K Number
K111055
Device Name
GALAXY SYSTEM; JUPITER
Date Cleared
2011-12-21

(250 days)

Product Code
Regulation Number
882.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
More Information

K100683, K04059

Not Found

No
The document explicitly states "The device does not provide any automatic scoring algorithms" and the software functionalities are described as recording, displaying, and providing tools for manual review and report generation. There is no mention of AI or ML in the description of the device's operation or capabilities.

No
The device is described as a polysomnographic system intended to acquire, record, display, print, and store physiological parameters for diagnostic review, not for providing therapy.

Yes

The provided text states that the device is intended "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." It also states the device is for documenting "sleep or other physiological disorders," and for "diagnostic review." This clearly indicates its use in diagnosing medical conditions by presenting physiological data for review and analysis by medical professionals.

No

The device description explicitly states that the "Galaxy System" includes both the "Jupiter amplifier" (hardware) and the "Galaxy software". It also lists other hardware components like the Headbox/Amplifiers, Ethernet Interface, Isolator, Connecting Wires, and Desktop Computer as part of the system. Therefore, it is not a software-only medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly states that the system is for acquiring, recording, displaying, printing, and storing physiological parameters to assist clinicians/physicians in diagnosing sleep or other physiological disorders. It focuses on measuring electrical and physical signals from the body.
  • Device Description: The device description details the acquisition and display of various biophysical parameters like EEG, EOG, EMG, ECG, respiratory effort, nasal flow, body position, snoring, and oximetry. These are all measurements taken directly from the patient's body.
  • Lack of In Vitro Testing: An IVD device is designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis. This device does not perform any such testing. It measures physiological signals in vivo (within the body).

The device is a polysomnographic system, which is a type of medical device used for sleep studies and the diagnosis of sleep disorders. These systems are classified differently than IVD devices.

N/A

Intended Use / Indications for Use

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.

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

Product codes (comma separated list FDA assigned to the subject device)

OLV

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. Channel characteristics of each of the two available amplifiers are as follows:

    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.
    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.
  • 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.

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 or infants

Intended User / Care Setting

Clinicians/physicians; hospitals, institutions, sleep centers, clinics or other test environments.

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

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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

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.

K100683, K04059

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

§ 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).

0

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

1

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. Channel characteristics of each of the two available amplifiers are as follows:
Model 1166Model 1142
AC Channels (e.g., EEG, EOG, EMG, nasal flow
pressure, body position, respiratory effort)6432
DC Channels (e.g., body position)08
Oximetry and Event button connectionYesYes
Total number of connectable electrodes/ sensors
used for data collection6642
Number of grounds2 (G1, G2 - for
"common
reference
and
ground"2 (G1, G2 - for
"common
reference
and
ground"

2

    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.

3

  • 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

4

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.

5

Substantial Equivalence Comparison Table

| Characteristics | Galaxy | Alice 5 | Neurolink IP Model
PK 1117 |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | K100683 |
| 510 (K) ID | K111055 | K040595 | K100683 |
| Device
Classification | II | II | II |
| Product Code | OLV | GWQ | GWQ |
| Classification
Panel | Neurology | Neurology | Neurology |
| Intended use | The Galaxy System(Software
and Jupiter Amplifier) 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 or 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: This device is to be
used under the supervision of
a physician. | The Alice 5 System is a
Polysomnographic System
that is intended to record,
display, and print
physiological parameters 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 adult or
infant patients require the
documentation of various
sleep or other physiological
disorders.
The device does not provide
alarms and is not intended for
use as an automated apnea
monitor.
This device is to be used
under the supervision of a
physician. | Neurolink IP model PK1117
is intended to be used as an
electroencephalograph to
acquire, digitize and
transmit
electroencephalographic
and other physiological
signals (such as pulse and
oximetry) for EEG in
research and clinical
environments.
This device is to be used
under the supervision of a
physician. |
| Note | Electrophysiological characteristics of the Jupiter Amplifier are technically the same to both
predicates.
The software functions of Galaxy are functionally equivalent to Alice5. | | |
| Warning | Do not use in conjunction
with a defibrillator and
stimulators.
Do not use in conjunction
with medical imaging devices | Not known | Do not use in conjunction
with a defibrillator and
stimulators.
Do not use in conjunction
with medical imaging
devices. |
| Contra
indications | This device does not provide
alarms and is not intended
for use as an automated
apnea monitor. The software
is not intended for use as a
life-support equipment like
vital signs monitoring | This device does not provide
alarms and is not intended
for use as an automated
apnea monitor. | The device is not intended
for use as a life support
equipment such as vital
signs monitoring in
intensive care units |
| Characteristics | Galaxy | Alice 5 | Neurolink IP Model
PK 1117 |
| 510 (K) ID | K111055 | K040595 | K100683 |
| Prescription use | Yes | Yes | Yes |
| Contact of device
with patient body | None | None | None |
| Environment | The device can be used in
hospitals, institutions, sleep
centers or other similar
environments where patients
require the documentation of
various sleep or other
physiological disorders. | 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. | Neurolink can be used in
hospital environment and
clinics. |
| Environmental
Conditions | Normal: +5 to +40°C, max
80% rH non-condensing,
700-1060hPa | Not known | Normal: +5 to +40°C, max
80% rH non-condensing,
700-1060hPa |
| Data input types | ECG, neurological, respiratory | ECG, neurological,
respiratory | Neurological, othe
physiological |
| No. of AC
Channels | 32 or 64 (neurological or
physiological) | 26 neurological, 10
physiological | 64 neurological |
| AD sample rate | 32,768 | 2000 | 32,768 |
| Output Sample
Rate | 1024 | 2000 | 1024 |
| Storage rate | 1024 | 200 | 1024 |
| Digital resolution | 16bits | 16bits | 16bits |
| Oximeter channel | Yes | Yes | Yes |
| No. of DC
Channels | 8 (for patient safe sensors
like body position) for 1142
model. | 12 | None |
| Connection to
patient | By means of sensors like EEG,
ECG, EMG electrodes to AC
inputs In addition, some of
the AC inputs are used to
connect to external patient
safe sensors like respiration | By means of sensors like
EEG, ECG, EMG electrodes to
AC inputs.
In addition, some of the AC
inputs are used to connect to
external patient safe sensors
like respiration. | By means of sensors like
EEG, electrodes to AC inputs. |
| Connections for
42 channel
amplifier | 32 AC connections for
EEG/EOG/EMG/ECG. Active
sensors can be connected to
AC channels
8 DC channels for other
physiological sensors
Oximeter
Event | 26AC channels for
EEG/EOG/EMG/ECG. Active
sensors can be connected to
AC channels
10 DC channels for other
physiological signals
Oximeter
Event | Not applicable
-no-
Oximeter
Event |
| Connections for
64 AC channel | 64 AC connections for
EEG/EOG/EMG/ECG. Active
sensors can be connected to
AC channels
NO DC channels
Oximeter | Not Applicable
Not Applicable
Oximeter | 64 AC connections for EEG
NO DC channels
Oximeter |
| List of | | | |
| Characteristics | Galaxy | Alice 5 | Neurolink IP Model |
| | | | PK 1117 |
| 510 (K) ID | K111055 | K040595 | K100683 |
| Main amplifier
unit | JUPITER: Separate Brainbox
EEG-1166 for 64channel AC,
oximetery and event
This can be used in
neurological disorders during
sleep. | None | Brainbox EEG1166 for 64
channel AC, oximetery and
event |
| Main amplifier
unit | Brainbox EEG1142 for 32
Channel AC and 8 Channel
DC, oximetery and event | Base Station | Not supported |
| Patient
connection box | 1142 or 1166 input box | Patient headbox | 1166 input box |
| Patient Isolation
unit | ISO101 | This function is in the Base
StationPC | ISO101 |
| Computer
interface | Ethernet 102 | This function is in the Base
station | Ethernet 102 |
| Power supply | AC-DC adapter | This function is in the Base
Station | AC-DC adapter |
| Oximeter | Oximeter Nonin | In Patient Headbox | Oximeter Nonin |
| Electrode Check : | Same as PK1117 | Yes | The impedance of the EEG
electrodes can be tested
under PC control. |
| Impedance Check
level : | Same as PK1117 | Yes, detailed specs not
known | The electrode impedance
check level can be selected
in 6 steps: 5 - 10 - 20 - 50 -
100 and 200 K-Ohm. ± 20%
accuracy. |
| Impedance check
signal : | Same as PK1117 | Yes, detailed specs not
known | Sine wave of approx. 128 Hz.
With a measuring current Used as advisory standard
for software development | ANSI/AAMI SW68: 2001
Medical Device Software -
Software Life Cycle
Processes | |

6

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:

7

8

9

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10

11

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

12

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

.

:

13

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:

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.

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) NumberK111055