(155 days)
The Disposable Medical 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(s), provided non-sterile.
The proposed device(s) are blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. 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, ear loops, is held in place over the users' 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 polyethylene coated steel wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the 510(k) premarket notification for a Disposable Medical Surgical Mask (K202511). This is a regulatory submission for a medical device, and as such, the "study" referred to is primarily a set of performance tests conducted to demonstrate substantial equivalence to a predicate device, rather than a clinical trial or an AI algorithm validation study.
Therefore, many of the requested elements regarding AI performance, human reader studies, and sophisticated ground truth establishment are not applicable to this type of medical device submission. The device in question is a physical product (a surgical mask), not an AI algorithm or diagnostic tool.
Here's the breakdown based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from recognized standards for surgical masks, primarily ASTM F2100 levels. The study demonstrates performance against these criteria.
| Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance Performance | 29 out of 32 pass at 160 mmHg | 32 out of 32 pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency | $\ge$ 98% | 98.6% | Pass |
| Bacterial Filtration Efficiency | $\ge$ 98% | 99.9% | Pass |
| Differential Pressure (Delta-P) Test | < 6.0mmH2O/cm² | 3.5 mmH2O/cm² | Pass |
| Flammability Testing | Class 1 | Class 1 | Pass |
Study Details (Applicable to a Medical Device Performance Test)
2. Sample size used for the test set and the data provenance:
- Sample Size:
- For Fluid Resistance Performance (ASTM F1862): 32 samples were tested.
- Data Provenance: The tests were conducted according to established ASTM and MIL-M standards. The country of origin of the data is not explicitly stated beyond the manufacturer's location in China. The data is retrospective in the sense that it's a test of the manufactured product to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is a performance test for a physical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" is defined by the objective measurement protocols of the ASTM and MIL standards.
4. Adjudication method for the test set:
- Not applicable for a physical device performance test. Test results are quantitative measurements against predefined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). This submission is for a surgical mask.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The performance tests (e.g., filtration efficiency, fluid resistance) are "standalone" in the sense that they are objective measurements of the mask's physical properties.
7. The type of ground truth used:
- The ground truth is based on objective measurement standards and specifications (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, MIL-M36954C, 16 CFR 1610, ISO 10993-1). For example, for "Fluid Resistance," the ground truth is the pressure at which fluid penetrates the mask when challenged with a synthetic blood spray.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI model that requires a training set. The manufacturing process itself could be seen as "training" in a very abstract sense, but not in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI model with a training set and associated ground truth.
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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 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.
February 2, 2021
Improve Medical (HuNan) Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanhan District Shenzhen, Guangdong 518067 China
Re: K202511
Trade/Device Name: Disposable Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 6, 2021 Received: January 6, 2021
Dear Kevin 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. 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.
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
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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 CAPT Elizabeth Claverie, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K202511
Device Name
Disposable Medical Surgical Mask
Indications for Use (Describe)
The Disposable Medical 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(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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
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510(K) Summary
K202511
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2020/12/31
Submission sponsor 1.
Name: Improve Medical (HuNan) Co., Ltd.
Address: No. 6. Yizhang East Avenue, Economic Development District, 424200, Yizhang, HuNan, China
Contact person: Wang Jing
Title: RA manager
E-mail: wjing 2008@163.com
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China
Contact person: Kevin Wang
E-mail: kevin(@chonconn.com
Tel: +86-755 33941160
| Trade/Device Name | Disposable Medical Surgical Mask |
|---|---|
| Model | Flat (17.5cm*9.5cm) |
| Common Name | Surgical Face Mask |
| Regulatory Class | Class II |
| Regulation | 21CFR 878.4040 |
| Classification name | Mask, Surgical |
| Product code | FXX |
| Submission type | Traditional 510(K) |
Subject Device Information 3.
4. Predicate Device
Manufacturer: Xiantao Zhibo Non-woven Products Co., Ltd. Device: Surgical Face Mask 510(k) No.: K182514.
ട്. Device Description
The proposed device(s) are blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-
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bond polypropylene, and the middle layer is made of melt-blown polypropylene filter.
The model of proposed device, ear loops, is held in place over the users' 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 polyethylene coated steel wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
6. Intended use & Indication for use
The Disposable Medical 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(s), provided non-sterile.
| Features | Subject Device K202511 | Predicate Device K182514 | Remark |
|---|---|---|---|
| Disposable Medical SurgicalMask | Surgical Face Mask | ||
| Applicant | Improve Medical (HuNan) Co.,Ltd. | WUHAN DYMEXHEALTHCARECO., LTD | / |
| ClassificationRegulation | 21CRF 878.4040 | 21CRF 878.4040 | Same |
| Classificationand Code | Class II,FXX | Class II,FXX | Same |
| Common name | Surgical Face Mask | Surgical Face Mask | Same |
| Indication foruse | The Surgical Face Masks areintended to be worn to protect boththe patient and healthcare personnelfrom transfer of microorganisms,body fluids and particulate material.These face masks are intended foruse in infection control practices toreduce the potential exposure toblood and body fluids. This is asingle use, disposable device(s),provided non-sterile. | The Surgical Face Masks areintended to be worn to protect boththe patient and healthcare personnelfrom transfer of microorganisms,body fluids and particulate material.These face masks are intended foruse in infection control practices toreduce the potential exposure toblood and body fluids. This is asingle use, disposable device(s),provided non-sterile. | Same |
| Model | Ear loops, Flat Pleated, 3 layers | Ear loops, Flat Pleated, 3 layers | Same |
| Material | Outer facing layer: Spun-bondpolypropyleneMiddle layer: Melt-blown | Outer facing layer: Spun-bondpolypropyleneMiddle layer: Melt-blown | Same |
| polypropylene filter | polypropylene filter | ||
| Inner facing layer: Spun-bondpolypropylene | Inner facing layer: Spun-bondpolypropylene | Same | |
| Nose wire: Polyethylene coatedsteel wire | Nose wire: Malleable polyethylenewire | Different(1) | |
| Ear loops: Polyester | Ear loops: Spandex | Different(2) | |
| Color | Blue | White | Different(3) |
| Dimension(Width) | 17.5cm ± 0.2cm | 17.5cm ± 0.2cm | Same |
| Dimension(Length) | 9.5 ± 0.2cm | 9.5 ± 0.2cm | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Usage | Single use, disposable | Single use, disposable | Same |
| ASTM F2100Level | Level 3 | Level 2 | Similar |
| FluidResistancePerformanceASTM F1862 | 32 out of 32 pass at 160 mmHg | 32 out of 32 pass at 120 mmHg | Similar |
| ParticulateFiltrationEfficiencyASTM F2299 | Pass at 98.6% | pass at 99.88% | Similar |
| BacterialFiltrationEfficiencyASTM F2101 | Pass at 99.9% | pass at 99.6% | Similar |
| DifferentialPressure (DeltaP) MIL-M36954C | Pass at $3.5 mmH2O/cm²$ | pass at $3.0mmH2O/cm2$ | Similar |
| Flammability16 CFR 1610 | Class 1 | Class 1 | Similar |
| Biocompatibility | Under the condition of this studythe device is non-cytotoxic, non-sensitizing and non-irritating. | Under the condition of this studythe device is non-cytotoxic, non-sensitizing and non-irritating. | Same |
| Item | Proposed device | Acceptance criteria | Result |
| Fluid ResistancePerformance | 32 out of 32 pass at 160 mmHg | 29 out of 32 pass at 160 mmHg | Pass |
| Particulate FiltrationEfficiency | 98.6% | $\ge$ 98% | Pass |
| Bacterial FiltrationEfficiency | 99.9% | $\ge$ 98% | Pass |
| Differential Pressure(Delta-P) Test | 3.5 mmH2O/cm² | < 6.0mmH2O/cm² | Pass |
| Flammability Testing | Class 1 | Class 1 | Pass |
7. Comparison to the Predicate Device
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Justification of differences:
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Justifications for differences between subject device and the predicate device are shown as below:
Different (1), (2), (3): The difference in the materials and colors. Biocompatibility testing accordance with ISO 10993-1 and performance testing accordance with ASTM F2100 have been conducted on the final finished device. Therefore, this difference does not raise any safety or effectiveness issue.
8. Performance Data
The proposed devices were tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004.
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Biocompatibility guidance, 2016 (Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process") and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Under the condition of this study the device is non-cytotoxic, non-sensitizing and non-irritating.
Clinical data
No clinical study is included in this submission.
9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K182514, 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.