(192 days)
No
The summary describes a nasal pillow mask interface for PAP devices and does not mention any AI or ML components or functionalities.
No.
The device is a mask interface that channels airflow; it is not the PAP device itself which provides the therapeutic pressure.
No
The device is described as a mask interface for delivering positive airway pressure, which is a treatment for sleep-disordered breathing, not a diagnostic tool.
No
The device description clearly states it is a "mask interface, of the nasal pillow variety," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Willow™ is a mask interface used to deliver airflow from a PAP device to a patient's nose for the treatment of sleep disordered breathing. It is a physical device that interacts with the patient's airway, not a test performed on a biological sample.
- Intended Use: The intended use clearly states it's for delivering airflow for treatment, not for diagnosis based on biological samples.
- Device Description: The description details a physical mask and headgear, not a diagnostic test kit or instrument.
Therefore, the Willow™ falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Willow™ channels airflow noninvasively to a patient from a positive airway pressure (PAP) device or a bilevel system The Willow ™ is:
- (1) to be used by adult patients (> 66lb / 30 kg) for the treatment of sleep disordered breathing, such as obstructive sleep apnea (OSA), for whom positive airway pressure has been prescribed.
- (2) to be used for single-patient reuse in the home environment.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The 3B Willow™ is a mask interface, of the nasal pillow variety, that directs airflow from a positive pressure device to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.
The 3B Willow™ is safe when used under the conditions and purposes intended as indicated the labeling provided with the product.
The 3B Willow™ is a prescription device supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose (patient's nose)
Indicated Patient Age Range
Adult patients (> 66lb / 30 kg)
Intended User / Care Setting
Home environment.
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)
A comparative table of the Willow TM alongside the three identified predicate devices indicates that the Willow Nasal Pillows is substantially equivalent with the other three with respect to the form, performance, materials, structures and the ventilation characteristics.
To verify the substantial equivalence claim, the Willow™ was performance bench tested against the ResMed Mirage Swift (K042043). The results of the performance bench testing, along with a description of the testing protocol are found at Appendix A. In terms of performance characteristics (i.e. passive exhalation port flow, resistance to flow, and dead space), the two devices are substantially equivalent.
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
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
Section 5: 510(k) Summary
3B Willow™ Nasal Mask
FEB 1 6 2012
Section 5:
510(k) SUMMARY [As required by 21 CFR §807.92(c)]
Date Prepared:
July 27, 2011
Official Contact:
Alex Lucio Managing Partner 3B Products, LLC 1142 N. Scenic Highway Lake Wales, FL 33853 Tel: (863) 676-5948 Email: alucio@3Bproducts.com
| Device Trade Name: | 3B Willow™ Nasal Mask | |
|---|---|---|
| Device Common Name/ | ||
| Classification Name: | Vented Nasal Mask | |
| Classification: | 21 CFR §868.5905, 73 BZD (CLASS II) | |
| Predicate Devices: | Manufacturer: | Resmed |
| Trade Name: | Mirage Swift II | |
| 510(k) Number: | K042403 |
Manufacturer: Respironics ComfortLite 2 Trade Name: 510(k) Number: K082558
Fisher & Paykel Manufacturer: Opus 360 Trade Name: K063036 510(k) Number:
Device Description:
The 3B Willow™ is a mask interface, of the nasal pillow variety, that directs airflow from a positive pressure device to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.
The 3B Willow™ is safe when used under the conditions and purposes intended as indicated the labeling provided with the product.
1
Section 5: 510(k) Summary
3B Willow™ Nasal Mask
The 3B WillowTM is a prescription device supplied non-sterile.
Intended Use:
The Willow™ channels airflow noninvasively to a patient from a positive
airway pressure (PAP) device or a bilevel system. The Willow™ is:
- (1) to be used by adult patients (> 66lb / 30 kg) for the treatment of sleep disordered breathing, such as obstructive sleep apnea (OSA), for whom positive airway pressure has been prescribed.
- (2) to be used for single-patient reuse in the home environment.
Contraindications:
None
Technological Characteristics Comparison:
A comparative table of the Willow TM alongside the three identified predicate devices indicates that the Willow Nasal Pillows is substantially equivalent with the other three with respect to the form, performance, materials, structures and the ventilation characteristics.
| Manufacturer | BMC | ResMed | Respironics | Fisher&Paykel |
|---|---|---|---|---|
| Model | WillowTM | |||
| Nasal Pillows | ||||
| System | Mirage Swift | |||
| II Nasal | ||||
| Pillows | ||||
| System | ||||
| (K042403) | ComfortLiteTM 2 | |||
| System | ||||
| (K082558) | OpusTM 360 Nasal | |||
| Pillows Mask | ||||
| (K063036) | ||||
| Pic | Image: BMC Willow Nasal Pillows System | Image: ResMed Mirage Swift II Nasal Pillows System | Image: Respironics ComfortLite 2 System | Image: Fisher&Paykel Opus 360 Nasal Pillows Mask |
| Nasal pillows | Yes | Yes | Yes | Yes |
| With headgear | Yes | Yes | Yes | Yes |
| Latex free | Yes | Yes | Yes | Yes |
| Multi Size | Yes | Yes | Yes | Yes |
| Connector | 22mm | 22mm | 22mm | 22mm |
| Therapy | ||||
| Pressure | 4-20cmH20 | 4-20cmH20 | 4-30cmH20 | 3-25cmH20 |
| Intentional | 4cmH20=20L/ | 4cmH20=20L | 4cmH20=22L/min | 5cmH20=22L/min |
2
| leak | min
10cmH20=31.5
L/min
20cmH20=45L/min | /min
12cmH20=37
/min
20cmH20=49
L/min | 12cmH20=34L/min
20cmH20=42L/min | 11cmH20=33L/min
21cmH20=48L/min
25cmH20=52L/min |
|------------|-------------------------------------------------|---------------------------------------------------|------------------------------------|-------------------------------------------------------|
| Resistance | 1.0 cmH20 at 50L/min
3.1 cmH20 at 100L/min | 0.4 cmH20 at 50L/min
1.6 cmH20 at 100L/min | NA | 1.2 cmH20 at 50L/min
5.4 cmH20 at 100L/min |
| Dead Space | 96ml | 91ml | 19-36ml(mask only) | 22ml(mask only) |
To verify the substantial equivalence claim, the Willow™ was performance bench tested against the ResMed Mirage Swift (K042043). The results of the performance bench testing, along with a description of the testing protocol are found at Appendix A. In terms of performance characteristics (i.e. passive exhalation port flow, resistance to flow, and dead space), the two devices are substantially equivalent.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
3B Products, LLC C/O Mr. Alex Lucio Managing Partner 1142 N. Scenic Highway Lake Wales, Florida 33853
FEB 1 6 2012
Re: K112271
Trade/Device Name: 3B Willow™ Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: February 4, 2012 Received: February 9, 2012
Dear Mr. Lucio:
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. 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.
Page 2 - Mr. Lucio
4
Page 2 - Mr. Lucio
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Sempilations ification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I bailing) of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
3B Willow™ Nasal Mask
Section 4: Indications for Use
K1112271
Indications for Use
510(k) Number: K112271 Device Name: 3B Willow™ Nasal Mask
Indications For Use:
The Willow™ channels airflow noninvasively to a patient from a positive airway pressure (PAP) device or a bilevel system The Willow ™ is:
- (1) to be used by adult patients (> 66lb / 30 kg) for the treatment of sleep disordered breathing, such as obstructive sleep apnea (OSA), for whom positive airway pressure has been prescribed.
- (2) to be used for single-patient reuse in the home environment.
AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________ × Prescription Use _ (Part 21 CFR 801 Subpart D) (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)
y. Schulther
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 以上1227/