(218 days)
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. This device is intended for Adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile.
UNIWEB SURGICAL MASK are 3-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer and middle layer, and is provided with ear loops and nose wire for individualized fit.
The provided text describes the acceptance criteria and the study results for the UNIWEB Surgical Mask, a medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose of the Test | Acceptance Criteria (Level 1) | Reported Performance (UNIWEB Surgical Mask - Level 1) | Acceptance Criteria (Level 2) | Reported Performance (UNIWEB Surgical Mask - Level 2) |
|---|---|---|---|---|---|
| Bacteria Filtration Efficiency | Determine bacterial filtration efficiency as directed in ASTM F2101 | ≥ 95 % | 96/96 (3 lots) passed at ≥ 99% | ≥ 98 % | 96/96 (3 lots) passed at ≥ 99% |
| Particle Filtration Efficiency | Determine particulate filtration efficiency as directed in ASTM F2299 | ≥ 95 % | 96/96 (3 lots) passed at ≥ 99% | ≥ 98 % | 96/96 (3 lots) passed at ≥ 99% |
| Differential Pressure (Delta-P) | Determine breathing resistance/differential pressure as directed in EN 14683:2019, Annex C | < 5.0 mmH₂O/cm² | 96/96 (3 lots) show 3.6-4.2 H₂O/cm², pass at < 5.0 H₂O/cm² | < 6.0 mmH₂O/cm² | 96/96 (3 lots) show 3.6-4.2 H₂O/cm², pass at < 6.0 H₂O/cm² |
| Resistance to Penetration by Synthetic Blood | Determine synthetic blood penetration resistance as specified in Test Method F1862 | 80 mmHg (≥ 29/32 show passing results per lot) | 96/96 (3 lots) passed at 80 mmHg | 120 mmHg (≥ 29/32 show passing results per lot) | 95/96 (3 lots) passed at 120 mmHg |
| Flammability | Determine flammability as specified in 16 CFR Part 1610 | Class I (Burn time ≥ 3.5 s, IBE, or DNI) | 96/96 (3 lots) show IBE, passed at class I | Class I (Burn time ≥ 3.5 s, IBE, or DNI) | 96/96 (3 lots) show IBE, passed at class I |
Biocompatibility Testing:
| Test Methodology | Purpose of the Test | Acceptance Criteria | Test Results |
|---|---|---|---|
| In vitro Cytotoxicity test | Determine the effects on cells following ISO 10993-5 | Cell viability of 100% test article extract is ≥ 70% of control group | Passed |
| Skin sensitization Test | Estimate the potential for contact sensitization following ISO 10993-10 | Grades = 0 | Passed |
| Skin Irritation Test | Estimate the irritation potential of medical device following ISO 10993-10 | Mean score 0-0.4 (Negligible) | Passed |
2. Sample size used for the test set and the data provenance:
- Sample Size: The non-clinical tests used "3 lots" of the UNIWEB Surgical Mask for evaluation. For each test, results are reported as "96/96 (3 lots)" or "95/96 (3 lots)" indicating the number of successful samples out of a total of 96 samples across the 3 lots.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, the manufacturer is listed as "UNIVERSAL INCORPORATION, Zhongshan Dist., Taipei City, 10446, Taiwan," which suggests the testing was likely conducted in or overseen by entities associated with Taiwan. The nature of the tests (non-clinical, standard laboratory tests for medical devices) means the data provenance is less about patient demographics and more about adherence to international testing standards (ASTM, EN, ISO, CFR). The data is retrospective in the sense that the tests were completed and the results compiled for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes non-clinical performance and biocompatibility testing for a surgical mask. No human experts were used to establish ground truth in the way they would for diagnostic imaging or clinical trials. The "ground truth" for these tests is defined by the objective performance standards and methodologies outlined in the referenced international standards (e.g., ASTM F2101 for Bacterial Filtration Efficiency, ISO 10993 for Biocompatibility). The tests themselves provide the objective data.
4. Adjudication method for the test set:
- Given that these are non-clinical, objective laboratory tests against pre-defined international standards, there was no adjudication method as typically applied in studies involving human interpretation or clinical outcomes (e.g., 2+1, 3+1). The results are quantitative and directly compared against the numerical acceptance criteria.
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:
- No MRMC comparative effectiveness study was done. This submission is for a physical medical device (surgical mask) and not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- As this is a physical medical device (surgical mask), no standalone algorithm performance study was conducted.
7. The type of ground truth used:
- The "ground truth" for the performance tests consists of objective, quantitatively measurable properties of the mask as defined by recognized international standards and test methodologies (e.g., ASTM F2101, ASTM F2299, EN 14683, ASTM F1862, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards themselves serve as the basis for determining whether the device "meets" its intended performance.
8. The sample size for the training set:
- This is a submission for a physical medical device. There is no "training set" in the context of machine learning or AI. The product undergoes manufacturing and quality control, and then specific production lots are sampled for performance validation testing.
9. How the ground truth for the training set was established:
- As there is no "training set" in the AI sense for this device, this question is not applicable. The design and manufacturing process would be guided by the requirements of the standards, and then validated by the non-clinical tests described.
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September 29, 2021
Universal Incorporation % Tyra Chiu Regulatory Consultant VOLER Biotech Consulting Co., Ltd. 1 Ft, No 3-1, Ln. 58, Hejiang St., Zhongshan Dist. Taipei, 72548 Taiwan
Re: K210513
Trade/Device Name: UNIWEB Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 13, 2021 Received: August 31, 2021
Dear Tyra Chiu:
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.
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210513
Device Name UNIWEB Surgical Mask
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. This device is intended for Adult use Only. The UNIWEB Surgical Masks are single use, disposable device, 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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510(k) Summary
Date September 29, 2021
| Manufacturer/ | UNIVERSAL INCORPORATION10F., No.372 Linsen N. Rd.,Zhongshan Dist.,Taipei City10446,Taiwan |
|---|---|
| Contact Person | Mei-Hui HuangPhone: +886-2-25119161E-mail: uk@uk.com.tw |
| Device Trade Name | UNIWEB Surgical Mask |
| Common Name | Surgical Masks |
| Classification Name | Masks, Surgical |
| Device Class | II |
| Classification Panel | General & Plastic Surgery |
| Regelation Number | 878.4040 |
| Product Code | FXX |
| Device Description | UNIWEB SURGICAL MASK are 3-layer surgical masks |
that covers and Technology the user's nose and mouth and provides a physical barrier to fluids Characteristics and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer and middle layer, and is provided with ear loops and nose wire for individualized fit.
Models ASTM Level 1, ASTM Level 2
- The Surqical Mask is intended to be worn to protect both the Indications for Use patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile.
Predicate Device(s) K141085 WestTec Procedure Facemask, WestTec Surgical Facemask/ WESTTEC, LLC
| Proposed Device | Predicate Device | Comparison | |
|---|---|---|---|
| Device Name | UNIWEB Surgical Mask | WestTec Procedure Facemask,WestTec Surgical Facemask | - |
| 510(k) # | K210513 | K141085 | - |
| Applicant | Universal Incorporation | WESTTEC, LLC | - |
| Product code | FXX (21 CFR 878.4040) | FXX (21 CFR 878.4040) | Same |
| Classification | II | II | Same |
| OTC use | YES | YES | Same |
| Intended Use | The Surgical Mask is intendedto be worn to protect both thepatient and healthcarepersonnel from the transfer ofmicroorganisms, body fluidsand particulate material. Thisdevice is intended for adult useOnly. The UNIWEB SurgicalMasks are single use,disposable device, providednon-sterile. | WestTec Procedure andSurgical facemasks areintended to be worn byhealthcare workers to protectthe user and patient againsttransfer of microorganisms,blood and body fluids, andairborne particulates. TheWestTec Procedure andSurgical facemasks are singleuse, disposable devicesprovided non-sterile. | Same |
| Dimensions | 175 mm x 95 mm | 175 mm x 90 mm | Similar |
| Layers | Three | Three | Same |
| Mask Style | Flat-pleated | Flat-pleated | Same |
| Design Feature | Ear loops | Ear loops | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| Material: | Surface Layer: PolypropyleneSpunbondMiddle Layer: PolypropyleneMeltblownBottom Layer: PolypropyleneSpunbondNose Wire: galvanized ironwire covered with polyethyleneEar Loops: Nylon and Spandex | Outer Layer: spunbondpolypropylene.Middle Layer: meltblownpolypropylene filter media.Inner Layer: spunbondpolypropylene.Earloops are soft non naturalrubber latex,elastic loops.Nose Band: steel wiresencased in polyethylene | similar |
| Fluid Resistance(ASTM F1862) | Pass at 80 mmHg,Pass 120 mmHg | Pass at 120 mmHg | Same |
| Bacterial FiltrationEfficiency (ASTM F2101) | ≥ 99.8 % | 99.7 % | Same. Meet Level 2requirement |
| Differential Pressure(Mil-M-36954C) | $3.6{\sim}4.2$ mmH2O/cm² | $3.3{\sim}3.6$ mmH2O/cm² | Same. Meet Level 2requirement |
| Particle FiltrationEfficiency(ASTM F2299) | $99.74{\sim}99.95$ % (at 0.1microgram) | 98 % | Same. Meet Level 2requirement |
| Flammability(16 CFR 1610) | Class I | Class I | Same |
| Biocompatibility(ISO 10993-5, -10) | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Same |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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Discussion on Performance Data Non-Clinical Tests
The proposed devices were 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.
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Non-Clinical Testing Summary:
| Test Methodology | Purpose of the test | F2100-19Level 1Requirement | F2100-19Level 2Requirement | UNIWEBSurgical MaskTest ResultLevel 1 | UNIWEBSurgical MaskTest ResultLevel 2 |
|---|---|---|---|---|---|
| Bacteria FiltrationEfficiency | Determine the bacterialfiltration efficiency asdirected in Test MethodASTM F2101. | ≥ 95 % | ≥ 98 % | 96/96 (3 lots)passed at ≥99% | 96/96 (3 lots)passed at ≥99% |
| Particle FiltrationEfficiency | Determine particulatefiltration efficiency asdirected in Test MethodF2299. | ≥ 95 % | ≥ 98 % | 96/96 (3 lots)passed at ≥99% | 96/96 (3 lots)passed at ≥99% |
| DifferentialPressure (Delta-P) | Determine breathingresistance or differentialpressure as directed inEN 14683:2019, AnnexC. | <5.0mmH2O/cm² | <6.0mmH2O/cm² | 96/96 (3 lots)show 3.6~4.2H2O/cm², pass at <5.0H2O/cm² | 96/96 (3 lots)show 3.6~4.2H2O/cm², passat <6.0H2O/cm² |
| Resistance topenetration bysynthetic blood,minimum pressurein mm Hg for passresult | Determine syntheticblood penetrationresistance as specifiedin Test Method F1862 | 80 mmHg(≥ 29/32 showpassing resultsper lot) | 120 mmHg(≥ 29/32 showpassing resultsper lot) | 96/96 (3 lots)passed at 80mmHg | 95/96 (3 lots)passed at 120mmHg |
| Flammability | Determine flammabilityas specified in 16 CFRPart 1610 | Class I(Burn time ≥3.5s, IBE, or DNI) | Class I(Burn time ≥3.5s, IBE, or DNI) | 96/96 (3 lots)show IBE,passed at class I | 96/96 (3 lots)show IBE,passed atclass I |
Biocompatibility Testing Summary:
| Test Methodology | Purpose of the test | Acceptance Criteria | Test Results |
|---|---|---|---|
| In vitro Cytotoxicitytest | Determine the effects on cellsfollowing ISO 10993-5 | Cell viability of 100%test article extract is ≥70% of control group | Passed. |
| Skin sensitization Test | Estimate the potential for contactsensitization following ISO 10993-10 | Grades =0 | Passed. |
| Skin Irritation Test | Estimate the irritation potential ofmedical device following ISO 10993-10 | Mean score 0~0.4(Negligible) | Passed. |
A shelf-life evaluation was conducted, and the test results demonstrate that the device maintain its performance in its claimed 3-year shelf life.
Discussion on Not applicable Clinical Test Performed
The subject device has same indications for use, technology,
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operation principle and technical characteristics with the predicate device(s). Verification activities were performed on subject device and all tests were verified to meet the required acceptance criteria. The non-clinical tests demonstrate that the differences in the devices do not affect the indications for use of the device or raise any unsolved issues. There are no significant differences between subject device and the predicate device(s) that would adversely affect the use of the product.
- Conclusion The conclusions drawn from the non-clinical tests demonstrate that the subject device, UNIWEB Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K141085, WestTec procedure facemask.
§ 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.