DEVILBISS AUTOADJUST, MODEL 9054 SERIES

K043282 · Sunrise Medical · BZD · Feb 11, 2005 · Anesthesiology

Device Facts

• Record ID: K043282
• Device Name: DEVILBISS AUTOADJUST, MODEL 9054 SERIES
• Applicant: Sunrise Medical
• Product Code: BZD · Anesthesiology
• Decision Date: Feb 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The DeVilbiss Model 9054 AutoAdjust CPAP is intended for use in treating OSA in spontaneously breathing patients 30 Kg and above by means of application of positive air pressure. The device is to be used in home and clinical environments.

Device Story

AC-powered blower provides CPAP therapy for obstructive sleep apnea (OSA). Device monitors patient air stream via pressure and flow transducers; microcontroller processes flow signals to detect respiratory events (apnea, hypopnea, snoring, exhale puffing). Algorithm adjusts motor speed to increase pressure upon event detection or decrease pressure at timed intervals. Used in home and clinical settings; operated by patients under physician order. Benefits include automatic pressure titration to patient needs, reducing discomfort associated with constant high-pressure CPAP. Output pressure delivered via 22 mm ID tube. System includes internal switch-mode power supply, brushless DC motor, and reverse-curved impeller.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on functional, technological, and design similarities to legally marketed predicate devices.

Technological Characteristics

Microprocessor-controlled blower; brushless DC motor with reverse-curved impeller; pressure and flow transducers; AC-powered (100-240 VAC) with internal switch-mode power supply; 22 mm ID tube interface; metal and plastic construction; LCD display. Operates via software-based pressure regulation algorithm.

Indications for Use

Indicated for treatment of obstructive sleep apnea in spontaneously breathing patients weighing 30 kg or more.

Regulatory Classification

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.

Predicate Devices

• DeVilbiss Model 7354 AutoAdjust CPAP with Remote Control Module (K950849)
• DeVilbiss Model 9055 Bilevel CPAP (K032056)
• Resmed AutoSet Spirit with Reslink (K024191)
• Resmed AutoSet T (K032480)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES --

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Public Health Service

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FEB 1 1 2005

villa MD 20050

-

Mr. Stephen F. Krepelka Project Engineer Sunrise Medical 100 DeVilbiss Drive Somerset, Pennsylvania 15501-2125

Re: K043282

Trade/Device Name: DeVilbiss Model 9054 RPM AutoAdjust CPAP Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Il Product Code: BZD Dated: January 18, 2005 Received: January 19, 2005

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 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.

If your device is classified (see above) into either class II (Special Controls) or class 111 (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 Federal Register

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### Page 2 -- Mr. Krepelka

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 (OS) 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 vour 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 [phone]. Also, please note the regulation cntitled. "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 [phone] or [phone] 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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Page 1 of 1

### Not get assigned KO43 282 510(k) Number: (if known): __

DeVilbiss Model 9054 RPM AutoAdjust CPAP Device Name:

Indications For Use:

The Model 9054 RPM AutoAdjust CPAP is intended for use in treating obstructive sleep apnea in patients 30 Kg and above.

> Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Chuu, Sdiem

. General Hospica

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Section 10.0 - 1

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K043282

510(k) Summary 11.0

# FEB 1 1 2005

Sunrise Medical HHG, Inc. Submitter's Name: Respiratory Products Division 100 DeVilbiss Drive Somerset PA 15501

- Contact Person: Stephen F. Krepelka Phone: [phone] Fax: [phone] Email: [e-mail]
November 22, 2004 Date Prepared:

AutoAdjust CPAP Device Name:

AutoAdjust CPAP with Remote Control Common or Usual Name: Module and Analog Breakout Box

2515872

DeVilbiss Model Number: Model 9054

Trade Proprietary Name:

Established Registration Number:

Classification Panel: Anesthesiology

FDA Classification: Class II

CFR Section: 868.5905 - Noncontinuous Ventilator (IPPB)

DeVilbiss AutoAdjust CPAP with Remote Control Module and Analog Breakout Box

Product Code: BZD

## Legally Marketed Predicate Devices:

| Device Name | 510(k) Notification |
|-----------------------------------------------------------------|---------------------|
| DeVilbiss Model 7354 AutoAdjust CPAP with Remote Control Module | K950849 |
| DeVilbiss Model 9055 Bilevel CPAP | K032056 |
| Resmed AutoSet Spirit with Reslink | K024191 |
| Resmed AutoSet T | K032480 |

Section 11.0 - 1

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### Description of Device:

The new DeVilbiss Mode! 9054 AutoAdjust CPAP is an AC powered blower designed to be used in providing CPAP therapy to the spontaneously breathing (>30kg) patient population with Obstructive Sleep Apnea. The benefit of autoadjusting technology is that it reacts to obstructive events, i.e. apnea, hyponnea. and snoring, by increasing and decreasing pressures as needed, rather than providing a constant level of continuous positive airway pressure. Auto-adjusting units are used over conventional CPAP units due to high pressures, positional or REM related sleep apnea and/or patient intolerance to continuous pressure. Pressure regulation is achieved by monitoring a pressure and flow transducer in the patient air stream. The net result of the compensation activities is a motor control signal that produces a pressure change that closely maintains the prescribed or required patient pressures during patient respiratory activities, environmental conditions, and moderate system leak conditions. The operating software monitors the flow transducer signal to detect fluctuations in the patient system flow, caused by patient inhalation and exhalation. The operating software in the device analyzes the patient flow signal during device operation in order to detect patient respiratory events such as apneas, hypopneas, mixed apneas, snoring, and exhale puffing. These respiratory events are defined by programmable settings. In AutoAdjust mode the pressure adjustment algorithm evaluates these respiratory events and makes pressure adjustments in response. The output pressure is increased when a series of events is detected. Events that cause a pressure increase are apneas, hypopneas and snoring. Events scored as mixed do not cause a pressure increase. The pressure is decreased on a regular timed interval.

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 9054 AutoAdjust CPAP is intended for use in treating OSA in spontaneously breathing patients 30 Kg and above 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 9054 AutoAdjust CPAP is equivalent in both function and indications for use to the DeVilbiss Model 7354 AutoAdjust CPAP, Resmed

11/22/2004

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Sullivan AutoSet Spirit with Reslink CPAP, and Resmed AutoSet T CPAP marketed predicate devices. Displays and constructional details are equivalent to the DeVilbiss Model 9055 with Remote Control and Analog Breakout Box CPAP.

The DeVilbiss Model 9054 AutoAdjust 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 auto adjusting CPAP is designed to provide automatic changes in air pressure by increasing or decreasing pressure regulation by monitoring a pressure and flow transducer in the patient air stream. The method of automatically adjusting this pressure change and other characteristics of the Model 9054 AutoAdjust CPAP are substantially equivalent to other legally marketed devices.

### Technological Characteristics:

The DeVilbiss Model 9054 AutoAdjust CPAP is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize a microprocessor controlled system to provide a mechanism for automatically requlating blower motor pressure for the treatment of Obstructive Sleep Apnea. All of the devices are tested and approved to recognized agency safety standards. No new technologies affecting safety or efficacy have been introduced in the Model 9054 AutoAdjust CPAP device.

Section 11.0 - 3