(113 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
The Nordiwell Medical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile. This device is not made from Natural Rubber Latex. Shelf-life of the device is 2 years.
The provided text describes the acceptance criteria and the study conducted for the Nordiwell Medical Face Mask (K202615) to demonstrate substantial equivalence to a predicate device. This is a medical device, specifically a surgical face mask, not an AI/ML powered device. Therefore, many of the requested categories in the prompt, such as those related to AI model performance, expert ground truth, adjudication methods, and training/test sets for AI, are not applicable.
Here's the information that can be extracted from the provided text, focused on the device's physical and performance characteristics:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Nordiwell Medical Face Mask (K202615)
| Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862-17) | ≥29 of 32 pass at 160 mmHg | 32 of 32 pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299-17) | ≥ 98% | > 99.9% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥ 98% | > 99.9% | Pass |
| Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM F2100-19) | <6.0 mmH2O/cm² | 5.6 mmH2O/cm² | Pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Pass |
| In Vitro Cytotoxicity Test (ISO 10993-5: 2009) | Non-Cytotoxic | Non-Cytotoxic | Pass |
| Skin Irritation Test (ISO 10993-10:2010) | Non-Irritating | Non-Irritating | Pass |
| Skin Sensitization Test (ISO 10993-10:2010) | Non-Sensitizing | Non-Sensitizing | Pass |
2. Sample size used for the test set and the data provenance
The document indicates that for fluid resistance testing (ASTM F1862-17), a sample size of 32 units was used for testing against the acceptance criteria of "≥29 of 32 pass". For the shelf-life accelerated aging test, 3 non-consecutive lots were used (sample size per lot not specified for each performance test, but it can be inferred that appropriate sample sizes were used for each test on these lots).
Data Provenance: The tests were conducted internally by the manufacturer, Changzhou Combat Protective Equipment Co., Ltd., in China, or by their designated testing facilities. The data is prospective, generated specifically 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
Not Applicable. This device is a physical medical face mask. Ground truth is established through standardized laboratory bench testing rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. Adjudication methods are relevant for subjective assessments, typically in clinical or image-based studies. The performance of this device is measured using objective, standardized bench tests.
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 a physical medical device, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is derived from objective measurements against established industry standards and regulatory criteria through bench testing (e.g., ASTM and EN standards for filtration, pressure, flammability, and ISO standards for biocompatibility).
8. The sample size for the training set
Not Applicable. This product is a physical medical device, not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no training set, 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.
December 31, 2020
Changzhou Combat Protective Equipment Co., Ltd. Yanmei Song Official Correspondent QingSiTang village, Henglin Town, Wujin District Changzhou, Jiangsu 213101 China
Re: K202615
Trade/Device Name: Nordiwell Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 23, 2020 Received: November 30, 2020
Dear Yanmei Song:
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,
For CAPT Elizabeth Claverie, M.S. 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) K202615
Device Name Nordiwell Medical Face Mask
Indications for Use (Describe)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
| 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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K202615
510(k) Summary
1. Contact Information
1.1. Applicant
Applicant Name: Changzhou Combat Protective Equipment Co., Ltd. Address: Qingsitang, Henglin, Changzhou, Jiangsu, 213101 China Contact Person: Yanmei Song Title: Sales Manager Telephone: +86-519-85190068; +86-15051998125 E-mail: xinyaoutdoor08@126.com
1.2. Consultant
Company: Sinow Medical AS Address: Vestre Fantoft åsen 44, 5072, Bergen, Norway Contact Person: Huifang Zhao Telephone: +86 13961151430 Email: zhao@bergemed.com
2. Device information
Trade Name: Nordiwell Medical Face Mask Common Name: Surgical Face Mask Regulatory information: Classification Name: Mask, Surgical Classification: II Product Code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital
3. Legally Marketed Primary Predicate Device
Product name: _ Avianz® Surgical Face Mask 510(k) Number: K200847 Product Code: FXX Manufacture: MEXPO INTERNATIONAL INC.
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4. Indication for use
When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
5. Device Description
The Nordiwell Medical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile.
This device is not made from Natural Rubber Latex.
Shelf-life of the device is 2 years.
| Device | Subject Device (K202615)Nordiwell Medical FaceMask,Model 952001 | Predicate Device (K200847)Avianz® Surgical Face Mask | Comparison |
|---|---|---|---|
| Intend use | When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only. | When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only. | Same |
| Material | |||
| Outer Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Filter(Middle layer) | Melt Blown PolypropyleneFilter | Melt Blown Polypropylene Filter | Same |
| Inner Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Nose Wire | Single Galvanize Wire, Coated | Single Galvanize Wire, Coated | Similar |
| by Polypropylene | by PE | ||
| Ear Loops | Spandex and Nylon, naturalrubber latex free | Not made with natural rubberlatex | Same |
| Design Features | |||
| Colors | Blue | White | Different |
| Style | Flat - Pleated | Flat - Pleated | Same |
| MultipleLayers | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | |||
| Sterile | Non-Sterile | Non-Sterile | Same |
| Dimension | |||
| Length | 17.5cm ±0.5cm | 17.5cm ±0.5cm | Same |
| Width | 9.5cm ±0.5cm | 9.0cm ±0.5cm | Similar |
| Performance | |||
| Fluid Resistance PerformanceASTM F1862 | 32 of 32 pass at 160 mmHg | 30 Out of 32 pass at 120 mmHg | Better |
| Particulate Filtration EfficiencyASTM F2299 | > 99.9% | 99.9% | Same |
| Bacterial Filtration EfficiencyASTM F2101 | > 99.9% | ≥98% | Better |
| Differential Pressure(Delta P) | 5.6 mmH20/cm²( EN 14683:2019, Annex Cand ASTM F2100-19) | 3.0 mmH20/cm²(MILM-36954C) | Similar |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | Same |
| Biocompatibility | |||
| In Vitro Cytotoxicity TestISO 10993-5: 2009 | Non-Cytotoxic | Non-Cytotoxic | Same |
| Skin Irritation TestISO 10993-10:2010 | Non-Irritating | Non-Irritating | Same |
| Skin Sensitization TestISO 10993-10:2010 | Non-Sensitizing | Non-Sensitizing | Same |
6. Substantially Equivalent (SE) Comparison
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7. Non-Clinical Test
Non clinical tests were conducted to verify that the proposed device met all design
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specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
(1) Performance test:
Bench test was conducted on Medical Face Mask for proposed device to determine substantially equivalence. The bench tests include the following tests:
| Item | Proposed Device | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid Resistance PerformanceASTM F1862-17 | 32 of 32 pass at 160 mmHg | ≥29 of 32 pass at 160 mmHg | Pass |
| Particulate FiltrationEfficiency ASTM F2299-17 | > 99.9% | ≥ 98% | Pass |
| Bacterial Filtration EfficiencyASTM F2101-19 | > 99.9% | ≥ 98% | Pass |
| Differential Pressure(Delta P) EN 14683:2019,Annex C and ASTMF2100-19. | 5.6 mmH20/cm² | <6.0 mmH20/cm² | Pass |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | Pass |
(2) Biocompatibility evaluation and test
Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance and ISO10993-1:2018 supports that the subject devices are biocompatible.
The biocompatibility test includes the following tests:
In Vitro Cytotoxicity Test(ISO 10993-5: 2009)
Skin Irritation Test(ISO 10993-10:2010)
Skin Sensitization Test(ISO 10993-10:2010)
(3) Shelf-life accelerated aging test
The accelerated aging tests were conducted with 3 non-consecutive lots. The following performances were tested both for before and after aged products:
Fluid Resistance Performance according to ASTM F1862-17.
Particulate Filtration Efficiency according to ASTM F2299-17.
Bacterial Filtration Efficiency according to ASTM F2101-19.
Differential Pressure (Delta P) according to EN 14683:2019, Annex C and ASTM F2100-19.
Flammability according to 16 CFR 1610.
8. Clinical Test Conclusion
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No clinical study is included in this submission.
9. Conclusion
The summary includes the conclusions drawn from the nonclinical and clinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as or better than the 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.