(109 days)
ADI 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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The ADI Medical Surgical Face Masks are single use, three-layer, flat -folded masks with ear loops and nose clamp. The ADI Medical Surgical Face Masks 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 ear loops are 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 clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. ADI Medical Surgical Face Masks will be provided in blue. ADI Medical Surgical Face Masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text describes the regulatory filing for a surgical face mask, not an AI-powered diagnostic device. Therefore, the questions related to AI device performance, expert ground truth, MRMC studies, and training/test set sample sizes are not directly applicable.
However, I can extract the information relevant to the device's acceptance criteria and the study proving it meets those criteria based on the provided document.
Device: ADI Medical Surgical Face Mask
Regulatory Filing: K213347
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ADI Medical Surgical Face Mask are defined by various ASTM and EN standards for surgical masks. The performance tests were conducted to demonstrate that the device meets these standards.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Test (Standard) | Acceptance Criteria | Reported Device Performance (ADI Medical Surgical Face Mask) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 samples pass at 120 mmHg | 94 out of 96 samples pass at 120 mmHg (from 3 non-consecutive lots) | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Average: 99.47% (96 out of 96 samples pass) | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Average: 99.48% (96 out of 96 samples pass) | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mmH2O/cm² | Average: 3.52 mmH2O/cm² (96 out of 96 samples pass) | PASS |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | PASS |
| Biocompatibility: Cytotoxicity | Non-Cytotoxic | Non-Cytotoxic | PASS |
| Biocompatibility: Irritation | Non-Irritating | Non-Irritating | PASS |
| Biocompatibility: Sensitization | Non-Sensitizing | Non-Sensitizing | PASS |
Details of the Study Proving Device Meets Acceptance Criteria
Given that this is a physical medical device (surgical face mask) and not an AI/software as a medical device (SaMD), many of the typical questions for an AI study are not applicable. Below are the relevant answers based on the provided document.
-
A table of acceptance criteria and the reported device performance: (See table above)
-
Sample size used for the test set and the data provenance:
- Sample Size: The non-clinical tests were conducted on 3 non-consecutive lots, with each lot containing 32 samples. This means a total of 96 samples (3 lots * 32 samples/lot) were tested for most performance criteria (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability). Biocompatibility testing is typically done on specific extracts or samples, not necessarily a batch of 96.
- Data Provenance: Not specified in terms of country of origin for the data. The tests are "non-clinical tests" meaning laboratory assessments. The document doesn't indicate if they were prospective or retrospective in the sense of a clinical trial; rather, they are standard product performance verification tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable. The "ground truth" for a surgical mask's performance is established by the specified ASTM/EN standards and test methods, not by human expert interpretation or consensus. The tests involve objective measurements (e.g., pressure, filtration efficiency, flammability rating).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As described above, the test results are objective measurements against defined standards, not subjective interpretations requiring adjudication.
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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:
- Not applicable. This is a physical device, not an AI-driven medical imaging or diagnostic device. No human reader studies (with or without AI assistance) were part of this premarket notification. The document explicitly states: "No clinical study is included in this submission."
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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 inherent to its physical properties and material construction.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or more accurately, the performance benchmark/standard) for this device is based on established national and international performance standards (ASTM F1862, ASTM F2299, ASTM F2101, EN 14683 Annex C, 16 CFR 1610) and recognized biocompatibility standards (e.g., ISO 10993 for Cytotoxicity, Irritation, Sensitization). These standards define the acceptable physical and biological properties of surgical masks.
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The sample size for the training set:
- Not applicable. This is not an AI device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. Since there is no training set for an AI model, there is no "ground truth" for it to be established.
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January 25, 2022
Asia Dynamics Inc., d/b/a ADI Medical Timothy Kania Official Correspondant Mdi Consultants Inc. 55 Northen Blvd, Suite 200 Great Neck. New York 11021
Re: K213347
Trade/Device Name: ADI Medical Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 27, 2021 Received: December 29, 2021
Dear Timothy Kania:
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 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,
For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213347
Device Name ADI Medical Surgical Face Masks
Indications for Use (Describe)
ADI 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 posure of the wearer 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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510(k) SUMMARY
1. Submitter's Identification:
| Applicant: | Asia Dynamics Inc., d/b/a ADI Medical |
|---|---|
| Address: | 1565 South Shields Drive Waukegan, IL 60085 |
| Contact Person: | Jonathan Zhu |
| Tel: | (847)-688-9968 |
| Email: | Jon@adimedical.com |
| Date Summary Prepared: | December 27, 2021 |
| Official Correspondent: | Mr. Tim Kania |
| Mdi Consultants, Inc. | |
| Address: | |
| Tel: | 732-796-4565 |
| Email: | tim@mdiconsultants.com |
Name of the Device: ನ
| Proprietary Name: | ADI Medical Surgical Face Mask |
|---|---|
| Classification Name: | Mask,Surgical |
| Common Name: | Surgical Mask |
| Regulatory Class: | II |
| Product Code: | FXX |
| Regulation Name: | Surgical Apparel |
| Regulation Number: | 878.4040 |
| Review Panel: | General Hospital |
Information for the 510(k) Cleared Device (Predicate Device): ನೆ
Disposable Medical Face Mask, K202513
Surgical Face Mask
Shenzhen Jinko Industrial Co., Ltd..
No reference devices were used in this submission.
4. Device Description:
The ADI Medical Surgical Face Masks are single use, three-layer, flat -folded masks with ear loops and nose clamp. The ADI Medical Surgical Face Masks 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 ear loops are 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 clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. ADI Medical Surgical Face Masks will be
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provided in blue. ADI Medical Surgical Face Masks are sold non-sterile and are intended to be single use, disposable devices.
5. Indications for Use:
ADI 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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Technological Characteristics Comnarison: la
| Device | Proposed Device | Predicate Device | Result | |
|---|---|---|---|---|
| Manufacturer | Asia Dynamics Inc., d/b/a ADI Medical | Shenzhen Jinko Industrial Co., Ltd. | - | |
| 510K number | K213347 | K202513 | - | |
| Model Name | ADI Medical Surgical Face Mask | Disposable Medical Face Mask | Similar | |
| Model No. | 76120 | FM-04 | - | |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | |
| Intend use | ADI Medical Surgical Masks are intended to be worn to protect both the patientand 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 of the wearer to blood and body fluids.This is a single use, disposable device(s), provided non-sterile. | The Medical Masks are intended to be worn to protect both the patientand 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 of thewearer to blood and body fluids.This is a single 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-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner Facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose Clamp | Malleable polypropylene with steel wire | Malleable polypropylene with steel wire | Same | |
| Ear Loops | Polyester, Spandex | Polyester, Spandex | Same | |
| Color | BlueCAS#147-14-8 | Variety (include blue) | Similar | |
| Dimension(Length) | $175 \pm 2.5$ mm | $175 \pm 8$ mm | Similar | |
| Dimension(Width) | $95 \pm 2.5$ mm | 95+4.5 mm | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same | |
| Biocompatibility(ISO10993) | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Same |
Table 1: Comparison to Predicate Device
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7.Summary of Non-Clinical Tests:
The following testing was conducted to demonstrate that the subject device (3 nonconsecutive lots with each lot containing 32 samples) met the acceptance criteria and specification of the standard shown below.
| Standard | Results of tests onsubject device | Pass Criteria | Results |
|---|---|---|---|
| Fluid ResistancePerformanceASTMF1862 | 94 out of 96 pass at 120 mmHg, 3 non-consecutive lots tested | 29 out of 32 pass at 120 mmHg | PASS |
| Particulate FiltrationEfficiencyASTM F2299 | 96 out of 96 passAverage: 99.47%$\ge$ 98% | $\ge$ 98% | PASS |
| Bacterial FiltrationEfficiencyASTM F2101 | 96 out of 96 passAverage: 99.48%$\ge$ 98% | $\ge$ 98% | PASS |
| Differential Pressure (DeltaP)EN 14683 Annex C | 96 out of 96 passAverage: 3.52< 5.0mmH2O/cm2 | < 6.0mmH2O/cm2 | PASS |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | PASS |
| Table 2: Performance testing | ||
|---|---|---|
| -- | ------------------------------ | -- |
Table 3: Biocompatibility Testing
| Item | Proposed device | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | Under theconditions of thestudy, thedevice is non-cytotoxic. | Non-Cytotoxic | PASS |
| Irritation | Under theconditions of thestudy, the deviceis non-irritating. | Non-Irritating | PASS |
| Sensitization | Under theconditions of thestudy, the deviceis non-sensitizing | Non-Sensitizing | PASS |
8.Discussion of Clinical Tests Performed:
No clinical study is included in this submission.
9.Conclusions:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K213347, the ADI Medical Surgical Masks, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202513.
§ 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.