(344 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on standard CPAP technology components.
Yes
The device is intended to provide positive airway pressure therapy for the treatment of Obstructive Sleep Apnea, indicating a therapeutic purpose.
No
Explanation: The device, Invacare Polaris EX CPAP, is intended for treatment (positive airway pressure therapy for Obstructive Sleep Apnea), not diagnosis.
No
The device description explicitly lists hardware components such as a flow generator (blower), patient circuit, exhalation port, humidifier, microprocessor based control system, and pressure sensor.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Invacare Polaris EX CPAP provides positive airway pressure therapy directly to the patient's airway. It does not analyze any biological specimens.
- Intended Use: The intended use is to treat Obstructive Sleep Apnea (OSA) by providing air pressure, not by analyzing samples.
The information provided clearly describes a therapeutic device that interacts directly with the patient's respiratory system, not a diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The intended function and use of the Invacare Polaris EX CPAP is to provide positive airway pressure therapy to adult patients (>30kg.) for the treatment of Obstructive Sleep Apnea (OSA).
The intended use of the Invacare Polaris EX CPAP is to provide positive airway pressure therapy to adult patients (>30 kg) for treatment of Obstructive Sleep Apnea (OSA)
Product codes
BZD
Device Description
All units consist of a flow generator (blower), patient circuit, exhalation port, humidifier (if desired), microprocessor based control system, pressure sensor and operate on 120 volts AC, 60Hz.
The Invacare Polaris CPAP EX differs from the Invacare Polaris -CPAP in that it has a single stepper motor valve as part of the exhalation unloading feature
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
Not Found
Key Metrics
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
MAR 1 2 2004
510(k) SUMMARY OF SAFETY & EFFECTIVENESS Invacare Polaris EX CPAP
Submitter's Information:
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Contact Person:
Janice K. Brownlee Director of Regulatory Affairs and Quality Systems
Manufacturing Location/Establishment Registration Number Invacare Corporation 2101 E. Lake Mary Blvd. Sanford, Florida 32773 Establishment Registration Number: 1031452
Name of Device: Invacare Polaris EX CPAP
Common or Usual Name: CPAP
Classification Name: Ventilator, Non-continuous (Respirator)
Predicate Device(s): Respironics REMstar Pro with C-Flex CPAP System (K021861, 6/19/02). Invacare Polaris CPAP (K982242, 01/27/1999)
Intended Use
The intended function and use of the Invacare Polaris EX CPAP is to provide positive airway pressure therapy to adult patients (>30kg.) for the treatment of Obstructive Sleep Apnea (OSA).
Similarities/Differences with the predicate device(s):
Similarities:
- Intended use is the same. All units are intended to provide positive । airway pressure therapy to adult patients
- । The REMstar Pro and the Polaris EX CPAP both have exhalation unloading features
- All units use an impeller blower as the source of positive pressure ।
- All units consist of a flow generator (blower), patient circuit, । exhalation port, humidifier (if desired), microprocessor based control system, pressure sensor and operate on 120 volts AC, 60Hz
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Differences:
- The Invacare Polaris CPAP EX differs from the Invacare Polaris -CPAP in that it has a single stepper motor valve as part of the exhalation unloading feature
2
Image /page/2/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. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.
Public Health Service
MAR 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janice K. Brownlee Director Regulatory Affairs and Quality Systems Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125
Re: K031064
Trade/Device Name: Invacare Polaris EX CPAP Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: March 8, 2004 Received: March 9, 2004
Dear Ms. Brownlee:
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 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.
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
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Page 2 - Ms. Brownlec
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 your 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 (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 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/dsma/dsmamain.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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Indications for Use
510(k) Number (if known): K031064/S1
Device Name: Invacare Polaris EX CPAP
Indications for Use:
The intended use of the Invacare Polaris EX CPAP is to provide positive airway pressure therapy to adult patients (>30 kg) for treatment of Obstructive Sleep Apnea (OSA)
Signature
(Division Sigh-Off) (Livision Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_
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)
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