BREATHEX OMEGA CPAP DEVICE, MODEL 322

K052597 · Hoffman Laboratories, LLC · BZD · Dec 16, 2005 · Anesthesiology

Device Facts

• Record ID: K052597
• Device Name: BREATHEX OMEGA CPAP DEVICE, MODEL 322
• Applicant: Hoffman Laboratories, LLC
• Product Code: BZD · Anesthesiology
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BreatheX Omega continuous positive airway pressure (CPAP) device is intended for use in the treatment of obstructive sleep apnea (OSA). The BreatheX Omega CPAP is used while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is by the delivery of Continuous Positive Airway Pressure (CPAP) at a specified pressure level in order to prevent airway obstruction. The BreatheX Omega CPAP is for use on adult patients weighing at least 30 kg, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep clinic. The BreatheX Omega is not intended for life support.

Device Story

BreatheX Omega CPAP provides continuous positive airway pressure to treat obstructive sleep apnea; device consists of motorized blower assembly, battery/charger, and therapy tubing; patient interface (mask) is separate accessory. Device operates by delivering mono-level positive air pressure to prevent airway obstruction; blower speed controlled by embedded software. Used in home or sleep clinic settings by adult patients; prescribed by physician. Output is continuous air pressure; healthcare provider uses device to maintain airway patency during sleep; benefits patient by preventing apnea events.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety, electromagnetic compatibility, shock/vibration, environmental testing, and static/dynamic pressure performance testing compared to predicate.

Technological Characteristics

Motorized blower system; battery-powered; mono-level CPAP delivery; no integrated humidification. Software-controlled blower speed. Tested for electrical safety, EMC, and environmental standards.

Indications for Use

Indicated for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg. Not for life support.

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

• HC200 CPAP (K973161)
• PillowPositive Cervical Pillow (K990871)

Submission Summary (Full Text)

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# DEC 16 2005

## Summary of Safety and Effectiveness in accordance with 21 CFR 807.92

Company Name: Hoffman Laboratories, LLC 9305 Eton Ave Chatsworth CA 91311

Contact: Keith Bosecker, President

Phone: [phone]

Fax: [phone]

Email: [e-mail]

Summary Date: November 30, 2005

Trade Name: BreatheX™ Omega™ CPAP Device

Common Name: CPAP Device

Common Classification/Name: Ventilator, non-continuous, non-life supporting

Product Code(s): 21 CFR 868.5905 BZD

Class: Class II

Predicate Device(s):

- 510K Number: K973161 .
- Manufacturer: Fisher & Paykel Healthcare ◆
- Trade Name: HC200 CPAP .
- 510K Number: K990871 .
- Manufacturer: LifeSleep Systems, Inc. ●
- Trade Name: PillowPositive Cervical Pillow .

Reason for Submission: New Device

#### Description of Device

The BreatheX provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. The device is battery operated.

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The BreatheX Omega is comprised of a motorized blower assembly that provides positive air pressure. The blower speed is directly related to air pressure, and is controlled by software.

The BreatheX Omega CPAP device consists of the following main components:

- CPAP blower .
- Battery/Battery charger .
- Therapy Tubing .

The patient interface (CPAP mask) is a commercially available accessory provided separately. The patient interface is not covered in this submission.

### Intended Use

The BreatheX Omega continuous positive airway pressure (CPAP) device is intended for use in the treatment of obstructive sleep apnea (OSA).

The BreatheX Omega CPAP is used while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is by the delivery of Continuous Positive Airway Pressure (CPAP) at a specified pressure level in order to prevent airway obstruction.

The BreatheX Omega CPAP is for use on adult patients weighing at least 30 kg, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep clinic.

The BreatheX Omega is not intended for life support.

### Indications for Use

The BreatheX Omega CPAP device is intended for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg.

The BreatheX Omega CPAP device provides continuous positive airway pressure.

Caution: Federal law restricts this device to sale by or on the order of a physician.

### Technology

The BreatheX Omega CPAP device utilizes similar technological characteristics as the predicate CPAP device. Both devices employ a computer controlled

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blower system which is attached via tubing to a nasal mask/exhaust port to deliver a specified mono-level CPAP treatment to a patient.

The BreatheX Omega utilizes a battery for the power source. The device does not provide integrated humidification.

# Non-Clinical Tests Submitted:

The device was tested in accordance with applicable standards for medical I no Clectrical Safety, Electromagnetic Compatibility, Shock and Vibration, and Environmental Temperature and Humidity. The BreatheX Omega CPAP device passed all of the tests.

Static and dynamic pressure testing was performed in comparison with the predicate device. The device met specified requirements and was comparable to the applicable specifications of the predicate device.

Embedded software in the device was verified to requirements and validated to meet intended use by software and system level performance testing.

## Clinical Tests Submitted: None

#### Conclusions

The function of the BreatheX Omega CPAP device is substantially equivalent to the predicate device(s). Laboratory, software, and standards compliance tests are provided to support the safety and performance of the BreatheX Omega.

As described above, all of the testing demonstrates that the Hoffman Laboratories BreatheX Omega CPAP device is as safe and effective and performs in a manner equivalent to the predicate device, the Fisher and Paykel HC200.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of three overlapping lines that resemble an abstract human figure.

Public Health Service

DEC 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Keith Bosecker President Hoffman Laboratories, LLC 9305 Eton Avenue Chatsworth, california 91311

Re: K052597

K032377
Trade/Device Name: Hoffman Laboratories BreatheX Omega CPAP Device Regulation Number: 868.5905 Regulation Name: Noncontinuous ventilator (IPPB Regulatory Class: II Product Code: BZD Dated: December 1, 2005 Received: December 5, 2005

Dear Mr. Bosecker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becases over is substantially equivalent (for the referenced above and have determinosure) to legally marketed predicate devices marketed in indications for use stated in the environment date of the Medical Device micrstate comments, or to devices that have been reclassified in accordance with the provisions of Alliendinents, of to devroes and have o Act (Act) that do not require approval of a premarket the Federal F00d, Drug, and Cosment Por (Pres) - market the device, subject to the general approval application (x Mr.). - FTa general controls provisions of the Act include controls provisions of the Piet. Into given station, listing of devices, good manufacturing practice, requirements for sibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (500 additional controls. Existing major rogulations affecting (PMA), it may of subject to such additions, Title 21, Parts 800 to 898. In your device can be found in the could nouncements concerning your device in the Federal Register.

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#### Page 2 - Mr. Bosecker

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 mean that I DA mas made a actess and regulations administered by other Federal agencies. of the Act of ally I oderal statues and squirements, including, but not limited to: registration 1 ou must comply with and no Hood ong (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pur 807), labeling systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality systems (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 begin mained of substantial equivalence of your device to a premits of notification. - The PD : Insults 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 at not to your at [phone]. 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 other general miorinational and Consumer Assistance at its toll-free Division of Binastic or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carl, 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

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## Indications for Use

#### 510(k) Number (if known):

Hoffman Laboratories BreatheX™ Omega™ CPAP Device Device Name:

#### Indications for use:

The BreatheX Omega CPAP device is intended for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg.

The BreatheX Omega CPAP device provides continuous positive airway pressure.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Alan Juhom

K082597

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