(121 days)
Not Found
No
The device description explicitly states that the Alice PDx's role is "only to record the data" and that it is "not in any way involved in the data management performed by the host." The analysis and reporting are done by separate software. There are no mentions of AI, DNN, or ML in the document.
No
The device is a physiological data recorder used for collecting and storing data for diagnosis, not for providing therapy.
No
The device collects and records physiological data but explicitly states that its role is "only to record the data" and it is "not in any way involved in the data management performed by the host," meaning it does not analyze or interpret the data itself to provide a diagnosis. The data is analyzed by separate clinical software.
No
The device description explicitly states that the Alice PDx is a "wearable data recorder" that "collects and stores physiological signals," indicating it is a hardware device. While it interacts with software for analysis, the core device itself is hardware.
Based on the provided information, the Alice PDx is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Alice PDx Function: The Alice PDx is described as a physiological data recorder that collects and records physiological signals directly from the patient's body (EEG, EOG, airflow, etc.). It does not process or analyze specimens taken from the body.
- Intended Use: The intended use is for collecting and recording data for use by clinical software in polysomnography and sleep disorder studies. This is focused on monitoring and recording bodily functions, not analyzing biological samples.
Therefore, the Alice PDx falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Alice PDx is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician. It is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.
Product codes
MNR
Device Description
The Alice PDx is a wearable data recorder that collects and stores physiological signals. The role of the Alice PDx is only to record the data. The following physiological signals may be collected and stored by the Alice PDx device:
- EEG, EOG, EMG, ECG
- Nasal/oral Airflow
- Snore
- Thoracic and Abdominal Effort
- Body Position
- Pulse Oximetry, including:
- Oxygen Saturation (SpO2) ...
- Pulse Rate
- Plethysmograph
The recorded data is stored on a secure digital (SD) card and may be passed on to a PC for analysis and reporting of the data by the Respironics Sleepware Software application. The Alice PDx data recorder is not in any way involved in the data management performed by the host.
- Oxygen Saturation (SpO2) ...
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
adults
Intended User / Care Setting
physician / supervised (hospital) or unsupervised (home) 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 vertification tests were performed on the Alice PDx as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respirences 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.
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
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
K09048y
Premarket Notification - Traditional 510(k)
JUN 26 2009
SUMMITATS 三二(C) 第二十四十 - 高清
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 724-387-7490 f
Classification Reference
Product Code
Common/Usual Name
Proprietary Name
Predicate Device(s)
Reason for submission
21 CFR 868.2375 MNR - Ventilatory Effort Recorder
Ventilatory Effort Recorder
Alice PDx
Respironics Galaxy (K083874)
Modified device
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- Same intended use.
- Same operating principle.
- Same technology.
- Same manufacturing process.
Design vertification tests were performed on the Alice PDx as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respirences 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 Pre-market Submissions for Software Contained in Medical Devices," May 2005.
Intended Use
The Alice PDx is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician. It is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.
Device Description
The Alice PDx is a wearable data recorder that collects and stores physiological signals. The role of the Alice PDx is only to record the data. The following physiological signals may be collected and stored by the Alice PDx device:
- EEG, EOG, EMG, ECG
- Nasal/oral Airflow
- Snore
- Thoracic and Abdominal Effort
- Body Position
- Pulse Oximetry, including:
- Oxygen Saturation (SpO2) ...
- Pulse Rate
- Plethysmograph ਼ਾ
- Oxygen Saturation (SpO2) ...
The recorded data is stored on a secure digital (SD) card and may be passed on to a PC for analysis and reporting of the data by the Respironics Sleepware Software application. The Alice PDx data recorder is not in any way involved in the data management performed by the host.
(End of Tab.)
2
020017
ATT 2:
510(k) Summary of Safety & Effectiveness
Alice PDx
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the caduceus symbol. The logo is black and white.
Public Health Service
JUN 26 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Zita A. Yurko Director, Regulatory Affairs Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K090484
Trade/Device Name: Respironics Alice PDx Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: May18, 2009 Received: May19, 2009
Dear Mr. 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 your device in the Federal Register.
4
Page 2 - Mr. 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 vours.
Susan Pinas
Susan Pinas, DDS, MS
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K090484
Device Name: Respironics Alice PDx
Intended Use/Indications for Use
The Alice PDx is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician. It is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.
Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (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)
L Schutter
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K 09048 510(k) Number:
1999001