(95 days)
No
The description mentions a "microprocessor controlled blower based positive pressure system" and "enhanced event detection and algorithm response," but there is no mention of AI, ML, or related terms. The focus is on hardware control and algorithmic adjustments for comfort and event detection, which are typical for traditional medical devices.
Yes
Explanation: The device delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea, indicating a therapeutic purpose.
No
The device is a CPAP system used for therapy (treatment) of Obstructive Sleep Apnea, not for diagnosing it.
No
The device description explicitly states it is a "microprocessor controlled blower based positive pressure system with integrated heated humidifier," indicating it is a hardware device with software control, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Respironics REMstar M-Series Auto with AFLEX CPAP System is a therapeutic device that delivers positive airway pressure to treat Obstructive Sleep Apnea. It works by physically assisting breathing, not by analyzing biological samples.
- Intended Use: The intended use clearly states it's for "delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea." This is a therapeutic function, not a diagnostic one.
The device description and intended use focus on the mechanical delivery of air pressure and comfort features, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Respironics REMstar M-Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Respironics REMstar M-Series Auto with AFLEX CPAP System is a microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar M-Series Auto with AFLEX System also includes the auto mode and the flex therapy feature cleared in K063830 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. In addition the device includes an AFLEX therapy feature which provides added comfort for the user. As stated in the submission, the purpose of this modification is to provide enhanced event detection and algorithm response to these new event types. Like its predicate, this device 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, an exhalation device, 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
patients weighing over 30kg.
Intended User / Care Setting
For use 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 M-Series Auto with AFLEX 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Respironics REMstar AFLEX CPAP System (K063830)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/2 description: The image shows the title "TAB 3" and "510(K) SUMMARY OF SAFETY & EFFECTIVENESS". There is also a handwritten annotation that appears to be a tracking or identification number. The image is a close-up shot of the text, with a slightly blurred background.
| Official Contact | Zita A. Yurko
Director, Regulatory Affairs
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668
Zita.yurko@respironics.com
724-387-4120 t
724-882-4120 c
724-387-4216 f |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - - ventilator, non-continuous (respirator) |
| Common/Usual Name | CPAP System |
| Proprietary Name | Respironics REMstar M-Series Auto with AFLEX CPAP System |
| Predicate Device(s) | Respironics REMstar AFLEX CPAP System (K063830) |
| Reason for submission | modified device |
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- ロ Same intended use.
- Same operating principle. ට
- D Same technology.
- Same manufacturing process.
Design verification tests were performed on the Respironics REMstar M-Series Auto with AFLEX 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
1
the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.
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 2006.
Intended Use
The Respironics REMstar M-Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.
Device Description
The Respironics REMstar M-Series Auto with AFLEX CPAP System is a microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar M-Series Auto with AFLEX System also includes the auto mode and the flex therapy feature cleared in K063830 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. In addition the device includes an AFLEX therapy feature which provides added comfort for the user. As stated in the submission, the purpose of this modification is to provide enhanced event detection and algorithm response to these new event types. Like its predicate, this device 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, an exhalation device, and a patient interface device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract human figure.
Public Health Service
MAY - 8 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Zita A. Yurko Director, Regulatory Affairs Respironics Incorporated, Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K090243
Trade/Device Name: Respironics REMstar M-Series Auto with AFLEX CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 9, 2009 Received: April 10, 2009
Dear Ms. Yurko:
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 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 vour device in the Federal Register.
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Page 2 Ms. Yurko
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Ronder.
Susan Runner, D.D.S., MA Acting 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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510(k) Number (if known): _
Device Name: Respironics REMstar M-Series Auto with AFLEX CPAP System
Intended Use/Indications for Use
The Respironics REMstar M-Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg.
Environment of Use/Patient Population
For use in the home or hospital/institutional environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription UseXXXXX (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Susan Rosen
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090243