PRIMED Surgical Masks and PRIMED Procedure Masks are single use, non-sterile products intended to be worn by operating room and health care personnel in health care setting and during surgical procedures to protect both the patient and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.

Device Description

PRIMED Surgical masks and PRIMED Procedure masks are single use, non-sterile masks composed of a melt-blown filter layer placed between layers of non-woven inner and SS outer layer(s) material. PRIMED Medical Products Inc. offers various models in two main categories: Procedure masks with ear loops and Surgical masks with head ties. The level of protection varies based on the basis weight of the inner layer and the number of outer layers used in the mask's construction, in accordance with ASTM F2100:2023 specifications.

AI/ML Overview

The provided text is an FDA 510(k) summary for PRIMED Surgical Masks and PRIMED Procedure Masks. It describes the acceptance criteria and the study that proves the device meets those criteria. However, it does not include information about a complex AI-driven medical device, a multi-reader multi-case (MRMC) study, or detailed information about ground truth establishment by experts as would be relevant for an AI/CADe system.

Therefore, the following response will be tailored to the information available in the provided document, which pertains to a physical medical device (surgical masks) and its performance against established standards, rather than an AI/software device.

Here's the information as extracted and interpreted from the document:

Acceptance Criteria and Device Performance for PRIMED Surgical Masks and PRIMED Procedure Masks

The device under review is PRIMED Surgical Masks and PRIMED Procedure Masks. The performance of these masks is evaluated against established physical and biocompatibility standards rather than a typical AI/CADe performance criteria.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are derived from ASTM F2100-23 standards for medical face masks and other relevant ISO and CFR standards for biocompatibility and flammability.

Test Performed	Test Method	Acceptance Criteria (Level 1 Masks)	Acceptance Criteria (Level 3 Masks)	Results (All Variants)
Bacterial Filtration Efficiency	ASTM F2101	≥ 95%	≥ 98%	Pass
Sub-micron Particulate Filtration	ASTM F3502	≥ 80%	≥ 85%	Pass
Differential Pressure (Breathability)	EN 14683	< 5 mmH2O/cm²	< 6 mmH2O/cm²	Pass
Resistance to Penetration by Synthetic Blood	ASTM F1862	80 mmHg	160 mmHg	Pass
Flammability	16 CFR 1610	Class I	Class I	Pass
Cytotoxicity	ISO 10993-5	Non-Cytotoxic	Non-Cytotoxic	Pass
Sensitization	ISO 10993-10	Non-sensitizing	Non-sensitizing	Pass
Irritation	ISO 10993-23	Not an irritant	Not an irritant	Pass

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., number of masks tested for BFE). These are typically defined by the test methodologies themselves (e.g., ASTM F2101 specifies sample sizes).
The data provenance is from non-clinical testing performed by the manufacturer, PRIMED Medical Products Inc., which is based in Edmonton, AB, Canada. The studies are prospective in the sense that they are conducted specifically for the purpose of demonstrating device performance for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the device is a physical product (surgical masks) and not an AI or diagnostic software. Therefore, human experts are not establishing "ground truth" in terms of clinical diagnoses or interpretations of images. The "truth" is established by direct physical, chemical, and biological testing against engineering and material standards.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation or decision-making process being adjudicated. The tests involve objective measurements against predefined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/software in diagnostic imaging where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a physical product (surgical mask), not an algorithm or software. The "performance" is the inherent physical and chemical properties of the mask.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the surgical masks is established directly through physical, chemical, and biological laboratory testing against well-defined, objective national and international consensus standards (e.g., ASTM F2100-23, EN 14683, ISO 10993 series, 16 CFR 1610). There is no "expert consensus," "pathology," or "outcomes data" utilized to establish ground truth in the context of diagnostic accuracy for this device.

8. The Sample Size for the Training Set

This is not applicable. Surgical masks are physical devices, not AI or machine learning models that require training sets. The document describes performance testing of the final manufactured product.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above. There is no training set for a physical device like a surgical mask.

Summary

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August 26, 2024

Primed Medical Products Inc. Mitra Fard Manager, Regulatory Affairs 200, 2003-91 St. SW Edmonton, AB T6X0W8 Canada

Re: K240286

Trade/Device Name: PRIMED Surgical Masks and PRIMED Procedure Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 22, 2024 Received: July 25, 2024

Dear Mitra Fard:

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.

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.

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices

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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) K240286

Device Name

PRIMED Surgical Masks and PRIMED Procedure Masks

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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PRIMED Surgical and Procedure Masks

Summary Date:	July 22, 2024
Manufacturer:	PRIMED Medical Products Inc.
Address:	200, 2003-91 St. SW, Edmonton, AB, Canada, T6X 0W8
Phone Number	+1.877.877.4633
Fax Number	+1.780.497.7670
Email	mitra.fard@primed.com
Contact person:	Mitra Fard
Common name of the device	Mask, Surgical
Trade or Proprietary Name:	PRIMED Surgical Masks and PRIMED Procedure Masks
Models	PG4-1001: ASTM Level 1, Procedure Ear Loop, Yellow Mask,PG4-1223: ASTM Level 3, Procedure Ear Loops, Black Mask,PG4-2001: ASTM Level 1, Surgical Ties, Blue Mask,PG4-4053: ASTM Level 3, Anti-fog Tape, Surgical Ties, Green Mask,PG4-5033: ASTM Level 3 Soft Mask, Anti-fog, Anti-Glare, Surgical Ties, Visor White,PG4-5553: ASTM Level 3 Visor Anti-Fog Anti-Glare Surgical Ties Indigo Mask
Regulation Description	Surgical Apparel
Review Panel	General and Plastic Surgery
Regulation number	21 CFR 878.4040
Device Class:	2
Product Code:	FXX
Predicate device(s)	PRIMAGARD Surgical Masks, # K081633

Device Description:

Indication for Use:

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Here below is the summary of the technological characteristics and the proposed device compared to the predicate device.

Table 1: Technological Characteristics Comparison Table

Elements ofComparison	Proposed device	Predicate	comments
Trade name	PRIMED Surgical Masks and PRIMEDProcedure Masks	PRIMAGARD Surgical Masks	-
510k number	K240286	K081633	-
Manufacturer	PRIMED Medical Products Inc.	PRIMED Medical Products Inc.	-
Regulationnumber	21 CFR 878.4040	21 CFR 878.4040	Same
Product code	FXX	FXX	Same
Common name	Mask, Surgical	Mask, Surgical	Same
Intended use	PRIMED Surgical Masks and PRIMEDProcedure Masks are single use, non-sterileproducts intended to be worn by operatingroom and health care personnel in healthcare setting and during surgical procedures toprotect both the patient and the operatingroom personnel from transfer ofmicroorganisms, body fluids and particulatematerials.	PRIMAGARD Surgical Masks are surgical apparelas identified in 21 CFR 878.4040 and are intendedto be worn by operating room personnel duringprocedures to protect both the surgical patientand the operating room personnel from transferof microorganisms, body fluids and particulatematerial.	Similar
ASTM F2100 level	Level 1 and Level 3	Level 1, Level 2 and Level 3	Similar
Biocompatibility	Under the conditions of the testing, not asensitizer, not an irritant, and not cytotoxic	Under the conditions of the testing, not a sensitizer,not an irritant, and not cytotoxic	Same
Single use vs.reusable	Single Use	Single Use	Same
Sterile vs.non-sterile	Non-sterile	Non-sterile	Same
Outer layer	Spunbond material	PSB PP material
Filter layer	Meltblown PP	Meltblown PP	Similar - PRIMED masks
Inner layer	SSS materialWetlaid CelluloseES material	Wetlaid Cellulose	have different inner layerand different basis weightof outer and filter layer.
Ear loop	Spandex Polyester Ear loops	Spandex Polyester Ear loops	The testing demonstrates
Head Tie	SSS Head tie	Spunlace viscose	the safety and
Nose piece	Annealed AluminiumPlastic coated nosepiece	Aluminium nosepiece	effectiveness of the masks
Color	White, Yellow, Green, Blue, Black, Indigocolour	Blue, White, Green, Indigo	Similar - masks aretested. Additional coloursin the new masks do notintroduce any additionalsafety or performanceconcern
Design	Pleated designPleated Omega design	Pleated designPleated Omega designDuckbill design	Similar
Elements ofComparison	Proposed device	Predicate	comments
Welding	Ultrasonic welding pattern	Ultrasonic welding pattern	same
Accessories	Anti-fog, visor	Anti-fog, visor	Same

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PRIMED Surgical and Procedure Masks

K240286 - 510(K) Summary

Summary of non-clinical testing:

Table 2: Summary of the Non-Clinical Tests:

ASTM F2100-23
Test Performed	Test method	Acceptance Criteria	Results (Pass/Fail)
Bacterial Filtration Efficiency	ASTM F2101	Level 1: ≥ 95%, Level 3: ≥ 98%	Pass
Sub-micron Particulate Filtration	ASTM F3502	Level 1: ≥ 80%, Level 3: ≥ 85%	Pass
Differential Pressure	EN 14683	Level 1: < 5 mmH2O/cm2, Level 3: < 6 mmH2O/cm2	Pass
Resistance to Penetration by synthetic Blood	ASTM F1862	Level 1: 80 mmHg, Level 3: 160 mmHg	Pass
Flammability	16 CFR 1610	Class I	Pass
Cytotoxicity	ISO 10993-5	Under the conditions of the testing, non-Cytotoxic	Pass
Sensitization	ISO 10993-10	Under the conditions of the testing, non sensitizing	Pass
Irritation	ISO 10993-23	Under the conditions of the testing, not an irritant	Pass

Summary of clinical testing:

N/A

Conclusion:

Based on the non-clinical testing performed, it can be concluded that the subject device, PRIMED Surgical masks and PRIMED Procedure masks are as safe, as effective and perform as well as or better than the legally marketed predicate device, K081633, PRIMAGARD Surgical Masks.

Regulation Number and Section

§ 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.