(42 days)
The TAIJI Professional Series Level 3 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 intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single use, disposable device, provided non-sterile.
The TAIJI Professional Series Level 3 Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided nonsterile.
This document pertains to the 510(k) premarket notification for a medical device: TAIJI Professional Series Level 3 Surgical Face Mask (K211861).
The acceptance criteria and study proving the device meets these criteria are outlined in the "Summary of Non-Clinical Testing" section.
Here's the breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard/Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood | Barrier Testing | At least 29 out of 32 specimens show passing results at 160 mmHg | Samples met the predetermined acceptance criteria. |
| ASTM F2101-19: Standard Specification for Performance of Materials Used in Medical Face Masks | Barrier Testing | ≥98% | Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each). |
| EN 14683:2019 Annex C and ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks | Physical Testing | <6.0 mm H2O/cm² | Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each). |
| ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks | Barrier Testing | ≥98% | Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each). |
| 21 CFR 1610 | Safety Testing | Class 1, Does not ignite | Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each). |
| ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Safety Testing | Non-cytotoxic | Fail (The document states "Fail" for this specific test. However, the comparative table on page 4 notes "Fail - Acute Systemic Study was recommended by 3PR and agreed upon by FDA" for the subject device's cytotoxicity, while the predicate was Non-cytotoxic. The "Summary of Non-Clinical Testing" then states "Pass No systemic toxicity: device is not toxic" for ISO 10993-11 for the subject device. This implies that while the initial cytotoxicity test might have failed, a systemic toxicity test (ISO 10993-11) was subsequently conducted successfully as an alternative or follow-up to address the concern.) |
| ISO 10993-11: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Safety Testing | Under conditions of the study, the device is non-cytotoxic | Pass (No systemic toxicity: device is not toxic). This likely addresses the initial "Fail" from ISO 10993-5. |
| ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Safety Testing | Non-irritating | Pass |
| ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Safety Testing | Non-sensitizing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates the following sample sizes for the test set (non-clinical testing):
- For barrier and physical testing (ASTM F1862, ASTM F2101-19, EN 14683:2019, ASTM F2100-19, 21 CFR 1610 Flammability): "96 Samples, 3 non-consecutive lots of 32 each" are consistently reported as meeting acceptance criteria.
- For biocompatibility testing (ISO 10993-5, ISO 10993-11, ISO 10993-10): The specific sample sizes are not explicitly stated in the provided text, but testing was performed according to the ISO standards.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond stating that they are non-clinical tests typically performed in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document is for a medical device (surgical face mask) and the testing described is non-clinical performance and safety testing (e.g., fluid resistance, particulate filtration, flammability, biocompatibility).
Therefore, the concept of "experts used to establish the ground truth" in the context of clinical decision-making (like radiologists for image interpretation) is not applicable here. The ground truth is established through standardized laboratory test methods and their defined acceptance criteria.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation (e.g., medical image reading) where there might be inter-reader variability.
Since this document describes non-clinical, quantitative laboratory testing of a physical device, an adjudication method is not applicable. The results are based on objective measurements against pre-defined ASTM/ISO standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. These types of studies are relevant for AI/CADe systems that assist human readers in interpreting medical images or data. The device here is a surgical face mask, and the studies are non-clinical performance and safety tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is a physical medical device (a surgical face mask), not a software algorithm. Therefore, the concept of "standalone performance" without human-in-the-loop does not apply in the context of an algorithm. The device's performance is measured directly through laboratory testing.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective measurements under standardized test methods (ASTM, EN, ISO, CFR standards). These standards define the parameters and acceptance criteria for surgical masks (e.g., fluid resistance, bacterial filtration efficiency, differential pressure, flammability, biocompatibility).
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device. The concepts of "training set" and "validation set" are used in machine learning and artificial intelligence model development. This document describes the testing of the manufactured face mask according to established regulatory standards, not the training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As explained above, this concerns a physical device, not an AI or machine learning model.
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Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 28,2021
Taiji Medical Supplies, Inc. % Abdel Halim President, Global and Regulatory Affairs Global Quality and Regulatory Services 10 Scenic Way Monroe, New Jersey 08831
Re: K211861
Trade/Device Name: TAIJI Professional Series Level 3 Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 21, 2021 Received: July 23, 2021
Dear Abdel Halim:
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
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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,
For Clarence W. Murray, III, PhD 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
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Indications for Use
510(k) Number (if known) K211861
Device Name
TAIJI Professional Series Level 3 Surgical Face Mask
Indications for Use (Describe)
The TAIJI Professional Series Level 3 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 intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single use, disposable device, 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 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for TAJI Medical Supplies. The logo consists of the letters "TMS" in blue, with the words "TAJI Medical Supplies" in a smaller font below. To the right of the letters is a red graphic that looks like two curved lines. The logo is simple and professional, and the colors are eye-catching.
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submissions, Issued March 5, 2004 (corrected July 14, 2004).
1. Device and Company Details:
510(k) Number: K211861
| Submitter / OwnerTaiji Medical Supplies, Inc.3211 Progress DriveLincolnton, NC 28092T: (828) 310-2802E: tiffany@taijimedical.com | Contact PersonMs. Katherine L. Giannamore, Esq.Shehadeh Giannamore, PLLC396 Alhambra Circle, Suite 100ACoral Gables, FL 33134T: (305) 507-9843E: katherine@sglawfl.com |
|---|---|
| Date of Preparation of this Summary: | June 10, 2021 |
| Device Trade or Proprietary Name: | TAIJI Professional Series Level 3 SurgicalFace Mask |
| Device Common/Usual Name: | Surgical Mask |
| Regulation Name/Device Class/Product Code: | Surgical Apparel/Class II/FXX |
| Predicate Device Name/K Number: | Premier Guard USA 3 Layer Ear LoopASTM Level 3 Surgical Face Mask/K202595 |
- Device Description: The TAIJI Professional Series Level 3 Surgical Face Mask is in accordance with the FDA Guidance Document, Surgical Masks - Premarket Notification [510K)] Submissions issued on March 5, 2004. TAIJI Professional Series Level 3 Surgical Face mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene).
The mask is a single use, disposable device, provided nonsterile.
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Image /page/4/Picture/0 description: The image contains the logo for TAJI Medical Supplies. The logo consists of the letters "TMS" in blue, with the words "TAJI Medical Supplies" in a smaller font below. To the right of the letters are two red curved lines that resemble a stylized heartbeat or wave pattern. The logo is simple and modern, with a clear emphasis on the company's name and medical focus.
Intended Use: The TAIJI Professional Series Level 3 Surgical Face Mask is a non- sterile, single-use, disposable mask, intended to be worn in healthcare and surgical procedures.
3. Technological Characteristics Comparison:
The following is a summary of the technological characteristics of the TAIJI Professional Series Level 3 Surgical Face Mask as compared to the predicate device.
| Items | Subject DeviceTAIJIProfessionalSeries Level 3Surgical FaceMask | Predicate DeviceK202595 | Comparison | ||
|---|---|---|---|---|---|
| Manufacturer | TAIJI MedicalSupplies, Inc. | Premier GuardUSA, LLC | N/A | ||
| 510(k) Number | K211861 | K202595 | N/A | ||
| FDA Product Code | FXX | FXX | Same | ||
| Indications for Use | The TAIJIProfessionalSeries Level 3Surgical FaceMasks areintended to beworn to protectboth the patientand healthcarepersonnel fromtransfer ofmicroorganisms,body fluids andparticulatematerial. Theseface masks areintended for usein infectioncontrol practicesto reduce thepotentialexposure toblood and bodyfluid. This is asingle use,disposabledevice, providednon-sterile | The PremierGuard USA 3Layer Ear LoopASTM Level 3Surgical FaceMasks areintended to beworn to protectboth the patientand healthcarepersonnel fromtransfer ofmicroorganisms,body fluids andparticulatematerial. Theseface masks areintended for use ininfection controlpractices toreduce thepotential exposureto blood and bodyfluid. This is asingle use,disposable device,provided non-sterile | Same | ||
| Inner and OuterLayers | Spun-bondpolypropylene | Spun-bondpolypropylene | |||
| Materials | Middle Layer | Melt blownpolypropylenefilter | Melt blownpolypropylenefilter | Same | |
| Ear Loops | Polyester withSpandex inner-core | Nylon andSpandex | Similar | ||
| Nose Piece | Malleablepolyethylenewith aluminumwire | Polyethylenelaminated softannealed carbonsteel wire | Similar | ||
| Dimensions | 17.5cm length x9.5cm height | 17.5cm length x9.5cm height | Same | ||
| Mask Style | Flat Pleated | Flat Pleated | Same | ||
| Design Features | Malleablenosepiece, flat-pleated elasticear loops | Malleablenosepiece, flat-pleated elastic earloops | Same | ||
| Sterility | Non-sterile | Non-sterile | Same | ||
| Use | Single Use,Disposable | Single Use,Disposable | Same | ||
| Color | Blue and White | Blue and White | Same | ||
| ASTM F2100 Level | Level 3 | Level 3 | Same | ||
| Biocompatibility | |||||
| Cytotoxicity | Underconditions of thestudy,thedeviceconsidered iscytotoxic (neatand 1:2 extractswere scored 3) | Under conditionsof the study, thedevice is Non-cytotoxic | Fail -Acute SystemicStudy wasrecommendedby 3PR andagreed upon byFDA | ||
| Systemic Study / SystemicInjection Test / ISO GLP ISO10993-11:evaluation of medical devices- Part 11: Tests for systemictoxicity | Underconditions of thestudy,thedevice is non-cytotoxic | N/A | PassNo systemictoxicity: deviceis not toxic | ||
| Irritation | Underconditions of thestudy,thedevice is Non-irritating | Under conditionsof the study, thedevice is Non-irritating | |||
| Sensitization | Underconditions of thestudy, thedevice is Non-sensitizing | Under conditions ofthe study, thedevice is Non-sensitizing | Same | ||
| Fluid Resistance Performance(mmHg) | Pass at 160mmHg | Pass at 160mmHg | Same | ||
| Particulate Filtration EfficiencyPerformance (%) | Pass at ≥98% | Pass at ≥98% | Same | ||
| Bacterial Filtration EfficiencyPerformance (%) | Pass at ≥98% | Pass at ≥98% | Same | ||
| Differential Pressure (Delta-P) (mm H O/cm ) | Pass at ≤6.0 | Pass at <6.0 | Same | ||
| Flammability classClass 1 | Pass Class 1 | Pass Class 1 | Same |
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Image /page/5/Picture/0 description: The image shows the logo for TMS, which likely stands for TAUi Medical Supplies. The letters 'TMS' are in bold, blue font, with 'TAUi Medical Supplies' written in a smaller font underneath. To the right of the letters is a red graphic that resembles two curved lines, possibly representing a medical symbol or a stylized design element.
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Image /page/6/Picture/0 description: The image shows the logo for TAJI Medical Supplies. The logo has the letters "TMS" in blue, with the words "TAJI Medical Supplies" in a smaller font below the letters. To the right of the letters is a red graphic that looks like two curved lines, possibly representing a medical symbol. The logo is simple and professional, and the colors are eye-catching.
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Image /page/7/Picture/0 description: The image contains the logo for TMS, which stands for TAUI Medical Supplies. The letters "TMS" are in a bold, sans-serif font and are colored blue. Below the letters, the words "TAUI Medical Supplies" are written in a smaller, lighter font. To the right of the letters, there are two curved, red shapes that resemble waves or swooshes.
4. Summary of Non-Clinical Testing
Per FDA document Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submissions, the below testing has been completed on the subject device:
| Standard/Test Methodology | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|
| ASTM F1862: Standard TestMethod for Resistance ofMedical Face Masks toPenetration by SyntheticBlood | Barrier Testing | At least 29out of 32 specimensshow passingresults at 160mmHg | Samples metthepredetermined acceptancecriteria |
| ASTM F2101-19: StandardSpecification forPerformance of MaterialsUsed in Medical FaceMasks | Barrier Testing | ≥98% | Samples metthepredetermined acceptancecriteria96 Samples,3 non-consecutivelots of 32each |
| EN 14683:2019 Annex Cand ASTM F2100-19:Standard Specification forPerformance of MaterialsUsed in Medical FaceMasks | Physical Testing | <6.0 mmH2O/cm² | Samples metthepredetermined acceptancecriteria96 Samples,3 non-consecutivelots of 32each |
| ASTM F2100-19: StandardSpecification forPerformance of MaterialsUsed in Medical FaceMasks | Barrier Testing | ≥98% | Samples metthepredetermined acceptancecriteria96 Samples,3 non-consecutive |
| lots of 32each | |||
| 21 CFR 1610 | Safety Testing | Class 1, Does notignite | Samplesmet thepredeterminedacceptancecriteria96 Samples,3 non-consecutivelots of 32each |
| ISO 10993-5: Biologicalevaluationofmedicaldevices - Part 5: Testsfor in vitro cytotoxicity | Safety Testing | Non-cytotoxic | Fail |
| ISO 10993-11: Biologicalevaluation of medicaldevices - Part 11: Tests forsystemic toxicity | Safety Testing | Under conditions ofthe study, the deviceis non- cytotoxic | PassNo systemictoxicity: deviceis not toxic |
| ISO 10993-10: Biologicalevaluation of medicaldevices - Part 10: Testsfor irritation and skinsensitization | Safety Testing | Non-irritating | Pass |
| ISO 10993-10: Biologicalevaluationofmedicaldevices - Part 10: Testsfor irritation andskin sensitization | Safety Testing | Non- sensitizing | Pass |
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Image /page/8/Picture/0 description: The image shows the logo for TAUI Medical Supplies. The logo consists of the letters "TMS" in blue, with the words "TAUI Medical Supplies" in a smaller font below. To the right of the letters is a red graphic that resembles two curved lines. The logo is simple and professional, and the colors are eye-catching.
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Image /page/9/Picture/0 description: The image shows the logo for TMS, which likely stands for TAUI Medical Supplies. The letters "TMS" are in bold, blue font, with the words "TAUI Medical Supplies" in a smaller font underneath. To the right of the letters is a red graphic that looks like two curved lines, possibly representing a flag or a medical symbol. The logo is simple and professional, suggesting a reliable and trustworthy company.
5. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device K211861 TAIJI Medical Professional Series Level 3 Surgical Face Mask is as safe, as effective and performs as well or better than the legally marketed predicate device, K202595 Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face 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.