The Honeywell Procedure Mask is 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 potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

Device Description

The Honeywell Procedure Mask is composed of three layers that are a flat, pleated style mask with earloops to secure it over the users' mouth and face. The inner and outer layers are manufactured from spun-bond polypropylene. The middle layer is made of melt-blown polypropylene. The mask is a single use, disposable device, provided nonsterile and is not made from natural rubber latex.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device, specifically the "Honeywell Procedure Mask". It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

However, it's crucial to understand that this document does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the physical and performance characteristics of a surgical mask, not the performance of an AI algorithm in a diagnostic imaging context.

Therefore, many of the requested points related to AI/MRMC studies, such as the number of experts, adjudication methods, effect size, and ground truth establishment for AI training/test sets, are not applicable to this submission.

I will interpret the request in the context of the provided document, focusing on the acceptance criteria and performance testing for the surgical mask device.

Here's the information extracted from the document:

1. A table of acceptance criteria and the reported device performance:

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance (Results)
Performance Testing
ASTM F1862	Fluid Resistance/Synthetic Blood Penetration	120 mmHg	120 mmHg
ASTM F2299	Particulate Filtration Efficiency	≥98%	≥99.45% @ 0.1 micron
ASTM F2101	Bacterial Filtration Efficiency	≥98%	≥98.2% @ 3.0 micron
EN 14683 Annex C	Differential Pressure "Breathability"	<6.0 mmH2O/cm²	≤4.8 mmH2O/cm²
16 CFR Part 1610	Flammability	IBE or ≥3 seconds burn time, Class 1	IBE, Class 1
Biocompatibility Testing
ISO 10993-5	Cytotoxicity	Non-Cytotoxic	This device is non-cytotoxic
ISO 10993-10	Dermal Sensitization	Negligible	This device is not considered a contact sensitizer
ISO 10993-10	Skin Irritation	Negligible	This device is classified as negligibly irritating to the skin

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

Sample Size: For performance testing (ASTM F1862, F2299, F2101, EN 14683 Annex C, 16 CFR Part 1610), 32 samples in each of 3 different, non-consecutive lots were used. Biocompatibility testing typically uses a smaller number of samples as per the specific ISO guidance.
Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective beyond the standard laboratory testing procedures. It is implied these are prospective laboratory tests conducted to meet regulatory requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable. This is not an AI/ML study involving human interpretation of data where "experts" establish ground truth. The "ground truth" here is established through standardized laboratory test results and measurements by trained technicians using calibrated equipment according to specified ASTM, EN, and ISO standards.

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

Not Applicable. As this is a physical device testing, not an AI diagnostic study, there is no need for adjudication methods for interpretations. The results are obtained from objective measurements.

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:

No. An MRMC comparative effectiveness study was not conducted. This is a 510(k) submission for a physical medical device (surgical mask), not an AI-assisted diagnostic tool.

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

Not Applicable. This submission is for a physical medical device, not a standalone algorithm.

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

For the purposes of this submission, the "ground truth" for the device's performance is established by objective measurements obtained through standardized laboratory test methodologies (e.g., precise measurement of fluid penetration at a given pressure, filtration efficiency percentage, differential pressure measurement). Biocompatibility is determined by standardized in-vitro or in-vivo biological tests according to ISO 10993 standards.

8. The sample size for the training set:

Not Applicable. There is no "training set" in the context of this traditional medical device submission, as it does not involve AI or machine learning. The device's characteristics are determined by its design and material properties, validated by testing.

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

Not Applicable. As there is no training set for an AI/ML model, this question is not relevant to the provided document.

Summary

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July 28, 2021

Honeywell Safety Products Ivy Grieco Senior Advanced Quality Engineer 10 Thurber Boulevard Smithfield, Rhode Island 02917

Re: K211497

Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 11, 2021 Received: May 14, 2021

Dear Ivy Grieco:

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

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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 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 Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery 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)

K211497

Device Name Honeywell Procedure Mask

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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510(k) Summary (K211497)

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

I. SPONSOR

Honeywell Safety & Productivity Solutions 10 Thurber Blvd. Smithfield, RI 02917 USA

II. CONTACT PERSON

Ivy Grieco Title: Sr. Adv. Quality Engineer Phone: 401-864-0496 Email: Ivy.Grieco@Honeywell.com Date Prepared: July 21, 2021

III. DEVICE

Name of Device: Honeywell Procedure Mask Common or Usual Name: Procedure Mask Classification Name: Surgical Apparel (21 CFR §878.4040) Requlatory Class: II Product Code: FXX

IV. PREDICATE DEVICE

Manufacturer: Changzhou Combat Protective Equipment Co., Ltd. Device: Nordiwell Medical Face Mask 510(k) Number: K210445 This predicate has not been subject to a design-related recall.

V. DEVICE DESCRIPTION

VI. INDICATIONS FOR USE

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VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Honeywell Procedure Mask is compared with the predicate device Nordiwell Face Mask (K210445)). The results are shown below in the Technological Characteristics Comparison Table:

Item	Subject DeviceHoneywell Procedure Mask	Predicate DeviceNordiwell Medical Face Mask	Comparison
510(k) Number	K211497	K210445
Intended UseStatement	The Honeywell Procedure Mask isintended to be worn to protect both thepatient and healthcare personnel fromtransfer of microorganisms, body fluids,and particulate material.These face masks are intended for usein infection control practices to reducepotential exposure to blood and bodyfluids. This is a single use, disposabledevice, provided non-sterile.	The Nordiwell Medical Face Mask isintended to be worn to protect bothpatient and healthcare personnel fromtransfer of microorganisms, bodyfluids, and particulate matters.These face masks are intended for usein infection control practices to reducepotential exposure to blood and bodyfluids. This is a single use, disposabledevice(s) and provided nonsterile	Same
Materials
Outer Layer	Polypropylene Spun-bond	Polypropylene Spun-bond	same
Middle Layer	Polypropylene Melt-blown	Polypropylene Melt-blown	same
Inner Layer	Polypropylene Spun-bond	Polypropylene Spun-bond	same
Earloop	Round Knit Polyester and Lycra	Spandex and Nylon	different
Nose Wire	Polyethylene Coated Steel Wire	Polyethylene Coated Steel Wire	same
Design Features
Color	White	White	same
Style	Flat, Pleated	Flat, Pleated	same
Layers	3	3	same
Physical State	Single Use Only	Single Use Only	same
Sterility	Non-Sterile	Non-Sterile	same
Dimensions
Length	173mm ± 3mm	160mm ± 5mm	different
Width	95mm ± 3mm	106mm ± 5mm	different
Performance Specifications & Testing
ASTM Level	2	2	same
Fluid Resistance(ASTM F1862)	Passed at 120 mmHg	Passed at 120 mmHg	same
ParticulateFiltrationEfficiency (PFE)	Passed at ≥98% @ 0.1 micron	Passed at ≥98% @ 0.1 micron	same
Bacterial FiltrationEfficiency (BFE)	Passed at ≥98%	Passed at ≥98%	same
DifferentialPressure	Passed at <5.0 mmH $2$ O/cm $2$	Passed at <5.0 mmH $2$ O/cm $2$	same
Flammability(16 CFR 1610)	Class 1	Class 1	same
Biocompatibility
Cytotoxicity	Non-Cytotoxic	Non-Cytotoxic	same
Skin Irritation	Non-Irritating	Non-Irritating	same
DermalSensitization	Non-Sensitizing	Non-Sensitizing	same

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VIII. SUMMARY OF NON-CLINICAL TESTING

Performance Testing

Mask performance was tested to ASTM's F2100 standard. Each type of performance testing used 32 samples in each of 3 different, non-consecutive lots. Testing consisted of the following:

Test Methodology	Purpose	Acceptance Criteria	Results
ASTM F1862	Fluid Resistance/Synthetic BloodPenetration	120 mmHg	120 mmHg
ASTM F2299	Particulate Filtration Efficiency	≥98%	≥99.45% @ 0.1micron
ASTM F2101	Bacterial Filtration Efficiency	≥98%	≥98.2% @ 3.0micron
EN 14683 Annex C	Differential Pressure"Breathability"	<6.0 mmH2O/cm²	≤4.8 mmH2O/cm²
16 CFR Part 1610	Flammability	IBE or ≥3seconds burntime, Class 1	IBE, Class 1

Biocompatibility testing

The biocompatibility evaluation for the Honeywell Procedure Mask device was conducted in accordance with the FDA's Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Test Methodology	Purpose	Acceptance Criteria	Results
ISO 10993-5	Cytotoxicity	Non-Cytotoxic	This device is non-cytotoxic
ISO 10993-10	Dermal Sensitization	Negligible	This device is notconsidered a contactsensitizer
ISO 10993-10	Skin Irritation	Negligible	This device is classifiedas negligibly irritating tothe skin

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IX. SUMMARY OF CLINICAL TESTING

Clinical testing is not needed for this device.

X. CONCLUSION

The proposed device has the same indication for use and similar technological characteristic as the predicate device. Non-clinical testing demonstrates that the proposed device performs as safe and effective as the 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.