The Willson® ONE-Fit™ HC-NB095 Healthcare Particulate Respirator and Surgical Mask is a NIOSHapproved N95 single use respirator intended for use by healthcare personnel during medical/surgical procedures to protect both the wearer and the patient by protecting the wearer against the spatter of blood and other potentially infectious materials and reducing the transfer of microorganisms and other airborne particulate matter.

The Willson ONE-Fit also meets the CDC guidelines for TB exposure control within healthcare facilities and is intended for use as an isolation mask.

Device Description

The Willson ONE-Fit HC-NB095 Healthcare Particulate Respirator and Surgical Mask is a one size fits all, cup type, particulate respirator and surgical mask. The inner layer is constructed of polypropylene; the middle layer is a filtration layer made of polypropylene; and the outer layer is a covering of non woven polyester. The cup is thermoformed while the perimeter layers are heat sealed to form a small flange around the perimeter of the mask. Two latex free, synthetic elastic straps are stapled to the flange and are used to secure the mask to the wearer's face.
The Willson ONE-Fit HC-NB095 is approved by NIOSH in accordance with 42 CFR Part 84. NIOSH has issued certification number TC-84A-4357 as a type N95 Particulate Respirator. It is a single use, disposable device.

AI/ML Overview

The provided document describes a 510(k) summary for a medical device, the Willson® ONE-Fit™ HC-NB095 Healthcare Particulate Respirator and Surgical Mask. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and study methodologies.

The document highlights the device's performance through standardized tests and states that it passed these tests. It also mentions a comparison to predicate devices, noting that "Like the predicates, it has been performance tested and passed standardized tests for fluid resistance, filter efficiency, bacterial and viral filtration efficiency, flammability and breathing resistance." The materials used were also determined to be biocompatible.

Based on the information provided, here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Fluid Resistance	Meets standardized test criteria for fluid resistance.	Passed standardized tests for fluid resistance.
Filter Efficiency	Meets standardized test criteria for filter efficiency.	Passed standardized tests for filter efficiency.
Bacterial Filtration Efficiency (BFE)	Meets standardized test criteria for BFE.	Passed standardized tests for bacterial filtration efficiency.
Viral Filtration Efficiency (VFE)	Meets standardized test criteria for VFE.	Passed standardized tests for viral filtration efficiency.
Flammability	Meets standardized test criteria for flammability.	Passed standardized tests for flammability.
Breathing Resistance	Meets standardized test criteria for breathing resistance.	Passed standardized tests for breathing resistance.
Biocompatibility (Cytotoxicity)	Materials determined to be biocompatible (no significant cytotoxicity).	Materials determined to be biocompatible by cytotoxicity testing.
Biocompatibility (Sensitization)	Materials determined to be biocompatible (no significant sensitization).	Materials determined to be biocompatible by sensitization testing.
Biocompatibility (Skin Irritation)	Materials determined to be biocompatible (no significant skin irritation).	Materials determined to be biocompatible by skin irritation testing.
NIOSH Approval (N95)	Approved in accordance with 42 CFR Part 84.	Approved by NIOSH with certification number TC-84A-4357 as a type N95 Particulate Respirator.

Missing Information: The specific numerical or qualitative acceptance criteria for these standardized tests are not detailed in this document. The document only states that the device "passed" them. To provide exact acceptance criteria, reference to the specific standards (e.g., ASTM F1862 for fluid resistance, 42 CFR Part 84 for NIOSH N95, etc.) would be needed, which are not included here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided document. The document only mentions "performance tested" and "passed standardized tests" without detailing the number of units or samples tested for each criterion.
Data Provenance: Not specified. The document does not indicate the country of origin of the test data or whether the studies were retrospective or prospective.

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

This section is not applicable as the device is a physical product (respirator/surgical mask) and its performance is evaluated against objective engineering and biological standards, not through subjective assessment by human experts where "ground truth" would be established by consensus. The "ground truth" here is determined by the results of the standardized physical and biological tests.

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

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., medical image analysis) to resolve discrepancies among expert readers. The performance of a respirator is determined by 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

This section is not applicable. An MRMC study is relevant for diagnostic or interpretive devices, often involving AI assistance with human readers. This device is a passive protective medical device (respirator/surgical mask) and does not involve human readers or AI in its direct function or evaluation described here.

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

This section is not applicable. This device is not an algorithm or software. Its performance is inherent to its physical properties and construction.

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

The "ground truth" for this device's performance is established by objective measurements and observations from standardized physical and biological tests. Examples include:

Measurement of filter penetration for filter efficiency.
Observation of liquid penetration for fluid resistance.
Microbiological challenge tests for bacterial and viral filtration efficiency.
Flammability tests based on burn rate or extent.
Pressure drop measurements for breathing resistance.
Laboratory assays for cytotoxicity, sensitization, and irritation.

8. The sample size for the training set

This section is not applicable. The device is a physical product. The concept of a "training set" is relevant for machine learning algorithms or AI models, which are not part of this device's description. The manufacturing process is likely subject to quality control and statistical process control, but this is different from a "training set" for AI.

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

This section is not applicable for the reasons stated in point 8.

Summary

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K070/39

MAR 92 2007

5. 510(k) Summary

Submitter/ContactPerson	Richard O. WoodThe Wood Burditt GroupFDA Regulatory Counseling1025 W. Everett Rd., Suite 100Lake Forest, IL 60045
Applicant	Survivair Respirators LLC3001 S. Susan St.Santa Ana, CA 92704
Manufacturer	Bacou Dalloz Plaintel (SAS)Gare22940 Plaintel, France
Device Name	Willson® ONE-Fit™ HC-NB095 Healthcare ParticulateRespirator and Surgical Mask
Common Name	Surgical N95 NIOSH-certified Respirator
Classification	Class IIProcode MSH21 C.F.R. §878.4040
Identification ofPredicates and Summaryof SubstantialEquivalence	The Willson® ONE-Fit™ HC-NB095 is substantiallyequivalent to Inovel Health Care's N95 ParticulateRespirators and Surgical Masks (K051182) and Aearo Co.Pleats Plus 1050 and 1050S (K041855). Like the predicates,it has been performance tested and passed standardized testsfor fluid resistance, filter efficiency, bacterial and viralfiltration efficiency, flammability and breathing resistance.The materials used in the mask are the same as used on thecited predicates, but were also determined to be biocompatibleby cytotoxicity, sensitization and skin irritation testing.
Device Description	The Willson ONE-Fit HC-NB095 Healthcare ParticulateRespirator and Surgical Mask is a one size fits all, cup type,particulate respirator and surgical mask. The inner layer isconstructed of polypropylene; the middle layer is a filtrationlayer made of polypropylene; and the outer layer is a coveringof non woven polyester. The cup is thermoformed while theperimeter layers are heat sealed to form a small flange aroundthe perimeter of the mask. Two latex free, synthetic elasticstraps are stapled to the flange and are used to secure the maskto the wearer's face.The Willson ONE-Fit HC-NB095 is approved by NIOSH inaccordance with 42 CFR Part 84. NIOSH has issuedcertification number TC-84A-4357 as a type N95 ParticulateRespirator. It is a single use, disposable device.
Intended Use andIndications	The Willson® ONE-Fit™ HC-NB095 HealthcareParticulate Respirator and Surgical Mask is a NIOSH-approved N95 single use respirator intended for use byhealthcare personnel during medical/surgicalprocedures to protect both the wearer and the patientby protecting the wearer against the spatter of bloodand other potentially infectious materials and reducingthe transfer of microorganisms and other airborneparticulate matter.
	The Willson ONE-Fit also meets the CDC guidelinesfor TB exposure control within healthcare facilitiesand is intended for use as an isolation mask.

K070139 510(k) -- Willson® ONE-Fit™ HC-NB095 Healthcare Particle Respirator and Surgical Mask

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 2 2007

Survivair, Incorporated C/O Mr. Richard O. Wood Official Correspondent The Wood Burditt Group LLC 1025 West Everett Road Lake Forest, Illinois 60045

Re: K070139

Trade/Device Name: Willson® ONE-Fit™ HC-NB095 Healthcare Particulate Respirator and Surgical Mask Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: February 23, 2007 Received: February 26, 2007

Dear Mr. Wood:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Wood

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sujata Y. Michael m.d.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K070139

Willson® ONE-Fit™ HC-NB095 Healthcare Particulate Device Name: Respirator and Surgical Mask

Indications For Use:

The Willson ONE-Fit also meets the CDC guidelines for TB exposure control within healthcare facilities and is intended for use as an isolation mask.

ਸ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule A. Murphy, M.D.

Control, Evidence

Page 1 of 1

ದ್ರಿ ವಿ

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.