(191 days)
The Disposable Surgical Face 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(s), provided non-sterile.
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The blue colorant is polypropylene (PP) master batch.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
This document describes the premarket notification (510(k)) for a Disposable Surgical Face Mask, and as such, it does not detail a study involving AI or human reader performance for diagnostic purposes. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.
Therefore, many of the requested criteria related to AI/human reader studies, expert ground truth, adjudication, and large-scale data sets for training/testing are not applicable to this type of device and submission.
However, I can provide the information that is available in the document regarding the acceptance criteria and the study that proves the device meets them, primarily focusing on its physical and biological performance characteristics.
Acceptance Criteria and Device Performance (for a Disposable Surgical Face Mask)
The acceptance criteria for this medical device are based on demonstrating that the proposed Disposable Surgical Face Mask is substantially equivalent to a legally marketed predicate device (K133070 Surgical Face Mask). This is primarily achieved through non-clinical testing against established industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ASTM F2100-11 for Level 2 classification, MIL-M-36945C, 16 CFR 1610, and ISO 10993 standards for biocompatibility. The reported device performance is the result of the non-clinical tests conducted on the proposed device.
| ITEM | Acceptance Criteria (ASTM F2100 Level 2 / Other Standard) | Reported Device Performance (Proposed Device) | Remark (vs. Predicate) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862-13) | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | SE (Substantially Equivalent) |
| Particulate Filtration Efficiency (ASTM F2299) | $\ge$ 98% | 98.46% | SE |
| Bacterial Filtration Efficiency (ASTM F2101) | $\ge$ 98% | 98.7% | SE |
| Differential Pressure (Delta P) (MIL-M-36954C) | < 5.0 mmH2O/cm² | 4.2 mmH2O/cm² | SE |
| Flammability (16 CFR 1610) | Class 1 | Class 1 (Non Flammable) | SE |
| Cytotoxicity (ISO 10993-5) | Not cytotoxic | Under the conditions of the study, not cytotoxicity effect | SE |
| Irritation (ISO 10993-10) | Not an irritant | Under the conditions of the study, not an irritant | SE |
| Sensitization (ISO 10993-10) | Not a sensitizer | Under conditions of the study, not a sensitizer. | SE |
Note: "SE" in the remark column indicates that the proposed device performed as well as, or better than, the predicate device and met the established performance requirements, thus demonstrating substantial equivalence.
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the material performance tests (e.g., how many masks were tested for BFE or PFE). However, for Fluid Resistance, the sample size is explicitly stated as 32, with the acceptance criterion being 29 out of 32 passes.
The data provenance is from non-clinical tests conducted on the proposed device. The country of origin for the manufacturing and potentially the testing facility is China (Xiantao Rayxin Medical Products Co., Ltd. is located in Hubei, China). The studies are inherently prospective in nature, as they involve conducting new tests on specific samples of the manufactured device to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. The "ground truth" for material performance and biocompatibility is established by the standardized test methods themselves (e.g., ASTM, ISO standards). These standards outline the methodology and criteria for determining performance characteristics like filtration efficiency or biocompatibility, which are measured objectively. There are no human "experts" establishing unique ground truth interpretations for each test sample as in a diagnostic image analysis study. The tests are lab-based, quantitative measurements.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to establish a consensus ground truth. In the case of material performance testing, the results are quantitative and objective, directly measured by laboratory instruments and procedures outlined in the test 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
This information is not applicable. This submission is for a physical medical device (surgical face mask), not an AI-powered diagnostic tool. Therefore, no MRMC study, human reader assistance, or AI component is involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This submission is for a physical medical device (surgical face mask), not an algorithm or software as a medical device (SaMD).
7. The Type of Ground Truth Used
The "ground truth" for this device is based on established industry standards and objective measurements of the device's physical and biological performance characteristics. These include:
- Standard Specifications: ASTM F2100-11 for performance of materials in medical face masks.
- Standard Test Methods: e.g., ASTM F1862-13 (Fluid Resistance), ASTM F2101-14 (BFE), ASTM F2299-03 (PFE), MIL-M-36945C (Differential Pressure), 16 CFR 1610 (Flammability).
- Biocompatibility Standards: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization).
The ground truth is inherent in the pass/fail criteria or quantitative thresholds defined by these widely accepted standards.
8. The Sample Size for the Training Set
This information is not applicable. This submission is for a physical device, and does not involve AI or machine learning models that require training sets of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Xiantao Rayxin Medical Products Co., Ltd. June 15, 2016 % Mr. Ray Wang Official Correspondent Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District Beijing, 100024 CHINA
Re: K153496
Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: May 11, 2016 Received: May 16, 2016
Dear Mr. Wang:
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. 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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Page 2 - Mr. Wang
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153496
Device Name Disposable Surgical Face Mask Ear Loop and Tie-On
Indications for Use (Describe)
The Disposable Surgical Face 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(s), 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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Tab #3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K153496
-
- Date of Preparation:2016/06/11
-
- Sponsor Identification
Xiantao Rayxin Medical Products Co., Itd. No. 258 Pengchang Road, Middle Street, Xiantao city, Hubei 433018, China
Establishment Registration Number: Not yet registered
Contact Person: Liang Zhang Position: General Manager Tel: +86-728-2617592 Fax: +86-728-26177777 Email: zl@rayxin.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe Tech. Service Co., Ltd
5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China
Tel: +86-21-50313932, Fax: +86-21-68093116 Email: Ray.Wang@believe-med.com
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4. Identification of Proposed Device
Trade Name: Disposable Surgical Face Mask Common Name: Surgical Face Mask Model(s): Tie-On, Ear Loops
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product Code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
Indication for use Statement:
The Disposable Surgical Face 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(s), provided non-sterile.
Device Description
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The blue colorant is polypropylene (PP) master batch.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
5. Identification of Predicate Device(s)
Predicate Device K133070 Surgical Face Mask
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BH Medical Products Co., Ltd.
-
Non-Clinical Test Conclusion Q.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
ASTM F2100-11, Standard Specification For Performance Of Materials Used In Medical Face Masks.
-
ASTM F1862-13, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
-
MIL-M-36945C, Method 1 Military Specifications: Surgical Mask disposable;
-
ASTM F2101-14, Standard Test Method For Evaluating The Bacterial Filtration Efficiency > (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
-
ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
-
A 16 CFR 1610, Standard for the Flammability of clothing textiles;
-
Bench Testing for the performance of Dimensions.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
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Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Intended Use | The Disposable Surgical Face 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(s), provided non-sterile. | The Surgical Face 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(s), provided non-sterile. | SE | |
| Ear loop model and tie-on model | Ear Loops, Tie-On, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated, 3 layers | SE | |
| Materials | Outer Facing Layer | Spun-bond polypropylene | Spun-bond polypropylene | SE |
| Middle Layer | Melt blown polypropylene filter | Melt blown polypropylene filter | ||
| Inner Facing Layer | Spun-bond polypropylene | Spun-bond polypropylene | ||
| Tieon | Spun-bond polypropylene | Spun-bond polypropylene | ||
| Nose Piece | Malleable aluminum wire | Malleable aluminum wire | ||
| Ear Loops | Polyester | Polyester | ||
| Color | Blue | Blue, Green | SE | |
| Dimension (Width) | 17.5 cm +/- 1cm | 6.8" +/-0.25" (17.27 cm +/- 0.63cm) | SE | |
| Dimension (Length) | 9.5 cm +/- 1cm | 4.2" +/-0.25" (10.67 cm +/- 0.63cm)3.5" +/-0.25" (8.89 cm +/- 0.63cm) | ||
| OTC use | Yes | Yes | SE | |
| Single Use | Yes | Yes | SE | |
| Sterile | No | No | SE | |
| ASTM F2100 Level | Level 2 | Level 2 | SE |
Table 1 General Comparison
Table 2 Performance Characteristic Comparision
| ITEM | Proposed Device | Predicate Device | ASTM F2100Requirements forLevel 2Classification | Remark |
|---|---|---|---|---|
| Fluid ResistancePerformanceASTM F1862-13 | 32 out of 32 pass at 120 mmHg | Meet the ASTM F2100Requirements for Level 2Classification | 29 out of 32 pass at 120 mmHg | SE |
| ParticulateFiltrationEfficiency ASTM | 98.46% | Meet the ASTM F2100Requirements for Level 2Classification | $\ge$ 98% |
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| F2299 | ||||
|---|---|---|---|---|
| BacterialFiltrationEfficiency ASTMF2101 | 98.7% | Meet the ASTM F2100Requirements for Level 2Classification | ≥ 98% | |
| DifferentialPressure (DeltaP)MIL-M-36954C | 4.2 mmH2O/cm² | Meet the ASTM F2100Requirements for Level 2Classification | < 5.0 mmH2O/cm² | |
| Flammability16 CFR 1610 | Class 1Non Flammable | Class 1 | Class 1 | SE |
| Table 3 Biocompatibility Comparison | ||
|---|---|---|
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Cytotoxicity | Under the conditions of the study, notcytotoxicity effect | Comply with ISO 10993-5 | SE |
| Irritation | Under the conditions of the study, not anirritant | Comply with ISO 10993-10 | SE |
| Sensitization | Under conditions of the study, not asensitizer. | SE |
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
The Xianto Rayxin Medical Products Disposable Surgical Face Mask is substantially equivalent to the BH Medical Products Surgical Face Mask. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, BH Medical Products Surgical Face Mask cleared under K133070.
§ 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.