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

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.

AI/ML Overview

The provided document, a 510(k) Premarket Notification for the Respironics Alice PDx, states that "Design verification 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." However, it does not provide details about specific acceptance criteria or the results of these tests.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from the provided text.

Additionally, the document does not contain information regarding:

Sample size used for the test set or its data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human readers with/without AI assistance.
Whether a standalone (algorithm only) performance study was done.
The type of ground truth used (e.g., expert consensus, pathology, outcome data).
The sample size for the training set.
How ground truth for the training set was established.

The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Respironics Galaxy K083874) based on shared intended use, operating principle, technology, and manufacturing process. It confirms that the device records data for various physiological signals and is intended for use with clinical software for polysomnography and sleep disorder studies.

Summary

{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

Device Description

EEG, EOG, EMG, ECG
Nasal/oral Airflow
Snore
Thoracic and Abdominal Effort
Body Position
Pulse Oximetry, including:
- Oxygen Saturation (SpO2) ...
  - Pulse Rate
- Plethysmograph ਼ਾ

(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

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

Regulation Number and Section

§ 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).