(47 days)
Not Found
No
The document describes a microprocessor-controlled CPAP system with added modes and flags, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The modifications appear to be functional enhancements rather than the integration of AI/ML algorithms.
Yes
The device is described as delivering "positive airway pressure therapy for the treatment of Obstructive Sleep Apnea," which is a therapeutic function.
No
The device is described as a CPAP system for delivering positive airway pressure therapy for Obstructive Sleep Apnea. While it mentions an "NRAH flag for clinical use," its primary function is therapy delivery, not diagnosis. The "Split-Night with Auto-CPAP mode" is to simplify studies, not to perform a diagnosis.
No
The device description explicitly states it is a "microprocessorcontrolled, blower-based system" and generates positive airway pressures, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. This is a therapeutic device, not a diagnostic one that analyzes samples from the human body.
- Device Description: The description focuses on generating and delivering air pressure, connecting to a patient circuit and mask, and includes features related to sleep study modes and flagging events. It does not mention any analysis of biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is entirely external to the body, delivering air pressure.
Therefore, the REMstar Auto CPAP System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The REMstar Auto Continuous Positive Airway Pressure (CPAP) System is a microprocessorcontrolled, blower-based system that generates positive airway pressures from 4 to 20 cmH₂O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The previously cleared REMstar Auto has been modified to include a Split-Night with Auto-CPAP mode to simplify spilt night studies and to add a Non Responsive Apnea Hypopnea (NRAH) flag for clinical use. The basic functional and performance characteristics of the REMstar Auto CPAP System is unchanged from its device predicate (REMstar Auto CPAP System K012554).
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
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 REMstar Auto CPAP System in accordance with 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 devices.
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 Auto CPAP System (K012554), Respironics Virtuoso LX Smart CPAP System (K993433)
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
TAB 3
510(K) SUMMARY OF SAFETY & EFFECTIVENESS
| Official Contact | Zita A. Yurko
Manager, Regulatory Affairs
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 | K031460 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------|---------|
| Classification Reference | 21 CFR 868.5905 | |
| Product Code | BZD - Non-Continuous ventilator | |
| Common/Usual Name | CPAP System | |
| Proprietary Name | Respironics REMstar Auto CPAP System | |
| Predicate Device(s) | Respironics REMstar Auto CPAP System (K012554) | |
| | Respironics Virtuoso LX Smart CPAP System (K993433) | |
| Reason for submission | Modified design, additional accessories. | |
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate devices:
- 0 Same intended use.
- D Same operating principle.
- O Same technology.
- O Same manufacturing process.
Design verification tests were performed on the REMstar Auto CPAP System in accordance with 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 devices.
1
The modified device complies with the applicable standards referenced in the Guidance for FDA Reviewers and Industry "Guidance for the Content of premarket Submissions for Software Contained in Medical Devices", May 1998.
Intended Use
The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. This device is intended for use in the home or hospital/institutional environment on adult patients.
Device Description
The REMstar Auto Continuous Positive Airway Pressure (CPAP) System is a microprocessorcontrolled, blower-based system that generates positive airway pressures from 4 to 20 cmH₂O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The previously cleared REMstar Auto has been modified to include a Split-Night with Auto-CPAP mode to simplify spilt night studies and to add a Non Responsive Apnea Hypopnea (NRAH) flag for clinical use. The basic functional and performance characteristics of the REMstar Auto CPAP System is unchanged from its device predicate (REMstar Auto CPAP System K012554).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2003
Ms. Zita A. Yurko Manager, Regulatory Affairs Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K031460
Trade/Device Name: REMstar Auto CPAP System Regulation Number: 868.5905 Regulation Name: Non-Continuous Ventilator Regulatory Class: II Product Code: BZD Dated: June 5, 2003 Received: June 6, 2003
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 such additional controls. Existing major regulations affecting vour 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.
3
Page 2 -- Ms. Zita A. Yurko
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 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 vours.
Susan Rann
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of__1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Respironics® REMstar Auto CPAP System
Intended Use/Indications for Use
The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.
Environment of Use/Patient Population
For use in the home or hospital/institutional environment on adult patients.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| -- | -------------------------------------------------------- | -- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
| (Division Sign-Off)
Division of Anesthesiology, General Hospital,
| Infection Control, Dental Devices | |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | -- |
| 510(k) Number: | K031460 |
|---|---|
| ---------------- | --------- |