(74 days)
The AIC Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The 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 nonsterile.
The AIC Disposable Medical Masks are Blue and white 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 users' 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 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 malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device
This document is a 510(k) Summary for a disposable medical mask, not an AI-powered medical device. Therefore, much of the requested information about acceptance criteria, ground truth, expert adjudication, MRMC studies, and training sets is not applicable to this type of submission.
However, I can extract the relevant non-clinical performance data and the acceptance criteria for those tests, as this is how the device's performance is proven to meet the required standards for a medical mask.
Here's the breakdown based on the provided document, addressing what is applicable:
Device: AIC Disposable Medical Mask
Device Type: Surgical Apparel (Class II Medical Device)
Purpose of the Study: To demonstrate substantial equivalence to a legally marketed predicate device (K153496) by showing that the AIC Disposable Medical Mask is as safe and effective as the predicate device. This is primarily done through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for medical masks are based on recognized standards (e.g., ASTM F2100). The document specifically details the performance against ASTM Level 3 requirements.
| Test Item | Test Standard/Method | Acceptance Criteria (Pass Criteria) | Reported Device Performance (Average) | Conclusion |
|---|---|---|---|---|
| Bacterial Filtration Efficiency | ASTM F2101-19 | ≥ 98% | 99.3% | Pass |
| Differential Pressure (Delta-P) | ASTM F2100-19 | < 6 mm H₂O/cm² | 4.40 mm H₂O/cm² | Pass |
| Fluid Resistance Performance | ASTM F1862 | Pass at 160 mmHg | 96 out of 96 Pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | ≥ 98% | 99.9% | Pass |
| Flammability | 16 CFR 1610 | Class 1 (≥ 3.5 seconds) | Test Article ignited, but extinguished or did not ignite. (This phrasing usually implies Class 1) | Pass |
Biocompatibility Testing (Acceptance Criteria are implied non-toxicity/irritation/sensitization)
| Test Name | Standard Followed | Result |
|---|---|---|
| Cytotoxicity | ISO10993-5 | Under the conditions of the study, the proposed device extract demonstrated evidence of potential cytotoxicity. (Note: This finding necessitated further testing, which resolved the concern.) |
| Skin Irritation | ISO10993-10 | Under the conditions of the study, the proposed device extract was determined to be non - irritating |
| Skin Sensitization | ISO10993-10 | Under the conditions of the study, the proposed device extract was determined to be non - sensitizing |
| Acute Toxicity | ISO10993-11 | Under the conditions of the study, the proposed device extract was determined to be non-toxic. (Conducted to address the initial cytotoxicity finding, and confirmed biocompatibility.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the performance tests (Bacterial filtration efficiency, Differential pressure, Fluid Resistance Performance, Particulate Filtration Efficiency, Flammability), the sample size was specified as 3 lots, with 32 samples per lot, totaling 96 samples per test. For Fluid Resistance, the outcome was reported for "96 out of 96."
- Data Provenance: The document does not explicitly state the country of origin where the testing was performed, but the applicant (The Aleen International Corporation) is based in Heyuan, Guangdong, China. The data is retrospective in the sense that it was collected as part of the premarket submission based on standard laboratory testing of the manufactured product.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. For non-clinical performance testing of medical masks, "ground truth" is established by laboratory measurement against established engineering and material standards (e.g., ASTM, ISO). It does not involve human expert interpretation of images or other data which would require expert consensus.
4. Adjudication Method for the Test Set
Not Applicable. As per point 3, the ground truth is established by objective laboratory measurements and does not require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study (MRMC) is relevant for AI-powered diagnostic devices where human readers interpret medical images. This document is for a physical medical 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. Its performance is measured directly by physical and biological testing.
7. The Type of Ground Truth Used
The ground truth for the performance of the medical mask is based on objective laboratory measurements according to international and national standards (ASTM, ISO, 16 CFR) for:
- Bacterial Filtration Efficiency
- Differential Pressure
- Fluid Resistance
- Particulate Filtration Efficiency
- Flammability
- Biocompatibility (Cytotoxicity, Skin Irritation, Skin Sensitization, Acute Systemic Toxicity)
8. The Sample Size for the Training Set
Not Applicable. This is a physical product, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As per point 8, there is no AI training set.
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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.
March 12, 2021
The Aleen International Corporation % Diana Lam Regulatory Affairs Consultant Duocare, LLC 370 W. Grand Blvd. Suite 110 Corona, California 92882
Re: K203775
Trade/Device Name: AIC disposable medical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 28, 2020 Received: December 28, 2020
Dear Diana Lam:
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 and Part 809: 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 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 Ryan Ortega, PhD Acting 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) K203775
Device Name AIC Disposable Medical Mask
Indications for Use (Describe)
The AIC Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The 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 nonsterile.
| Type of Use (Select one or both, as applicable) | Routine Use Per 31 CFR 331.3(a)(2) - Payments Data File Comparison Under 31 CFR 331.3(a)(2) - Screening |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------ |
| | 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
K203775
Date Summary Prepared:
March 10, 2021
Applicant:
The Aleen International Corporation
Address: Jiutian Green Science and Technology Industrial Park, Heyuan High-Tech Zone, Heyuan, Guangdong, China 517000
Contact:
Can Huang
The Aleen International Corporation
Email: chuang@aleenic.com
Phone: (+001) 626-620-0184
Correspondent Contact:
Diana Lam,
DuoCare, LLC
info@@duocarepro.com
Device Information:
Device Name: AIC Disposable Medical Mask
Trade Name: AIC Disposable Medical Mask
Common Name: Disposable Medical Mask
Device Classification Name: Surgical Apparel
Classification Regulation Number: 21 CFR 878.4040
Device Classification: Class II
Classification Product Code: FXX
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Predicate Device
| Predicate Device | Disposable Surgical Face Mask | K153496 | Xiantao Rayxin MedicalProducts Co., Ltd. | |
|---|---|---|---|---|
| Item Name | Subject device | Predicate Device | Comparison | |
| Device name | AIC Disposable Medical | Disposable Surgical | - | |
| Mask | Face Mask | |||
| Manufacturer | The Aleen International | Xiantao Rayxin Medical | - | |
| Corporation | Products Co., ltd. | |||
| 510(K) No. | K203775 | K153496 | - | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Classification Name | Surgical Apparel | Surgical Apparel | Same | |
| Regulatory Class | Class II | Class II | Same | |
| Product Code | FXX | FXX | Same | |
| Indications for use | The AIC DisposableMedical Masks areintended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. The face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids. This is asingle use, disposabledevice, provided non-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. | Same | |
| Device Description | The AIC DisposableMedical Masks are Blueand white color, and FlatPleated type mask,utilizing Tie-On or EarLoops way for wearing,and they all has NosePiece design for fittingthe facemask around thenose.The blue colorant ispolypropylene (PP)master batch.The proposed device(s)are manufactured withthree layers, the innerand outer layers aremade of spun-bondpolypropylene, and themiddle layer is made of | The proposed device(s)are Blue color, and FlatPleated type mask,utilizing Tie-On or EarLoops way for wearing,and they all has NosePiece design for fittingthe facemask around thenose.The blue colorant ispolypropylene (PP)master batch.The proposed device(s)are manufactured withthree layers, the innerand outer layers aremade of spun-bondpolypropylene, and themiddle layer is made ofmelt blown polypropylenefilter | Same | |
| melt blown polypropylenefilter.The model of proposeddevice, tie-on, is held inplace over the user'smouth and nose by fourties welded to thefacemask. The tie ismade of spun-bondpolypropylene.The model of proposeddevice, ear loops, is heldin place over the user'smouth and nose by twoelastic ear loops weldedto the facemask. Theelastic ear loops are notmade with natural rubberlatex.The nose piececontained in theproposed device(s) is inthe layers of facemask toallow the user to fit thefacemask around theirnose, which is made ofmalleable aluminum wire.The proposed device(s)are sold non-sterile andare intended to be singleuse, disposable device | The model of proposeddevice, tie-on, is held inplace over the user'smouth and nose by fourties welded to thefacemask. The tie ismade of spun-bondpolypropylene.The model of proposeddevice, ear loops, is heldin place over the user'smouth and nose by twoelastic ear loops weldedto the facemask. Theelastic ear loops are notmade with natural rubberlatex.The nose piececontained in theproposed device(s) is inthe layers of facemask toallow the user to fit thefacemask around theirnose, which is made ofmalleable aluminum wire.The proposed device(s)are sold non-sterile andare intended to be singleuse, disposable device. | |||
| Ear loop model andtie-on model | Ear Loops, Tie-On, Flat | Ear Loops, Tie-On, FlatPleated, 3 layers | Same | |
| Outerlayer | Pleated, 3 layersSpun-bondpolypropylene | Spun-bondpolypropylene | ||
| Middlelayer | Melt blown polypropylenefilter | Melt blown polypropylenefilter | ||
| Mater-ial | Innerlayer | Spun-bondpolypropylene | Spun-bondpolypropylene | Same |
| Ties | Spun-bondpolypropylene | Spun-bondpolypropylene | ||
| Nose piece | Malleable aluminum wire | Malleable aluminum wire | ||
| Ear loops | Polyester | Polyester | ||
| Mask coverwidth | $9.5 \pm 1.0$ cm | $9.5 \pm 1.0$ cm | Same | |
| Mask coverlength | $17.5 \pm 1.0$ cm | $17.5 \text{ cm }\pm 1.0$ cm | Same | |
| Dimension | Single ear loop Length for Ear Loops style | $18.0 \pm 1.0$ cm | $17.0 \pm 1.0$ cm | Similar |
| Single tie Length for Tie-On style | $38.5 \pm 5.0$ cm | $40 \pm 1.0$ cm | Similar | |
| Nose piece length | $10.5\pm 1.0$ cm | $11.0\pm 1.0$ cm | Similar | |
| Actual performance values (Average) | Bacterial filtration efficiency | 99.3% (3 lots, 32 samples/lot) | 98.7% | Similar |
| Differential pressure (Delta-P) | 4.40 mmH2O/cm² (3 lots, 32 samples/lot) | 4.2 mmH2O/cm² | Similar | |
| Fluid Resistance Performance | 96 out of 96 Pass at160 mmHg (3 lots, 32 samples/lot) | 32 out of 32 pass at 120 mmHg | Same | |
| Particulate Filtration Efficiency | 99.9% (3 lots, 32 samples/lot) | 98.46% | Similar | |
| Flammability | Class 1 (3 lots, 32 samples/lot) | Class 1 | Same | |
| Biocompatibility | Cytotoxicity | Under the conditions of the study, the proposed device extract demonstrated evidence of potential cytotoxicity | Under the conditions of the study, not cytotoxicity effect | Different |
| Skin Irritation | Under the conditions of the study, the proposed device extract was determined to be non - irritating | Under the conditions of the study, not an irritant | Same | |
| Skin Sensitization | Under the conditions of the study, the proposed device extract was determined to be non - sensitizing | Under conditions of the study, not a sensitizer. | Same | |
| Acute Toxicity | Under the conditions of the study, the proposed device extract was determined to be non-toxic | - | Different, product safety concern was addressed | |
| Color | Blue (outside), White (inside) | Blue | Same | |
| OTC use | Yes | Yes | Same | |
| Single use | Yes | Yes | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| ASTM F2100 Level | Level 3 | Level 2 | Different |
Description of Device
The AIC Disposable Medical Masks are blue and white 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 users' 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 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 malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device
Indications for use
The AIC Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The 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 non-sterile.
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Technological Characteristics Comparison
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Non-Clinical performance Data
| Test item(ASTM Level 3) | Test Standard/method | Pass criteria | Test results | Conclusion |
|---|---|---|---|---|
| Bacterial filtrationefficiency | ASTM F2101-19 | ≥ 98% | 99.3% | Pass |
| Differential pressure(Delta-P) | ASTM F2100-19 | < 6 mmH2O/cm² | 4.40 mm H₂O/cm² | Pass |
| Fluid ResistancePerformance | ASTM F1862 | Pass at160 mmHg | 96 out of 96 Passat160 mmHg | Pass |
| Particulate FiltrationEfficiency | ASTM F2299 | ≥ 98% | 99.9% | Pass |
| Flammability | 16 CFR 1610 | Class 1 (≥3.5 seconds) | Test Article ignited,but extinguished ordid not ignite. | Pass |
Performance Testing summary
Biocompatibility testing summary
According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact are A-Limited (≤24h). The following tests for the subject device were conducted. Cytotoxicity testing conducted on the subject device revealed some evidence of potential cytotoxicity. Therefore, acute systemic toxicity was conducted to further assess biocompatibility of the subject device. Acute systemic toxicity testing revealed no evidence of the subject device causing acute systemic toxicity. In light of this finding, it is concluded that the subject device is biocompatible and safe for its intended use
| Test Name | Standardfollowed | Result |
|---|---|---|
| Cytotoxicity | ISO10993-5 | Under the conditions of the study, the proposed deviceextract demonstrated evidence of potential cytotoxicity |
| Skin Irritation | ISO10993-10 | Under the conditions of the study, the proposed deviceextract was determined to be non - irritating |
| SkinSensitization | ISO10993-10 | Under the conditions of the study, the proposed deviceextract was determined to be non - sensitizing |
| Acute Toxicity | ISO10993-11 | Under the conditions of the study, the proposed deviceextract was determined to be non-toxic |
Clinical performance Data
Clinical data was not included in this submission.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K203775, the AIC Disposable Medical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device 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.