(199 days)
This device is intended for single use by operating room personnel healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluid, and particulate materials.
The device is single use multi-layer surgical mask with outer layer and inner layer (spunbond plypropylene) that sandwich a meltblown polypropylene filter material. The surgical mask is secured on user via earloops. Earloops are made of polyester and spandex. The nose piece is a plastic covered iron strip. The materials used to make the surgical mask are being used in currently marketed surgical masks.
The provided text describes the acceptance criteria and performance of the CiRx® Surgical Mask based on non-clinical testing. It does not mention any studies involving AI, human readers with or without AI assistance, or the creation of ground truth by experts in a clinical context. Therefore, many of the requested fields cannot be filled from the given document.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance:
| Performance Test (Test Methodology) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Synthetic Blood Penetration Resistance (ASTM F1862) | 29 out of 32 pass at 160 mmHg | Pass at 160 mmHg. Synthetic blood penetration was not seen. Four lots were tested, with 32 out of 32 passing for each lot. |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥ 98% | Pass, ≥ 99.7%. Four lots were tested. |
| Particle Filtration Efficiency (PFE) (ASTM F2299) | ≥ 98% | Pass, ≥ 99.814%. Four lots were tested. |
| Differential Pressure (Delta P) (ASTM F2100-19) | < 5.0 mmH2O/cm2 | Pass, ≤ 4.9 mmH2O/cm2. Four lots were tested. |
| Flammability (16 CFR 1610) | Class 1 | Pass. Four lots were tested. |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | No cytotoxicity | No cytotoxicity |
| Biocompatibility (ISO 10993-10) | No sensitization | No sensitization |
| Biocompatibility (ISO 10993-10) | No irritation | No irritation |
2. Sample size used for the test set and the data provenance:
- Synthetic Blood Penetration Resistance: 32 samples per lot, tested across four lots (total of 128 samples).
- Bacterial Filtration Efficiency (BFE): Four lots were tested. The exact number of individual mask samples per lot for BFE, PFE, and Differential Pressure is not specified, but it's implied that multiple samples were tested to achieve the reported averages.
- Particle Filtration Efficiency (PFE): Four lots were tested.
- Differential Pressure (Delta P): Four lots were tested.
- Flammability: Four lots were tested.
- Biocompatibility: The document does not specify the sample size for biocompatibility testing, but it refers to ISO 10993 standards which would guide the sample selection.
- Data Provenance: The tests were conducted to demonstrate that the device met established standards and specifications. The document does not specify the country of origin of the testing data, but the manufacturer is Ningbo Shun Ye Medical Company, Ltd. in China. The nature of the tests (laboratory performance tests for surgical masks) makes the "retrospective or prospective" distinction less applicable than in clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The tests are laboratory performance tests against established international standards for surgical masks. Ground truth is determined by the results of these standardized physical and biological tests, not by expert consensus on clinical findings.
4. Adjudication method for the test set:
Not applicable. As these are objective laboratory tests, there is no adjudication method in the context of expert review. The results are compared directly against predefined acceptance criteria from international standards.
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:
No. The document describes a surgical mask, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a surgical mask, not an algorithm.
7. The type of ground truth used:
The ground truth is based on the results of standardized laboratory performance tests, which are objective measurements against established international and national standards (e.g., ASTM, ISO, CFR).
8. The sample size for the training set:
Not applicable. This document describes the performance of a physical medical device (surgical mask), not a machine learning algorithm. 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 for a physical surgical mask.
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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 - USA 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 19, 2021
Ningbo Shun Ye Medical Company, Ltd. Frank Yu General Manager No.5 Industry Road, Zhangqi Industry Zone, Cixi Ningbo, Zhejiang 315313 China
Re: K210256
Trade/Device Name: CiRx® Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 6, 2021 Received: May 18, 2021
Dear Frank Yu:
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,
Clarence W. Murray, III, PhD 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) K210256
Device Name
CiRx® Surgical Mask
Indications for Use (Describe)
This device is intended for single use by operating room personnel healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluid, and particulate materials.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows a logo with the letters "CiR" in a light blue color, with the "R" having a small registered trademark symbol next to it. Below the letters, there are two Chinese characters in a darker shade of blue. The overall design is simple and clean, suggesting a professional or corporate identity.
510(k) Summary
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Image /page/4/Picture/0 description: The image shows a logo with the letters "CiR" in a light blue color, stacked above two Chinese characters. A circled "R" trademark symbol is positioned to the upper right of the "R" in "CiR". The font appears to be sans-serif, and the overall design is simple and clean.
SIO(k) SUMMARY
5l0(k) Number: K210256
(Submitted As Required per 21 CFR 807.92)
GENERAL INFORMATION:
| Submitter Name: | Ningbo Shun Ye Medical Company,Lt d. |
|---|---|
| Establishment RegistrationNumber: | 3007593903 |
| Submitter Address: | No. 5 Industry Road,Zhangqi Industry Zone, Cixi, Ningbo City315313 Zhejiang, China |
| Submitter Telephone Number: | 011-86-574-6377-8018 |
| Submitter FAX Number: | 011-86-574-6377-8028 |
| Contact Person: | Frank YuGeneral Manager |
| Date Prepared: | Jan.20.2021 |
| DEVICE IDENTIFICATION: | |
| SIO(k) Number: | K210256 |
| Proprietary Name: | CiRx® Surgical Mask |
| Common Name: | Surgical Face Mask |
| Classification Name:Model Numbers | Mask, Surgical |
| Catalog# | Description |
|---|---|
| WZ-EN-L-S | Non-sterile Single Use Disposable Surgical Mask, Single Bag Package |
| WZ-EN-L-T | Non-sterile Single Use Disposable Surgical Mask, 10 Pcs Bag Package |
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Image /page/5/Picture/0 description: The image shows a logo with the text "CiRx" in a light blue, sans-serif font. Above and to the right of the "x" is a circled "R", indicating a registered trademark. Below the text "CiRx" are two Chinese characters, also in light blue.
Classification:
Legally Marketed
Predicate Device(s):
| 510(k) Number | Predicate Device Name | Predicate Device Manufacturer |
|---|---|---|
| K122717 | Surgical Mask | Tiger Medical Products Ltd. |
INTENDED USE/INDICATIONS
This device 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, blood and body fluid, and particulate materials.
DEVICE DESCRIPTION
The device is single use multi-layer surgical mask with outer layer and inner layer (spunbond plypropylene) that sandwich a meltblown polypropylene filter material. The surgical mask is secured on user via earloops. Earloops are made of polyester and spandex. The nose piece is a plastic covered iron strip. The materials used to make the surgical mask are being used in currently marketed surgical masks.
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Image /page/6/Picture/0 description: The image shows the logo for CiR, with the letters "CiR" in a light blue color. Below the letters are two Chinese characters in a darker shade of blue. A circled "R" trademark symbol is located in the upper right corner of the logo.
TECHNICOLOGICAL CHARACTERISTICS COMPARISON
| Feature/Characteristic | CiRx® Surgical Mask(K210256) | Surgical Mask, K122717(Tiger Medical Products Ltd.) |
|---|---|---|
| Intended Use | This device is intended for singleuse by operating room personneland other general healthcareworkers to protect both patientsand healthcare workers againsttransfer of microorganisms, bloodand body fluids, and particulatematerials. | Surgical mask is Intended for single useby operating room personnel and othergeneral healthcare workers to protectboth patients and healthcare workersagainst transfer of microorganisms,blood and body fluids, and airborneparticulates. |
| Mask Style | Flat pleated | Flat pleated |
| Design Feature | Earloop | Earloop or tie-on |
| Dimensions | 17.5 cm x 9.5 cm | 17.5 cm x 9.5 cm |
| Color | Blue | Blue |
| OTC Use | Yes | Yes |
| Single Use | Yes | Yes |
| Sterile | No | No |
| Materials | ||
| Inner Layer | Spunbond polypropylene | Spunbond polypropylene |
| Middle Layer | Meltblown polypropylene | Meltblown polypropylene |
| Outer Layer | Spunbond polypropylene | Spunbond polypropylene |
| Nosepiece(See note below) | Iron strip with PP covering | White aluminum strip with PP covering |
| Ear Loops | Polyester and spandex fabric | Urethane elastic fiber |
Note: The nosepiece material used to make CiRx® Surgical Mask is iron strip with PP covering. The predicate device uses white aluminum strip with PP covering.
The face mask is used to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluid, and particulate materials.
Use of nosepiece allows user to close the gap between the upper edge of a face mask and the bridge of the nose. The nosepiece material should be durable and flexible so that the nosepiece can be molded over the nose and fit individual nose shape. Both iron strip and aluminum strip meet the requirements above and can serve the purpose of nosepiece.
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Image /page/7/Picture/0 description: The image shows the logo for CiR, which is a company or organization. The logo consists of the letters "CiR" in a light blue, sans-serif font, stacked on top of two Chinese characters, also in light blue. A circled "R" trademark symbol is located in the upper right corner of the logo, next to the "R" in "CiR".
| Performance Test | ||
|---|---|---|
| Fluid Resistance | Fluid resistant(ASTM 1862) | Fluid resistant(ASTM 1862) |
| Particle FiltrationEfficiency (PFE} | Average 99.896% at 0.1 micron(ASTM F2299) | Average 99.54% at 0.1 micron(ASTM F2299) |
| Bacterial FiltrationEfficiency (BFE} | >99.8%(ASTM F2101) | >99.9%(ASTM F2101) |
| Flammability Class | Class 1(16 CFR 1610) | Class 1(16 CFR 1610) |
| DifferentialPressure (Delta-P} | Average 4.62 mmH₂O/ cm²(ASTM F2100-19) | Average 3.38 mmH₂O/ cm²(M IL-M -36945C 4.4.1.1.1) |
| Biocompatibility | No cytotoxicity (ISO 10993-5)No sensitization (ISO 10993-10)No irritation (ISO 10993-10) | No cytotoxicity (ISO 10993-5)No sensitization (ISO 10993-10)No irritation (ISO 10993-10) |
PERFORMANCE TESTING
Performance testing was completed to demonstrate the subject device met the standards and the specifications described in the named standards and test methodology below:
Performance testing
Performance testing was conducted for the proposed device in accordance with requirements of FDA's Guidance: Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification {510{k}] Submissions (issued on March 5, 2004).
Biocompatibility
Biocompatibility verification was performed in accordance with requirements of ISO 10993-1 and FDA's modified ISO guidelines in accordance with FDA's Biocompatibility guidance found at https://www.fda.gov/media/85865/download
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Image /page/8/Picture/0 description: The image shows a logo with the text "CiRx" in a stylized, light blue font. Below "CiRx" are two Chinese characters in a similar blue color. A circled "R" trademark symbol is located in the upper right corner of the logo.
All test requirements were met as specified by applicable standards. The CiRx® Surgical Mask was designed in accordance with the applicable standards listed below.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Synthetic BloodPenetrationResistance(ASTM F1862) | To evaluate the fluidresistance of surgicalmask | 29 out of 32 pass at 160mmHg | Pass at 160 mmHg.Synthetic bloodpenetration was notseen.Four lots were tested.For each lot, 32 out of32 passed. |
| Bacterial FiltrationEfficiency (BFE)(ASTM F2101-19) | To determine the filtrationefficiency of surgical mask | ≥ 98% | Pass≥99.7%Four lots were tested. |
| Particle FiltrationEfficiency (PFE)(ASTM F2299) | To evaluate the non-viableparticle filtration efficiency(PFE) of surgical mask | ≥ 98% | Pass≥99.814%Four lots were tested. |
| DifferentialPressure(Delta P)(ASTM F2100-19) | To determine thebreathability of surgicalmask | < 5.0 mmH20/cm2 | Pass≤ 4.9 mmH20/cm2Four lots were tested. |
| Flammability(16 CFR 1610) | To evaluate theflammability of surgicalmask | Class 1 | PassFour lots were tested. |
TEST METHODOLOGY/PURPOSE/RESULTS
APPLICABLE STANDARDS
| International Standard | Description |
|---|---|
| ASTM F2100-19 | Standard Specification for Performance of Materials Used inMedical Face Masks |
| ASTM F1862/F1862M-17 | Standard Test Method for Resistance of Medical Face Masks toPenetration by Synthetic Blood (Horizontal Projection of FixedVolume at a Known Velocity) |
| ASTM F2299-03 | Standard Test Method for Determining the Initial Efficiency ofMaterials Used in Medical Face Masks to Penetration byParticulates Using Latex Spheres |
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Image /page/9/Picture/0 description: The image shows a logo with the letters "CiR" in a stylized font, stacked above two Chinese characters. The letters "CiR" are in a light blue color. A circled "R" trademark symbol is located to the right of the "R". The Chinese characters are below the letters and are also in a light blue color.
| International Standard | Description |
|---|---|
| ASTM F2101-19 | Standard Test Method for Evaluating the Bacterial FiltrationEfficiency (BFE) of Surgical Masks Using a Biological Aerosolof Staphylococcus Aureus |
| 16 CFR 1610 | Standard for the Flammability of Clothing Textiles |
| ISO 10993-1:2018 | Biological Evaluation of Medical Devices - Part 1: Evaluation andTesting with a Risk Management Process |
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices- Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices - Part 10: Tests forIrritation and Skin Sensitization |
CLINICAL TEST CONCLUSION
Clinical tests were not needed for this device.
CONCLUSION
The conclusions drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K210256, the CiRx ® Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed device predicate cleared under K122717.
§ 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.