| Differential Pressure | |||
| (Delta-P) | Pass at Skin Sensitization (ISO 10993-10): the device was non-sensitizing. |
There is no additional safety risk for the proposed device when compared with the predicate device.
7.2 Performance testing - Bench
The performance testing was determined according to "ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks" to demonstrate the effectiveness of device.
| Test | Purpose | Acceptance Criteria
per ASTM F2100-19
Level 3 (AQL=4.0%) | Subject Device Test Results
ASTM F2100-19
Level 3 | | Average |
|---------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------|--|------------------|
| Fluid Resistance
(ASTM F1862) | Determine synthetic
blood penetration
resistance. | Pass at 160 mmHg | Pass at 160 mmHg
(96/96)
32 Samples each from
3 non-consecutive lots | | N/A |
| Bacterial filtration
efficiency (BFE)
(ASTM F2101) | Determine the
bacterial filtration
efficiency. | $\ge$ 98% | Pass (96/96)
32 Samples each from
3 non-consecutive lots | | 99.9% |
| Particulate
filtration
efficiency (PFE)
(ASTM F2299) | Determine
submicron
particulate filtration
efficiency at 0.1
micron. | $\ge$ 98% | Pass (96/96)
32 Samples each from
3 non-consecutive lots | | 99.8% |
| Differential
pressure
(Delta-P)
(EN 14683) | Determine breathing
resistance or
differential pressure. |