(233 days)
No
The description focuses on the electromechanical components and basic pressure control based on fixed prescription settings, with no mention of adaptive algorithms, learning, or AI/ML terminology.
Yes
The intended use explicitly states the device is "intended for use in treating obstructive sleep apnea in adult patients," which is a therapeutic purpose.
No
This device is described as a "Bilevel CPAP" intended for "treating obstructive sleep apnea." Its function is to "provide CPAP therapy," which is a treatment, not a diagnostic procedure.
No
The device description clearly outlines hardware components such as a blower, motor, power supply, and LCD display, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "treating obstructive sleep apnea in adult patients." This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a device that provides positive airway pressure to a patient. This is a treatment mechanism, not a method for analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, the DeVilbiss Model 9055 Bilevel CPAP is a medical device used for treating a condition, not for diagnosing it.
N/A
Intended Use / Indications for Use
The DeVilbiss Model 9055 Bilevel CPAP is intended for use in treating OSA in spontaneously breathing adult patients by means of application of positive air pressure. The device is to be used in home and clinical environments.
The Model 9055 Bilevel CPAP is intended for use in treating obstructive sleep apnea in adult patients.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The new DeVilbiss Model 9055 Bilevel CPAP is an AC powered, dual-pressure blower designed to be used in providing CPAP therapy to the spontaneously breathing adult patient population with Obstructive Sleep Apnea. Rapid changes in pressure between EPAP (Expiratory Positive Airway Pressure) and IPAP (Inspiratory Positive Airway Pressure) will be achieved by changing the operating speed of the blower.
The bilevel device will have two primary prescription settings: IPAP pressure and EPAP pressure.
Electrical power is supplied to the unit using an AC line cord (100 – 240 VAC, 50/60Hz, 400 Hz). The AC input voltage is converted to a DC voltage by an internal switch-mode power supply. The DC voltage is used to power the internal electronics of the product (microcontroller, motor control circuitry, blower, LCD display, etc.). Positive pressure is produced by spinning a reverse-curved impeller with a brushless DC motor. Room air is drawn into the blower through a filter, pressurized in the blower, and then discharged through a 22 mm ID tube.
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
adult patients
Intended User / Care Setting
Not Found
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): 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.
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
.
FEB 2 0 2004
| 16.0 | 510(k) Summary |
|---|---|
| Submitter's Name: | Sunrise Medical HHG, Inc. |
| Respiratory Products Division | |
| 100 DeVilbiss Drive | |
| Somerset PA 15501 | |
| Contact Person: | Stephen F. Krepelka |
| Phone: 814-443-7671 | |
| Fax: 814-443-7571 | |
| Email: steve.krepelka@sunmed.com | |
| Date Prepared: | July 1, 2003 |
| Device Name: | Bilevel CPAP |
| Common or Usual Name: | Bilevel Nasal CPAP with Remote Control Module and Analog |
| Breakout Box | |
| DeVilbiss Model Number: | Model 9055 |
| Trade Proprietary Name: | DeVilbiss Bilevel CPAP with Remote Control Module and Analog |
| Breakout Box | |
| Established Registration | |
| Number: | 2515872 |
| Classification Panel: | Anesthesiology |
| FDA Classification: | Class II |
| CFR Section: | 868.5905 |
| Product Code: | BZD |
| Legally Marketed Predicate Devices: | |
| Device Name | 510(k) Notification |
| DeVilbiss Model 7355 Bilevel CPAP with Remote | |
| Control Module | |
| Resmed Sullivan VPAP II | K952491 |
| K961783 | |
| DeVilbiss 9001 Series CPAP | K011229 |
:
1
Description of Device:
The new DeVilbiss Model 9055 Bilevel CPAP is an AC powered, dual-pressure blower designed to be used in providing CPAP therapy to the spontaneously breathing adult patient population with Obstructive Sleep Apnea. Rapid changes in pressure between EPAP (Expiratory Positive Airway Pressure) and IPAP (Inspiratory Positive Airway Pressure) will be achieved by changing the operating speed of the blower.
The bilevel device will have two primary prescription settings: IPAP pressure and EPAP pressure.
Electrical power is supplied to the unit using an AC line cord (100 – 240 VAC, 50/60Hz, 400 Hz). The AC input voltage is converted to a DC voltage by an internal switch-mode power supply. The DC voltage is used to power the internal electronics of the product (microcontroller, motor control circuitry, blower, LCD display, etc.). Positive pressure is produced by spinning a reverse-curved impeller with a brushless DC motor. Room air is drawn into the blower through a filter, pressurized in the blower, and then discharged through a 22 mm ID tube.
Statement of intended Use:
The DeVilbiss Model 9055 Bilevel CPAP is intended for use in treating OSA in spontaneously breathing adult patients by means of application of positive air pressure. The device is to be used in home and clinical environments.
Statement of Safety and Effectiveness:
The DeVilbiss Model 9055 Bilevel CPAP is equivalent in both function and indications for use to the DeVilbiss Model 7355 and Resmed Sullivan VPAP II Bilevel CPAP legally marketed predicate devices. Displays and constructional details are equivalent to the DeVilbiss Model 9001 CPAP.
The DeVilbiss Model 9055 Bilevel CPAP is designed for use on the order of a physician for the treatment of Obstructive Sleep Apnea. The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device.
The new dual pressure level CPAP is designed to provide rapid changes in air pressure between EPAP (expiratory positive airway pressure) and IPAP (inspiratory positive airway pressure). The method of making this pressure change and other characteristics of the Model 9055 Bilevel CPAP are substantially equivalent to other legally marketed devices.
Technological Characteristics:
The DeVilbiss Model 9055 Bilevel CPAP is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize a microprocessor controlled system to provide a range of dual pressures (IPAP and EPAP) for the treatment of Obstructive Sleep Apnea. All of the devices are tested and approved to recognized agency safety standards. No new technologies have been introduced in the Model 9055 Bilevel CPAP device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized symbol that resembles an abstract bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2004
Mr. Stephen F. Krepelkea Project Engineer Sunrise Medical 100 DeVilbiss Drive Somersrt, Pennsylvania 15501-2125
Re: K032056
Trade/Device Name: DeVilbiss Model 9055 Bilevel CPAP Regulation Number: 868-5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 5, 2004 Received: February 6, 2004
Dear Mr. Krepelka:
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 nay, 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 Eederal Register.
3
Page 2 - Ms. Falk
Please be advised that FDA's issuance of a substantial equivalence determination does not I Toast that FDA has made a determination that your device complies with other requirements moan that it 27 mas made a actes and regulations administered by other Federal agencies. of the Act of ally I oderal two Act's requirements, including, but not limited to: registration r ou inust comply with are research many (21 CFR Part 801); good manufacturing practice allo listing (21 CF R Part 067), absiting 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) I mis letter wifi and in Jo 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), If you desite special the Office of Compliance at (301) 594-4646. 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 obtain 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/dsma/dsmamain.html
Sincerely yours,
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): K032056
Device Name:
DeVilbiss Model 9055 Bilevel CPAP
Indications For Use:
The Model 9055 Bilevel CPAP is intended for use in treating obstructive sleep apnea in adult patients.
Vttach
(Sylision Sign-Off) (Owlsion Sign-Off)
Division of Anesthesiology, General Hospital, Division of Antool, Dental Devices
510(k) Number: K032056
Yes Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
No Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _ 1