The Galaxy is a physiological data recorder intended to collect and record data from multiple physiological channels. It is intended for use by or on the order of a physician. The Galaxy is intended for use in a supervised (hospital) or unsupervised (home) environment.

Device Description

The Galaxy is a wearable data recorder that collects and stores physiological signals. The role of the Galaxy is only to record the data. The following physiological signals may be collected and stored by the Galaxy 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 a cleared host software application. The Galaxy data recorder is not in any way involved in the data management performed by the host.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Respironics Galaxy device:

Based on the provided text, the device in question, the Respironics Galaxy Ventilatory Effort Recorder, is a data recorder. As such, the "acceptance criteria" and "device performance" in this context refer to its functionality in collecting and recording physiological signals, rather than diagnostic accuracy or direct clinical outcomes. The study mentioned is primarily focused on verification testing to demonstrate that the device functions as intended and meets safety standards, rather than a clinical trial in the traditional sense for diagnostic or treatment efficacy.

Here's a breakdown of the requested information based on the document:

Table of Acceptance Criteria and Reported Device Performance

The document mentions that "All tests met the required acceptance criteria," but it does not explicitly list specific quantitative acceptance criteria or detailed performance metrics for each physiological channel. Instead, it focuses on the device's functional equivalence to a predicate device and adherence to safety standards.

Since specific numerical acceptance criteria are not detailed for the recording accuracy of each physiological signal, the reported performance is general and refers to successful completion of verification tests.

Acceptance Criteria (Implied)	Reported Device Performance
Functionality verified through testing	All tests met the required acceptance criteria.
Safety assured by IEC 60601-1 and IEC 60601-1-2 testing	Completion of IEC 60601-1 and IEC 60601-1-2 testing.
Risk mitigation as per Risk Traceability Matrix	All hazards identified by the risk assessment are successfully mitigated.
Ability to collect and store various physiological signals	The device collects and stores specified physiological signals (EEG, EOG, EMG, ECG, Nasal/oral Airflow, Snore, Thoracic and Abdominal Effort, Body Position, Pulse Oximetry).
Data storage on SD card	Recorded data is stored on a secure digital (SD) card.
Compatibility with host software application for analysis	Data may be passed on to a PC for analysis and reporting by a cleared host software application.

Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in terms of patient data or clinical cases. The testing described is verification testing of the device's functionality and safety. Therefore, information about patient sample size, country of origin, or retrospective/prospective nature is not applicable here because it's not a clinical study that evaluates algorithm performance on patient data.

Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable. The device is a data recorder, not a diagnostic algorithm that produces interpretations requiring expert ground truth for its output. The "ground truth" in this context would be the actual physiological signals, and the device's performance would be assessed on its ability to accurately record these signals, not to interpret them. The document does not mention experts establishing ground truth for recorded data.

Adjudication Method for the Test Set

This question is not applicable, as there is no "test set" in the context of diagnostic performance involving human adjudication.

If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a physiological data recorder, not an AI-assisted diagnostic tool. An MRMC study is not relevant to its function.

If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. The device is hardware that records data. It is not an algorithm for diagnosis or interpretation that would have standalone performance.

The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This question is not applicable in the context of this device. The "ground truth" for a data recorder would be the actual physiological signals emitted by a patient or a signal generator, which the device aims to capture faithfully. The document does not specify how the fidelity of recorded signals was validated (e.g., comparison to a precise gold-standard measurement device), but it generally states that "functionality of the design of the device was verified through verification testing."

The sample size for the training set

This question is not applicable. This device is a physiological data recorder, not an AI/ML algorithm that requires a training set.

How the ground truth for the training set was established

This question is not applicable, as no training set is relevant to this device.

Summary

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TAB 5

K083874
page 1 of 4

JAN 2 6 2009

510(K) SUMMARY

Date of Submission

Official Contact

Image /page/0/Picture/5 description: The image shows the word "RESPIRONICS" in bold, black letters. Above the word, there are three curved lines that are also in black. The lines appear to be a stylized design element, possibly representing airflow or breathing.

19 November 2008 Manufacturing Facility Address Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 Andrew P. Zeltwanger Manager, Regulatory Affairs Respironics, Inc. 1740 Golden Mile Highway Monroeville, PA 15146 Phone: 724-387-7442 Fax: 724-387-7490 Andrew.Zeltwanger@Respironics.com

Proprietary Name Galaxy
Common/Usual Name Ventilatory Effort Recorder

Device Classification Name Ventilatory Effort Recorder

Classification Reference 21 CFR 868.2375

Classification

Product Code

Predicate Devices

Appropriate Classification Panel

MNR

EB Neuro, S.p.A. Sandman Pocket (K061996)

Class II

Anesthesiology

Reason for submission New device

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page 2 of 4

Galaxy

Substantial Equivalence

This premarket notification submission demonstrates that the Respironics, Inc. Galaxy data recorder is substantially equivalent to the EB Neuro, S.p.A. Sandman Pocket (K061996).

The functionality of the design of the device was verified through verification testing. All tests met the required acceptance criteria. The safety of the design was assured by the completion of IEC 60601-1 and IEC 60601-1-2 testing. The Risk Traceability Matrix provided in the Risk Assessment assured that all hazards identified by the risk assessment are successfully mitigated.

Intended Use

Device Description

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

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 a cleared host software application. The Galaxy data recorder is not in any way involved in the data management performed by the host.

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Galaxy
page 3 of 4

Technological Characteristics / Predicate Device Comparison

Like the Sandman Pocket predicate device, the Galaxy is intended to collect physiological signals from various points on the patient's body and to record those signals. Refer to Table 5-1 for a comparison of the Galaxy to the identified predicate device.

Characteristic	EB Neuro, S.p.A.Sandman Pocket(K061996)	RespironicsGalaxy Data Recorder
Intended Use	Intended for use in collecting andrecording physiological data to beused in polysomnography andsleep disorder studies. The deviceis intended for pediatric throughadult patient populations, and canbe used in either home or hospitalenvironments.The Sandman Pocket is notintended for use as life supportingequipment, such as a vital signmonitoring in an intensive careunit. The device does not producealarms and is not intended as anautomated apnea monitor.The Sandman Pocket is only to beused under the direction orsupervision of a physician,technologist or clinician.	The Galaxy is a physiological datarecorder intended to collect andrecord data from multiplephysiological channels. It isintended for use by or on the orderof a physician. The Galaxy isintended for use in a supervised(hospital) or unsupervised (home)environment.
Environment of Use	Home or Hospital	Same as K061996
FDA Device Class	Class II	Same as K061996
FDA Product Code	MNR	Same as K061996
FDA Device Type	Ventilatory Effort Recorder	Same as K061996
FDA Regulation Number	21 CFR 868.2375	Same as K061996
Simultaneous PatientRecording Capability	1 patient per unit	Same as K061996
Configuration	Wearable	Same as K061996
Portability	Portable	Same as K061996
Data Input Types	Respiratory, ECG, Neurological	Same as K061996
Maximum Number ofChannels	22	20
Characteristic	EB Neuro, S.p.A.Sandman Pocket(K061996)	RespironicsGalaxy Data Recorder
Channel Types Recorded	EEGEOGEMGECGRespiratory Efforts (abdominal andthoracic)AirflowSnoreBody PositionOxygen SaturationPulse RatePlethysmograph	Same as K061996
Pressure Therapy DeviceInput Channel	Stores data from Nellcor PuritanBennett pressure therapy devicesand can be used to transmit datastreams from the pressure therapydevice to a PC.	Stores data from Respironicspressure therapy devices.
Patient Event Marker(PEM)	Yes	Same as K061996
Sensors	FDA cleared sensors	FDA cleared sensors
Electrode ImpedanceCheck	Yes	No
Calibration Check	Yes	No
Memory	Recording stored on internalNAND flash chip	Recording stored on removablesecure digital (SD) Card
Amount of MemoryRequired for a Typical 8Hour Study	28 MB	230 MB
Power	Battery powered or USB powered	Battery powered
Data Transfer for Analysisand Report Generation	Data must be transferred. Dataanalysis and reporting is notperformed by the data recorder	Same as K061996

Table 5-1: Galaxy Data Recorder Comparison to Predicate Device

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Traditional 510(k) Tab 5 – 510(k) summary

(End of Tab.)

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Galax

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Respironics, Incorporated C/O Mr Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinors 60062

JAN 2 6 2009

Re K083874 Trade/Device Name Galaxy Regulation Number 21 CFR 868 2375 Regulation Name Breathing Frequency Monitor Regulatory Class II Product Code MNR Dated January 13, 2009 Received January 15, 2009

Dear Mr Devine

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

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Page 2 - Mr Devine

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), 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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the DIVISIOn of Surveillance Systems at 240-276-3464 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.

Anthony Oration for
Ginette Y Michaud, M D

Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Indications for Use

510(k) Number (if known):

Device Name: Galaxy

Indications for Use:

Prescription Use Over-The-Counter Use 1 resemption OSE
(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)

Signature

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083874

Page

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).