(135 days)
Not Found
No
The document describes a standard CPAP device with no mention of AI or ML capabilities. The device provides a constant pressure, which is a traditional CPAP function, not an adaptive or learning one.
Yes
The device is used to support treatment of a medical condition (Obstructive Sleep Apnea) by providing continuous positive airway pressure.
No
Explanation: The device, the aura CPAP System, is described as providing continuous positive airway pressure (CPAP) to support the treatment of Obstructive Sleep Apnea. It delivers a constant pressure to keep the airway open. There is no mention of the device being used to identify, diagnose, or monitor a disease or condition; its function is therapeutic.
No
The device description explicitly lists hardware components such as a CPAP Blower, Optional Humidifier, Optional Battery Pack, and Patient Interface, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide continuous positive airway pressure (CPAP) to support the treatment of Obstructive Sleep Apnea. This is a therapeutic intervention, not a diagnostic test performed on in vitro samples.
- Device Description: The description details a system that delivers pressurized air to the nasal airway. This is a physical therapy device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely mechanical/pneumatic.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The aura CPAP System does not perform any such analysis.
N/A
Intended Use / Indications for Use
The aura CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30kg) with Obstructive Sleep Apnea.
Product codes
BZD
Device Description
The aura CPAP System provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. During obstructive sleep apnea, the airway collapses. When interfaced with a CPAP Mask or CPAP Patient Interface the aura CPAP System provides a constant pressure of 4 to 20 cmH2O above the ambient atmospheric pressure to patient's nasal airway. This constant pressure supports retaining an open airway during sleep. The aura CPAP System is initially used under the direct supervision of a trained medical professional. The aura CPAP System function and applications may be reviewed in a clinical setting when the patient is treated for obstructive sleep apnea by the application of CPAP therapy.
The aura CPAP System has four significant components:
-
- CPAP Blower,
-
- Optional Humidifier,
-
- Optional Battery Pack, and
-
- Patient Interface.
The Patient Interface or CPAP Mask is a commercially available accessory provided to the user separately. The Patient Interface or CPAP Mask is not addressed in this submission.
- Patient Interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
adults (over 30kg)
Intended User / Care Setting
trained medical professional / clinical setting
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)
Laboratory and standards compliance were provided to support the aura CPAP System performance.
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
Image /page/0/Picture/0 description: The image shows the logo for AEIOMed. The logo is in black and white and features a stylized font. There is a curved line above the letters that adds a dynamic element to the design.
MAR 3 - 2005
1313 5" St. SE Suite 205 Minneapolis, MN 55414 Ph: 612-455-0550 Fax: 612-455-0551
Summary of Safety and Effectiveness
Company Name: AEIOMed, Inc. 1313 5th Street SE, Suite 205 Minneapolis, MN 55414
Dave Markovich, Senior Director of Operations Contact:
(612) 455-0550 Phone:
Fax: (612) 455-0551
Summary Date: January 26, 2005
aura CPAP System Trade Name:
Common Name: CPAP Device
Classification Name: 21 CFR 868.5905, Non-Continuous (Respirator) Ventilator
Predicate Devices:
| 510(k) Number: | K030985 |
|---|---|
| Manufacture: | Vital Signs, Inc. |
| Trade Name: | BREAS PV10 CPAP System |
| 510(k) Number: | K010263 |
| Manufacture: | Respironics, Inc. |
| Trade Name: | REMstar Plus CPAP System |
1.0 Description of Device
The aura CPAP System provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. During obstructive sleep apnea, the airway collapses. When interfaced with a CPAP Mask or CPAP Patient Interface the aura CPAP System provides a constant pressure of 4 to 20 cmH2O above the ambient atmospheric pressure to patient's nasal airway. This constant pressure supports retaining an open airway during sleep.
1
The aura CPAP System is initially used under the direct supervision of a trained medical professional. The aura CPAP System function and applications may be reviewed in a clinical setting when the patient is treated for obstructive sleep apnea by the application of CPAP therapy.
Intended Use 2.0
The aura CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30kg) with Obstructive Sleep Apnea.
3.0 Technology
The aura CPAP System has four significant components:
-
- CPAP Blower,
-
- Optional Humidifier,
-
- Optional Battery Pack, and
-
- Patient Interface.
The Patient Interface or CPAP Mask is a commercially available accessory provided to the user separately. The Patient Interface or CPAP Mask is not addressed in this submission.
4.0 Conclusions
The aura CPAP System is substantially equivalent to the predicate devices. Laboratory and standards compliance were provided to support the aura CPAP System performance. No new questions of safety or effectiveness are raised.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three wavy lines extending from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 - 2005
AEIOMed, Incorporated C/O Mr. Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K042945
Trade/Device Name: CPAP System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: January 28, 2005 Received: January 31, 2005
Dear Mr. Syring:
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 cither 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 Federal Register.
3
Page 2 - Mr. Syring
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 (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) 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 (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 Division 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/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
4
Indications for Use
510(k) Number (if known): _K042945
Device Name: aura CPAP System
Indications for Use:
.
The aura CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30kg) with Obstructive Sleep Apnea.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
inii in itti ﺎ ﺗﺄﻟﻴﻔﺎ ﺃﻳﻀﺎ ﺃﻳﺎﺭ ﺍﻟﻤﺮﺍﺟﻊ ﺃﻳﺎﺭ ﺍﻟﻤﺮﺍﺟﻊ ﺃﻭ ﺍﻟﻤﺮﺍﺟﻊ - - - - - - - - - - - - - - - - - - - - - -- Beneral Hospital, on Course Unitial De aces
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