(412 days)
Not Found
No
The description focuses on the physical materials and construction of a standard surgical mask and does not mention any AI/ML components or functionalities.
No.
The device, a surgical mask, is intended to protect against the transfer of microorganisms, blood, body fluids, and particulate materials, which is a prophylactic function, not a therapeutic one. It does not treat or cure a disease or condition.
No
The device is a surgical mask intended to protect against the transfer of microorganisms and particulate materials, not to diagnose a medical condition.
No
The device description clearly outlines a physical product made of non-woven fabric, melt blown fabric, nylon, and HDPE, with specific physical components like ear loops and a nose clip. The performance studies focus on physical properties and biological safety, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, blood, body fluids, and particulate materials. This is a physical barrier function, not a diagnostic function.
- Device Description: The description details the physical components and materials of the mask. There is no mention of reagents, assays, or any components used to test or analyze samples from the human body.
- Performance Studies: The performance studies focus on the physical and barrier properties of the mask (filtration efficiency, pressure, blood penetration, flammability, biocompatibility). These are not studies related to the accuracy or performance of a diagnostic test.
- Key Metrics: The key metrics are related to the mask's barrier and filtration capabilities, not diagnostic performance metrics like sensitivity, specificity, PPV, or NPV.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
INTAI Surgical Mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. This is a single use, disposable device and provided non-sterile.
Product codes
FXX
Device Description
The INTAI Surgical Mask is single use, three-layers, flat-pleated masks with ear loops, and nose clip. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The ear loops welded are used to keep the mask close to the mouth and the nose. The ear loops are made of Nylon. The nose clip, which is made by plasticity material (HDPE), contained in masks is in the layers of the surgical mask to allow the users to fit the facemask around their nose. The surgical mask are provided in one color (blue), non-sterile and 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
Operating room personnel and other general healthcare workers
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 tests were conducted to verify that the proposed device met all design specifications as was same to the predicate device. The test results demonstrated that the proposed device complies with 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:
ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests For Irritation And Skin Sensitization
ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity)
EN 14683, Medical Face Masks-Requirements and Test Methods
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus
ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulated using latex spheres
16 CFR 1610, Standard for the Flammability of clothing textiles
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Resistance to Penetration by Synthetic Blood: Achieve a 4% AQL at 160mmHg (Pass)
- Sub-Micron Particle Filtration Efficiency: >=98% (Pass)
- Differential Pressure: =98% (Pass)
- Flammability: Class 1 (Pass)
- Biocompatibility: Non-cytotoxic, Non-sensitizing, nonirritating (Identical to predicate)
- Bacterial Filtration Efficiency (BFE) Testing: >=98 % (PASS)
- Differential Pressure Testing: =98 % (PASS)
- Synthetic blood penetration Testing: 160 mmHg (PASS)
- Flammability Testing: Did Not Ignite (DNI) (PASS)
- In Vitro Cytotoxicity Test: No cell lysis, no reduction of cell growth (PASS)
- Skin Irritation Test: Non-irritant (PASS)
- Skin Sensitization Test: No visible change (PASS)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 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.
March 30, 2022
INTAI Technology Corp. Dale Chang Quality Management Representative of Implants Business Unit No. 9. Jingke Rd., Nantun Dist., Taichung 40852 Taiwan
Re: K210422
Trade/Device Name: INTAI Surgical Mask (non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 9, 2022 Received: March 9, 2022
Dear Dale Chang:
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.
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
1
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 (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 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,
Bifeng Qian, M.D., Ph.D. 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210422
Device Name INTAI Surgical Mask (non-sterile)
Indications for Use (Describe)
INTAI Surgical Mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. This is a single use, disposable device and 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for INTAI. The logo features the word "INTAI" in bold, blue letters. To the left of the word is a stylized graphic of a person with a yellow head and a blue body. The logo is reflected in a glossy surface below, creating a mirrored effect.
510(k) SUMMARY K210422
This summary regarding 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitted By | INTAI Technology Corp.
Registration No.3011187779
No.9 Jingke Rd., Nantun District, Taichung City, Taiwan, R.O.C.
Tel. +886 4 23595336
Fax.+886 4 36013076 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kevin Wang |
| Date Prepared | March 25th, 2022 |
| Device Name | INTAI Surgical Mask (non-sterile) |
| Classifications
Product Codes | Class II, 21 CFR 878.4040 - Surgical apparel.
FXX |
| Predicate Devices
Information | K210218
SURGICAL MASK, Model Name:C015
Qingdao Hainuo Biological Engineering Co., Ltd |
| Material | Nonwoven (Polypropylene) fabric, melt blown polypropylene |
| Indication for Use | INTAI Surgical Mask is intended to be worn by operating room
personnel and other general healthcare workers to protect both
patients and healthcare workers against transfer of
microorganisms, blood and body fluids, and particulate materials.
This is a single use, disposable device and provided non-sterile. |
| Device Description | The INTAI Surgical Mask is single use, three-layers, flat-pleated
masks with ear loops, and nose clip. The inner and outer layers are
made of Non-woven fabric (Polypropylene), and the middle filter
layer is made of a melt blown fabric (Polypropylene).
The ear loops welded are used to keep the mask close to the mouth and
the nose. The ear loops are made of Nylon. The nose clip, which is
made by plasticity material (HDPE), contained in masks is in the
layers of the surgical mask to allow the users to fit the facemask
around their nose.
The surgical mask are provided in one color (blue), non-sterile and
intended to be single use, disposable device. |
Detailed information of the blue color Surgical Masks, please see the table below.
4
Image /page/4/Picture/1 description: The image shows the logo for INTAI. The logo consists of a blue icon on the left, with a yellow circle above it. To the right of the icon is the word "INTAI" in blue, with a registered trademark symbol next to it. The logo has a reflection underneath it.
| Product Model | Feature | Layers | Nose Clip | Ear loop | Colorant |
|---|---|---|---|---|---|
| 9W001200 | |||||
| ASTM Level3 | Blue | ||||
| 50 pcs/box | Outer: 35g | ||||
| Non-woven | |||||
| Middle: 25g | |||||
| Melt Blown | |||||
| Inner: 20g Non- | |||||
| woven | plasticity | ||||
| material | |||||
| (HDPE) | |||||
| CAS# | |||||
| 9002-88-4 | Nylon | ||||
| CAS# | |||||
| 25038-54-4 | Outer Layer: | ||||
| 147-14-8 | |||||
| 980-26-7 | |||||
| 84632-65-5 | |||||
| Ear loop: | |||||
| 12234-64-9 | |||||
| 9W001201 | |||||
| ASTM Level3 | Blue | ||||
| 30 pcs/box | Outer: 35g | ||||
| Non-woven | |||||
| Middle: 25g | |||||
| Melt Blown | |||||
| Inner: 20g Non- | |||||
| woven | plasticity | ||||
| material | |||||
| (HDPE) | |||||
| CAS# | |||||
| 9002-88-4 | Nylon | ||||
| CAS# | |||||
| 25038-54-4 | Outer Layer: | ||||
| 147-14-8 | |||||
| 980-26-7 | |||||
| 84632-65-5 | |||||
| Ear loop: | |||||
| 12234-64-9 |
Technological Characteristic Comparison
The proposed device is the same as or similar to the predicate device in term of the intended use, design and construction, and performance characteristics.
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K210422 | K210218 | |
| Name | INTAI Surgical Mask | ||
| (non-sterile) | Surgical Mask | ||
| Model | 9W001200 | ||
| 9W001201 | C015 | ||
| Classification | Class II Device, FXX | ||
| (21CFR878.4040) | Class II Device, FXX | ||
| (21CFR878.4040) | Identical | ||
| Intended use / | |||
| Indications for Use | INTAI Surgical Mask is | ||
| intended to be worn by operating | |||
| room personnel and other | |||
| general healthcare workers to | |||
| protect both patients and | |||
| healthcare workers against | |||
| transfer of microorganisms, | |||
| blood and body fluids, and | |||
| particulate materials. This is a | |||
| single use, disposable device and | |||
| provided non-sterile. | The Surgical Mask is intended to | ||
| be worn to protect both the | |||
| patient and healthcare personnel | |||
| from the transfer of | |||
| microorganisms, body fluids and | |||
| particulate material. The face | |||
| mask is intended for use in | |||
| infection control practices to | |||
| reduce the potential exposure to | |||
| blood and body fluids. This is | |||
| Identical a single use, disposable | |||
| device(s), provided non-sterile. | Identical | ||
| Material | |||
| Outer Layer | Non-woven fabric | ||
| (Polypropylene) | Non-woven fabric | ||
| (Polypropylene) | Identical | ||
| Middle Layer | Melt blown fabric | ||
| (Polypropylene) | Melt blown fabric | ||
| (Polypropylene) | Identical | ||
| Inner Layer | Non-woven fabric | ||
| (Polypropylene) | Non-woven fabric | ||
| (Polypropylene) | Identical | ||
| Nose Clip | PE plastic | Iron strip and Polypropylene | Different |
Table 1 General Comparison
5
Image /page/5/Picture/1 description: The image shows the logo for INTAI. The logo is blue and yellow. The word "INTAI" is written in blue, with a yellow circle above the "i". There are some curved lines to the left of the word "INTAI". There is a reflection of the logo below it.
| Ear loop | Nylon | Polyester and Spandex | Similar |
|---|---|---|---|
| Mask Style | Flat Pleated | Flat Pleated | Identical |
| Color | Blue | Blue | Identical |
| Dimension | |||
| (Length × | |||
| Width) | $175 \pm 5 \text{ mm } \times 95 \pm 5 \text{ mm}$ | $175 \pm 5 \text{ mm } \times 95 \pm 5 \text{ mm}$ | Identical |
| OTC | Yes | Yes | Identical |
| Sterility | Non-Sterile | Non-Sterile | Identical |
| Use | Single use, disposable | Single use, disposable | Identical |
| Performance Testing (see Table 2) | |||
| ASTM F2100 | |||
| Level | Level 3 | Level 3 | Identical |
| Resistance to | |||
| Penetration | |||
| by Synthetic | |||
| Blood | Meet ASTM F1862 | Meet ASTM F1862 | Identical |
| Sub-Micron | |||
| Particle | |||
| Filtration | |||
| Efficiency | Meet ASTM F2299 | Meet ASTM F2299 | Identical |
| Differential | |||
| Pressure | Meet EN 14683: 2019, Annex C | Meet EN 14683: 2019, Annex C | Identical |
| Bacterial | |||
| Filtration | |||
| Efficiency | Meet ASTM F2101 | Meet ASTM F2101 | Identical |
| Flammability | Meet 16 CFR 1610 | Meet 16 CFR 1610 | Identical |
| Biocompatibility | Non-cytotoxic, Non-sensitizing, | ||
| nonirritating | Non-cytotoxic, Non-sensitizing, | ||
| nonirritating | Identical |
Table 2 Comparison of Performance testing
| Item | Proposed device
(K210422)
Blue | Predicate device
(K210218) | Acceptance criteria
(Level 3) | Result |
|-------------------------------------------------------|--------------------------------------|--------------------------------|-------------------------------------------------------|--------|
| Resistance to
Penetration
by Synthetic
Blood | Achieve a 4% AQL
at 160mmHg | Achieve a 4% AQL
at 160mmHg | Achieve a 4% AQL
(29 out of 32 pass at
160mmHg) | Pass |
| Sub-Micron
Particle
Filtration
Efficiency | ≥98% | ≥98% | ≥98% | Pass |
| Differential
Pressure |