(174 days)
No
The description focuses on microprocessor control, blower-based pressure generation, and detection of hypopneas, without mentioning AI or ML. The modifications described are related to humidifier interface and hypopnea detection, not AI/ML capabilities.
Yes
The Intended Use section explicitly states that the device "delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea." Therapy indicates a therapeutic device.
No
The device delivers positive airway pressure therapy for treatment; it does not diagnose the condition.
No
The device description explicitly states it is a "microprocessorcontrolled, blower-based system" and mentions a "patient circuit" and "patient interface (mask)," indicating it includes hardware components beyond just 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 deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. This is a therapeutic treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system that generates and delivers air pressure. It doesn't mention analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro analysis.
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 provide therapy, not to perform such analysis.
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
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 Respironics Model 7410 Voyager has been modified to detect hypopneas and to add an interface to adjust the settings of the Remstar Heated Humidifier. The design implementation of the humidifier and the humidifier interface is the same as the Remstar Plus CPAP System (K010263). The basic functional and performance characteristic of the REMstar Auto CPAP System is unchanged from the predicate device (Model 7410 Voyager K974879).
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 because of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Model 7410 Voyager (K974879), Respironics Remstar Plus CPAP System/Remstar Heated Humidifier (K010263), Respironics Virtuoso LX CPAP System (K993433)
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
17
| Official Contact
JAN 2 9 2002 | David J. Vanella
Manager, Regulatory Affairs/Product Assurance
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668
K012554 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| 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) | Model 7410 Voyager (K974879) |
| | Respironics Remstar Plus CPAP System/Remstar Heated Humidifier
(K010263) |
| | Respironics Virtuoso LX CPAP System (K993433) |
| Reason for submission | Modified design, additional accessories. |
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- Same intended use. 0
- D Same operating principle.
- Same technology.
- O Same manufacturing process.
Design verification tests were performed on the REMstar Auto CPAP System because 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.
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 Respironics Model 7410 Voyager has been modified to detect hypopneas and to add an interface to adjust the settings of the Remstar Heated Humidifier. The design implementation of the humidifier and the humidifier interface is the same as the Remstar Plus CPAP System (K010263). The basic functional and performance characteristic of the REMstar Auto CPAP System is unchanged from the predicate device (Model 7410 Voyager K974879).
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2002
Mr. David J. Vanella Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668
Re: K012554
Respironics® REMstar Auto CPAP System Regulation Number: 868.5905 Regulation Name: Non-continuous Ventilator Regulatory Class: Class II (two) Product Code: BZD Dated: January 2, 2002 Received: January 3, 2002
Dear Mr. Vanella:
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.
3
Page 2 - Mr. David J. Vanella
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a astad regulations administered by other Federal agencies. You must or any I catal statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 607); accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by some (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) I mis lotter will and in your e FDA finding of substantial equivalence of your device to a legally premails in the modicate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 011 594-4646. Additionally, for questions on the promotion and advertising of Compination at (301) 591-461 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general 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,
Qo. V. Tille
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): KOLZ554
Device Name: Respironics® REMstar Auto CPAP System
Intended UseAndications 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use | ||||
---|---|---|---|---|
(Per 21 CFR 801.109) |
OR
Concurrence of CDRH, Office of Device Evaluation (ODE) |
---|
-------------------------------------------------------- |
Over-The-Counter Use |
---|
(Optional Format 1-2-96) |
Division of Cardiovascular & Respiratory Devices
510(k) Number K012559