(21 days)
Not Found
No
The device description and intended use are for a physical respirator/surgical mask, and there is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a respirator and surgical mask intended for protection and reduction of microorganism transfer, not to treat or diagnose a disease or condition.
No
The device is a respirator and surgical mask used for protection, not for diagnosing medical conditions. Its intended use is to protect the wearer and patient by filtering particulates and potentially infectious materials.
No
The device description clearly outlines the physical components and construction of a particulate respirator and surgical mask, which is a hardware device. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "Healthcare Particulate Respirator and Surgical Mask" for protecting healthcare personnel and patients from airborne particles, spatter, and microorganisms. This is a protective barrier device, not a device used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical construction and materials of a mask designed for filtration and protection. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies mentioned focus on characteristics relevant to a mask's protective function (fluid resistance, filter efficiency, bacterial filtration efficiency, flammability, breathing resistance). These are not the types of performance studies conducted for IVD devices (e.g., accuracy, precision, sensitivity, specificity in detecting analytes).
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to diagnose or monitor medical conditions. This device is a physical barrier for respiratory protection.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MSH
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel, medical/surgical procedures, healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Flat-Fold masks have been performance tested in an identical manner to the predicate, and passed standardized tests for fluid resistance, filter efficiency, bacterial filtration efficiency, flammability and breathing resistance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
X070782
5. 510(k) Summary
| Submitter/Contact
Person | Richard O. Wood
The Wood Burditt Group
FDA Regulatory Counseling
1025 W. Everett Rd., Suite 100
APR 11 2007
Lake Forest, IL 60045
(847) 234-7500 x 203
rowood@woodburditt.com
(847) 574-0728 (fax) |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Survivair Respirators LLC
3001 S. Susan St.
Santa Ana, CA 92704 |
| Manufacturer | Bacou Dalloz Plaintel (SAS)
Gare
22940 Plaintel, France |
| Device Name | Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate
Respirator and Surgical Masks, Models HC-NB095F and HC-
NB295F |
| Common Name | Surgical N95 NIOSH-certified Respirator |
| Classification | Class II
Procode MSH
21 C.F.R. §878.4040 |
| Identification of
Predicates and Summary
of Substantial
Equivalence | The Willson® ONE-Fit™ Flat-Fold masks are substantially
equivalent to Survivair's own and recently cleared Willson®
ONE-Fit™ HC-NB095 Cup-style Healthcare
Particle
Respirator and Surgical Mask (K070139). The Flat-Fold
masks have been performance tested in an identical manner to
the predicate, and passed standardized tests for fluid
resistance, filter efficiency, bacterial filtration efficiency,
flammability and breathing resistance. The materials used in
the mask are virtually identical to the ones used on the cited
predicate, and were also determined to be biocompatible by
cytotoxicity, sensitization and skin irritation testing. |
| Device Description | 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). |
| Intended Use and
Indications | The Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate
Respirator and Surgical Masks (Models HC-NB095F and 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. |
・
1
510(k) -- Willson® ONE-Fit™ Flat Fold Healthcare Particle Respirator and Surgical Masks
2
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.
3
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
4
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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