(675 days)
The CAREWE Surgical Face Masks Models N001-AW, N002-AW, and N003-AW are intended to be worn to protect both the adult patient and healthcare personnel from transfer of microorganisms, body fluids and material. These face masks are intended for use in infection control practices to reduce the posure to blood and body fluids. The masks are single-use and disposable.
The CAREWE Surgical Face Masks Models N001-AW, and N003-AW are flat-folded, single-use, disposable face masks which cover the user's nose and mouth. The mask is held in place by two elastic nylon ear loops ultrasonically bound to the mask, which attach to the user's ears. The mask is white. The CAREWE Surgical Face Mask consists of 4 ultrasonically bound layers: 1) an outer layer made of hydrophobic non-woven polypropylene; 2) a middle-layer made of polyester fiber; 3) a medium composed of melt-blown polypropylene; and 4) an inner-layer made of hydrophilic non-woven polypropylene. The mask also features a polyurethane (PU) nose pad which is attached to the mask's interior (on the hydrophilic layer). The mask meets ASTM F2100 Level 2 standards. The design, configuration, materials, and production process are all the same for all three proposed models N001-AW, N003-AW, N003-AW. They are all manufactured with the same technical specifications. The models are labeled differently strictly for marketing, sales and logistic reasons only.
The information provided pertains to the FDA 510(k) clearance for CAREWE Surgical Face Masks. This document describes non-clinical performance tests for the device, not a study evaluating an AI algorithm. Therefore, many of the requested categories regarding AI-specific studies, such as sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable.
Here's a breakdown of the available information regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Description | Purpose | Acceptance Criteria (Level 2) | Results |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Demonstrate adequate resistance to fluid penetration | 29 out of 32 Pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency (PFE) (ASTM F2100) | Demonstrate adequate particulate barrier properties | ≥ 98% | Pass |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Demonstrate adequate bacterial barrier properties | ≥ 98% | Pass |
| Differential Pressure (Delta P) (ASTM F2100) | Demonstrate adequate air penetration properties | < 6.0 mmH2O/cm² | Pass |
| Flammability (16CFR 1610) | Demonstrate adequate flammability resistance | Class I | Pass |
| Cytotoxicity (ISO 10993-5) | Determine the cytotoxicity of the test article | Under the conditions of the study, the device is non-cytotoxic in accordance with ISO 10993-5:2010 standard | Pass |
| Skin Irritation (ISO 10993-10) | Evaluate potential of the test article to cause skin irritation | Under the conditions of the study, the device is non-irritating in accordance with ISO 10993-10:2010 standard | Pass |
| Skin Sensitization (ISO 10993-10) | Evaluate potential of the test article to cause delayed dermal contact sensitization | Under the conditions of the study, the device is non-sensitizing in accordance with ISO 10993-10:2010 standard | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for each test. For Fluid Resistance (ASTM F1862), it mentions "29 out of 32 Pass at 120 mmHg," implying a sample size of at least 32, but it's unclear if this is the standard sample size for all performance tests. The data provenance is not specified beyond being part of a non-clinical performance test for the device. It is inherently retrospective as these are tests conducted on manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as these are objective performance tests of a physical device against established industry standards (ASTM, ISO, CFR). There is no "ground truth" established by human experts in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. These are laboratory tests with objective pass/fail 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
Not applicable. This is not an AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for these tests is defined by the objective measurement protocols and performance thresholds specified in the referenced ASTM, ISO, and CFR standards for surgical face masks.
8. The sample size for the training set
Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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August 19, 2022
HuiZhou TianChang Industrial Co., Ltd % Viky Verna CEO Mhetra LLC 848 Brickell Ave. PH 5 Miami, Florida 33131
Re: K203078
Trade/Device Name: CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 8, 2022 Received: August 10, 2022
Dear Viky Verna:
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,
Bifeng Qian, M.D., 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203078
Device Name
CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
Indications for Use (Describe)
The CAREWE Surgical Face Masks Models N001-AW, N002-AW, and N003-AW are intended to be worn to protect both the adult patient and healthcare personnel from transfer of microorganisms, body fluids and material. These face masks are intended for use in infection control practices to reduce the posure to blood and body fluids. The masks are single-use and disposable.
Type of Use (Select one or both, as applicable)
| Registration Under Part 375, ECL Subject to Cleanup | Brownfield Cleanup Under Part 375, ECL Subject to Cleanup |
|---|---|
| ------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------ |
| | 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 K203078
1. Applicant/ Device Information
| Submitter Name: | Hui Zhou Tian Chang Industrial Co. Ltd |
|---|---|
| Responsible person: | Johnny Chan |
| E-mail: | johnny.chan@hktcgroup.com |
| Official Correspondent:Contact person: | Viky Verna, MS BME, MS Pharm, RAC |
| Phone: | +41 76 375 9 811 |
| Fax: | +41 26 492 5 071 |
| E-mail: | viky.verna@mhetra.com |
| Date prepared: | August 18, 2022 |
| Device Name | CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW |
| 510(k) Number | K203078 |
| Common Name | Surgical Face Mask |
| Classification Name: | Surgical apparel |
| Classification Regulation: | 21CFR 878.4040 |
| Product Code: | FXX |
2. Predicate Device Information
| Manufacturer | GUANGDONG KAIDI GARMENTS CO., LTD |
|---|---|
| Device Name | Disposable Medical Surgical Face Masks |
| 510(k) Number | K202211 |
| Classification Name: | Surgical apparel |
| Classification Regulation: | 21CFR 878.4040 |
| Product Code: | FXX |
3. Device Description
The CAREWE Surgical Face Masks Models N001-AW, and N003-AW are flat-folded, single-use, disposable face masks which cover the user's nose and mouth. The mask is held in place by two elastic nylon ear loops ultrasonically bound to the mask, which attach to the user's ears. The mask is white.
The CAREWE Surgical Face Mask consists of 4 ultrasonically bound layers:
- l) an outer layer made of hydrophobic non-woven polypropylene;
-
- a middle-layer made of polyester fiber;
-
- a medium composed of melt-blown polypropylene; and
-
- an inner-layer made of hydrophilic non-woven polypropylene.
The mask also features a polyurethane (PU) nose pad which is attached to the mask's interior (on the hydrophilic layer). The mask meets ASTM F2100 Level 2 standards.
The design, configuration, materials, and production process are all the same for all three proposed models N001-AW, N003-AW, N003-AW. They are all manufactured with the same technical specifications. The models are labeled differently strictly for marketing, sales and logistic reasons only.
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4. Indications For Use
The CAREWE Surgical Face Masks Models N001-AW, and N003-AW are intended to be worn to protect both the adult patient and healthcare personnel from transfer of microorganisms, body fluids and material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The masks are single-use and disposable.
న. Comparison of Technological Characteristics
Table 5.1 provides a comparison of the predominant technical characteristics of the subject device and the legally marketed predicate device.
| Description | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Device Name | Disposable Medical SurgicalFace Masks | CAREWE Surgical Face MaskModels N001-AW, N002-AW, andN003-AW | N/A |
| 510(k) Number | K202211 | K203078 | N/A |
| Manufacturer | Guangdong Kaidi Garments Co.,Ltd | Hui Zhou Tian Chang Industrial Co.Ltd | N/A |
| Classification,Product Code andRegulation | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same |
| Classification name/panel | Surgical apparel/ GeneralHospital | Surgical apparel/ GeneralHospital | Same |
| Indications For Use | The Disposable MedicalSurgical Face Masks areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non-sterile. | The CAREWE Surgical FaceMasks Models N001-AW, N002-AW, and N003-AW are intendedto be worn to protect both theadult patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andmaterial. These face masks areintended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. The masks aresingle-use and disposable. | Similar |
| Design | Flat pleated | Butterfly flat-fold | Different |
| Outer Facing layer | Spunbound non-wovenfabric | Non-woven PP hydrophobic | Similar |
| Inner Facing layer | Spunbound non-woven fabric | Non-woven PP hydrophilic | Similar |
| Filter Media | N/A | Meltblown PP charged | Different |
| Middle | Melt-blown non-woven fabric | Polyester Fiber | Different |
| Nose Piece | Polyethylene (PE) & iron wire | Polyvinylchloride (PVC) &annealed iron wire | Similar |
| Layers | 3ply | 4ply | Different |
Table 5.1: Comparison of Technological Characteristics
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| Description | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Ear Loop/ Strap | Ear Loop (Nylon & Spandex) | Ear Loop (Nylon) | Similar |
| Nose Foam | N/A | Polyurethane (PU) | N/A |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| ASTM F2100 | Level 2 | Level 2 | Same |
- Summary of Non-clinical Performance Tests:
The following tests were performed to verify appropriate safety and effectiveness.
| Description | Purpose | Acceptance Criteria(Level 2) | Results |
|---|---|---|---|
| Fluid ResistanceASTM F1862 | Demonstrate adequateresistance to fluid penetration | 29 out of 32 Pass at 120mmHg | Pass |
| ParticulateFiltrationEfficiency (PFE)ASTM F2100 | Demonstrate adequateparticulate barrier properties | ≥ 98% | Pass |
| Bacterial FiltrationEfficiency (BFE)ASTM F2101 | Demonstrate adequatebacterial barrier properties | ≥ 98% | Pass |
| Differential Pressure(Delta P) ASTMF2100 | Demonstrate adequate airpenetration properties | < 6.0mmH2O/cm² | Pass |
| Flammability 16CFR1610 | Demonstrate adequateflammability resistance | Class I | Pass |
| CytotoxicityISO 10993-5 | Determine the cytotoxicity ofthe test article | Under the conditions ofthe study, the device isnon-cytotoxic inaccordance with ISO10993-5:2010 standard | Pass |
| Skin IrritationISO 10993-10 | Evaluate potential of the testarticle to cause skin irritation | Under the conditions ofthe study, the device isnon-irritating inaccordance with ISO10993-10:2010 standard | Pass |
| Skin SensitizationISO 10993-10 | Evaluate potential of the testarticle to cause delayeddermal contact sensitization | Under the conditions ofthe study, the device isnon-sensitizing inaccordance withISO 10993-10:2010standard | Pass |
The nonclinical test results demonstrate compliance with ASTM F2100 Level 2 requirements for face masks.
7. Clinical testing
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No clinical testing was included in this submission.
8. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the CAREWE Surgical Face Mask Models N001-AW, N002-AW and N003-AW, the subject device, is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K202211).
§ 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.