(412 days)
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 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.
This document is a 510(k) premarket notification for a medical device, specifically the INTAI Surgical Mask. It details the device's characteristics and its comparison to a legally marketed predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document presents the acceptance criteria and performance results directly in Table 2: Comparison of Performance testing on page 5 and the subsequent Summary of Non-Clinical Test table on page 6.
| Item | Reported Device Performance (K210422) | Acceptance Criteria (Level 3) | Result |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood | Achieve a 4% AQL at 160mmHg | Achieve a 4% AQL (29 out of 32 pass at 160mmHg) | Pass |
| Sub-Micron Particle Filtration Efficiency (PFE) | ≥98% | ≥98% | Pass |
| Differential Pressure | <6.0 mm H2O/cm$^2$ | <6.0 mm H2O/cm$^2$ | Pass |
| Bacterial Filtration Efficiency (BFE) | ≥98% | ≥98% | Pass |
| Flammability | Class 1 (Did Not Ignite (DNI)) | Class 1 (Did Not Ignite (DNI)) | Pass |
| In Vitro Cytotoxicity Test | No cell lysis, no reduction of cell growth | No cell lysis, no reduction of cell growth | Pass |
| Skin Irritation Test | Non-irritant | Non-irritant | Pass |
| Skin Sensitization Test | No visible change | No visible change | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size for Resistance to Penetration by Synthetic Blood: "29 out of 32 pass at 160mmHg" indicates a sample size of 32 units for this specific test.
- Sample Size for other tests: The document generally states "Non-Clinical tests were conducted to verify that the proposed device met all design specifications" and lists the relevant ASTM/ISO standards. However, the exact sample sizes for each of the other performance tests (BFE, PFE, Differential Pressure, Flammability, Cytotoxicity, Irritation, Sensitization) are not explicitly provided in this summary document.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that "Non-Clinical tests were conducted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this document. The device is a surgical mask, and its acceptance criteria are based on standardized performance tests (e.g., filtration efficiency, fluid resistance, flammability, biocompatibility), not on expert subjective assessment of medical images or clinical outcomes. The "ground truth" is established by the test methods themselves and their specified thresholds.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation where multiple human readers assess cases and a consensus or tie-breaking mechanism is needed to establish ground truth or evaluate reader performance. For the physical and biological performance tests described for a surgical mask, the results are quantitative measurements or direct observations (e.g., "Pass/Fail," "Class 1," "≥98%"), not subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. This document is for a physical medical device (surgical mask), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a surgical mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The 'ground truth' for this device is based on standardized laboratory test results against established performance criteria, as defined by various national and international standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define the methodologies and acceptance thresholds for properties like bacterial filtration efficiency, particulate filtration efficiency, fluid resistance, differential pressure, flammability, cytotoxicity, and irritation.
8. The sample size for the training set
This section is not applicable. The device is a physical product (surgical mask) that undergoes performance testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set for a physical device.
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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
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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
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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)
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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.3011187779No.9 Jingke Rd., Nantun District, Taichung City, Taiwan, R.O.C.Tel. +886 4 23595336Fax.+886 4 36013076 |
|---|---|
| Contact Person | Kevin Wang |
| Date Prepared | March 25th, 2022 |
| Device Name | INTAI Surgical Mask (non-sterile) |
| ClassificationsProduct Codes | Class II, 21 CFR 878.4040 - Surgical apparel.FXX |
| Predicate DevicesInformation | K210218SURGICAL MASK, Model Name:C015Qingdao 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 roompersonnel and other general healthcare workers to protect bothpatients and healthcare workers against transfer ofmicroorganisms, 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-pleatedmasks with ear loops, and nose clip. The inner and outer layers aremade of Non-woven fabric (Polypropylene), and the middle filterlayer is made of a melt blown fabric (Polypropylene).The ear loops welded are used to keep the mask close to the mouth andthe nose. The ear loops are made of Nylon. The nose clip, which ismade by plasticity material (HDPE), contained in masks is in thelayers of the surgical mask to allow the users to fit the facemaskaround their nose.The surgical mask are provided in one color (blue), non-sterile andintended to be single use, disposable device. |
Detailed information of the blue color Surgical Masks, please see the table below.
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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 |
|---|---|---|---|---|---|
| 9W001200ASTM Level3 | Blue50 pcs/box | Outer: 35gNon-wovenMiddle: 25gMelt BlownInner: 20g Non-woven | plasticitymaterial(HDPE)CAS#9002-88-4 | NylonCAS#25038-54-4 | Outer Layer:147-14-8980-26-784632-65-5Ear loop:12234-64-9 |
| 9W001201ASTM Level3 | Blue30 pcs/box | Outer: 35gNon-wovenMiddle: 25gMelt BlownInner: 20g Non-woven | plasticitymaterial(HDPE)CAS#9002-88-4 | NylonCAS#25038-54-4 | Outer Layer:147-14-8980-26-784632-65-5Ear 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 | 9W0012009W001201 | C015 | |
| Classification | Class II Device, FXX(21CFR878.4040) | Class II Device, FXX(21CFR878.4040) | Identical |
| Intended use /Indications for Use | INTAI Surgical Mask isintended to be worn by operatingroom personnel and othergeneral healthcare workers toprotect both patients andhealthcare workers againsttransfer of microorganisms,blood and body fluids, andparticulate materials. This is asingle use, disposable device andprovided non-sterile. | The Surgical Mask is intended tobe worn to protect both thepatient and healthcare personnelfrom the transfer ofmicroorganisms, body fluids andparticulate material. The facemask is intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This isIdentical a single use, disposabledevice(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
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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 F2100Level | Level 3 | Level 3 | Identical |
| Resistance toPenetrationby SyntheticBlood | Meet ASTM F1862 | Meet ASTM F1862 | Identical |
| Sub-MicronParticleFiltrationEfficiency | Meet ASTM F2299 | Meet ASTM F2299 | Identical |
| DifferentialPressure | Meet EN 14683: 2019, Annex C | Meet EN 14683: 2019, Annex C | Identical |
| BacterialFiltrationEfficiency | 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 toPenetrationby SyntheticBlood | Achieve a 4% AQLat 160mmHg | Achieve a 4% AQLat 160mmHg | Achieve a 4% AQL(29 out of 32 pass at160mmHg) | Pass |
| Sub-MicronParticleFiltrationEfficiency | ≥98% | ≥98% | ≥98% | Pass |
| DifferentialPressure | <6.0 | <6.0 | <6.0 | Pass |
| BacterialFiltrationEfficiency | ≥98% | ≥98% | ≥98% | Pass |
| Flammability | Class 1 | Class 1 | Class 1 | Pass |
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Image /page/6/Picture/1 description: The image shows the logo for INTAI. The logo consists of a blue letter "i" with a yellow dot above it, followed by the word "INTAI" in blue. The logo has a reflection below it.
| Summary of Non-Clinical Test | 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 | |||
|---|---|---|---|---|
| Test Method | PurposeApplied Standards | Acceptancecriteria | Results | |
| BacterialFiltrationEfficiency(BFE) Testing | Determine thebacterial filtrationefficiencyASTM F2100 9.1ASTM F2101-2019 | ≥98 % | PASS | |
| DifferentialPressureTesting | Determine breathingresistance ordifferential pressureASTM F2100 9.2EN 14683:2019Annex C | <6.0 mmH2O/cm2 | PASS | |
| Sub-micronparticulate | Determineparticulate filtration | ≥98 % | PASS | |
| (PFE)efficiencyTesting | ASTM F2100 9.3ASTM F2299-2017 | |||
| SyntheticbloodpenetrationTesting | Determine syntheticblood penetrationresistanceASTM F2100 9.4ASTM F1862-2017 | 160 mmHg | PASS | |
| FlammabilityTesting | DetermineflammabilityASTM F2100 9.5CPSC 16 CFR1610-2008 | Did NotIgnite (DNI) | PASS | |
| In VitroCytotoxicityTest | The aim was toinvestigate thecytotoxic effectISO 10993-5 | No cell lysis,no reductionof cell growth | PASS | |
| Skin IrritationTest | Evaluate thepossibility of irritantreactionISO 10993-10 | Non-irritant | PASS | |
| SkinSensitizationTest | Evaluate thepossibility ofdelayedhypersensitivityISO 10993-10 | No visiblechange | PASS |
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Image /page/7/Picture/1 description: The image shows the logo for INTAI. The logo consists of a stylized "i" with a yellow circle above it and blue curved lines within the lower part of the "i". To the right of the "i" is the word "INTAI" in blue, block letters. The logo has a glossy effect, suggesting it may be used in digital media.
| Summary of Clinical Test | Clinical testing is not required. | |
|---|---|---|
| Conclusion | The conclusion drawn from the nonclinical tests demonstrate thatthe devices are as safe, as effective, and perform as well as orbetter than the legally marketed predicate device,K210218Qingdao Hainuo Biological Engineering Co., LtdSurgical Mask. |
§ 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.