(124 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a medical mask, with no mention of AI or ML.
No
The device is a medical mask intended for infection control by filtering particulate material and microorganisms, not for treating a disease or condition.
No
This device is a medical mask intended for protection and infection control, not for diagnosing conditions or diseases. Its purpose is to filter microorganisms and fluids, as indicated in the "Intended Use/Indications for Use" section.
No
The device is a physical medical mask, not a software application. The description details its physical components and materials.
No, based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose piece). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition
- Performance Studies: The performance studies focus on the physical properties of the mask (fluid resistance, filtration efficiency, flammability, pressure) and biocompatibility, which are relevant to a medical mask, not an IVD.
This device is a medical mask, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
The AOK 95A Medical Mask (20200049) is 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The AOK 95A Medical Mask (20200049) is single use, four-layer folded masks with ear loops, or straps to tie behind the user's head, and a nose piece. 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 piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The AOK 95A Medical Mask will be provided in white and blue. The AOK 95A Medical Mask is 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)
Bench testing including: Fluid Resistance, Flammability, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure. The results were similar to the predicate.
Biocompatibility tests including: Cytotoxicity, Sensitization, Irritation. The proposed device materials were found to meet the applicable requirements for biocompatibility safety for the intended population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid resistance: Pass at 120mmHg
Particulate efficiency level: ≥98%
Bacterial filtration level: ≥98%
Differential pressure:
§ 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.
0
Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
July 27, 2022
AOK Tooling Limited Paul Dryden Consultant AOK Tooling Limited c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K220876
Trade/Device Name: AOK 95A Medical Mask (20200049) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 20, 2022 Received: July 22, 2022
Dear Paul Dryden:
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.
1
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); 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 Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Prescription Use (Part 21 CFR 801 Subpart D)
510(k) Number (if known)
Device Name
AOK 95A Medical Mask (20200049)
Indications for Use (Describe)
The AOK 95A Medical Mask (20200049) is 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) | |
|---|---|
| ------------------------------------------------- | -- |
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_ XX Over-The-Counter Use (21 CFR 801 Subpart C)
3
Date Prepared:
20-Jul-2022
AOK Tooling Limited Flat 2009, 20/F, Kowloon Plaza, No.485 Castle Peak Road, Cheung Sha Wan, Kowloon Hong Kong, China
| Official Contact: | Jerry Teng
1-626-203-3809 |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name:
Common/Usual Name:
Classification Name: | AOK 95A Medical Mask (20200049)
Mask, Surgical
Product Code - FXX - Mask, Surgical |
| Predicate Device:
Common/Usual Name:
Classification Name: | AOK Tooling Limited - K211956
Mask, Surgical
Product Code - FXX - Mask, Surgical |
| Device Description: | The AOK 95A Medical Mask (20200049) is single use,
four-layer folded masks with ear loops, or straps to tie
behind the user's head, and a nose piece. 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
piece in the layers of facemask is to allow the user to fit
the facemask around their nose, which is made of
malleable polyethylene wire. The AOK 95A Medical
Mask will be provided in white and blue. The AOK 95A
Medical Mask is sold non-sterile and are intended to be
single use, disposable devices. |
| Principle of Operation: | The mask covers the user's nose and mouth and provides
a physical barrier to fluids and particulate materials. |
| Indications for Use: | The AOK 95A Medical Mask (20200049) is 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. |
4
| Description | Subject Device | Predicate Device | Differences |
|---|---|---|---|
| Manufacturer | AOK Tooling Ltd. | AOK Tooling Ltd. | |
| 510(k) Number | TBD | K211956 | |
| Model Name | AOK 95A Medical Mask (20200049) | 039 Surgical Face Mask | |
| Classification | Class II Device | ||
| FXX | |||
| 21 CFR 878.4040 | Class II Device | ||
| FXX | |||
| 21 CFR 878.4040 | Identical | ||
| Intended use | The AOK 95A Medical Mask (20200049) is 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 039 Surgical Face is 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. | Identical | ||
| Mask Style | Flat pleated | Folded | The mask style is |
| different, but | |||
| performance is similar to | |||
| the predicate | |||
| Materials | |||
| Cover Fabric(s) | Non-woven polypropylene; Melt blown non-woven | ||
| polypropylene filter | Non-woven polypropylene; Melt blown non- | ||
| woven polypropylene filter | Identical | ||
| Outer Cover Fabrics | 50g Non-woven Fabric | 50g Non-woven Fabric | Identical |
| Middle Layer-1 | 20g Melt blown Non-woven | 20g Melt blown Non-woven | Identical |
| Middle Layer-2 | 70g PET Non-woven Fabric | 70g PET Non-woven Fabric | Identical |
| Inner Facing | 30g Non-woven Fabric | 30g Non-woven Fabric | Identical |
| Nose Piece | Plastic | Silicone | The difference does not |
| impact device | |||
| performance | |||
| Ear Loops / Tie-on | Spandex | Spandex | Identical |
| Color | Blue and White | Blue and White | Similar |
| Design | Ear loop and tie-on | Ear loop and tie-on | Identical |
| Dimension (Width / | |||
| Length) | Small - 165mm × 70mm | ||
| Medium - 190mm × 80mm | |||
| Large - 210mm × 86mm | Small - 208x111 mm | ||
| Medium — 226x124 mm | |||
| Large - 250x138 mm | |||
| XL - 262x144 mm | The size difference and | ||
| lack of a small size mask | |||
| does not impact device | |||
| performance or safety | |||
| OTC Use | Yes | Yes | Identical |
| Use | Single Use, Disposable | Single Use, Disposable | Identical |
| ASTM 2100 Level | Level 2 | Level 2 | Identical |
| Fluid resistance | Pass at 120mmHg | Pass at 120mmHg | Identical |
| Particulate efficiency level | ≥98% | ≥98% | Identical |
| Bacterial filtration level | ≥98% | ≥98% | Identical |
| Differential pressure |