(86 days)
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.
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.
The BreatheX provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. The device is battery operated.
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.
The provided document is a 510(k) summary for the BreatheX™ Omega™ CPAP Device. It does not contain information about a study proving the device meets specific acceptance criteria in the context of a clinical performance study using human subjects or AI algorithms. Instead, it describes non-clinical tests conducted to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes non-clinical tests rather than specific clinical acceptance criteria or performance metrics directly comparable to a predicate device in a tabulated format. The acceptance criteria were implicit in "meeting specified requirements" and being "comparable to the applicable specifications of the predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with medical electrical safety standards | Device passed all applicable standards for medical electrical safety. |
| Compliance with electromagnetic compatibility standards | Device passed all applicable standards for electromagnetic compatibility. |
| Compliance with shock and vibration standards | Device passed all applicable standards for shock and vibration. |
| Compliance with environmental temperature and humidity standards | Device passed all applicable standards for environmental temperature and humidity. |
| Static and dynamic pressure performance | Device met specified requirements and was comparable to the applicable specifications of the predicate device (Fisher & Paykel HC200). |
| Software verification to requirements | Embedded software was verified to requirements. |
| Software validation to meet intended use | Embedded software was validated to meet intended use by software and system level performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable to this 510(k) submission. The non-clinical tests described were laboratory-based, focusing on engineering and software validation. There is no mention of a "test set" of patient data in the context of an AI/medical device study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for the non-clinical tests would be the accepted engineering standards and the specifications of the predicate device. Expert human review of data for diagnostic accuracy, as would be relevant for AI, is not mentioned.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states "Clinical Tests Submitted: None."
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The device described is a physical CPAP device, not an AI algorithm. The software mentioned is embedded control software for the device's function, not a diagnostic or interpretive algorithm.
7. Type of Ground Truth Used
The ground truth used for the non-clinical tests was based on:
- Applicable engineering and medical device standards (e.g., for safety, EMC).
- The specifications and performance of the predicate device (Fisher & Paykel HC200) for static and dynamic pressure testing.
- Software requirements and intended use for software validation.
8. Sample Size for the Training Set
Not applicable. The document describes a physical CPAP device and its embedded control software, not an AI model requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there was no AI model or training set, there was no establishment of ground truth for a training set.
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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: 818-341 4131
Fax: 818-341 4135
Email: keith_bosecker@hoffmanlaboratories.com
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 (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 obtain other general miorinational and Consumer Assistance at its toll-free Division of Binastic or (301) 443-6597 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
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§ 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).