(109 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
The device, a surgical mask, is intended for protection against the transfer of microorganisms and particulate material, not for treating or curing a disease or condition.
No
Explanation: The device is a surgical mask intended for protection from microorganisms and fluids, not for diagnosing any condition.
No
The device description clearly outlines a physical, multi-layer face mask made of materials like polypropylene and polyethylene, with ear loops and a nose clamp. The performance studies focus on physical properties and material biocompatibility, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Description and Intended Use: The description and intended use of the ADI Medical Surgical Masks clearly state their purpose is to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier device used on the body, not a device used to test samples from the body.
- Lack of Diagnostic Testing: The document describes performance testing related to the mask's physical properties (filtration, fluid resistance, flammability) and biocompatibility. There is no mention of any testing performed on biological samples or any diagnostic capabilities.
Therefore, based on the provided information, the ADI Medical Surgical Mask is a medical device, but it falls under the category of a personal protective equipment (PPE) or a barrier device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
FXX
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 provided in blue. ADI Medical Surgical Face Masks are sold non-sterile and are intended to be single use, disposable devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Fluid Resistance ASTM F1862: 94 out of 96 pass at 120 mmHg, 3 non-consecutive lots tested, Pass Criteria: 29 out of 32 pass at 120 mmHg, Results: PASS
- Particulate Filtration Efficiency ASTM F2299: 96 out of 96 pass, Average: 99.47%, >= 98%, Pass Criteria: >= 98%, Results: PASS
- Bacterial Filtration Efficiency ASTM F2101: 96 out of 96 pass, Average: 99.48%, >= 98%, Pass Criteria: >= 98%, Results: PASS
- Differential Pressure (Delta P) EN 14683 Annex C: 96 out of 96 pass, Average: 3.52,
§ 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.
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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
1
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
4
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 | Blue | |||
| CAS#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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6
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 on
subject device | Pass Criteria | Results |
|--------------------------------------------------------|--------------------------------------------------------------|-------------------------------|---------|
| Fluid Resistance
PerformanceASTM
F1862 | 94 out of 96 pass at 120 mmHg, 3 non-consecutive lots tested | 29 out of 32 pass at 120 mmHg | PASS |
| Particulate Filtration
Efficiency
ASTM F2299 | 96 out of 96 pass
Average: 99.47%
$\ge$ 98% | $\ge$ 98% | PASS |
| Bacterial Filtration
Efficiency
ASTM F2101 | 96 out of 96 pass
Average: 99.48%
$\ge$ 98% | $\ge$ 98% | PASS |
| Differential Pressure (Delta
P)
EN 14683 Annex C | 96 out of 96 pass
Average: 3.52