(21 days)
The Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate Respirator and Surgical Masks (HC-NB095F & HC-NB295F) are NIOSH-approved N95 single use respirators 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 Flat-Fold masks also meet the CDC guidelines for TB exposure control within healthcare facilities and are intended for use as an isolation mask.
The Willson ONE-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Masks are flat-fold style particulate respirator and surgical masks. The only difference between the two models is the number of straps; one has a single strap, the other a double strap.
The inner layer of the mask is constructed of spunbonded polypropylene, the middle layer is a filtration layer made of melt blown polypropylene and the outer layer is a covering of spunbonded polypropylene. The two halves that comprise the flat-fold facepiece are ultrasonically sealed together. The lower halves and is/are ultrasonically welded into the corners of the mask. The perimeter edges of the mask that contact the wearer's face are also ultrasonically sealed to provide reinforcement of the edges.
The Willson ONE-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Masks are approved by NIOSH in accordance with 42 CFR 84 as N95 particulate respirators. NIOSH has issued approvals TC-84A-4372 (single strap) and TC-84A-4371 (dual strap).
The provided text describes a 510(k) submission for the Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate Respirator and Surgical Masks. This is a submission for a medical device (respirator/surgical mask) and not an AI/ML (Artificial Intelligence/Machine Learning) powered device. Therefore, the information requested regarding acceptance criteria and performance metrics for AI/ML devices is not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through performance testing against standardized tests for physical characteristics and biocompatibility.
Here's an analysis based on the information provided, clearly stating what is not applicable for an AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Resistance | Standardized tests for fluid resistance (implied to meet relevant standards for surgical masks). | Passed standardized tests for fluid resistance. |
| Filter Efficiency | Standardized tests for filter efficiency (implied to meet relevant standards for N95 respirators, which is generally ≥95% filtration efficiency for 0.3 micron particles). | Passed standardized tests for filter efficiency. Additionally, the device is "NIOSH-approved N95 single use respirators" in accordance with 42 CFR 84, meaning it meets the N95 filtration criteria. |
| Bacterial Filtration Efficiency | Standardized tests for bacterial filtration efficiency (implied to meet relevant standards for surgical masks, typically ≥95% or ≥98% bacterial filtration efficiency). | Passed standardized tests for bacterial filtration efficiency. |
| Flammability | Standardized tests for flammability (implied to meet relevant standards). | Passed standardized tests for flammability. |
| Breathing Resistance | Standardized tests for breathing resistance (implied to meet relevant standards, ensuring user comfort and safety). | Passed standardized tests for breathing resistance. |
| Biocompatibility | Determined to be biocompatible by cytotoxicity, sensitization, and skin irritation testing. | Determined to be biocompatible by cytotoxicity, sensitization and skin irritation testing (materials "virtually identical" to predicate, which were also determined to be biocompatible). |
| NIOSH Approval (N95) | Approval by NIOSH in accordance with 42 CFR 84 as N95 particulate respirators. | Approved by NIOSH (TC-84A-4372 for single strap, TC-84A-4371 for dual strap). |
| CDC Guidelines for TB Exposure Control | Meets CDC guidelines for TB exposure control within healthcare facilities. | Meets the CDC guidelines for TB exposure control within healthcare facilities. |
| Protection against blood spatter | Protects the wearer against the spatter of blood and other potentially infectious materials (implied by fluid resistance and surgical mask classification). | Indicated for use "to protect the wearer against the spatter of blood and other potentially infectious materials." |
| Reduction of microorganism transfer | Reduces the transfer of microorganisms and other airborne particulate matter (implied by filter efficiency and bacterial filtration efficiency). | Indicated for use "reducing the transfer of microorganisms and other airborne particulate matter." |
| Design Differences (if any) | The only difference between the two models is the number of straps (one has a single strap, the other a double strap). The materials used in the mask are "virtually identical" to the predicate. Construction method (ultrasonically sealed) and specific materials (spunbonded polypropylene, melt blown polypropylene) are described. | The only difference between the two models is the number of straps; one has a single strap, the other a double strap. The inner layer is spunbonded polypropylene, middle layer is melt blown polypropylene, outer layer is spunbonded polypropylene. Halves are ultrasonically sealed, and perimeter edges are ultrasonically sealed for reinforcement. Materials are virtually identical to the predicate. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual performance test (fluid resistance, filter efficiency, etc.). It states that the "Flat-Fold masks have been performance tested in an identical manner to the predicate, and passed standardized tests." The data provenance is related to laboratory testing of physical materials and device performance under controlled conditions. No patient or human subject data is referenced.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device is established by objective engineering and laboratory performance standards and physical material properties, not expert clinical interpretation.
4. Adjudication method for the test set
Not applicable. The tests are based on objective pass/fail criteria against established standards, not on human adjudication of ambiguous cases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and no human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth is based on objective engineering and laboratory performance standards (e.g., specific filtration percentages, resistance to fluid penetration, flammability ratings) and material biocompatibility testing as defined by regulatory bodies like NIOSH and FDA-recognized standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not involve a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device and does not involve establishing ground truth for a training set.
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X070782
5. 510(k) Summary
| Submitter/ContactPerson | Richard O. WoodThe Wood Burditt GroupFDA Regulatory Counseling1025 W. Everett Rd., Suite 100APR 11 2007Lake Forest, IL 60045(847) 234-7500 x 203rowood@woodburditt.com(847) 574-0728 (fax) |
|---|---|
| Applicant | Survivair Respirators LLC3001 S. Susan St.Santa Ana, CA 92704 |
| Manufacturer | Bacou Dalloz Plaintel (SAS)Gare22940 Plaintel, France |
| Device Name | Willson® ONE-Fit™ Flat-Fold™ Healthcare ParticulateRespirator and Surgical Masks, Models HC-NB095F and HC-NB295F |
| 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™ Flat-Fold masks are substantiallyequivalent to Survivair's own and recently cleared Willson®ONE-Fit™ HC-NB095 Cup-style HealthcareParticleRespirator and Surgical Mask (K070139). The Flat-Foldmasks have been performance tested in an identical manner tothe predicate, and passed standardized tests for fluidresistance, filter efficiency, bacterial filtration efficiency,flammability and breathing resistance. The materials used inthe mask are virtually identical to the ones used on the citedpredicate, and were also determined to be biocompatible bycytotoxicity, sensitization and skin irritation testing. |
| Device Description | The Willson ONE-Fit Flat-Fold Healthcare ParticulateRespirator and Surgical Masks are flat-fold style particulaterespirator and surgical masks. The only difference betweenthe two models is the number of straps; one has a single strap,the other a double strap.The inner layer of the mask is constructed of spunbondedpolypropylene, the middle layer is a filtration layer made ofmelt blown polypropylene and the outer layer is a covering ofspunbonded polypropylene. The two halves that comprisethe flat-fold facepiece are ultrasonically sealed together. The |
| lower halves and is/are ultrasonically welded into the cornersof the mask. The perimeter edges of the mask that contact thewearer's face are also ultrasonically sealed to providereinforcement of the edges. | |
| The Willson ONE-Fit Flat-Fold Healthcare ParticulateRespirator and Surgical Masks are approved by NIOSH inaccordance with 42 CFR 84 as N95 particulate respirators.NIOSH has issued approvals TC-84A-4372 (single strap) andTC-84A-4371 (dual strap). | |
| Intended Use andIndications | The Willson® ONE-Fit™ Flat-Fold™ Healthcare ParticulateRespirator and Surgical Masks (Models HC-NB095F and HC-NB295F) are NIOSH-approved N95 single use respiratorsintended for use by healthcare personnel duringmedical/surgical procedures to protect both the wearer and thepatient by protecting the wearer against the spatter of bloodand other potentially infectious materials and reducing thetransfer of microorganisms and other airborne particulatematter.The Willson ONE-Fit Flat-Fold masks also meet the CDCguidelines for TB exposure control within healthcare facilitiesand are intended for use as an isolation mask. |
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510(k) -- Willson® ONE-Fit™ Flat Fold Healthcare Particle Respirator and Surgical Masks
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings and body. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Survivair Respirators, LLC C/O Mr. Richard O. Wood The Wood Burditt Group 1025 W. Everett Road Lake Forest, Illinois 60045
APR 1 1 2007
Re: K070782
Trade/Device Name: Willson® ONE-Fit Flat-Fold™ Healthcare Particulate Respirator and Surgical Mask, HC-NB095F & HC-NB295F Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: April 3, 2007 Received: April 4, 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 misbrandi, no 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, EDA coach 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 (QS) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
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);
Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate Device Name: Respirator and Surgical Masks, HC-NB095F & HC-NB295F
Indications For Use:
The Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate Respirator and Surgical Masks (HC-NB095F & HC-NB295F) are NIOSH-approved N95 single use respirators 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 Flat-Fold masks also meet the CDC guidelines for TB exposure control within healthcare facilities and are intended for use as an isolation mask.
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)
Sheila P. Murphy, MD
f Anesthesiology, General Hospital,
-ion Control, Central Services
Page 1 of 1
c(k) Number: K010/82
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§ 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.