(15 days)
No
The description mentions a "microprocessor controlled blower based continuous positive pressure system" and a "therapy feature to provide pressure relief during exhalation," but there is no mention of AI, ML, or related concepts. The performance studies are described as "design verification tests," which are typical for non-AI/ML devices.
Yes
The device is described as providing CPAP therapy for the treatment of adult Obstructive Sleep Apnea (OSA).
No
The device is described as a CPAP system intended for the treatment of Obstructive Sleep Apnea, not for diagnosis. Its function is to provide continuous positive airway pressure.
No
The device description explicitly states it is a "microprocessor controlled blower based continuous positive pressure system," indicating it is a hardware device with software control, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide CPAP for the treatment of adult Obstructive Sleep Apnea (OSA). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a blower-based system that provides positive pressure. This is consistent with a therapeutic device for respiratory support.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver air pressure to treat a condition, which falls under the category of a therapeutic medical device.
N/A
Intended Use / Indications for Use
The REMstar Auto with C-Flex CPAP System is intended to provide CPAP (Continuous Positive Airway Pressure) for the treatment of adult Obstructive Sleep Apnea (OSA) only. The REMstar Auto with C-Flex may be used in the home or hospital/institutional environment.
The REMstar Auto with C-Flex CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only. The device is for use in the home or hospital/institutional environment.
Product codes
BZD
Device Description
The Respironics REMstar Auto with C-Flex CPAP System is a microprocessor controlled blower based continuous positive pressure system. Respironics is adding an additional therapy feature to provide pressure relief during exhalation. The REMstar Auto with C-Flex CPAP System provides CPAP or Auto CPAP therapy with or without the C-Flex function and is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases, and a patient interface device.
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
Intended User / Care Setting
used in the home or hospital/institutional environment.
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)
Design verification tests were performed on the Respironics REMstar Auto with C-Flex CPAP System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Respironics REMstar Auto CPAP System (K012554/K031460), Respironics REMstar Pro with C-Flex CPAP System (K021861)
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
MAY - 5 2004
| Date | April 19, 2004 |
|---|---|
| Official Contact | Zita A. Yurko |
| Manager, Regulatory Affairs | |
| Respironics, Inc. | |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| Phone: 724-387-4120 | |
| Fax: 724-387-4216 | |
| Email: Zita. Yurko@Respironics.com | |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD – Non-Continuous ventilator |
| Common/Usual Name | CPAP System |
| Proprietary Name | Respironics REMstar Auto with C-Flex CPAP System |
| Predicate Device(s) | Respironics REMstar Auto CPAP System (K012554/K031460) |
| Respironics REMstar Pro with C-Flex CPAP System (K021861) | |
| Reason for submission | Modified design, enhanced mode. |
· ·· ··· ·····
:
:
1
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate devices:
- Same intended use.
- D Same operating principle.
- O Same technology.
- D Same manufacturing process.
Design verification tests were performed on the Respironics REMstar Auto with C-Flex CPAP System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate device.
The modified device complies with the applicable standards referenced in the Guidance for FDA Reviewers and Industry "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices", May 1998.
Intended Use
The REMstar Auto with C-Flex CPAP System is intended to provide CPAP (Continuous Positive Airway Pressure) for the treatment of adult Obstructive Sleep Apnea (OSA) only. The REMstar Auto with C-Flex may be used in the home or hospital/institutional environment.
Device Description
The Respironics REMstar Auto with C-Flex CPAP System is a microprocessor controlled blower based continuous positive pressure system. Respironics is adding an additional therapy feature to provide pressure relief during exhalation. The REMstar Auto with C-Flex CPAP System provides CPAP or Auto CPAP therapy with or without the C-Flex function and is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases, and a patient interface device.
(End of Tab.)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY = 5 2004
Ms. Zita Yurko Regulatory Affairs Manager Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, PA 15668
Re: K041010
Trade Name: REMstar Auto with C-Flex CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: April 19, 2004 Received: April 20, 2004
Dear Ms. Yurko:
We have reviewed your Section 510(k) promarket 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 gencral 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 complics 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
3
Page 2 -- Ms. Zita A. Yurko
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 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,
CluR
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): סוסום
Device Name:
Indications for Use:
The REMstar Auto with C-Flex CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only. The device is for use in the home or hospital/institutional environment.
Prescription Usc 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
Aurse
(Division Division r thesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K04070