The Humask Pro Vision 3000 mask is single use disposable intended to be worn in the operating room as well as dental, isolation, and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Device Description

The Humask Pro Vision 3000 is a clear window surgical mask. A Medical grade face mask with a transparent window.

AI/ML Overview

The provided text is a 510(k) Summary for the Humask Pro Vision 3000, a surgical mask. It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria for an AI/ML-based medical device. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, effect sizes, ground truth establishment) is not present in this document.

However, I can extract information related to the performance data provided for the physical mask itself and present what is available, while clearly indicating what information is not available based on the provided text.

Here's an attempt to answer your request based on the provided document, with many sections marked as "Not Applicable" or "Not Provided" due to the nature of the document.

Understanding the Device: The Humask Pro Vision 3000 is a physical surgical mask, not an AI/ML-based diagnostic or prognostic device. The performance data mentioned pertains to the physical characteristics and safety of the mask itself, such as its filtration efficiency and biocompatibility.

Acceptance Criteria and Reported Device Performance

The document describes performance tests conducted on the Humask Pro Vision 3000 to demonstrate its safety and effectiveness, similar to the predicate device. These tests align with FDA guidance for surgical mask submissions.

Table of Acceptance Criteria and Reported Device Performance (as detailed for a physical mask):

Performance Metric	Acceptance Criteria (Implied by standard compliance)	Reported Device Performance Against Criteria
Bacterial Filtration Efficiency (BFE) (ASTM F2101)	Must meet specified filtration efficiency for bacteria (e.g., typically ≥ 95% or ≥ 98% for Level 1, 2, or 3 surgical masks, though the specific class/level is not explicitly stated in the document, compliance implies meeting the relevant standard).	Met specified criteria. (Document states: "The subject devices met all specified criteria and did not raise new safety or performance questions.")
Particle Filtration Efficiency (PFE) (ASTM F2299)	Must meet specified filtration efficiency for particulate matter (e.g., typically ≥ 95% or ≥ 98% for Level 1, 2, or 3 surgical masks).	Met specified criteria.
Differential Pressure (EN 14683)	Must meet specified breathability requirements (e.g., a certain delta P in mm H2O/cm²). Allows for easy breathing while maintaining filtration.	Met specified criteria.
Flammability (16 CFR PART 1610)	Must demonstrate slow burning or non-burning characteristics when exposed to a flame. (Typically, Class 1 - Normal Flammability).	Met specified criteria.
Resistance to Synthetic Blood (ASTM F1862)	Must resist penetration of synthetic blood at specific pressures (e.g., 80, 120, or 160 mmHg, depending on the mask level). This tests fluid barrier protection.	Met specified criteria.
Cytotoxicity (ISO 10993-5)	Must not demonstrate cytotoxic effects.	Met specified criteria.
Allergenicity and Sensitization (ISO 10993-10)	Must not demonstrate significant allergenic or sensitization potential.	Met specified criteria.

Study Proving Device Meets Acceptance Criteria:

The document states: "The following performance data support the substantial equivalence of the Humask Pro Vision 3000." and "The subject devices met all specified criteria and did not raise new safety or performance questions. Based on the performance testing, the Humask Pro Vision 3000 was found to have a safety and effectiveness profile that is similar to the predicate device."

This indicates that various standardized tests (ASTM, EN, ISO, CFR) were performed on the Humask Pro Vision 3000, and the results demonstrated compliance with the requirements outlined in those standards, thus proving it meets the implied acceptance criteria for a surgical mask of its type.

Regarding AI/ML-specific Study Information (Not applicable to this device, but addressing your prompt structure):

Sample size used for the test set and the data provenance: Not applicable. This is a physical mask.
- Provenance: Not specified for the physical test samples (e.g., number of masks tested for BFE, PFE).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical mask is established by validated laboratory test methods and equipment, not human expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML device that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the physical mask's performance is established by standardized laboratory testing procedures (e.g., the specific methodologies outlined in ASTM F2101 for BFE, ASTM F2299 for PFE, etc.). These methods are designed to objectively measure the physical properties and performance of the mask.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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November 10, 2022

Entreprise Prémont Inc. Charlie Marchand Director of Product Development and Compliance 731 Boulevard Saint Laurent Est Louiseville, Quebec J5V 1J1 Canada

Re: K222551

Trade/Device Name: Humask Pro Vision 3000 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 15, 2022 Received: August 23, 2022

Dear Charlie Marchand:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K222551

Device Name Humask Pro Vision 3000

Indications for Use (Describe)

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

SUBMITTER Humask 731 Boulevard Saint Laurent Est Louiseville, Quebec, J5V 1J1 Canada Contact person: Charlie Marchand Phone: 819-519-3255 ext.215 Date prepared: 31st of October 2022
II. DEVICE Name of the device: Humask Pro Vision 3000 Common of usual name: Surgical Mask Classification name: Surgical Mask Regulatory Class: 2 Product Code: FXX Regulation: 21 CFR 878.4040
III. PREDICATE DEVICE Communicator (K152561)- primary predicate The predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTIONS The Humask Pro Vision 3000 is a clear window surgical mask. A Medical grade face mask with a transparent window.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological characteristics of the Humask Pro Vision 3000 is highly analogous to the predicate device, the Communicator (K152561).

The similarities and differences are illustrated in the tables below:

Characteristics	Humask Pro Vision 3000
	Communicator (K152561)

Humask Pro Vision 3000

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Indications for Use	The Humask Pro Vision 3000	The Communicator Surgical
	The Humask Pro Vision 3000mask is single use disposableintended to be worn in theoperating room as well as dental,isolation, and other medicalprocedures to protect both thepatient and healthcare personnelfrom transfer of microorganisms,body fluids, and particulatematerial.	Facemask with Clear Window,FM86000, is single use disposableintended to be worn in theoperating room as well as dental,isolation, and other medicalprocedures to protect both thepatient and healthcare personnelfrom transfer of microorganisms,body fluids, and particulatematerial
Prescription Only orOTC	OTC	OTC

The indications for use statement for the subject device is functionally the same as the predicate device.

	Humask Pro Vision 3000	PREDICATE Communicator (K152561)	Similarities/ differences
Principle of Operation	Protective mask	Protective mask	SAME
Single use	Yes	Yes	SAME
Mask Style	Surgical mask- flat, pleated	Surgical mask- flat, pleated	SAME
Design/ Const.
Materials	Polypropylene spun bond PTFE laminated Polypropylene 3ml steel wire (Noseband) Spandex (ear loops) Polyethylene plastic window	Polypropylene bicomponent spun bond Melt blown Plastic window Aluminum (Noseband)	DIFFERENT
Design features	Ear loops	Ear loops	SAME

Humask Pro Vision 3000

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	Humask Pro Vision3000	PREDICATECommunicator(K152561)	Similarities/differences
	Nose bandTransparent window	Nose bandTransparent window
Transparentwindow shape	Rectangular	Diamond	DIFFERENT
Transparentwindowdimensions	4.9 in x 1.7 in	4.75 in x 1.35 in(tapering to 0.5 width)	DIFFERENT
How provided	Non-sterile	Non-sterile	SAME
Biocompatibility	ISO 10993	ISO 10993 (presumed)	SAME
PerformanceData	ASTM F1862ASTM F2101ASTM F2299EN 1468316 CFR PART 1610ISO 10993-5ISO 10993-10	(Presumed - standardrequirements)ASTM F1862ASTM F2101ASTM F2299EN 1468316 CFR PART 1610ISO 10993-5ISO 10993-10	SAME

The performance test data demonstrating compliance with those requirements outlined in FDA Guidance Surgical Masks Premarket Notification Submissions, May 2003.

The technological characteristics of the subject device are similar to the technological characteristics of the predicate. The fundamental difference is the nature of the filter media used within the mask and the size and shape of the window. The Predicate product's media filter is a melt blown material which is a polypropylene spun bound product electrostatically charged to trap particles coming through the filter. The HuCareTM membrane is comprised of (polytetrafluorethylene) PTFE film laminated onto a polypropylene spun bound sheet. The HuCare™ membrane is also smooth and non-pilling as well as hydrophobic which plays a role in the resistance to body fluids and evacuation of humidity that can accumulate within the mask throughout use. The size and shape of the window in this mask is also a differentiation point between the predicate mask and the Humask Pro Vision 3000 mask: The predicate product's window is in the shape of a diamond (4.75 in x 1.35 in (tapering to 0.5 width)) reaching its widest point in the middle of the mask. The Humask Pro Vision 3000's window is rectangular (4.9 in x 1.7 in) and longer than the predicate.

At a high level, the subject and predicate devices are based on the following same technological elements:

. Outer layers are polypropylene spun bound material

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Mask type is based on a flat pleated mask
. Window material is clear see-through plastic
Ear loops and nose band for secure and comfortable wear
Mask contains inner filter layer ●

The following differences exist between the subject and predicate devices:

Window shape (Humask Pro Vision 3000 is rectangular and predicate is . diamond shaped)
. Inner filter material (Humask Pro Vision 3000 uses HuCare membrane (laminated PTFE) and predicate uses melt blown)

VII. PERFORMANCE DATA

The following performance data support the substantial equivalence of the Humask Pro Vision 3000.

Bacterial filtration efficiency (ASTM F2101) ●
. Particle filtration efficiency (ASTM F2299)
Differential Pressure (EN 14683) .
Flammability (16 CFR PART 1610) ●
Resistance to synthetic blood (ASTM F1862) ●
ISO 10993-5 Cytotoxicity ●
ISO10993-10 Allergenicity and sensitization ●

The subject devices met all specified criteria and did not raise new safety or performance questions. Based on the performance testing, the Humask Pro Vision 3000 was found to have a safety and effectiveness profile that is similar to the predicate device.

VIII. CONCLUSIONS

The Humask Pro Vision 3000 is substantially equivalent to the legally marketed predicate device.

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.