(264 days)
The LAITEST MEDICAL FACE MASK are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
LAITEST Surgical Face Mask are made of 3-layer non-woven material. The masks have a Bacterial Filtration Efficiency (BFE) and Particle Filtration Efficiency (PFE) Standards of 98%, and Virus Filtration Efficiency (VFE) Standards of 99%, which can effectively protect against sub-micron particles, fine dust, biological agents (bacteria, or viruses), and fluid splashes. The masks have ear loops and nose band which can provide a comfort wear for users.
The provided document is a 510(k) Premarket Notification for a surgical face mask (LAITEST Surgical Face Mask, K214035). This type of document focuses on demonstrating substantial equivalence to a previously cleared device, primarily through bench testing for safety and performance, rather than a clinical study involving human patients or complex AI algorithms.
Therefore, the requested information (sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, detailed ground truth establishment for AI, etc.) is not applicable to this submission, as it does not describe an AI medical device or a clinical study in the typical sense.
However, I can extract the acceptance criteria and performance data for the device based on the non-clinical (bench) tests performed.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
| Item | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Determine synthetic blood penetration resistance | ≥29 of 32 pass at 120 mmHg | Pass (≥29 of 32 pass at 120 mmHg) |
| Particulate Filtration Efficiency (ASTM F2299) | Determine the bacterial filtration efficiency | > 98% | Pass (≥ 98%) |
| Bacterial Filtration Efficiency (ASTM F2101) | Determine submicron particulate filtration efficiency | > 98% | Pass (≥ 98%) |
| Differential Pressure (Delta P) (EN 14683) | Determine breathing resistance or differential pressure | <6.0 mmH2O/cm² | Pass (<6.0 mmH2O/cm²) |
| Flammability (16 CFR Part 1610) | Determine flammability flame or spread | Class 1 | Pass (Class 1) |
Biocompatibility Testing:
| Item | Acceptance Criteria (Implied) | Reported Device Performance (Result) |
|---|---|---|
| Cytotoxicity | Noncytotoxic | Pass (device is noncytotoxic) |
| Sensitization | Non-sensitizing | Pass (device is non sensitizing) |
| Irritation | Non-irritating | Pass (device is nonirritating) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For Fluid Resistance: 32 samples (implied from "≥29 of 32 pass").
- For other tests (Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility): The specific sample size for each test is not explicitly stated, but these are typically standardized per test method (e.g., ASTM F2299, ASTM F2101).
- Data Provenance: Not specified, but generally, these are lab-based, non-clinical tests performed by the manufacturer or a contracted lab. The submitter is R&R Medical Corporation Ltd. from Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes performance testing of a physical medical device (surgical face mask) rather than an AI/ML diagnostic or assistive device that requires expert-established ground truth. The "ground truth" for these tests are the objective measurements against established international standards (ASTM, EN, CFR).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As mentioned above, this is for a physical device, not an AI output requiring human 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
- Not Applicable. No MRMC study was conducted as this is not an AI-assisted device for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no standalone algorithm or AI component discussed in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench Test Standards: The "ground truth" for this device's performance is based on established international and national standards for surgical masks. These standards define the methodology and criteria for evaluating properties like fluid resistance, filtration efficiency, breathability, flammability, and biocompatibility.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
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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.
September 13, 2022
R&R Medical Corporation Ltd. % Chih-Hao Kao Vice President Voler Biotech Consulting Co., Ltd. No. 3-1, Lane 58, Hejiang St., Zhongshan Dist. Taipei City, 10480 Taiwan
Re: K214035
Trade/Device Name: LAITEST Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 23, 2022 Received: August 31, 2022
Dear Chih-Hao Kao:
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 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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K214035
Device Name LAITEST MEDICAL FACE MASK
Indications for Use (Describe)
The LAITEST MEDICAL FACE MASK are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Type of Use (Select one or both, as applicable)
| Production Use: Part 21 CFR 601.2, Subpart E |
|---|
| Compassionate Use: Part 21 CFR 601.2, Subpart I |
| | 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
[As required by 21 CFR 807.92]
1. Submission Information
| Preparation date: | August 23th, 2022 |
|---|---|
| Submitter: | R&R Medical Corporation Ltd.No.4, Ln. 38, Zhongxing N. St., Sanchong Dist., New TaipeiCity 24158, Taiwan (R.O.C.) |
| Submitter contact: | Wilson ChangTel: +886-2-2697-6618/Fax: +886-2-2697-6609E-mail: wcchang@taiwanstanch.com |
| Official correspondent: | Chih Hao, KaoTel: + 886-933852972/Fax: + 886-78419003E-mail: leon.howard01@gmail.com |
2. Device Name and Classification
| Product Name: | LAITEST Surgical Face Mask |
|---|---|
| Classification Name: | Mask, Surgical |
| Common or Usual Name: | Surgical face mask |
| Regulation medical specialty: | General & Plastic Surgery |
| Regulation Description: | Surgical apparel. |
| Review Panel: | General Hospital |
| Regulation Number: | 21 CFR 878.4040 |
| Device Class: | Class 2 |
| Product Code: | FXX |
3. Primary Predicate Device(s)
| Product Name: | Surgical Face Mask (K182515) |
|---|---|
| Classification: | Class II |
| Common or Usual Name: | Surgical face mask |
| Classification Panel: | Surgical Apparel |
| Regulation Number: | 21 CFR 878.4040 |
| Device Class: | Class 2 |
| Product Code: | FXX |
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4. Device Description
LAITEST Surgical Face Mask are made of 3-layer non-woven material. The masks have a Bacterial Filtration Efficiency (BFE) and Particle Filtration Efficiency (PFE) Standards of 98%, and Virus Filtration Efficiency (VFE) Standards of 99%, which can effectively protect against sub-micron particles, fine dust, biological agents (bacteria, or viruses), and fluid splashes. The masks have ear loops and nose band which can provide a comfort wear for users.
5. Indications for Use
The LAITEST Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
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6. Substantial Equivalence
| Proposed Device | Primary predicatedeviceK182515 | Differences | ||
|---|---|---|---|---|
| Item | LAITEST SurgicalFace Mask | Surgical Face Mask | NA | |
| Classification | 2(21CFR878.4040) | 2(21CFR878.4040) | Same Classification | |
| Product Code | FXX | FXX | Same Product Code | |
| Indications for Use | The LAITESTSurgical Face Maskare intended to beworn to protect boththe patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infectioncontrol practices toreduce the potentialexposure to blood andbody fluids. This is asingle use, disposabledevice(s), providednon-sterile. | The Surgical FaceMasks are intended tobe worn to protectboth the patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided non-sterile. | Both devices aresurgical face maskand have sameintended use. | |
| Basic design | Ear Loops, FlatPleated, 3 layers | Ear Loops, FlatPleated, 3 layers | Same | |
| Proposed Device | Primary predicatedeviceK182515 | Differences | ||
| Item | LAITEST SurgicalFace Mask | Surgical Face Mask | NA | |
| Externallayer | Spun-bondpolypropylene | Spun-bondpolypropylene | Same | |
| Material | Filterlayer | Melt blown filter | Melt blownpolypropylene filter | Same |
| Innerlayer | Spun-bondpolypropylene | Spun-bondpolypropylene | Same | |
| Nose band | PE coating AluminumLine | Malleablepolyethylene wire | Different | |
| Ear loops | Nylon + Spandex | Spandex | Similar | |
| Color | Blue | Yellow | Different | |
| Dimension-Width | 17.5 cm ± 5% cm(0.875 cm) | 17.5cm±0.2cm | Similar | |
| Dimension-Length | 9.5 cm±5% cm(0.475 cm) | 9.5cm±0.2cm | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use,Disposable | Single Use,Disposable | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same |
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Performance Data
Non-clinical Test performed on the proposed device
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 issued on March 5, 2004.
| Item | Purpose | Proposed device | AcceptanceCriteria | Result |
|---|---|---|---|---|
| FluidResistancePerformanceASTM F1862 | Determinesyntheticbloodpenetrationresistance | ≥29 of 32 pass at120 mmHg | ≥29 of 32 pass at120 mmHg | Pass |
| ParticulateFiltrationEfficiencyASTM F2299 | Determine thebacterialfiltrationefficiency | > 98% | ≥ 98% | Pass |
| BacterialFiltrationEfficiencyASTM F2101 | Determinesubmicronparticulatefiltrationefficiency | > 98% | ≥ 98% | Pass |
| DifferentialPressure(Delta P)EN 14683 | DeterminebreathingresistanceOrdifferentialpressure | <6.0mmH2O/cm² | <6.0mmH2O/cm² | Pass |
| Flammability16 CFR Part1610 | Determineflammabilityflameorspread | Class 1 | Class 1 | Pass |
All results of testing met ASTM F2100 Level 2 acceptance criteria
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| Item | Proposed device | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, thedevice is noncytotoxic. | Pass |
| Sensitization | Under the conditions of the study, thedevice is non sensitizing. | Pass |
| Irritation | Under the conditions of the study, thedevice is nonirritating. | Pass |
Biocompatibility Testing
Similarity and differences
The differences between proposed device and the primary predicate device in materials and colors do not raise additional questions for safety and effectiveness.
The proposed device has been tested on safety and performance, and the results were complied with the test requests. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials and color additives.
Therefore, the differences did not raise any safety or effectiveness issue. The proposed device is substantially equivalent to the primary predicate device in intended use, design, safety and performance claims.
Conclusion
After analyzing bench test, device description and indication for use, it can be concluded that LAITEST Surgical Face Mask is as safe and effective as the primary predicate device.
§ 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.