(100 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 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, and provided as sterile.
Level 3 Surgical mask model (Ear-loop): XT10A1
Level 3 Surgical mask model (Tie-on): XT10B1
The surgical mask consists of a mask body, a nose piece, and ear loops or ties. The mask body is divided into three layers, the inner and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of polyethylene coated steel wire, the ear loops are made of polyester silk & polyurethane filament, and the ties are made of polypropylene.
The size specification of the surgical mask:
- Mask body for ear-loop type: 17.5cm×9.5cm & 14.5cm×9.5cm;
- Mask body for Tie-on type: 17.5cm×9.5cm
The provided text is a 510(k) summary for a surgical mask (K211454) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving human readers or AI assistance. Therefore, information related to AI performance, human reader improvement with AI, or MRMC studies is not available in this document.
Here's the breakdown of the acceptance criteria and the study proving the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test Methodology (standard) | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM F1862-17 | Fluid Resistance Performance | 29 out of 32 pass at 160 mmHg | Lot 1# pass at 160mmHg; Lot 2# pass at 160mmHg; Lot 3# pass at 160mmHg |
| ASTM F2101-19 | Bacterial Filtration Efficiency Performance | ≥ 98% | Lot 1# 99.7%-99.9%; Lot 2# 99.7%-99.9%; Lot 3# 99.7%-99.9% |
| EN 14683:2019 | Differential Pressure (Delta-P) | < 6.0mm H2O/cm² | Lot 1# 2.3-4.6; Lot 2# 2.3-4.5; Lot 3# 2.0-3.9 |
| ASTM F2299-2007 | Particulate Filtration Efficiency Performance | ≥ 98% | Lot 1# 99.2%-99.8%; Lot 2# 99.0%-99.7%; Lot 3# 99.3%-99.7% |
| 16 CFR Part 1610 | Flammability | Class I | Lot 1# Class I; Lot 2# Class I; Lot 3# Class I |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under the conditions of the study, the subject device was non-cytotoxic |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under the conditions of the study, the subject device was non-sensitizing |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, the subject device was non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions testing "Lot 1#", "Lot 2#", and "Lot 3#" for Fluid Resistance, Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, and Flammability. For Fluid Resistance, it specifies "32 Out of 32 pass", indicating a sample size of 32 for that particular test per lot. The exact sample sizes for other performance tests are implied by the "Lot #" reporting but not explicitly stated numerically as a single count per test.
The data provenance is from non-clinical performance testing conducted on the proposed device's materials and finished products, performed by Jiangsu Xingtong Biotechnology Group Co., Ltd. through various standard test methodologies (e.g., ASTM, EN, ISO). This is prospective testing of the manufactured device. There is no indication of country of origin for the specific data collection, but the manufacturer is based in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical study involving standardized physical, chemical, and biological tests, not subjective expert evaluation of medical images or conditions. The "ground truth" is established by the predefined acceptance criteria of the testing standards.
4. Adjudication Method for the Test Set
Not applicable. As this is non-clinical testing against standardized criteria, there is no need for expert adjudication. The tests have objective outcomes against set thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission is for a surgical mask and relies on non-clinical performance and biocompatibility testing for substantial equivalence, not AI or human-in-the-loop performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone AI algorithm performance study was not done. This device is a physical surgical mask, not an AI-powered diagnostic or therapeutic device.
7. The Type of Ground Truth Used
The ground truth for evaluating the surgical mask's performance is based on pre-defined acceptance criteria set by international and national standards for medical device performance and biocompatibility. These include:
- Physical performance standards: ASTM F1862-17 (Fluid Resistance), ASTM F2101-19 (Bacterial Filtration Efficiency), EN 14683:2019 (Differential Pressure), ASTM F2299-2007 (Particulate Filtration Efficiency), 16 CFR Part 1610 (Flammability).
- Biocompatibility standards: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization, Irritation).
- Sterilization validation standards: ISO 11135:2014, ISO 11737-1:2018, ISO 10993-7:2008.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning model. Therefore, no training set for an algorithm was used.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI algorithm.
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Image /page/0/Picture/0 description: The image contains 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.
August 18, 2021
Jiangsu Xingtong Biotechnology Group Co., Ltd. % James Tsai Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K211454
Trade/Device Name: Surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 6, 2021 Received: July 12, 2021
Dear James Tsai:
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.
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) K211454
Device Name Surgical mask
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 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, and provided as sterile.
Level 3 Surgical mask model (Ear-loop): XT10A1 Level 3 Surgical mask model (Tie-on): XT10B1
| 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
K211454
1. Administrative Information
| Date of Summary prepared | August 5, 2021 |
|---|---|
| Manufacturer information | Company: Jiangsu Xingtong Biotechnology GroupCo., Ltd. |
| Company address:No.8, Kele road, Touqiao Area, Beizhou IndustrialPark, Guangling Zone, Yangzhou City, ChinaContact person: Li HuaTel: +86-0514-87485222 | |
| Fax: +86-0514-87481010 | |
| E-mail: 920740335@qq.com | |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd.Address: 1713A, 17th Floor, Block A, ZhongguanTimes Square, Nanshan District, ShenzhenContact person: James TsaiE-Mail: james tsai@cefda.com; field@cefda.com |
2. Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Surgical mask |
| Classification name: | Surgical Face Mask, Apparel |
| Review Panel: | General and plastic surgery devices |
| Product Code: | FXX |
| Common name | Surgical mask |
| Device Class: | II |
| Regulation Number: | 878.4040 |
3. Predicate Device Information
| Sponsor: | SAN-M PACKAGE CO., LTD. |
|---|---|
| Device trade name: | Surgical face mask (Ear loops and Tie-on) |
| Device Class: | II |
| 510(K) Number: | K160269 |
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| Regulation name | Masks, Surgical |
|---|---|
| Production regulation: | 21 CFR §878.4040 |
| Product code: | FXX |
| Review Panel: | General and plastic surgery device |
4. Device Descriptions
The surgical mask consists of a mask body, a nose piece, and ear loops or ties. The mask body is divided into three layers, the inner and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of polyethylene coated steel wire, the ear loops are made of polyester silk & polyurethane filament, and the ties are made of polypropylene.
The size specification of the surgical mask:
- Mask body for ear-loop type: 17.5cm×9.5cm & 14.5cm×9.5cm;
- Mask body for Tie-on type: 17.5cm×9.5cm
5. 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 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, provided as sterile.
6. Technological Characteristics Comparison
| Comparisonitem | Proposed Device(Jiangsu XingtongBiotechnology Group Co.,Ltd.) | Predicate Device(K160269, SAN-MPACKAGE CO., LTD.) | Remark |
|---|---|---|---|
| Product name | Surgical mask | Surgical face mask | Similar |
| Product model | Ear loops: XT10A1;Tie-on: XT10B1 | Ear loops: EL 30000;Tie-on: TO 30000 | Similar |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR878.4040) | Class II (21 CFR878.4040) | Same |
| Intendeduse &Indications forUse | The surgical masks areintended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids. and particulate | The surgical face masksare intended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids. and particulate | Similar |
| material. These facemasks are intended for usein infection controlpractices to reduce thepotential exposure to bloodand body fluids. This is asingle-use, disposabledevice, provided as sterile. | material. These facemasks are intended for usein infection controlpractices to reduce thepotential exposure to bloodand body fluids. This is asingle-use, disposabledevice, provided non-sterile. | ||
| Mask features | Ear Loops and Tie-on;Flat Pleated | Ear Loops and Tie-on;Flat Pleated | Same |
| Layers | 3 layers | 4 layers | Different |
| Outer layer | Polypropylene | Polypropylene | Same |
| Filter media | Melt-blown cloth(polypropylene) | Polypropylene spunbondPolypropylene meltblown | Different |
| Inner layer | Polypropylene | Polypropylene | Same |
| Ear loops | -Ear loops: Polyester silk &Polyurethane filament-Ties: Polypropylene | -Ear loops: Polyester,polyurethane-Side tapes: Polyesterspunbond (ear loops maskonly)-Tie tapes: Polypropylenespunbond or polyesterspunbond | Similar |
| Nose piece | Polyethylene coatedsteel wire | Polyethylene coatedsteel wire | Same |
| Color | Blue | White or Blue | Similar |
| Dimension | Mask body for ear-looptype: 17.5cm×9.5cm &14.5cm×9.5cmMask body for Tie-on type:17.5cm×9.5cm | Mask body for both ear-loop and tie-on types:17.5cm×9.0cm &18.0cm×9.0cm | Different |
| OTC Use | Yes | Yes | Same |
| Sterility | Sterile | Non-sterile | Different |
| Packagingmaterial | Paper plastic bag | Not publicly available | Different |
| Sterilizationmethod andS.A.L. | Sterilized by ethyleneoxide gas, SAL= $10-6$ | Not applied | Different |
| Shelf life | 2 years | No shelf life claim | Different |
| Use | Single-use, disposable | Single-use, disposable | Same |
| Performance | Level 3 | Level 3 | Same |
| level | |||
| FluidResistancePerformance | 32 Out of 32 pass at160mmHg(ASTM F1862) | 32 Out of 32 pass at160mmHg(ASTM F1862) | Same |
| ParticulateFiltrationEfficiency | Pass at ≥ 98%(ASTM F2299) | Pass at ≥ 98%(ASTM F2299) | Same |
| BacterialFiltrationEfficiency | Pass at ≥ 98%(ASTM F2101) | Pass at ≥ 98%(ASTM F2101) | Same |
| DifferentialPressure(Delta-P) | Pass at <6mm H2O/cm²(EN 14683:2019) | Pass at <5mm H2O/cm²(MIL-M36945C) | Different |
| Flammability | Pass at Class I(16 CFR 1610) | Pass at Class I(16 CFR 1610) | Same |
| CytotoxicityISO 10993-5 | Under the conditions of thestudy, the subject devicewas non-cytotoxic | Under the conditions of thestudy, the subject devicewas non-cytotoxic | Same |
| SensitizationISO 10993-10 | Under the conditions of thestudy, the subject devicewas non-sensitizing | Under the conditions of thestudy, the subject devicewas non-sensitizing | Same |
| IrritationISO 10993-10 | Under the conditions of thestudy, the subject devicewas non-irritating | Under the conditions of thestudy, the subject devicewas non-irritating | Same |
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Both of the proposed device and predicate device conform to ASTM F2100, the difference is the versions of the standard, the proposed device was tested by the latest version, and this difference will not raise any new safe and effective issue.
From the comparison table and the gaps analysis above, the differences in the materials, layers, sizes, sterility status and packaging material will not raise any new issue for safety and effectiveness. Physical performance tests and biocompatibility evaluation have been carried out on the finished devices; EO sterilization validation has also been provided to prove the product sterility and performance; Accelerated aging test validates the shelf life of the proposed device.
In summary, the performance and biocompatibility testing of the subject device meet all the requirements of standards of ASTM F2100 and ISO 10993-5 &-10. So, the differences between the predicate device and subject device will not raise any new issue of safety and effectiveness of the subject device.
7. Summary of Non-clinical Testing
The following performance data of proposed device was provided in support of the substantial equivalence determination:
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Biocompatibility testing
The biocompatibility evaluation for the proposed device was conducted in accordance with the International Standard ISO 10993-1: 2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The outer layer, inner layer and ear loops or tie-on are considered to be contacted with patient's intact face skin for duration of less than 24 hours. And the biocompatibility evaluation included the following tests:
- · Cytotoxicity
- · Skin Sensitization
- Skin Irritation
Physical performance testing
Physical performance was conducted, and the results show that the proposed device complies with the following standards:
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
Ethylene oxide Sterilization Validation
The proposed device is also provided for sterilization validation is performed and the results show that the proposed device complies with the following standards:
- · ISO 11135:2014 Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- · ISO 11737-1:2018 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on product
- · ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- ASTM F88-2015 Standard Test Method for Seal Strength of Flexible Barrier Materials
- · ASTM F1929-2015 Standard test method for detecting seal leaks in porous medical packaging by dye penetration
Summary
Based on the non-clinical performance data as documented above in the device development, the proposed device has a safety and effectiveness profile that is similar to the predicate device, the testing results are summarized in the following table:
| Name of TestMethodology(standard) | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|
| ASTM F | Fluid Resistance | 29 out of 32 | Lot 1# pass at 160mmHg; |
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| 1862-17 | Performance | pass at160 mmHg | Lot 2# pass at 160mmHg;Lot 3# pass at 160mmHg |
|---|---|---|---|
| ASTMF2101-19 | Bacterial FiltrationEfficiencyPerformance | ≥ 98% | Lot 1# 99.7%-99.9%;Lot 2# 99.7%-99.9%;Lot 3# 99.7%-99.9% |
| EN 14683:2019 | DifferentialPressure (Delta-P) | < 6.0mmH2O/cm² | Lot 1# 2.3-4.6;Lot 2# 2.3-4.5;Lot 3# 2.0-3.9 |
| ASTMF2299-2007 | ParticulateFiltration EfficiencyPerformance | ≥ 98% | Lot 1# 99.2%-99.8%;Lot 2# 99.0%-99.7%;Lot 3# 99.3%-99.7% |
| 16 CFR Part1610 | Flammability | Class I | Lot 1# Class I;Lot 2# Class I;Lot 3# Class I |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under the conditions of thestudy, the subject device wasnon-cytotoxic |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under the conditions of thestudy, the subject device wasnon-sensitizing |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of thestudy, the subject device wasnon-irritating |
8. Brief discussion of clinical tests
No clinical tests were performed.
9. Conclusions
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(K) submission, the surgical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under 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.