(218 days)
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The surgical masks are three-layer, flat-pleated style mask with ear loops and nose clip design for fitting the mask around the nose and mouth. The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of meltblown polypropylene. The ear loops are made of nylon and spandex and the nose clip is made of galvanized iron wire. The masks not made with natural rubber latex materials, and all materials are being used in currently marketed devices. The masks will be provided in blue and the model CR02-2 will be labeled to Level 2, the CRO2 will be labeled to Level 3. The masks are single-use, disposable devices, provided non-sterile.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Surgical Mask (Model: CR02-2, CR02).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The device performance is reported for two models, CR02-2 (Level 2) and CR02 (Level 3), conforming to ASTM F2100 standards.
| Test Item | Acceptance Criteria (Level 2) | Reported Device Performance (CR02-2) | Acceptance Criteria (Level 3) | Reported Device Performance (CR02) |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | Pass | ≥ 98% | Pass |
| Differential Pressure (Delta-P) | < 6.0 mm H2O/cm² | Pass | < 6.0 mm H2O/cm² | Pass |
| Particulate Filtration Efficiency (PFE) | ≥ 98% | Pass | ≥ 98% | Pass |
| Fluid Resistance | ≥ 120 mm Hg | Pass at 120 mm Hg | ≥ 160 mm Hg | Pass at 160 mm Hg |
| Flammability | Class 1 | Pass | Class 1 | Pass |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic |
| Irritation | Non-irritating | Non-irritating | Non-irritating | Non-irritating |
| Sensitization | Non-sensitizing | Non-sensitizing | Non-sensitizing | Non-sensitizing |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each performance test (e.g., number of masks tested for BFE, Delta-P, etc.). It only indicates that the tests were conducted and "Pass" results were obtained. The data provenance is not specified beyond the tests being performed as part of a 510(k) submission from a Chinese company (Foshan Xinbao Technology Co., Ltd. in China). There's no information on whether it was retrospective or prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to this type of device and study. The testing involves standardized laboratory performance tests on the physical properties of the surgical masks, not diagnostic interpretation by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. The performance testing relies on objective measurements against established international standards (ASTM F2100, EN 14683, ISO 10993), not subjective 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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. This is a medical device (surgical mask), not an AI-powered diagnostic or assistive technology that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study for an algorithm is not applicable to this device, as it is a physical medical device (surgical mask) and does not involve any algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical performance testing of the surgical masks is based on established objective laboratory test methods and corresponding international standards/criteria such as ASTM F2101-14 for BFE, EN 14683:2019 for Differential Pressure, ASTM F2299-03 for PFE, ASTM F1862/F1862M-17 for Fluid Resistance, 16 CFR Part 1610 for Flammability, and ISO 10993 series for Biocompatibility.
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is not a machine learning or AI-based device requiring model training.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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March 31, 2021
Foshan Xinbao Technology Co., Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong 510700 China
Re: K202424
Trade/Device Name: Surgical Mask-Model CR02-2, CR02 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 21, 2020 Received: August 25, 2020
Dear Cassie Lee:
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.
Ryan Ortega, PhD Acting 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) K202424
Device Name Surgical Mask (Model: CR02-2, CR02)
Indications for Use (Describe)
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for K202424
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Foshan Xinbao Technology Co., Ltd. Establishment Registration Number: Applying Address: No. 20 Changjiang Road, Sanshan New Town, Nanhai District, Foshan City, Guangdong, China Contact Person: Weishan Peng Email: pengweishan1120@foxmail.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
Date of the summary prepared: November 26, 2020 2.
3. Revision date: March 4, 2021
4. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Common Name: Surgical apparel Trade Name: Surgical Mask Model Name: CR02-2, CR02 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Requlatory Class: II
5. Predicate Device Information
Sponsor: San-M Package Co., Ltd. Trade Name: Surgical Face Masks (Ear Loops And Tie-On) Classification Name: Mask, Surgical Common Name: Surgical apparel 510(K) Number: K160269 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulation Class: II
6. Device Description
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The surgical masks are three-layer, flat-pleated style mask with ear loops and nose clip design for fitting the mask around the nose and mouth. The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of meltblown polypropylene. The ear loops are made of nylon and spandex and the nose clip is made of galvanized iron wire. The masks not made with natural rubber latex materials, and all materials are being used in currently marketed devices. The masks will be provided in blue and the model CR02-2 will be labeled to Level 2, the CRO2 will be labeled to Level 3. The masks are single-use, disposable devices, provided non-sterile.
7. Intended Use / Indications for Use
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
8. Comparison to predicate device and conclusion
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Company | Foshan Xinbao Technology Co., Ltd. | San-M Package Co., Ltd. | -- |
| 510 (k) | K202424 | K160269 | -- |
| Trade Name | Surgical Mask | Surgical Face Masks (Ear LoopsAnd Tie-On) | -- |
| Model | CR02-2CR02 | EL 10000EL 20000EL 30000 | -- |
| ClassificationName | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II Device, FXX (21 FR78.4040) | Class II Device, FXX (21 CFR78.4040) | Same |
| Intended use | The Surgical Masks are intended tobe worn to protect both the patientand healthcare personnel fromtransfer of microorganisms, bodyfluids, and particulate material.These masks are intended for use ininfection control practices to reducepotential exposure to blood andbody fluids. This is a single use,disposable device, provided non-sterile. | The surgical face masks areintended to be worn to protect boththe patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. Theseface masks are intended for use ininfection control practices to reducethe potential exposure to blood andbody fluids. This is a single use,disposable device, provided non-sterile. | Same |
| Material | |||
| Outer facinglayer | Spun-bond polypropylene | Polypropylene | Same |
| Middle layer | Melt blown polypropylene | 1. Polypropylene spunbond2. Polypropylene meltblown | SimilarNote 1 |
| Inner facinglayer | Spun-bond polypropylene | Polypropylene | Same |
| Nose clip | Galvanized iron wire | Polyethylene coated steel wire | SimilarNote 1 |
| Ear loops | Nylon and Spandex | Ear loops: Polyester,polyurethane | SimilarNote 1 |
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| Side tapes: Polyester spunbond(ear loops mask only) | ||||||
|---|---|---|---|---|---|---|
| Color | Blue | White, Blue | Same | |||
| Mask Style | Flat Pleated | Flat Pleated | Same | |||
| Specificationand Dimension | Length: 17.5cm±1cmWidth: 9.5cm±1cm | Length: 90 ± 3 mmWidth:175 ± 5 mm | SimilarNote 1 | |||
| OTC use | Yes | Yes | Same | |||
| Sterility | Non-Sterile | Non-Sterile | Same | |||
| Use | Single Use, Disposable | Single Use, Disposable | Same | |||
| ASTM F2100Level | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Same |
| FluidResistancePerformance | Pass at 120mmHg | Pass at 160mmHg | Pass at 80mmHg | Pass at120mmHg | Pass at160mmHg | Same |
| ParticulateFiltrationEfficiency | Pass at ≥98% | Pass at ≥98% | Pass at99.6% | Pass at99.6% | Pass at99.7% | SimilarNote 2 |
| BacterialFiltrationEfficiency | Pass at ≥98% | Pass at ≥98% | Passat >98% | Passat >98% | Passat >99% | SimilarNote 2 |
| DifferentialPressure | Pass at <6.0mm H2O/cm² | Pass at <6.0 mmH2O/cm² | Pass at2.0 mmH2O/cm² | Pass at1.6 mmH2O/cm² | Pass at2.5 mmH2O/cm² | SimilarNote 2 |
| Flammability | Class 1 | Class 1 | Same | |||
| Biocompatibility | ||||||
| Cytotoxicity | Under the conditions of the study,the subject device extract wasdetermined to be non-cytotoxic. | Under the conditions of the study,the subject device extract wasdetermined to be non-cytotoxic. | Same | |||
| Irritation | Under the conditions of the study,the subject device non-polar andpolar extracts were determined to benon-irritating. | Under the conditions of the study,the subject device non-polar andpolar extracts were determined tobe non-irritating. | Same | |||
| Sensitization | Under the conditions of the study,the subject device non-polar andpolar extracts were determined to benon-sensitizing. | Under the conditions of the study,the subject device non-polar andpolar extracts were determined tobe non-sensitizing. | Same |
Comparison in Detail(s): Note 1:
Although the "Middle layer", "Nose clip", "Ear loops" and "Specification and Dimension" of subject device is little difference with predicate device, it meets the requirement of essential performance standard ISO 10993. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 2:
Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is little difference with predicate device, and they all meet the requirements of essential performance standard ASTM F2100. So, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
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9. Summary of Non-Clinical Performance Testing Performance Testing summary
| Pass criteria | Test | |||
|---|---|---|---|---|
| Test item | Test method | For Level2 | For Level3 | results/Verdict |
| Bacterialfiltrationefficiency | ASTM F2101-14 Standard TestMethod for Evaluating the BacterialFiltration Efficiency (BFE) of MedicalFace Mask Materials, Using aBiological Aerosol of Staphylococcusaureus according to ASTMF2100:2019 | ≥ 98% | ≥ 98% | Pass |
| Differentialpressure(Delta-P) | EN 14683: 2019, Annex C Medicalface masks - Requirements and testmethods according to ASTMF2100:2019 | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | Pass |
| Sub-micronparticulatefiltrationefficiency at 0.1um ofPolystyreneLatex Spheres | ASTM F2299-03 Standard TestMethod for Determining the InitialEfficiency of Materials Used in MedicalFace Masks to Penetration byParticulates Using Latex Spheresaccording to ASTM F2100:2019 | ≥ 98% | ≥ 98% | Pass |
| Resistance topenetration bysyntheticblood, minimumpressure in mmHg for passresult | ASTM F1862/F1862M-17Standard Test Method for Resistance ofMedical Face Masks to Penetration bySynthetic Blood (Horizontal Projection ofFixed Volume at a Known Velocity)according to ASTM F2100:2019 | Fluidresistantclaimedat 120mm Hg | Fluidresistantclaimedat 160mm Hg | Pass |
| Flame spread | 16 CFR Part 1610 Standard for theFlammability of Clothing according toASTM F2100:2019 | Class 1 | Class 1 | Pass |
Biocompatibility Testing
According to ISO 10993-1: 2018, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is B-prolonged (>24 h to 30 d). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
-
In vitro Cytotoxicity Test per ISO 10993-5: 2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity,
-
Skin Sensitization Tests per ISO 10993-10: 2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization,
-
Skin Irritation Tests per ISO 10993-10: 2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization.
10. Summary of Clinical Performance Test
No clinical study is included in this submission.
11. Final Conclusion:
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The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed device identified in K160269.
§ 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.