(82 days)
Aurelia Surgical Masks ASTM Level-3 (2130) is intended for use to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device and provided non-sterile
The Aurelia Surgical Masks ASTM Level 3 are constructed with three layers of nonwoven polypropylene. The direct body contact materials include polypropylene, polyurethane, and nylon. The indirect body contacting materials include polypropylene and aluminum wire coated with melt-blown polypropylene embedded within the three layers.
The provided text is a 510(k) summary for the Aurelia Surgical Mask ASTM Level-3 (2130). It details the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than a study proving a device meets AI/ML acceptance criteria.
Therefore, many of the requested data points (like sample size for test/training sets in an AI/ML context, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training) are not applicable to this document. This document describes the testing of a physical medical device (a surgical mask) against established performance standards for such devices.
Here's a breakdown based on the provided text, focusing on the relevant information:
Acceptance Criteria and Device Performance for Aurelia Surgical Mask ASTM Level-3 (2130)
This section describes the performance testing of a physical product (surgical mask) against established standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F2101-19 | Bacterial Filtration Efficiency | ≥ 98% | 99% (Pass) |
| ASTM F2299/F2299M-03(2017) | Sub-micron Particulate Filtration Efficiency | ≥ 98% | 99% (Pass) |
| EN 14683:2019, Annex C | Differential Pressure (Breathability) | <6 H2O/cm² | 5.5 H2O/cm² (Pass) |
| ASTM F1862/F1862M-17 | Resistance to penetration by synthetic blood | 160 mmHg | 160 mmHg (Pass) |
| 16 CFR Part 1610 | Flame Spread | Class 1 | Class 1 (Pass) |
| ISO 10993-5 | Cytotoxicity | Non-toxic | Non-cytotoxic (Pass) |
| ISO 10993-10 | Irritation | Non-irritating | Not an irritant (Pass) |
| ISO 10993-10 | Sensitization | Non-sensitizing | Not a sensitizer (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of masks) used for each individual test. It refers to "non-clinical tests" conducted to verify design specifications. The data provenance is implied to be from laboratory testing related to the device manufacturer (Supermax Healthcare Canada), rather than patient data. The tests are "non-clinical" and therefore do not involve retrospective or prospective human subject data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is not an AI/ML diagnostic device requiring expert consensus for ground truth on medical images or conditions. The "ground truth" here refers to the physical properties and performance metrics of the surgical mask, established through standardized laboratory testing methods (e.g., measuring filtration efficiency, pressure differential).
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML medical device.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth is based on established objective performance standards and test methods (e.g., ASTM F2101-19 for Bacterial Filtration Efficiency, ISO 10993 for biocompatibility). These standards define what constitutes a "pass" or "fail" for the specified performance characteristics of a medical face mask.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved for this type of device.
In summary, this document is a regulatory submission for a physical medical device (surgical mask), providing evidence of its performance against established industry standards. It does not pertain to the development or validation of an AI/ML diagnostic or therapeutic device.
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November 12, 2024
Supermax Healthcare Canada - Supermax Medical % Sajeev Joseph Senior Director- QA, RA Maxter Healthcare Inc 14559 County Road 48 Rosharon, Texas 77583
Re: K242502
Trade/Device Name: Aurelia Surgical Mask ASTM Level-3 (2130) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 5, 2024 Received: August 22, 2024
Dear Sajeev Joseph:
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"
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(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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
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Sincerely,
Allan Guan -S
For Bifeng Qian, M.D, Ph.D. Assistant Director DHT4C: Division of Infection Control 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) K242502
Device Name Aurelia Surgical Mask ASTM Level-3 (2130)
Indications for Use (Describe)
Aurelia Surgical Masks ASTM Level-3 (2130) is intended for use to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device and 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
K242502
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter Information
●
| • | Company Name: | Supermax Healthcare Canada - Supermax Medical |
|---|---|---|
| --- | --------------- | ----------------------------------------------- |
- Address: 1001 rue Jean-Talon bureau 100
Saint-Bruno-de-Montarville
Quebec, J3V ON3, Canada ● Phone Number: +1 (866) 428 9188
- Contact: Chiew Yi Tay
VP Operations, Supermax Healthcare Canada-Supermax Medical Cell: +1 (647) 835-3882 Email: cytay@supermaxcanada.com
2.0 Designated Submission Correspondent
- Company Name: Sajeev Joseph
- Maxter Healthcare Inc.14559 County Rd 48, Rosharon, Texas 77583 ● Address:
- Phone Number: +1 (832) 598-3858
- Contact: +1 (713) 282-1136
- Email: sajeev.joseph@maxtergloves.com
3.0 Date of Preparation: 10/28/2024
Device Information 4.0
●
- . Trade/Device Name: Aurelia Surgical Mask ASTM Level 3
- . Model(s): 2130
- . Common Name: Surgical Mask
- 510(k) Number: . K242502
5.0 Classification
- · Device: Surgical Face Mask
- 21 CFR878.4040 · Regulation Description:
- · Review Panel: General Hospital
- Product Code: FXX
- Submission Type: Traditional 510(k)
- Regulation Number: 21 CFR §878.4040
- Device Class: Class II
6.0 Predicate Device Information
| • Device Name: | Crosstex® Surgical Masks |
|---|---|
| • 510(k) Number: | K082258 |
- Manufacturer: Crosstex International Inc.
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7.0 Device Description
The Aurelia Surgical Masks ASTM Level 3 are constructed with three layers of nonwoven polypropylene. The direct body contact materials include polypropylene, polyurethane, and nylon. The indirect body contacting materials include polypropylene and aluminum wire coated with melt-blown polypropylene embedded within the three layers.
8.0 Indications for Use
Aurelia Surgical Masks ASTM Level 3 are intended to minimize contamination caused by inhaled and exhaled microorganisms and reduce the wearer's potential exposure to blood and body fluids. This is a single- use, disposable device that is provided non-sterile.
| General Comparison | |||
|---|---|---|---|
| Particulars | Proposed Device-K242502 | Predicate K082258 | Conclusion |
| Material: Ear loops | A mixture of Nylon & Polyurethane | Not available | Unknown |
| Material: Nose clip | 3mm Aluminum Flat Wire | Aluminum | Same |
| Material: Mask body(inner & outer) | Spunbonded Polypropylene | Spunbonded Polypropylene | Same |
| Material: Middle layer | Melt-blown Polypropylene | Melt-blown Polypropylene | Same |
| Color | White for the contact surface | White and various colors | Similar |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single-Use | Single-Use | Same |
| Rx Only or OTC | ОТС | ОТС | Same |
9.0 Comparison of Characteristics of Proposed and Predicate Devices
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| Technological Comparison | |||
|---|---|---|---|
| Particulars | Proposed Device K242502 | Predicate K082258 | Conclusion |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication For Use | Aurelia Surgical Masks ASTMLevel 3 are intended for use tominimize contamination causedby inhaled and exhaledmicroorganisms and reduce thepotential exposure of the wearerto blood and body fluids. This isa single-use, disposable deviceandis provided non-sterile. | Crosstex® Surgical Masks areintended for use in infectioncontrol practices to minimizecontamination caused byinhaled and exhaledmicroorganisms and reducethe potential exposure of thewearer to blood and bodyfluids. | Same |
| Design Feature | Ear Loop | Ear Loop | Same |
| Dimensions | 17.5 cm x 9.5 cm | Not Available | Unknown |
| Level | III | III | Same |
| Fluid Resistance, minimum | 160mmHg | 160mmHg | Same |
| Particulate FiltrationEfficiency (PFE) | 99% | 98% | Similar |
| Bacterial FiltrationEfficiency (BFE) | 99% | 98% | Similar |
| Differential pressure(Delta P) | 5.5 mm H2O/cm² | <6.0 mm H2O/cm² | Similar |
| Flammability | Class 1 | Class 1 | Same |
| Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
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| Biocompatibility Comparison | |||
|---|---|---|---|
| Particulars | Proposed Device K242502 | Predicate K082258 | Conclusion |
| CytotoxicityISO 10993-5 | Under the condition of this study, the device non cytotoxic | Details not available | Proposed device is found safe to use |
| IrritationISO 10993-10 | Under the condition of this study, the device non Irritant | Details not available | Proposed device is found safe to use |
| Skin SensitizationISO 10993-10 | Under the condition of this study, the device non Sensitizer | Details not available | Proposed device is found safe to use |
10.0 Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks.
- ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus.
- . ASTM F2299/F2299M-03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres.
- ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity).
- EN 14683:2019, Annex C Method for determination of breathability (differential pressure).
- 16 CFR Part 1610 Standard for Flammability of Clothing Textiles.
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
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| Summary of non-clinical performance testing | |||
|---|---|---|---|
| Test Method | Purpose | AcceptanceCriteria | Results |
| ASTM F2101-19 | Bacterial FiltrationEfficiency | $\ge$ 98% | 99% Pass |
| ASTM F2299/F2299 M-03(2017) | Sub-micronParticulate FiltrationEfficiency | $\ge$ 98% | 99% Pass |
| EN 14683:2019, Annex C | Differential Pressure,H2O/cm² | <6 H2O/cm² | 5.5 H2O/cm², Pass |
| ASTM F1862/F1862M-17 | Resistance topenetration bysynthetic blood, minpressure in mm Hgfor pass | 160 mmHg | 160 mmHg, Pass |
| 16 CFR Part 1610 | Flame Spread | Class 1 | Class 1, Pass |
| ISO 10993-5 | Cytotoxicity | Non-toxic | Under the conditions of the study,the device extract is non-cytotoxic/Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study,not an irritant. / Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under the conditions of the study,not a sensitizer. / Pass |
11.0 Summary of Clinical Testing
Clinical testing is not needed for this device.
12.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device Aurelia Surgical Masks ASTM Level 3 is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K082258.
§ 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.