The Impertech Surgical Face Mask are intended to be worn to protect 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 fluid. This is a single use, disposable device, provided non-sterile.

Device Description

The Impertech Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the user's mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of melt blown fiber. The outer facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided non-sterile.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the Impertech Surgical Face Mask to demonstrate its substantial equivalence to a predicate device. This is a 510(k) submission for a medical device (a surgical mask), not an AI/ML-enabled device. Therefore, many of the requested details, such as human reader studies, AI training data, and ground truth establishment for AI models, are not applicable to this document as it does not concern an AI system.

The study proves the device meets the acceptance criteria through non-clinical performance testing based on recognized standards for surgical masks.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The device is claiming to be an ASTM F2100 Level 3 Surgical Face Mask. The acceptance criteria are defined by the ASTM F2100 standard for Level 3, and the reported performance indicates that the Impertech Surgical Face Mask passes these criteria.

Performance Testing Characteristic (ASTM F2100 Level 3 Requirement)	Acceptance Criteria	Reported Device Performance	Meets Criteria?
Bacterial Filtration Efficiency (BFE)	≥98%	Pass	Yes
Differential Pressure (Airflow Resistance)	<6 mm H2O/cm²	Pass	Yes
Sub-micron Particulate Filtration Efficiency (PFE) at 0.1 micron	≥98%	Pass	Yes
Resistance to Penetration by Synthetic Blood	160 mm Hg	Pass	Yes
Flammability	Class 1	Pass	Yes

Biocompatibility Acceptance Criteria and Performance:

Biocompatibility Evaluation	Acceptance Criteria	Reported Device Performance	Meets Criteria?
Cytotoxicity	Not cytotoxic	Not cytotoxic	Yes
Sensitization	Non-sensitizing	Non-sensitizing	Yes
Irritation	Non-irritating	Negligibly irritating	Yes

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each of the performance tests (e.g., how many masks were tested for BFE or PFE). However, the tests are conducted in accordance with the relevant ASTM and EN standards (ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610) and ISO standard for biocompatibility (ISO 10993). These standards typically define minimum sample sizes for testing to ensure statistical validity.

Data Provenance: The origin of the data (e.g., country) is not explicitly stated for the testing labs, but the manufacturer is Impertech Industries Ltd. located in Barkan, IL (presumably Israel, given the phone number starting with +972). The testing is non-clinical performance testing, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as this is not an AI/ML device or a diagnostic study requiring human expert interpretation for ground truth. The "ground truth" for a surgical mask is established by its physical performance against a set of objective, measurable engineering and material standards (ASTM F2100, ISO 10993 tests).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable as there is no human interpretation or subjective assessment involved that would require an adjudication method. The testing results are quantitative and objective measurements performed by laboratories.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This is a physical device (surgical mask), not an AI-enabled diagnostic tool that would involve human readers or AI assistance.

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

This is not applicable. There is no algorithm or software component for this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is based on objective, quantitative measurements against established medical device performance standards (ASTM F2100 for filtration efficiency, differential pressure, fluid resistance, flammability; and ISO 10993 for biocompatibility) conducted in laboratories. It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

This is not applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the document demonstrates that the Impertech Surgical Face Mask meets the performance requirements for an ASTM F2100 Level 3 Surgical Face Mask through a series of standard physical and biological tests. The context is a 510(k) submission for a non-AI medical device, which explains why many of the questions regarding AI/ML study design are not relevant.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 18, 2021

Impertech Industries Ltd. Vaibhav Rajal Official Correspondent for Impertech Industries Ltd. mdi Consultants Inc 55 Northern Blvd. Suite 200 Great Neck, New York 11021

Re: K212046

Trade/Device Name: Impertech Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 14, 2021 Received: October 18, 2021

Dear Vaibhav Rajal:

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

{1}------------------------------------------------

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 Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212046

Device Name Impertech Surgical Face Mask

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Impertech Surgical Face Mask ASTM F2100 Level 3 Surgical Face Mask 510(k) Submission

510(k) SUMMARY

The assigned 510(k) number is: K212046.

1. Submitter's Identification:

Impertech Industries Ltd. 20 Derech Barkan St. Barkan Industrial Zone, Barkan, IL 4482000

Contact Person: Mohamad Khweis Quality Assurance Manager Position: Phone: +972-3-9367682 mohamadk@supergum.co.il Email:

Date Prepared: November 15, 2021

2. Name of the Device:

Trade Name:	Impertech Surgical Face Mask
Common Name:	Surgical Mask
Classification Name:	Surgical Mask
Regulation Number:	21 CFR 878.4040
Classification Panel:	General Hospital
Regulatory Class:	Class II
Product Code:	FXX

3. Information for the 510(k) Cleared Device (Predicate Device):

Trade/Device Name:	Premier Guard USA 3 Layer Ear Loop ASTM Level 3 SurgicalFace Mask
510(k) Number:	K202595
Common Name:	Mask, Surgical
Regulation Number:	21 CFR 878.4040
Regulation Name:	Surgical apparel.
Regulatory Class:	Class II
Product Code:	FXX

4. Device Description:

The device description for the Impertech Surgical Face Mask is in accordance with the FDA Guidance Document, Surgical Masks -Premarket Notification [510K)] Submissions issued on March 5, 2004. The Impertech Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the user's mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of melt blown fiber. The outer facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided nonsterile.

The mask is in accordance to ASTM F2100 Level 3.

The proposed device is not made from natural rubber latex

{4}------------------------------------------------

5. Indications for Use:

The Impertech Surgical Face Mask are 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 fluid. This is a single use, disposable device, provided non-sterile.

6. Comparison to the 510(k) Cleared Devices (Predicate Devices):

DeviceCharacteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Impertech Surgical Face Mask	Premier Guard USA 3 LayerEarLoop ASTM Level 3 SurgicalFace Mask	Similar
510(k) Reference	K212046	K202595	Similar
Product Owner	Impertech Industries Ltd.	Premier Guard USA LLC	Similar
Product Code	FXX	FXX	Same
Indications for Use	The Impertech Surgical FaceMask are intended to be worn toprotect both patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potential exposureto blood and body fluids. Thisis a single use, disposabledevice(s) provided non-sterile.	The Premier Guard USA 3Layer Ear Loop ASTM Level 3Surgical Face Masks areintended to be worn toprotect both patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potential exposureto blood and body fluids. Thisis a single use, disposabledevice(s) provided non-sterile.	Same
Regulation Number	21 CFR 878.4040	21 CFR 878.4040	Same
Mask Style	Flat Pleated, Ear Loops, 3Layers	Flat Pleated, Ear Loops, 3Layers	Same
Mask Color	White	Blue	Similar
Materials
Nose Piece(material)	Polypropylene laminated softannealed carbon steel wire	Polyethylene laminated softannealed carbon steel wire	Same
Ear Loops (material)	Nylon and Spandex	Nylon and Spandex	Same
Outer Facing Layer	Spunbond polypropylene	Spunbond polypropylene	Same
Middle Layer	Melt blown fiber	Melt blown fiber	Same
Inner Facing Layer	Spunbond polypropylene	Spunbond polypropylene	Same
Dimensions - Width	175 mm	175 mm	Same
Dimensions -Length	95 mm	95 mm	Same
ASTM F2100 Level	Level 3	Level 3	Same
Biocompatibility
Cytotoxicity	Under the conditions of thestudy, the device is noncytotoxic	Under the conditions of thestudy, the device isnoncytotoxic	Same
Sensitization	Under the conditions of thestudy, the device isnonsensitizing	Under the conditions of thestudy, the device isnonsensitizing	Same
Irritation	Under the conditions of thestudy, the device is nonirritating	Under the conditions of thestudy, the device isnonirritating	Same
Prescription vs.OTC	OTC	OTC	Same
Sterile vs. Non-Sterile	Non-Sterile	Non-Sterile	Same
Disposable vs. Non-Disposable	Disposable	Disposable	Same
Single Use vs.Reusable	Single Use	Single Use	Same

{5}------------------------------------------------

Discussion of Similarities and Differences between subject device and predicate device:

The subject Impertech Surqical Face Mask subject device surgical mask and the Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask predicate device are same with all the parameters except for the color of the mask. The color of the subject device mask is without Color (white) whereas the predicate device is blue in color. The change in the mask between the subject device and the predicate device does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device.

None of the biocompatibility testing or performance testing results demonstrated any safety hazards or any design characteristics that violated the requirements set forth in the Guidance for Industry regarding Premarket Notification Submissions of Surgical Masks

7. Non-Clinical Performance Testing

The Impertech Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document, Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission issued March of 2004. Based upon the quidance document the following testing has been performed.

{6}------------------------------------------------

Fluid Resistance per ASTM F1862 ●
Particulate Filtration Efficiency per ASTM F2299 .
Bacterial Filtration Efficiency per ASTM F2101 ●
Differential Pressure (Delta P) per EN 14683 ●
Flammability per 16 CFR 1610 ●

Performance Testing
Surgical Mask Characteristics – ASTM F2100	Level 3Barrier	Result
Bacterial filtration efficiency %	≥98	Pass
Differential pressure, mm H2O/cm²	<6	Pass
Sub-micron particulate filtration efficiency at 0.1 micron %	≥98	Pass
Resistance to penetration by synthetic blood, minimum pressin mm Hg for pass result	160	Pass
Flammability	Class I	Pass

Performance Testing (Animal)

The biocompatibility evaluation for the Impertech Surgical Face Mask was conducted in accordance with ANSI/AAMI/ISO 10993-1:2018 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The Impertech Surgical Face Mask is classified as a surface contacting device. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2018 Annex A.

Biocompatibility Evaluation
	Bilogical Effect	Standard	Results
1	Cytotoxicity	ISO 10993-5	Not cytotoxic	Pass
2	Sensitization	ISO 10993-10	Non sensitizing	Pass
3	Irritation	ISO 10993-10	Negligibly irritating	Pass

8. Clinical Performance Testing

Not Applicable

9. Conclusions:

The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device. K202595 Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask.

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.