(287 days)
The Disposable surgical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials 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 is 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 is manufactured with three layers, the inner and outer layers are made of spun-bond Nonwoven fabric polypropylene, and the middle layer is made of melt blown polypropylene filter. The filter fiber is used for particle adsorption, mechanical sieve retention, inertial deposition, and electrostatic adsorption deposition, so that the air containing harmful substances is filtered through the filter material of the mask and then inhaled or exhaled.
The style of the device, ear loops, is held in place over the users' mouth and nose by two ear loops welded to the facemask. The ear loops are not made with natural rubber latex but made of polyester and spandex.
The nose piece contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and iron.
The proposed device should be stored in a dry, ventilated and pollution-free area; the temperature should be 0-40 ℃, and the humidity should not be higher than 80%; Keep away from fire sources, avoid dust exposure and direct sunlight.
The proposed device is sold non-sterile and is intended to be a single use, disposable device.
The provided text is a 510(k) summary for a disposable surgical face mask. It does not detail a study involving AI assistance for human readers or the establishment of ground truth by multiple experts for an AI device. Instead, it focuses on demonstrating substantial equivalence of the new medical device (a surgical mask) to a legally marketed predicate device through non-clinical performance testing and biocompatibility studies.
Therefore, most of the requested information regarding AI device acceptance criteria, MRMC studies, ground truth establishment for AI, and training/test set details for an AI model cannot be extracted from this document as it pertains to a different type of medical device evaluation.
However, I can provide information based on the performance testing of the surgical mask, interpreted as its "acceptance criteria" and "device performance".
Here's the information that can be extracted:
Device Acceptance Criteria and Performance (for a Disposable Surgical Face Mask)
The acceptance criteria and performance data are based on non-clinical testing against established standards for medical face masks and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
The device (Disposable surgical face mask, Model: AD-PR02, AD-PR02-2, AD-PR02-S01, AD-PR02-S02 manufactured by Shandong Aida Medical Products Co., Ltd) was tested against the requirements for an ASTM F2100-2020 Level 2 classification mask.
| Characteristic | Acceptance Criteria (ASTM F2100-2020 Level 2) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood | ≥ 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | Yes |
| Particulate Filtration Efficiency (PFE) | ≥ 98% | Pass (specific value: 98.46%) | Yes |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | 99.9% | Yes |
| Differential Pressure (Delta P) | < 6.0 mmH₂O/cm² | Max: 4.8 mmH₂O/cm² Min: 4.2 mmH₂O/cm² | Yes |
| Flame Spread (16 CFR 1610) | Class 1 | Class I (Non-Flammable) | Yes |
| Biocompatibility: Cytotoxicity (ISO 10993-5) | No potential cytotoxicity | Not showing potential toxicity to L929 cells | Yes |
| Biocompatibility: Irritation (ISO 10993-10) | Non-Irritating | Response categorized as negligible | Yes |
| Biocompatibility: Sensitization (ISO 10993-10) | Non-Sensitizing | No evidence of skin sensitization | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The sample sizes for specific tests are not uniformly detailed:
- Resistance to Penetration by Synthetic Blood: 32 samples were tested.
- Other performance tests (PFE, BFE, Differential Pressure, Flame Spread): Specific sample sizes are not explicitly mentioned, but the results are reported as meeting the criteria for the product.
- Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): Standard test methods (ISO 10993) would dictate the sample sizes for these biological evaluations, but specific numbers are not provided in the summary.
Data Provenance: The tests were conducted by Shandong Aida Medical Products Co., Ltd, located in China. The data were collected retrospectively as part of the 510(k) submission process to demonstrate equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable to this document as the device being assessed is a physical medical device (surgical mask), not an AI/software device that requires expert-established ground truth for image or data interpretation. The "ground truth" here is defined by performance standards and laboratory test results.
4. Adjudication Method for the Test Set
This is not applicable for the type of device and testing described. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert reviews for AI/diagnostic devices to resolve discrepancies. The performance tests for a surgical mask are based on objective measurements against defined standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to a surgical mask.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This question pertains to AI algorithm performance.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective laboratory test methods and international/national standards (e.g., ASTM F2100, ASTM F2101, EN 14683, ASTM F1862, ASTM F2299, 16 CFR Part 1610, ISO 10993). These standards define the acceptable performance metrics for properties like filtration efficiency, fluid resistance, breathability, flammability, and biocompatibility.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve an AI algorithm that learns from data.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
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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.
November 16, 2022
Shandong Aida Medical Products Co., Ltd Wang Bing Technical Manager Wangjiazhuang, Wangliu Street Office, Weicheng District Weifang, Shandong 261053 China
Re: K220302
Trade/Device Name: Disposable surgical face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 17, 2022 Received: October 17, 2022
Dear Wang Bing:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220302
Device Name Disposable surgical face mask
Indications for Use (Describe)
The Disposable surgical face mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials 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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K220302 page 1 of 8
B-2. 510(K) Summary
Summary Date: July 23, 2021
| 1 Submitted by : | Shandong Aida Medical Products Co.,LtdWangjiazhuang, Wangliu Street Office, Weicheng District,Weifang City, Shandong province, P.R.China, 2610530086-536-8131936zoro@aidamasks.com |
|---|---|
| ------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
2 Contact Person: Primary Contact: WangBing Wangjiazhuang, Wangliu Street Office,Weicheng District, Weifang City, Shandong Province, P.R. China 0086-15263613795 zoro@aaidamasks.com
Secondary Contact: Yu guangjiang Wangjiazhuang, Wangliu Street Office, Weicheng District, Weifang City, Shandong Province P.R. China 0086-13792660238 914424647@qq.com
3 Device Information
Trade Name: Disposable surgical face mask Common/Usual Name: Disposable surgical mask Model: AD-PR02, AD-PR02-2,AD-PR02-S01,AD-PR02-S02
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Regulatory Information Classification Name: Mask, Surgical Classification: Class II Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Description: Surgical Apparel
4 Legally Marketed Predicate device:
Trade Name: Disposable Surgical Face Mask 510(K) Number: K153496 Product Code: FXX Manufacturer: Xiantao Rayxin Medical Products Co.,Ltd.
5 Device Description:
The proposed device is 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 is manufactured with three layers, the inner and outer layers are made of spun-bond Nonwoven fabric polypropylene, and the middle layer is made of melt blown polypropylene filter. The filter fiber is used for particle adsorption, mechanical sieve retention, inertial deposition, and electrostatic adsorption deposition, so that the air containing harmful substances is filtered through the filter material of the mask and then inhaled or exhaled.
The style of the device, ear loops, is held in place over the users' mouth and nose by two ear loops welded to the facemask. The ear loops are not made with natural rubber latex but made of polyester and spandex.
The nose piece contained in the proposed device is in the layers of facemask to allow
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the user to fit the facemask around their nose, which is made of polypropylene and iron.
The proposed device should be stored in a dry, ventilated and pollution-free area; the temperature should be 0-40 ℃, and the humidity should not be higher than 80%; Keep away from fire sources, avoid dust exposure and direct sunlight.
The proposed device is sold non-sterile and is intended to be a single use, disposable device.
6 Intended Use/Indications for Use:
The Disposable surgical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials 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.
7 Performance Data
Non-Clinical Test Conclusion:
Non-clinical tests were conducted to verify that the device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the device complies with the following standards:
Biocompatibility:
The Disposable surgical face mask has been subjected to biocompatibility studies to demonstrate the safety of device. The biocompatibility studies are in accordance with ISO10993:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests
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for Irritation and Skin Sensitization.
Performance:
- A ASTM F2100-2020, Standard Specification for Performance of Materials Used in Medical Face Masks.
- ASTM F2101-2019, Standard Test Method for Evaluating the Bacterial Filtration A Efficiency (BFE) Of Medical Face Mask Materials, Using a nebulizer and a culture suspension of staphylococcus aureus.
- A EN 14683:2019+AC:2019 Annex C, Standard Test Method for differential pressure of Medical Face Masks
- A ASTM F2299/F2299M-03(Reapproved 2017), Standard test method for determining the initial filtration efficiency of materials used in medical face masks to penetration by particulates using latex sphere aerosol.
- ASTM F1862/F1862M-2017, Standard Test Method for Resistance of Medical △ Face Masks to penetration by synthetic blood.
- A 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles.
Clinical Test Conclusion :
No clinical study is included in this submission.
8 Substantially Equivalent (SE) Comparison with The Predicate Device:
Comparison with the predicate devices, the device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table
| Table B-II-1 General Comparison | |
|---|---|
| ITEM | Proposed Device | Predicate | Remark |
|---|---|---|---|
| PredicateDevice(K153496) |
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K220302 page 5 of 8
| Manufacturer | Shandong Aida MedicalProducts Co.,Ltd | Xiantao Rayxin MedicalProducts Co.,Ltd. | ||
|---|---|---|---|---|
| Trade name | Disposable surgical facemask | Disposable SurgicalFace Mask | ||
| Classification | Class II Device, FXX (21CFR § 878.4040) | Class II Device, FXX(21CFR § 878.4040) | SE | |
| Indications for use | The Disposable surgicalface mask is intended to beworn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids, and particulatematerials in infectioncontrol practices to reducethe potential exposure toblood and body fluids. Thisis a single use, disposabledevice(s), providednon-sterile. | The Disposable SurgicalFace Masks are intendedto be worn to protectboth the patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided non-sterile. | SE | |
| Mask Styles andDesign features | Ear Loops, Flat Pleated, 3layers | Ear Loops/Tie-on, FlatPleated, 3 layers | Different | |
| Materials | ||||
| Outer FacingLayer | Spun-bond Nonwovenfabric polypropylene | Spun-bondpolypropylene | SE | |
| Middle layer | Melt blown polypropylenefilter | Melt blownpolypropylene filter | SE | |
| Inner FacingLayer | Spun-bond Nonwovenfabric polypropylene | Spun-bondpolypropylene | SE | |
| Nose clip | Polypropylene and iron | Malleable aluminumwire | Different | |
| Tie-one | Spun-bondpolypropylene | Different | ||
| Ear loops | Polyester and spandex | Polyester | Different | |
| Color | Blue | Blue | SE | |
| Dimension (Width) | 17.5 cm +/- 5% | 17.5 cm +/- 1 cm | Different | |
| Dimension (Length) | 9.5 cm +/- 5% | 9.5 cm +/- 1 cm | Different | |
| OTC use | Yes | Yes | SE | |
| Sterility | No | No | SE | |
| Single Use | Yes | Yes | SE | |
| ASTM F2100-2020 | Level 2 | Level 2 | SE | |
| Biocompatibility | ISO10993 | ISO10993 | SE |
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K220302 page 6 of 8
Table B-II-2 Performance Characteristic Comparison
| Test Methodology | Proposed Device | PredicateDevice(K153496) | ASTM F2100-2020Requirements for Level2 Classification | Remark |
|---|---|---|---|---|
| Resistance toPenetration bySynthetic Blood | 32 out of 32 passat 120 mmHg | 32 out of 32 passat 120 mmHg | 29 out of 32 pass at120 mmHg | Meet |
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K220302 page 7 of 8
| ASTM F1862 | ||||
|---|---|---|---|---|
| ParticulateFiltration EfficiencyASTMF2299 | Pass | 98.46% | $\u2265$ 98% | Meet |
| Bacterial FiltrationEfficiencyASTMF2101 | 99.9% | 98.7% | $\u2265$ 98% | Meet |
| DifferentialPressure (Delta P)EN 14683 | Max: 4.8 mmH₂O/cm²Min: 4.2 mmH₂O/cm² | 4.2 mmH₂O /cm² | < 6.0 mmH₂O/ cm² | Meet |
| Flame spread16 CFR 1610 | Class I | Class INon-Flammable | Class 1 | Meet |
Table B-II-3 Biocompatibility Comparison
| Item | Subject device | AcceptanceCriteria | Remark |
|---|---|---|---|
| Cytotoxicity | Under the conditions of this study, the testarticle extract did not show potential toxicity toL929 cells | No potentialcytotoxicity | SE |
| Irritation | The test result showed that the response of thetest article extract was categorized as negligibleunder the test condition. | Non-Irritating | SE |
| Sensitization | Under the conditions of this study, no evidenceof skin sensitization in guinea pigs was found. | Non-Sensitizing | SE |
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All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.
9 Conclusion:
Based on the comparison and analysis above, the devices are determined to be Substantially Equivalent (SE) to the predicate devices.
The Shandong Aida Medical Products Disposable surgical face mask is substantially equivalent to the Xiantao Rayxin Medical Products Disposable 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, Xiantao Rayxin Medical Products Disposable Surgical Face Mask cleared under K153496.
§ 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.