The Galaxy System (which includes the Jupiter amplifier and Galaxy software) is intended for use as a polysomnographic system to acquire record, display, print and store physiological parameters to assist clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers, clinics or other test environments where adults or infants require the documentation of sleep or other physiological disorders. The Galaxy system does not provide alarms and is not intended for use as an automated apnea monitor.

Device Description

The Galaxy system (which includes the Jupiter and Galaxy software) is a Polysomnography System that is intended to acquire, record, display and print physiological information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adults or infant patients require the documentation of various sleep or other physiological disorders.

The system can record, monitor, store and transfer of up to 42 channels of biophysical parameters. Generally the device is capable of acquiring and displaying the following parameters:

EEG .
EOG (eye movement) ●
Chin EMG .
. Leg EMG (leg movement)
ECG (single channel) ●
. Chest respiratory effort
. Abdomen respiratory effort
. Nasal Flow Thermistor
. Nasal Flow Pressure
. Body position
. Snoring
Oximeter .
. Patient "Event" button

The components of the Galaxy system include:

Headbox/Amplifiers (i.e., "BrainBox EEG amplifier, "Touchproof connector box", "Jupiter 1. amplifier") – Galaxy can support two amplifier/headbox models, 1166 and 1142. Both models are electrically exactly the same, except for the differences between the number of channels.
Ethernet Interface
Isolator (ISO101)
Connecting Wires
Desktop Computer
Electrodes Third party electrodes and sensors such as surface electrodes compatible with 32 AC inputs by means of touch-proof connectors, "Nonin oximeter (XPOD3012)," and "respiratory effort sensors" can be used with the system, but these sensors are not provided with the device. Only sensors specifically tested and verified for use with the device should be used and are listed in the user's manual.
Galaxy Software The Galaxy software's main functionalities include the following:
- a. Record and display signals Collect and display PSG parameters. Plot acquired data on screen (within a time window of 30 seconds) and store on hard-disk of computer.
- b. Provide tools for Manual Review of Data Allow the user to review and manually analyze data, edit this analysis and delete the entered events if needed. Software also displays the user annotations along with the signal traces, as trend overview over the night and as a list, and allows the user to review the acquired data after the completion of the recording to examine and annotate afterwards (offline).
- c. Generate Patient Reports The software calculates summaries of the manually scored data and print them as tabulated reports and shows simple computer calculations like average value, rates etc ...

Galaxy also has the following additional functions:

changing the mode of the amplifier for calibration, impedance check or data acquisition .
sending commands to set sample rate of the digitization, to specify the recording montage . and to receive data from the Jupiter amplifier via Ethernet interface.

The device does not provide any automatic scoring algorithms.

AI/ML Overview

I am programmed to be an obedient and helpful AI assistant. I will do my best to fulfill your request.

The provided document describes a 510(k) premarket notification for the Galaxy System, a Polysomnography (PSG) System. The submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove specific performance metrics through a clinical study with acceptance criteria in the typical sense of algorithm performance. The device itself (Galaxy System) is a data acquisition and display system for physiological parameters, not an automated diagnostic algorithm. Thus, the "acceptance criteria" and "study" are focused on safety, effectiveness, and functional equivalence to existing legally marketed devices, rather than a clinical performance study with predefined statistical endpoints for an AI algorithm.

However, I will extract the information that aligns closest to your request, interpreting "acceptance criteria" as the comparable characteristics to predicate devices that demonstrate safety and effectiveness for its intended use, and "study" as the testing and verification performed to support these claims.

Here's a breakdown of the information based on your request, as much as can be gleaned from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Because this is a 510(k) submission for substantial equivalence of a polysomnograph system (not an AI algorithm with specific performance metrics like sensitivity/specificity), the "acceptance criteria" are interpreted as the functional and technical characteristics deemed equivalent to the predicate devices. The "reported device performance" is essentially the detailed specification of the Galaxy System, demonstrating its equivalence to the predicate devices.

Characteristic (Acceptance Criteria - implicitly from Predicate)	Galaxy System Reported Performance
Intended Use (Polysomnographic system to acquire, record, display, print, store physiological parameters for diagnostic review, for adults/infants, not for alarms/automated apnea monitor)	Meets this intended use.
Safety Standards Compliance (IEC 60601-1-1, IEC 60601-2-26, IEC 60601-1-2)	Compliance tested and verified.
Software Development Standard (ANSI/AAMI SW68: 2001)	Used as advisory standard for development and testing.
Hardware Equivalence (e.g., Amplifier type, connections, patient isolation, power supply)	Jupiter Amplifier (BrainBox EEG amplifier 1166/1142) is technically the same or functionally equivalent to Neurolink IP Model PK1117 and Alice 5 components. Specific parameters like AD sample rate, digital resolution, input bias current, input noise, input impedance, max input signal, sensitivity, filters are listed as "Same as PK1117" or specific values.
Software Functions (Record/display signals, manual data review, generate patient reports, amplifier control, specific event marking/calculations)	Functionally equivalent to Alice 5 software. Supports detailed manual review and patient reports. Provides calculations like average, count, index, max/min value, total duration.
Data Input Types (ECG, neurological, respiratory, oximeter)	Supports these data input types.
Number of AC Channels (32 or 64)	Offers 32 or 64 AC channels.
Number of DC Channels (8 for 1142 model)	Offers 8 DC channels for 1142 model.
Output Sample Rate (1024 / 2000)	1024
Storage Rate (1024 / 200)	1024
Digital Resolution (16 bits)	16 bits

2. Sample Size Used for the Test Set and the Data Provenance

The document does not describe a clinical study with a "test set" of patient data for evaluating an algorithm's performance. The testing mentioned in the document is primarily hardware and software verification and validation, safety testing, and compliance with standards.

Test Set Sample Size: Not applicable in the context of an algorithm's performance on patient data.
Data Provenance: Not applicable. The device itself records physiological data; it does not process pre-existing data or make interpretations. The testing involved "work-bench by developers, in the factory by developers and in the field by sleep-technicians and researchers." This suggests functional testing, not a clinical trial on a specific dataset.

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

This is not applicable. The device does not involve an AI algorithm that requires expert-established ground truth on a test set. It's a data acquisition and display system. Clinicians/physicians use the displayed parameters for "diagnostic review," but the device itself does not provide automated diagnoses or interpretations that would require ground truth for validation.

4. Adjudication Method for the Test Set

This is not applicable, as there is no test set in the sense of a dataset requiring expert adjudication for algorithm performance evaluation.

5. 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 such study was done or is mentioned. The Galaxy System "does not provide any automatic scoring algorithms" and "does not provide alarms and is not intended for use as an automated apnea monitor." Therefore, there is no AI component for human readers to interact with or improve upon.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

No. The device "does not provide any automatic scoring algorithms." Its function is to "acquire, record, display, print and store physiological parameters to assist clinicians/physicians."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not applicable. As highlighted, this device is a data acquisition and display system, not an AI diagnostic tool. Its validation focuses on accurate signal acquisition, display, and compliance with safety and electrical standards.

8. The Sample Size for the Training Set

Not applicable. The document describes a traditional medical device (polysomnograph system) that acquires and displays physiological data. It is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI algorithm.

Summary of Device Nature and 510(k) Context:

This 510(k) submission is for a Polysomnography (PSG) System, which is a device designed to collect, display, and store physiological signals for manual review by clinicians. It explicitly states it does not contain automatic scoring algorithms, alarms, or automated apnea monitoring. The "testing" described is focused on:

Hardware verification and validation: Ensuring the amplifier, interfaces, and other physical components function correctly and meet specifications.
Software verification and validation: Ensuring the software accurately records, displays, stores, and allows for manual review and reporting of data.
Safety and EMC compliance: Adhering to relevant IEC and EN standards for medical electrical equipment.
Substantial Equivalence: Demonstrating that its technological characteristics and intended use are similar to legally marketed predicate devices (Natus Neurolink IP Model PK1117 and Alice 5 by Respironics), thereby establishing its safety and effectiveness without requiring a new clinical performance study for an AI component.

Therefore, the types of "acceptance criteria" and "studies" you are asking about, which are typical for AI/ML-based diagnostic devices, are not relevant or present in this specific 510(k) document because the device does not incorporate AI or automated diagnostic functions.

Summary

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K111055

510(k) Summary

Submitter

DEC 2 1 2011

Personal Health Institute (PHI) international Rijswijkstraat 141e 1062 ES Amsterdam The Netherlands

Phone: 011 31 646104625 011 31 207071538 Fax:

Registration Number:

Will apply

Contact person

Anand Kumar

Preparation Date

December 21, 2011

Device

Trade Name:

Galaxy System

Classification Name: Standard polysomnograph with electroencephalograph Regulation Number: 882.1400 Product Code: OLV Class II Device Class: Classification Panel: Neurology

Predicate Devices

Neurolink IP Model PK1117 by Natus Medical Product code: GWQ 510(k) number: K100683

Alice 5 by Respironics Product code :GWQ 510(k) number: K04059

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Device Description

The system can record, monitor, store and transfer of up to 42 channels of biophysical parameters. Generally the device is capable of acquiring and displaying the following parameters:

EEG .
EOG (eye movement) ●
Chin EMG .
. Leg EMG (leg movement)
ECG (single channel) ●
. Chest respiratory effort
. Abdomen respiratory effort
. Nasal Flow Thermistor
. Nasal Flow Pressure
. Body position
. Snoring
Oximeter .
. Patient "Event" button

The components of the Galaxy system include:

Headbox/Amplifiers (i.e., "BrainBox EEG amplifier, "Touchproof connector box", "Jupiter 1. amplifier") – Galaxy can support two amplifier/headbox models, 1166 and 1142. Both models are electrically exactly the same, except for the differences between the number of channels. Channel characteristics of each of the two available amplifiers are as follows:

	Model 1166	Model 1142
AC Channels (e.g., EEG, EOG, EMG, nasal flowpressure, body position, respiratory effort)	64	32
DC Channels (e.g., body position)	0	8
Oximetry and Event button connection	Yes	Yes
Total number of connectable electrodes/ sensorsused for data collection	66	42
Number of grounds	2 (G1, G2 - for"commonreferenceandground"	2 (G1, G2 - for"commonreferenceandground"

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1. Ethernet Interface connects the power supply and IP connections with the amplifiers (through the "Isolator") for converting serial data of the amplifier to the Ethernet data of the PC.
Isolator (ISO101) Isolates the AC power and Ethernet signals for patient safety. 3.
Connecting Wires the amplifiers and isolator are connected with a "BrainBus" serial 4. interface; the Isolator and Ethernet Interface are connected with a "BrainNet Connector".
Desktop Computer Receives the EEG data through the Ethernet and TCP/IP connection from 5. the "Amplifier" and then stores and displays it to the user. It also serves as the user interface for the device (receiving and implementing commands from the user).
1. Electrodes Third party electrodes and sensors such as surface electrodes compatible with 32 AC inputs by means of touch-proof connectors, "Nonin oximeter (XPOD3012)," and "respiratory effort sensors" can be used with the system, but these sensors are not provided with the device. Only sensors specifically tested and verified for use with the device should be used and are listed in the user's manual.

The interconnections of the components of the Amplifier are shown below:

Image /page/2/Figure/6 description: The image shows a setup of EEG equipment. There is an isolator labeled ISO-101, and a main amplifier labeled EEG 1142 or PSG 1142. There is also an input box labeled INBOX-1142 A. Cables connect the devices, including an Ethernet cable connected to a PC and a cable connecting to Isolator ISO-101.

Figure 1: Jupiter Hardware Set-up

All the connections and functions are exactly similar to the predicate device Natus Neurolink IP 1117. The Galaxy software does not support the control of the flash unit and the digital I/O.

1. Galaxy Software The Galaxy software's main functionalities include the following:
- a. Record and display signals Collect and display PSG parameters. Plot acquired data on screen (within a time window of 30 seconds) and store on hard-disk of computer.

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b. Provide tools for Manual Review of Data Allow the user to review and manually analyze data, edit this analysis and delete the entered events if needed. Software also displays the user annotations along with the signal traces, as trend overview over the night and as a list, and allows the user to review the acquired data after the completion of the recording to examine and annotate afterwards (offline).
c. Generate Patient Reports The software calculates summaries of the manually scored data and print them as tabulated reports and shows simple computer calculations like average value, rates etc ...

Galaxy also has the following additional functions:

changing the mode of the amplifier for calibration, impedance check or data acquisition .
sending commands to set sample rate of the digitization, to specify the recording montage . and to receive data from the Jupiter amplifier via Ethernet interface.

Image /page/3/Figure/5 description: The image shows a polysomnography (PSG) report, which is a sleep study. The report is divided into several panes, including a label pane, a signal pane, a trend pane, an event pane, and a hypnogram. The signal pane displays various physiological signals, such as EKG, SaO2, and EEG. The hypnogram shows the different sleep stages throughout the night, and the event pane lists various events that occurred during the sleep study, such as desaturations and arousals.

A screen shot below shows the features of Galaxy.

Figure 2: Sample Galaxy Software output screen

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The device does not provide any automatic scoring algorithms.

Intended Use

The Galaxy System (which includes the Jupiter and Galaxy software) is intended for use as a polysomnographic system to acquire record, display, print and store physiological parameters to assist clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers, clinics or other test environments where adults or infants require the documentation of sleep or other physiological disorders. The Galaxy system does not provide alarms and is not intended for use as an automated apnea monitor.

Caution: Federal law restricts this device to sale by or on the order of a Physician.

Technological Characteristics

The comparison table is provided as a summary of the technological characteristics relative to the predicate devices. The items like Intended use, principle of operation, are compared. The summary of this comparison table demonstrates that the Galaxy System has no significant differences from the predicate devices that would adversely affect product safety and effectiveness.

Testing

The Galaxy System has been tested and verified in various phases, internal testing, verification and validation as well as external testing and validation. The device passed verification and validation testing that includes tests for amplifier voltages and functioning, flash memory, pulse width specifications, impedance testing, channel outputs with and without input signals, noise, electrode grounding, and oximeter interface functionality.

The design was verified throughout the design process. Risk analysis was done, appropriate measures were implemented and their effectiveness verified. The external test house DARE was used to confirm compliance to EMC requirements.

Safety Tests have been performed to verify compliance with IEC 60601-1-1 and IEC 60601-2-26 to ensure that there are no potential hazards on patients, other persons, or the surroundings. Electromagnetic Compatibility tests according to IEC 60601-1-2 have been performed to ensure no intolerable magnetic disturbances are introduced into its electromagnetic environment. Immunity tests to IEC 60601-1-2 have been performed to ensure that the EEG equipment has the ability to operate satisfactorily in its electromagnetic environment.

The Galaxy system was tested for displaying and printing of signals and scoring. These tests were performed at the work-bench by developers, in the factory by developers and in the field by sleep-technicians and researchers. The standard ANSI/AAMI SW68: 2001 Medical Device Software - Software Life Cycle Processes was used as advisory standard for the development and testing of all software functions.

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Substantial Equivalence Comparison Table

Characteristics	Galaxy	Alice 5	Neurolink IP ModelPK 1117
			K100683
510 (K) ID	K111055	K040595	K100683
DeviceClassification	II	II	II
Product Code	OLV	GWQ	GWQ
ClassificationPanel	Neurology	Neurology	Neurology
Intended use	The Galaxy System(Softwareand Jupiter Amplifier) isintended for use as apolysomnographic system toacquire record, display; printand store physiologicalparameters to assistclinicians/physicians. Theseparameters are presentedgraphically on a computerscreen for diagnostic review,similar in application to theuse of a traditional paperbased polygraph recorder.The device will be used inhospitals, institutions, sleepcenters or clinics or other testenvironments where adultsor infants require thedocumentation of sleep orother physiological disorders.The Galaxy system does notprovide alarms and is notintended for use as anautomated apnea monitor.Caution: This device is to beused under the supervision ofa physician.	The Alice 5 System is aPolysomnographic Systemthat is intended to record,display, and printphysiological parameters toclinicians/physicians. Theseparameters are presentedgraphically on a computerscreen for diagnostic review,similar in application to theuse of a traditional paperbased polygraph recorder. Thedevice will be used inhospitals, institutions, sleepcenters or clinics, or other testenvironments where adult orinfant patients require thedocumentation of varioussleep or other physiologicaldisorders.The device does not providealarms and is not intended foruse as an automated apneamonitor.This device is to be usedunder the supervision of aphysician.	Neurolink IP model PK1117is intended to be used as anelectroencephalograph toacquire, digitize andtransmitelectroencephalographicand other physiologicalsignals (such as pulse andoximetry) for EEG inresearch and clinicalenvironments.This device is to be usedunder the supervision of aphysician.
Note	Electrophysiological characteristics of the Jupiter Amplifier are technically the same to bothpredicates.The software functions of Galaxy are functionally equivalent to Alice5.
Warning	Do not use in conjunctionwith a defibrillator andstimulators.Do not use in conjunctionwith medical imaging devices	Not known	Do not use in conjunctionwith a defibrillator andstimulators.Do not use in conjunctionwith medical imagingdevices.
Contraindications	This device does not providealarms and is not intendedfor use as an automatedapnea monitor. The softwareis not intended for use as alife-support equipment likevital signs monitoring	This device does not providealarms and is not intendedfor use as an automatedapnea monitor.	The device is not intendedfor use as a life supportequipment such as vitalsigns monitoring inintensive care units
Characteristics	Galaxy	Alice 5	Neurolink IP ModelPK 1117
510 (K) ID	K111055	K040595	K100683
Prescription use	Yes	Yes	Yes
Contact of devicewith patient body	None	None	None
Environment	The device can be used inhospitals, institutions, sleepcenters or other similarenvironments where patientsrequire the documentation ofvarious sleep or otherphysiological disorders.	The device will be used inhospitals, institutions, sleepcenters or clinics, or othertest environments whereadults or infant patientsrequire the documentationof various sleep or otherphysiological disorders.	Neurolink can be used inhospital environment andclinics.
EnvironmentalConditions	Normal: +5 to +40°C, max80% rH non-condensing,700-1060hPa	Not known	Normal: +5 to +40°C, max80% rH non-condensing,700-1060hPa
Data input types	ECG, neurological, respiratory	ECG, neurological,respiratory	Neurological, othephysiological
No. of ACChannels	32 or 64 (neurological orphysiological)	26 neurological, 10physiological	64 neurological
AD sample rate	32,768	2000	32,768
Output SampleRate	1024	2000	1024
Storage rate	1024	200	1024
Digital resolution	16bits	16bits	16bits
Oximeter channel	Yes	Yes	Yes
No. of DCChannels	8 (for patient safe sensorslike body position) for 1142model.	12	None
Connection topatient	By means of sensors like EEG,ECG, EMG electrodes to ACinputs In addition, some ofthe AC inputs are used toconnect to external patientsafe sensors like respiration	By means of sensors likeEEG, ECG, EMG electrodes toAC inputs.In addition, some of the ACinputs are used to connect toexternal patient safe sensorslike respiration.	By means of sensors likeEEG, electrodes to AC inputs.
Connections for42 channelamplifier	32 AC connections forEEG/EOG/EMG/ECG. Activesensors can be connected toAC channels8 DC channels for otherphysiological sensorsOximeterEvent	26AC channels forEEG/EOG/EMG/ECG. Activesensors can be connected toAC channels10 DC channels for otherphysiological signalsOximeterEvent	Not applicable-no-OximeterEvent
Connections for64 AC channel	64 AC connections forEEG/EOG/EMG/ECG. Activesensors can be connected toAC channelsNO DC channelsOximeter	Not ApplicableNot ApplicableOximeter	64 AC connections for EEGNO DC channelsOximeter
List of
Characteristics	Galaxy	Alice 5	Neurolink IP Model
			PK 1117
510 (K) ID	K111055	K040595	K100683
Main amplifierunit	JUPITER: Separate BrainboxEEG-1166 for 64channel AC,oximetery and eventThis can be used inneurological disorders duringsleep.	None	Brainbox EEG1166 for 64channel AC, oximetery andevent
Main amplifierunit	Brainbox EEG1142 for 32Channel AC and 8 ChannelDC, oximetery and event	Base Station	Not supported
Patientconnection box	1142 or 1166 input box	Patient headbox	1166 input box
Patient Isolationunit	ISO101	This function is in the BaseStationPC	ISO101
Computerinterface	Ethernet 102	This function is in the Basestation	Ethernet 102
Power supply	AC-DC adapter	This function is in the BaseStation	AC-DC adapter
Oximeter	Oximeter Nonin	In Patient Headbox	Oximeter Nonin
Electrode Check :	Same as PK1117	Yes	The impedance of the EEGelectrodes can be testedunder PC control.
Impedance Checklevel :	Same as PK1117	Yes, detailed specs notknown	The electrode impedancecheck level can be selectedin 6 steps: 5 - 10 - 20 - 50 -100 and 200 K-Ohm. ± 20%accuracy.
Impedance checksignal :	Same as PK1117	Yes, detailed specs notknown	Sine wave of approx. 128 Hz.With a measuring current <4 µA pk/pk.Duty cycle perelectrode is 1/64.
Calibration	Variable freq. square wave,Calibration voltage and freq.under software control	1 Hz, 98mV square wave	Variable freq. square wave,Calibration voltage and freq.under software control
Input Bias Current	Same as PK1117	Detailed specs not knownbut satisfy the usualrequirements	Less than 0.001 $µ$ A (1 nA).
Input Noise EEGAmps :	Same as PK1117	Detailed specs not knownbut satisfy the usualrequirements	Less than 1 $µ$ V rms. at abandwidth of 1 - 70 Hz
Input ImpedanceEEG Amps :	Same as PK1117	1.66	10 Meg-Ohm ± 10 %
Max. input signalEEG Amps :	Same as PK1117	±3.3mV	10 mV pk/pk forundistorted output.
Sensitivity EEGAmps :	Same as PK1117	Detailed specs not knownbut satisfy the usualrequirements	The sensitivity of the EEGamplifier is: 11.73 mV forfull scale of 16 bits, resultingin 65536 levels. One LSBstep corresponds to approx.0.17895 $µ$ V
Max. DC offset ofelectrodes :	Same as PK1117	Detailed specs not knownbut satisfy the usualrequirements	+ or -300 mV DC. At 300 mVDC, max. undistorted inputis 8.4 mV pk/pk.
Characteristics	Galaxy	Alice 5	Neurolink IP ModelPK 1117
510 (K) ID	K111055	K040595	K100683
Accuracy of EEGsensitivity :	Same as PK1117	Detailed specs not knownbut satisfy the usualrequirements	Overall max. ± 3% error.The software in the PCshould run a calibrationcycle to correct the totalsensitivity error.
Common moderejection ratio	Same as PK1117	not known	120dB
Bandwidth	Same as PK1117	0.32 Hz to 106Hz	0.15Hz-1500Hz. Effectivefilter bandwidth depends onthe sample rate chosen toavoid Nyquist aliasingproblem
High pass filterAC/EEG Amps :	Same as PK1117	Detailed specs not knownbut satisfy the usualrequirements	Fixed time constant of 1second. (min.0.78 sec./max.1.2 sec.)
Low pass filterAC/EEG Amps :	Same as PK1117	Detailed specs not knownbut satisfy the usualrequirements	1500 Hz. ± 15% (-3dB). Thefilter is 2nd order (-12dB/octave).
Nyquist Filtertype :	Same as PK1117	Detailed specs not knownbut satisfy the usualrequirements	Multisection decimating FIRequiripple with linear phasecharacteristic.
Nr. of sections :	Same as PK1117		3
Decimation ratio :	Same as PK1117		32
Passbandfrequency :	Same as PK1117		1/3 of the output samplerate.
Stopbandfrequency :	Same as PK1117		1/2 of the output samplerate.
Ripple in passband:	Same as PK1117		0.01 dB
Attenuation at 1/2Sample Rate :	Same as PK1117		Better than 40 dB.
DC channelssample rate	1024		Not supplied
Input ImpedanceDC Amps	1 MΩ ± 10 %		Not supported
Low pass filter DCAmps :	70 Hz. ± 15% (-3dB). Thefilter is 1st order (-6dB/octave).		Not supported
Amplifier Option	1142 or 1166	None	4 Brainbox EEG1166 tomeasure 256 AC channel
Input Connection	Separate Inbox	Patient interface box	Separate Inbox-
Signal Calibration	Done by software, dependson the recording functions	Done by software - dependson recording functions	Done by software - dependson recording functions
Electrodeimpedance check	Yes	Yes	Yes
MultipleElectrodeconnection cable	Yes (optional)	No	Yes (optional)
Patient Isolation	BrainBox Isolation box ISO101	Yes in Base station	BrainBox Isolation box ISO101
Power Supply	External AC power withpatient Isolation	Integrated in Base Station	External AC power withpatient Isolation
Characteristics	Galaxy	Alice 5	Neurolink IP Model
			PK 1117
510 (K) ID	K111055	K040595	K100683
PC connectioncable	CAT5	CAT5	CAT5
Number ofPatientsmonitoredsimultaneously	One per PC	One per PC	Not known
Portable design	Yes	Yes	Yes
Record signals	Yes	Yes	Yes
Monitoring	Yes	Yes	Yes
Display	Yes	Yes	Yes
Print	Yes	Yes	Yes
Capable of Datatransfer foranalysis andreport generation	Yes	Yes	Yes
Computerconfiguration	Desktop or laptop computer	Desktop	Not defined, probablydesktop
Operating system	Windows7 or Windows Vista	Windows	Not defined, probablyWindows
Number ofsimultaneouspatients	One per unit.	One per unit	One per unit
Data Analysis	Optional (Always present, butclinician may choose to use)Note only the analysis of userscored events and stages isprovided	Optional(Always present,but clinician may choose touse)	Not applicable, AmplifierOnly .
Events marked and annotated by user
	Sleep Stage	Yes	Not applicable, AmplifierOnly
	Apnea	Yes	Not applicable, AmplifierOnly
	Arousal	Yes	Not applicable, AmplifierOnly
	Leg movements	Yes	Not applicable, AmplifierOnly
	Desaturations	Yes	Not applicable, AmplifierOnly
	Cardiac events	Yes	Not applicable, AmplifierOnly
	Body Positions	Yes	Not applicable, AmplifierOnly
	Nap Start Stop	Yes	Not applicable, AmplifierOnly
	Sleep Onset, End of sleep	Yes	Not applicable, AmplifierOnly
	Lights On off	Yes	Not applicable, AmplifierOnly
	CPAP level	Yes	Not applicable, AmplifierOnly
	User annotations	Yes	Not applicable, AmplifierOnly
Characteristics	Galaxy	Alice 5	Neurolink IP ModelPK 1117
510 (K) ID	K111055	K040595	K100683
	Recording comments	Yes	Not applicable, AmplifierOnly
Calculations done by the software and reported
	Average value	Yes	Not applicable, AmplifierOnly
	Count (total number)	Yes	Not applicable, AmplifierOnly
	Index (number of events perhour sleep)	Yes	Not applicable, AmplifierOnly
	Maximum value	Yes	Not applicable, AmplifierOnly
	Minimum value	Yes	Not applicable, AmplifierOnly
	Total duration of the events	Yes	Not applicable, AmplifierOnly
	Total duration of the eventsdivided by time range	Yes	Not applicable, AmplifierOnly
	Standard deviation of themean duration of the events	Yes	Not applicable, AmplifierOnly
	Latency to the occurrence ofan event or a stage	Yes	Not applicable, AmplifierOnly
Report	Optional (Always present, butclinician may choose to use)	Optional (Always present,but clinician may choose touse)	Not applicable, AmplifierOnly
Data file format	EDF, or Galaxy Standard	Alice Standard or EDF	Not applicable, AmplifierOnly
Annotation onstudy	Yes	Yes	Not applicable, AmplifierOnly
Study modes	Recording, monitoring,retrieval and display	Recording, long termmonitoring, retrieval anddisplay	Not applicable, AmplifierOnly
Digital Video	Yes (optional)	Yes (optional)	Not applicable, AmplifierOnly
Optionalequipment	Printer, multiple displays	Printer	Not applicable, AmplifierOnly
Support multipledisplays	Yes	Not defined	Not applicable, AmplifierOnly
Patientprotection	Type of protection againstelectric shock: Class IIDegree of protection againstelectric shock: No appliedpartEquipment not suitable foruse in the presence of aflammable anesthetic mixturewith air or with oxygen ornitrous oxide.		Type of protection againstelectric shock: Class IIDegree of protection againstelectric shock: No appliedpartEquipment not suitable foruse in the presence of aflammable unaestheticmixture with air or withoxygen or nitrous oxide.
Standards	Medical Electrical Equipmentpart 1: General requirementsfor Safety adopted IEC 601-12ed (90)	IEC 60601-1: 1988 + Al: 1991 + A2: 1995, MedicalElectrical Equipment - Part1: GeneralRequirements for Safety	Medical ElectricalEquipment part 1: Generalrequirements for Safetyadopted IEC 601-1 2ed (90)
Characteristics	Galaxy	Alice 5	Neurolink IP ModelPK 1117
510 (K) ID	K111055	K040595	K100683
	Medical Electrical Equipmentpart 1-1: Generalrequirements for Safety -Collateral Standard SafetyRequirements for MedicalElectrical Systems adoptedIEC 60601-1 2ed. (01)	IEC 60601-1-2: 2001Medical ElectricalEquipment Part 1-2:Collateral Standard:ElectromagneticCompatibility-Requirements and tests	Medical ElectricalEquipment part 1-1: Generalrequirements for Safety -Collateral Standard SafetyRequirements for MedicalElectrical Systems adoptedIEC 60601-1 2ed. (01)
	EN60601-2:26:2003Particular requirements forthe safety ofelectroencephalographs	IEC 60601-2-26: 2002Medical ElectricalEquipment - Part 2-26:Particular requirements forthe safety ofelectroencephalographs.	EN60601-2:26:2003Particular requirements forthe safety ofelectroencephalographs
	ANSI/AAMI SW68: 2001Medical Device Software -Software Life Cycle Processes.Used as advisory standardfor software development	ANSI/AAMI SW68: 2001Medical Device Software -Software Life CycleProcesses

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Substantial Equivalence Conclusion:

A thorough comparison between the Galaxy System and the predicate devices is shown in a tabular form (see above table). All the characteristics that affect the safety and effectiveness of the polysomnographic system are compared and presented in a clear format. The hardware of the Galaxy System (Jupiter amplifier) is identical to that of the Neurolink IP by Natus Medical. Both of them are manufactured by Braintronics and hence are same in safety and effectiveness. They were tested for safety by CSA and TUV. All the third party sensors that are recommended to be used in the Galaxy System have prior 510(k) approval from FDA. Calibration check, electrode impedance check are done and tested. The specifications meet the requirements of the Draft FDA guidance for 510(k) content for Electroencephalograph Devices.

The predicate Neurolink IP is not only equivalent to Jupiter amplifier but it is also exactly the same hardware, except that Jupiter also supports a 42 channel version. The main differences are 32 AC(EEG/EOG/EMG, ECG etc.) channels in the 42 channel version instead of 64 AC channels. The 42 channel version also has 8 DC channels that are not available in the predicate device.

The Galaxy software resides on a PC just like the Alice 5 and has the same indications for use and characteristics. The functions of the Galaxy software are the software of the predicate device, Neurolink IP uses similar software to collect, store and visualize signals. These functions are generic for all three devices.

From the comparison table and the discussion, it can be seen that the Galaxy System is the same in safety and effectiveness as the predicate devices.

Conclusion

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The test results demonstrate that the Galaxy system meets its objective of being reliable, safe and effective for its intended use.

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Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Personal Health Institute International c/o Mr. Kumar Kulkarni USA Contact RTS, Inc. 263 Cedar Creek Drive Battle Creek, MI 49015

Re: K111055

Trade/Device Name: Galaxy System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV Dated: November 30, 2011 Received: December 7, 2011

Dear Mr. Kulkarni:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

DEC 2 1 2011

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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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Debra Falls

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Personal Health Institute international Applicant:

510(k) Number (if known): K111055

Device Name: Galaxy System

Indications For Use:

Caution: Federal law restricts this device to sale by or on the order of a Physician.

YES Prescription Use 801 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use NO__ (Part 21 CFR

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Optional Format 3-10-98)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

John Grimes
510(k) Number	K111055

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).