(126 days)
No
The device description focuses solely on the mechanical components of a nasal CPAP mask and its function in delivering air pressure. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the treatment of Obstructive Sleep Apnea (OSA) by providing continuous positive airway pressure, which directly addresses a medical condition.
No
The device is a CPAP mask, intended to deliver positive airway pressure for the treatment of Obstructive Sleep Apnea, not to diagnose it.
No
The device description clearly describes a physical nasal CPAP mask with headgear, tubing connections, and exhaust holes, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states that the Nasal CPAP Mask is a mechanism for connecting a patient to a source of positive air pressure for the treatment of Obstructive Sleep Apnea. It delivers air to the patient's nose and allows for the exhalation of carbon dioxide.
- No Sample Analysis: The device does not collect or analyze any samples from the patient's body. Its function is purely mechanical and related to delivering air pressure.
Therefore, the Nasal CPAP Mask falls under the category of a therapeutic device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The new Nasal CPAP Mask is intended to be used with nasal continuous positive airway pressure (CPAP), auto-adjusting CPAP and Bilevel systems for the treatment of adult (>30kg) Obstructive Sleep Apnea (OSA). The device is to be used in home and clinical environments by or on order of a physician. The device can be used with auto-adjusting PAP devices which depend on patient flow signals or flow-based snoring signals for the determination of pressure adjustment.
Product codes
BZD
Device Description
The new DeVilbiss Nasal CPAP Mask serves as a mechanism for reliably connecting an adult (>30kg) patient diagnosed with sleep apnea to a source of continuous or bilevel positive air pressure needed to maintain an open airway. The nasal mask is securely fastened over a patient's nose by use of specialized headgear. A soft contact area is provided on the side of the mask that contacts the patient's face; the front side of the mask assembly has a tubing connection which is compatible with the industry standard 22mm air tubing.
The CPAP mask is required to be secure fitting to insure proper pressure delivery to the patient, but comfortable enough to maintain patient compliance with the treatment.
Air is supplied to the mask by a CPAP device (the CPAP device can be a standard CPAP, AutoAdiust CPAP or Bi-Level type device). Air is channeled to the nose chamber via the tubing/swivel adapter connections. The patient inhales air from the mask and exhales into the mask where continuous airflow from the CPAP device purges the exhaled carbon dioxide from the mask through the mask diffusion based exhaust holes. The mask will be held in place on the patient through the use of a cloth/elastic headgear.
The new Nasal CPAP Mask is strapped to the patient's face covering the nose, and connected via 22mm tubing to a source of continuous or Bilevel positive air pressure, creating an airway splint in the throat. Positive pressure ventilation is thus applied to the lungs in a non-invasavive way.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose, Airway/Throat
Indicated Patient Age Range
Adult (>30kg)
Intended User / Care Setting
Home and clinical environments by or on order of a physician.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 1 4 2005
16.0 510(k) Summary
| Submitter's Name: | Sunrise Medical HHG, Inc.
Respiratory Products Division
100 DeVilbiss Drive
Somerset PA 15501 | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Allan Jones
Phone: 814-443-7618
Fax: 814-443-7571
Email: allan.jones@sunmed.com | |
| Date Prepared: | September 1, 2004 | |
| Device Name: | Nasal CPAP Mask | |
| Common or Usual Name: | Nasal CPAP Mask | |
| DeVilbiss Model Number: | Model 9354 Series | |
| Trade Proprietary Name: | DeVilbiss Nasal CPAP Mask | |
| Established Registration
Number: | 2515872 | |
| Classification Panel: | Anesthesiology | |
| FDA Classification: | Class II | |
| CFR Section: | 868.5905 - Noncontinuous Ventilator (IPPB) | |
| Product Code: | BZD | |
| Legally Marketed Predicate Devices: | | |
| Respironics Gel MaskK954207 | | |
Description of Device:
Invacare Twilight Nasal Mask
The new DeVilbiss Nasal CPAP Mask serves as a mechanism for reliably connecting an adult (>30kg) patient diagnosed with sleep apnea to a source of continuous or bilevel positive air pressure needed to maintain an open airway. The nasal mask is securely fastened over a patient's nose by use of specialized headgear. A soft contact area is provided on the side of the mask that contacts the patient's face; the front side of the mask assembly has a tubing connection which is compatible with the industry standard 22mm air tubing.
The CPAP mask is required to be secure fitting to insure proper pressure delivery to the patient, but comfortable enough to maintain patient compliance with the treatment.
1
Air is supplied to the mask by a CPAP device (the CPAP device can be a standard CPAP, AutoAdiust CPAP or Bi-Level type device). Air is channeled to the nose chamber via the tubing/swivel adapter connections. The patient inhales air from the mask and exhales into the mask where continuous airflow from the CPAP device purges the exhaled carbon dioxide from the mask through the mask diffusion based exhaust holes. The mask will be held in place on the patient through the use of a cloth/elastic headgear.
Statement of Intended Use:
The new Nasal CPAP Mask is intended to be used with nasal continuous positive airway rressure (CPAP), auto-adjusting CPAP and Bilevel systems for the treatment of adult (>30kg) Obstructive Sleep Apnea (OSA). The device is to be used in home and clinical environments by or on order of a physician. The device can be used with auto-adjusting PAP devices which depend on patient flow signals or flow-based snoring signals for the determination of pressure adjustment.
Statement of Safety and Effectiveness:
The new Nasal CPAP Mask is equivalent in both function and indications for use to the Respironics Gel Mask (K954207) and Invacare Twilight Nasal Mask (K022642) legally marketed predicate devices.
The new Nasal CPAP Mask is designed for use on the order of a physician for the treatment of adult (>30kg) Obstructive Sleep Apnea. The mask is constructed of materials that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with voluntary standards applicable to this type of device.
The new Nasal CPAP Mask is designed to serve as a mechanism for reliably connecting an adult (>30kg) patient to a source of continuous or bilevel positive air pressure needed to maintain an open airway. The method of serving as the mechanism of connection to a continuous or Bilevel positive air pressure and other characteristics of the new Nasal CPAP Mask are substantially equivalent to other legally marketed devices.
Technological Characteristics:
The new Nasal CPAP Mask is strapped to the patient's face covering the nose, and connected via 22mm tubing to a source of continuous or Bilevel positive air pressure, creating an airway splint in the throat. Positive pressure ventilation is thus applied to the lungs in a non-invasavive way. The new Nasal CPAP Mask is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all function in providing a reliable mechanism of connection to a continuous, auto adjust or Bilevel positive air pressure source for the treatment of Obstructive Sleep Apnea. No new technologies have been introduced in the new Nasal CPAP Mask device.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized symbol that resembles three overlapping chevrons or stripes.
JAN 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Allan Jones Manager, Sleep Products Engineering Sunrise Medical 100 DeVilbiss Drive Somerset, Pennsylvania 15501-2125
Re: K042455
Trade/Device Name: DeVilbiss Nasal CPAP Mask, Model 9354 Series Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 24, 2004 Received: November 29, 2004
Dear Mr. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because mined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to art cosmetic Act (Act) that do not require approval of a premarket the Federal F 000, Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions on 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 (1 Mrs), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Jones
Please be advised that FDA's issuance of a substantial equivalence determination does not I least be advisod that I Da determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal statues and reguirements, including, but not limited to: registration rou must comply with and are rebeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pat 007), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as sot form in the quasily ion 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) This letter will anow you to organ mading of substantial equivalence of your device to a premiarket notification. This 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), IT you desire specific advice for your de at (240) 276-0120. 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 may overnment general 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/dsma/dsmamain.html
Sincerely yours,
Carls
Chiu Lin, Ph.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
4
Indications for Use
510(k) Number (if known):_K042455
Device Name: DeVilbiss 9354 Series Nasal CPAP Mask
Indications For Use:
The new Nasal CPAP Mask is intended to be used with nasal continuous positive rine fressure (CPAP), auto-adjusting CPAP and Bilevel systems for the treatment of allway pressure (Or A. )) and on Apnea (OSA). The device is to be used in home and autit ( ourgy Oberably or on order of a physician. The device can be used with autoonlined on virentherite - which depend on patient flow signals or flow-based snoring signals for the determination of pressure adjustment.
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)
Sta. Luvill
(Division Sign-Off)
General Hospital,
Page 1 of 1
510(k) Number: Ko42455