(242 days)
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
The device, a surgical mask, is intended for protective purposes (blocking transfer of microorganisms, body fluids, and particulate material, and reducing exposure), not for treating or rehabilitating a disease or injury.
No
The device, Aurelia Surgical Mask, is intended for infection control by protecting against microorganism and fluid transfer, not for diagnosing medical conditions.
No
The device description clearly outlines a physical product (surgical mask) made of nonwoven polypropylene, with ear loops and a nose clip. It does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of the mask and its components. There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostics.
- Performance Studies and Key Metrics: The performance studies and key metrics listed (Fluid Resistance, Bacterial Filtration Efficiency, etc.) are all related to the physical barrier properties and safety of the mask, not to the detection or measurement of substances in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
In vitro diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Aurelia Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Aurelia Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, provided nonsterile.
Product codes
FXX
Device Description
The proposed device, Aurelia Surgical Masks are three-layer masks constructed of nonwoven polypropylene. The inner and outer layers are made of spun-bonded polypropylene. The middle layer consists of 25gsm melt-blown polypyrene. The mask contains an ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of polyurethane and nylon. The nose clip which is made of 3mm aluminum flat wire. The disposable surgical face mask is available in two different specifications: ASTM Level 1 and ASTM Level 2. The masks meet the following ASTM 1 and ASTM 2 Technical standards.
| Test | ASTM 1 | ASTM 2 |
|---|---|---|
| Fluid Resistance | 80mmHg | 120mmHg |
| Bacterial Filtration Efficiency | ≥95% | ≥98% |
| Particulate Filtration Efficiency | ≥95% | ≥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.
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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 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.
December 5, 2023
Supermax Healthcare Canada-Supermax Medical % Alicja Wojewnik CEO dicentra, Inc. 7 St Thomas Street, Unit 603 Toronto. Ontario M5S 2B7 Canada
Re: K231005
Trade/Device Name: Aurelia Surgical Mask ASTM Level 1: Aurelia Surgical Mask ASTM Level 2 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: November 1, 2023 Received: November 1, 2023
Dear Alicja Wojewnik:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231005
Device Name
Aurelia Surgical Mask ASTM Level 1: Aurelia Surgical Mask ASTM Level 2
Indications for Use (Describe)
The Aurelia Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Aurelia Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, provided nonsterile.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Registration Use (Part 21 CFR 201.2 Subpart D) | ☑ |
|---|---|
| OTC Therapeutic Use (21 CFR 201.2 Subpart G) | ☐ |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the Dicentra logo. The logo features the word "dicentra" in a stylized font, with the "d" in purple and the rest of the letters in black. To the left of the "d" is a purple sphere made up of interconnected dots. Below the word "dicentra" are the words "GUIDANCE | INNOVATION | TRUST" in a smaller font.
510(k) Summary
Aurelia Surgical Mask
| Applicant | Supermax Healthcare Canada – Supermax Medical
1001 rue Jean-Talon bureau 100
Saint-Bruno-de-Montarville, Quebec, J3V 0N3
Canada |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Nicolas Bergeron
Executive Vice President
Tel. +1 (866) 428-9188
Cell: +1 (514) 512-4123
nbergeron@supermaxcanada.com |
| Correspondent: | dicentra, Inc.
603 - 7 St. Thomas Street
Toronto, Ontario M5S2B7 Canada
Alicja Wojewnik
Tel. (416) 361-3400 Ext 228
radicentra@dicentra.com |
| Summary Date | October 20, 2023 |
| Proprietary Name | Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 |
| Common Name | Surgical Mask |
| Classification Regulation | 21 CFR 878.4040. |
| Product Codes | FXX |
| Device Classification | Class II |
| Predicate Device | a. Crosstex® Isofluid® Earloop Face Mask (K082258) Primary Predicate
b. Crosstex® Procedural Earloop Face Mask (K082258) |
4
Image /page/4/Picture/1 description: The image is a logo for "dicentra". The logo features the word "dicentra" in a stylized font, with the "d" in purple and the rest of the letters in black. To the left of the "d" is a purple graphic that resembles a network of connected dots. Below the word "dicentra" are the words "GUIDANCE | INNOVATION | TRUST" in a smaller font.
Indications for Use
The Aurelia Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Aurelia Surgical Mask is intended for use in infection control practices to reduce the posure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Device Description
The proposed device, Aurelia Surgical Masks are three-layer masks constructed of nonwoven polypropylene. The inner and outer layers are made of spun-bonded polypropylene. The middle layer consists of 25gsm melt-blown polypyrene. The mask contains an ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of polyurethane and nylon. The nose clip which is made of 3mm aluminum flat wire. The disposable surgical face mask is available in two different specifications: ASTM Level 1 and ASTM Level 2. The masks meet the following ASTM 1 and ASTM 2 Technical standards.
| Test | ASTM 1 | ASTM 2 |
|---|---|---|
| Fluid | ||
| Resistance | 80mmHg | 120mmHg |
| Bacterial | ||
| Filtration | ||
| Efficiency | ≥95% | ≥98% |
| Particulate | ||
| Filtration | ||
| Efficiency | ≥95% | ≥98% |
| Differential | ||
| Pressure |