Who is the manufacturer of GALAXY SYSTEM; JUPITER?

Personal Health Institute International filed the 510(k) submission for GALAXY SYSTEM; JUPITER (K111055).

What is the FDA product code for GALAXY SYSTEM; JUPITER?

OLV. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for GALAXY SYSTEM; JUPITER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GALAXY SYSTEM; JUPITER?

Neurolink IP Model PK1117 (K100683); Alice 5 (K040595).

Who can help prepare an FDA 510(k) submission like GALAXY SYSTEM; JUPITER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GALAXY SYSTEM; JUPITER

K111055 · Personal Health Institute International · OLV · Dec 21, 2011 · Neurology

Device Facts

Record ID	K111055
Device Name	GALAXY SYSTEM; JUPITER
Applicant	Personal Health Institute International
Product Code	OLV · Neurology
Decision Date	Dec 21, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	Pediatric

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.

Device Story

Galaxy System is a polysomnography device for acquiring, recording, displaying, and storing physiological parameters (EEG, EOG, EMG, ECG, respiratory effort, nasal flow, body position, snoring, oximetry). System comprises Jupiter headbox/amplifiers (models 1166/1142), ISO101 isolator, and PC-based Galaxy software. Input signals are digitized and transmitted via Ethernet to a PC. Software provides manual review, annotation, and report generation tools for clinicians. Used in hospitals, sleep centers, and clinics by physicians/technicians. Device does not provide automated scoring, alarms, or apnea monitoring. Output is graphical display of physiological traces for diagnostic review, aiding clinical decision-making for sleep disorders.

Clinical Evidence

Bench testing only. Verification and validation included amplifier functionality, impedance testing, noise, grounding, and oximeter interface. Software verified per ANSI/AAMI SW68:2001. EMC and safety testing performed per IEC 60601 series.

Technological Characteristics

Polysomnography system; 32 or 64 AC channels; 8 DC channels (model 1142). Connectivity: Ethernet/TCP/IP to PC. Power: AC-DC adapter with ISO101 patient isolation. Digital resolution: 16-bit. Sampling: 32,768 Hz (AD), 1024 Hz (output/storage). Standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-26, ANSI/AAMI SW68:2001.

Indications for Use

Indicated for adults and infants requiring documentation of sleep or other physiological disorders in clinical settings (hospitals, sleep centers, clinics). Not for use as an automated apnea monitor or life-support equipment.

Regulatory Classification

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.

Predicate Devices

Neurolink IP Model PK1117 (K100683)
Alice 5 (K040595)

Related Devices

K083874 — GALAXY · Respironics Inc., Sleep & Home Respiratory Group · Jan 26, 2009
K022037 — XLTEK SLEEP SYSTEM · Excel Tech. , Ltd. · Sep 10, 2002
K161650 — Polysmith Sleep System, Model NTI7593 · Neurotronics, Inc. · Jan 19, 2017
K040595 — ALICE 5 · Respironics, Inc. · Mar 18, 2004
K012085 — SOMNO STAR & SERIES SLEEP SYSTEM · Sensor Medics Corp. · Aug 2, 2001

Submission Summary (Full Text)

{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 1166 | Model 1142 | |----------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------| | AC Channels (e.g., EEG, EOG, EMG, nasal flow pressure, 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/ sensors used for data collection | 66 | 42 | | Number of grounds | 2 (G1, G2 - for "common reference and ground" | 2 (G1, G2 - for "common reference and ground" | {2}------------------------------------------------ - 2. 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). - 6. 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. - 7. 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…