(188 days)
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials.
Surgical Face Mask is a non-sterile, single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2 options for the Surgical Face Mask to be secured on user via earloops (model CM2006 and A88) or ties (model CM2008). Earloops are of Chinlon+Spandex Elastic Fiber (model CM2006) and polyester fibre (model A88) and not made with natural rubber latex; and ties are of spun-bond polypropylene and also not made with natural rubber latex. The nose piece is a single galvanize wire, coated by Polyethylene (model CM2006 and CM2008) and aluminum (model A88). All of the materials used in the construction of the surgical face mask are being used in currently marketed devices.
The provided text describes a 510(k) submission for a Surgical Face Mask and outlines the performance criteria and testing conducted to demonstrate substantial equivalence to a predicate device. This is a medical device submission, not an AI/ML product, so the questions regarding AI/ML-specific criteria (like effect size of AI assistance, AI-only performance, training set details) are not applicable.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance ASTM F1862-17 | To evaluate the effectiveness of the test article in protecting the user from possible exposure to body fluids. | No penetration pass at 160mmHg | Pass, no penetration pass at 160mmHg. |
| Particulate Filtration Efficiency ASTM F2299-17 | To evaluate the effectiveness of the test article in protecting the user from possible exposure to particulates. | ≥98% | Pass, CM2006 and CM2008: Average 99.88%; A88: Average 99.56% |
| Bacterial Filtration Efficiency ASTM F2101-19 | To evaluate the bacterial filtration efficiency (BFE) of mask. | ≥98% | Pass, CM2006 and CM2008: Average 99.88%; A88: Average 99.9% |
| Differential Pressure (Delta P) EN 14683:2019, Annex C and ASTM F2100-19 | To measure the differential pressure of mask which is related to breathability. | <6.0 mmH2O/cm2 | Pass, CM2006 and CM2008: Average 3.69 mmH2O/cm2; A88: Average 3.55 mmH2O/cm2 |
| Flammability 16 CFR 1610 | To evaluate the flammability of mask. | Class 1 | Pass, Class 1 |
| In vitro cytotoxicity ISO 10993-5 | To evaluate the biological safety of the product which has direct contact with intact skin. | The test article should not have potential toxicity to L-929 in the MTT method. | Pass, the test article Surgical face mask has no potential toxicity to L-929 in the MTT method. |
| Skin sensitization ISO 10993-10 | To evaluate the biological safety of the product which has direct contact with intact skin. | The test article should not cause delayed dermal contact sensitization in the guinea pig. | Pass, the test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article Surgical face mask has no potential skin sensitization on guinea pigs in the extraction method. |
| Skin irritation ISO 10993-10 | To evaluate the biological safety of the product which has direct contact with intact skin. | The irritation response category in the rabbit should be negligible. | Pass, the response of the test article extract was categorized as negligible under the test condition. The test article Surgical Face Mask has no potential skin irritation on rabbit in the extraction method. |
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. The tests are general medical device performance and biocompatibility studies, not clinical trials with human participant data. The provenance for these tests would typically be laboratory testing conducted by the manufacturer or a contracted lab. The manufacturer is based in Shenzhen, China.
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)
Not applicable. These are physical and biological performance tests, not studies requiring expert interpretation of results in the way an AI/ML diagnostic device would. The "ground truth" for these tests comes from standardized testing methodologies outlined in the referenced ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for standardized physical and biological performance testing.
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 device is a surgical face mask, not an AI/ML-powered diagnostic tool, so MRMC studies or human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests comes from the established parameters and measurement techniques defined within the cited international standards (e.g., ASTM F1862-17 for fluid resistance, ASTM F2299-17 for particulate filtration, ISO 10993-5 for cytotoxicity). These are objective measurements rather than subjective interpretations or clinical outcomes.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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September 28, 2021
Shenzhen RealTone Medical Appliance Co., Ltd. % Tracy Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Oianhai Road Shenzhen, Guangdong 518052 China
Re: K210878
Trade/Device Name: Surgical Face Mask (Model: CM2006, CM2008, A88) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 19, 2021 Received: March 24, 2021
Dear Tracy Che:
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 medical devices and radiation-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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210878
Device Name
Surgical Face Mask (Model: CM2006, CM2008, A88)
Indications for Use (Describe)
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials.
| 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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K210878 510 (k) Summary
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information
| 510 (k) owner's name: | Shenzhen RealTone Medical Appliance Co., Ltd. |
|---|---|
| Address: | Flat B, 5 Floor, Yaoxiang Industrial Building, No.92 Fukang Road,Henggang Street, Longgang District, Shenzhen, China |
| Contact person: | Wei Zhou |
| Phone number: | 86-755-28266631 |
| Fax number: | / |
| Email: | akoszhou@163.com |
| Date of summary prepared: | 2021-9-7 |
(2) Reason for the submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
| Trade name: | Surgical Face Mask (Model: CM2006, CM2008, A88) |
|---|---|
| Regulation Name: | Surgical apparel |
| Regulation number: | 21 CFR 878.4040 |
| Product code: | FXX |
| Review panel: | General & Plastic Surgery |
| Regulation class: | Class II |
(4) Predicate device
| Sponsor | Mexpo International Inc. |
|---|---|
| Device Name | Avianz® Surgical Face Mask |
| 510(k) Number | K200847 |
| Product Code | FXX |
| Regulation Number | 21 CFR 878.4040 |
| Regulation Class | II |
(5) Description/ Design of device
Surgical Face Mask is a non-sterile, single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2
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options for the Surgical Face Mask to be secured on user via earloops (model CM2006 and A88) or ties (model CM2008). Earloops are of Chinlon+Spandex Elastic Fiber (model CM2006) and polyester fibre (model A88) and not made with natural rubber latex; and ties are of spun-bond polypropylene and also not made with natural rubber latex. The nose piece is a single galvanize wire, coated by Polyethylene (model CM2006 and CM2008) and aluminum (model A88). All of the materials used in the construction of the surgical face mask are being used in currently marketed devices.
(6) Indications for use
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials.
(7) Materials
| Component of DeviceRequiringBiocompatibility | Material of Component | Body ContactCategory(ISO 10993-1) | Contact Duration(ISO 10993-1) |
|---|---|---|---|
| Surgical Face Mask(Model:CM2006) | Spun-bond polypropylene;melt-blown polypropylene;Single Galvanize Wire,Coated By Polyethylene;Chinlon+Spandex ElasticFiber. | Surface-contactingdevice: skin | < 24hours |
| Surgical Face Mask(Model:CM2008) | Spun-bond polypropylene;melt-blown polypropylene;Single Galvanize Wire,Coated By Polyethylene. | Surface-contactingdevice: skin | < 24hours |
| Surgical Face Mask(Model:A88) | Spun-bond polypropylene;melt-blown polypropylene;aluminum; polyester fibre. | Surface-contactingdevice: skin | < 24hours |
The body-contacting material used in the Surgical Face Mask have all passed biocompatibility test. Details can be seen in "Biocompatibility Discussion".
Note:
Dyes used in this product: Blue colorant is used for model CM2008, and no colorant is used for model A88. No printing ink has been used in the three models. The Blue colorant information is as follows.
| Name: Blue masterbatch | |
|---|---|
| Supplier: Shantou Kecai New Materials Co., Ltd. | |
| Component | CAS number |
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Shenzhen RealTone Medical Appliance Co., Ltd.
510(k)s – Section 8. 510 (k) Summary
| Polypropylene | 9003-07-0 |
|---|---|
| Titanium dioxide | 1317-80-2 |
| Pigment blue 15:3 | 147-14-8 |
| Pe wax | 9002-88-4 |
(8) Comparison to Predicate Device
| Item | Proposed device | Predicate device | Remark | |
|---|---|---|---|---|
| Trade name | Surgical Face Mask | Avianz® Surgical Face Mask | / | |
| 510 (k) number | K210878 | K200847 | / | |
| Regulation number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Regulation description | Surgical apparel | Surgical apparel | Same | |
| Product code | FXX | FXX | Same | |
| Class | II | II | Same | |
| Indications for use/ Intended use | Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials. | 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. | Similar, only wording difference | |
| Inner layer | Spun-bond Polypropylene | Spunbond Polypropylene | Same | |
| Middle layer | Melt-blown Polypropylene | Melt Blown Polypropylene Filter | Same | |
| Outer layer | Spun-bond Polypropylene | Spunbond Polypropylene | Same | |
| Materials | Nosepiece | Model CM2006 andCM2008: Single Galvanize Wire, Coated By Polyethylene;Model A88: Aluminum. | Single Galvanize Wire, Coated By PE | Differences resolved by biocompati bility testing |
| Headband | Model CM2006: Chinlon+Spandex Elastic Fiber;Model CM2008: Spun-bond Polypropylene ;Model A88: Polyester Fibre. | Not made with natural rubber latex | Differences resolved by biocompati bility testing | |
| Dyes | Blue Masterbatch which is composed of | / | Differences resolved by | |
| polypropylene (CAS No.:9003-07-0), titaniumdioxide (CAS No.:1317-80-2), pigment blue15:3 (CAS No.: 147-14-8),pe wax (CAS No.:9002-88-4) | biocompatibilitytesting | |||
| Mask style | Flat pleated | Flat pleated | Same | |
| Design feature | Earloop or tie-on | Earloop | Similar | |
| Dimensions | Model CM2006 andCM2008: 17.5cm×9.5cm;Model A88: 19.5cm×8cm. | (17.5cm±0.5cm)×(9.0cm±0.5cm) | Similar | |
| Latex | Not made with naturalrubber latex | Not made with natural rubberlatex | Same | |
| Color | Model CM2006 andCM2008: Blue&WhiteModel A88: White | White | Differencesresolved bybiocompatibilitytesting | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Use | Single use | Single use | Same | |
| Prescription or OTC | OTCLevel 3 | OTCLevel 2 | SameProposeddevicedemonstrat | |
| ASTM F2100 Level | ed higherresistanceto fluidpenetration | |||
| Performance test result | ||||
| Fluid resistance | No penetration pass at 160mmHg | 30 out of 32 pass at 120mmHg | Proposeddevicedemonstrated higherresistanceto fluidpenetration | |
| Particle FiltrationEfficiency | CM2006 and CM2008:Average 99.88%A88: Average 99.56% | 99.9% | Similar | |
| Bacterial FiltrationEfficiency | CM2006 and CM2008:Average 99.88%A88: Average 99.9% | > 99.9% | Similar | |
| Delta - P | CM2006 and CM2008:Average 3.69 mmH2O/cm²A88: Average 3.55 mmH2O/cm² | 3.0 mmH2O/cm² | Similar,both masksmetrequirements of <6.0 mmH2O/cm² | |
| Biocompatibility | No cytotoxicity (ISO 10993- 5)No sensitization (ISO 10993- 10)No irritation (ISO 10993-10) | Non-Cytotoxic,Non-Sensitizing,Non-Irritating | Same |
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Shenzhen RealTone Medical Appliance Co., Ltd.
510(k)s – Section 8. 510 (k) Summary
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Shenzhen RealTone Medical Appliance Co., Ltd. 510(k)s – Section 8. 510 (k) Summary
(9) Non-clinical studies and tests performed
The following performance tests of Surgical Face Mask were conducted:
| Test Methodology | Purpose | Acceptance criteria | Results |
|---|---|---|---|
| Fluid ResistancePerformanceASTM F1862-17 | To evaluate theeffectiveness of the testarticle in protecting theuser from possibleexposure to bodyfluids. | No penetration pass at160mmHg | Pass, no penetrationpass at 160mmHg. |
| ParticulateFiltrationEfficiency ASTMF2299-17 | To evaluate theeffectiveness of the testarticle in protecting theuser from possibleexposure toparticulates. | ≥98% | Pass, CM2006 andCM2008: Average99.88%A88: Average 99.56% |
| Bacterial FiltrationEfficiencyASTM F2101-19 | To evaluate thebacterial filtrationefficiency (BFE) ofmask. | ≥98% | Pass, CM2006 andCM2008: Average99.88%A88: Average 99.9% |
| DifferentialPressure(Delta P) EN14683:2019,Annex C andASTMF2100-19 | To measure thedifferential pressure ofmask which is relatedto breathability. | <6.0 mmH2O/cm2 | Pass, CM2006 andCM2008: Average3.69 mmH2O/cm2A88: Average 3.55mmH2O/cm2 |
| Flammability 16CFR 1610 | To evaluate theflammability of mask. | Class 1 | Pass, Class 1 |
| In vitrocytotoxicityISO 10993-5 | To evaluate thebiological safety of theproduct which hasdirect contact withintact skin. | The test article should nothave potential toxicity toL-929 in the MTTmethod. | Pass, the test articleSurgical face maskhas no potentialtoxicity to L-929 inthe MTT method. |
| Skin sensitizationISO 10993-10 | To evaluate thebiological safety of theproduct which hasdirect contact withintact skin. | The test article should notcause delayed dermalcontact sensitization in theguinea pig. | Pass, the test articleshowed no evidenceof causing delayeddermal contactsensitization in theguinea pig. The testarticle Surgical facemask has no potentialskin sensitization onguinea pigs in theextraction method. |
| Skin irritationISO 10993-10 | To evaluate thebiological safety of theproduct which hasdirect contact withintact skin. | The irritation responsecategory in the rabbitshould be negligible. | Pass, the response ofthe test article extractwas categorized asnegligible under thetest condition. Thetest article SurgicalFace Mask has nopotential skinirritation on rabbit inthe extraction method |
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Shenzhen RealTone Medical Appliance Co., Ltd. 510(k)s – Section 8. 510 (k) Summary
(9) Conclusion
Based on the nonclinical tests performed, the subject device, K210878, is as safe, as effective, and performs as well as the legally marketed predicate device, K200847, Avianz® Surgical Face Mask.
§ 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.