K Number
K955841
Device Name
SLEEP SYSTEM FOR CLINICS & RESEARCH
Date Cleared
1997-03-11

(445 days)

Product Code
Regulation Number
868.2375
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Compumedics Sleep Monitoring System is used as an aid in the diagnosis of sleep and respiratory related sleep disorders. The use of this sleep monitoring system is to be under the supervision of a physician, sleep technologist or clinician. The Compumedics Sleep Monitoring System is an information management tool to record, display, organise, redisplay (retrieve) and generate user-defined reports based on the subject's data received from monitoring devices typically used to evaluate sleep and sleep related respiratory disorders.
Device Description
The Compumedics Sleep Monitoring System is a device which integrates the monitoring and recording function of these individual devices, and provides the means to gather all these signals simultaneously into a single "box" where these signals can be viewed, stored, and retrieved in formats selected by the clinician or sleep technologist.
More Information

Not Found

Yes
The summary explicitly mentions "Sleep Stage Scoring Using the Neural Network Model" and references a publication discussing the comparison between visual and automatic analysis using a neural network. This indicates the use of a machine learning technique (neural network) for automatic sleep stage scoring.

No.
The device is used for diagnosis and information management of sleep and respiratory-related sleep disorders, not for providing therapy or treatment.

Yes

The intended use explicitly states, "The Compumedics Sleep Monitoring System is used as an aid in the diagnosis of sleep and respiratory related sleep disorders."

No

The device description explicitly states that the system "integrates the monitoring and recording function of these individual devices, and provides the means to gather all these signals simultaneously into a single 'box'". This indicates the presence of hardware components beyond just software for data acquisition and integration.

Based on the provided information, the Compumedics Sleep Monitoring System is likely an IVD (In Vitro Diagnostic) device, although it doesn't fit the most common definition of an IVD which typically involves testing samples like blood or urine.

Here's why:

  • Intended Use: The system is used "as an aid in the diagnosis of sleep and respiratory related sleep disorders." This clearly indicates a diagnostic purpose.
  • Function: It records, displays, organizes, retrieves, and generates reports based on physiological data from monitoring devices. While it's not analyzing biological samples in vitro, it is processing and interpreting data from the patient to aid in diagnosis.
  • Comparison to Predicate Devices: The predicate devices listed (Nicolet Expert Sleep/Wake Analysis System, SensorMedics Series 4000 System) are also systems used for sleep monitoring and diagnosis, which are generally considered medical devices with a diagnostic function.
  • Mention of AI/ML for Sleep Stage Scoring: The mention of using a "Neural Network Model" for sleep stage scoring further supports its role in analyzing physiological data for diagnostic purposes.

Why it's not a typical IVD:

Traditional IVDs analyze biological samples (blood, urine, tissue) outside the body. This system is collecting physiological signals from the body.

Why it still fits the broader concept of a diagnostic device:

Regulatory bodies often classify devices based on their intended use and how they contribute to diagnosis. Devices that collect, process, and interpret physiological data to aid in diagnosing a condition are considered diagnostic devices, even if they don't fit the narrow definition of an IVD.

In conclusion: While not a traditional IVD in the sense of analyzing biological samples, the Compumedics Sleep Monitoring System's intended use as an aid in diagnosis and its function of processing physiological data for this purpose strongly suggest it is classified as a diagnostic medical device, which falls under the broader umbrella of devices used for diagnostic purposes. Regulatory classifications can be nuanced, but based on the provided text, it aligns more with a diagnostic device than a general-purpose tool.

No
The provided input states "Control Plan Authorized (PCCP) and relevant text Not Found". There is no explicit mention that the FDA has reviewed, approved, or cleared a PCCP for this device.

Intended Use / Indications for Use

The Compumedics Sleep Monitoring System is used as an aid in the diagnosis of sleep and respiratory related sleep disorders. The use of this sleep monitoring system is to be under the supervision of a physician, sleep technologist or clinician. The Compumedics Sleep Monitoring System is an information management tool to record, display, organise, redisplay (retrieve) and generate user-defined reports based on the subject's data received from monitoring devices typically used to evaluate sleep and sleep related respiratory disorders.

The users of the Compumedics Sleep Monitoring System are medical professionals who have received training in the areas of hospital procedures, physiological monitoring of human subjects, and sleep disorder investigation.

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

73MNR

Device Description

The Compumedics Sleep Monitoring System consists of three sub-systems:

  • S-Series
  • P-Series
  • W-Series

The S-Series is for monitoring multiple subjects simultaneously in the clinical setting. The P-Series allows for monitoring a single individual remotely, outside the clinical site (e.g. in their home). Both the S-Series and P-Series software modules operate using MS-DOS. The W-Series offers the user the capability to operate the Sleep Monitoring System in Windows (TM) instead of MS-DOS.

The Compumedics Sleep Monitoring System is comprised of hardware modules which allow for the collection and organisation of sleep study information. These modules have been expressly designed to be used in varying combinations to meet the wide range of needs of the sleep assessment device user. The minimum modules for the Compumedics Sleep Monitoring System consists of the following:

S-Series:

  • (1 to 8) Patient Interface Box(es) One for each patient
  • (1 to 8) Preamplifier Module(s) One for each patient
  • (1) Workstation Module using MS-DOS Software

P-Series:

  • (1) Patient Interface Box
  • Portable Main Unit (1)
  • Memory Card (1)
  • W-Series: Optional software for S-Series and P-Series to run Windows (TM)

The hardware and software modules are used in combinations to aquire, digitise, and record a variety of physiological signals during polysomnography (PSG) studies. Following the acquisition of the study data, the other hardware and software module combinations allow the sleep technician to review, process, generate reports, and archive all study information. The automated data processing functions the Compumedics Sleep Monitoring System can perform are:

  • Sleep staging
  • Respiratory scoring
  • Detection of arousal events
  • Detection of periodic leg movement (PLM) events

These sleep staging functions are based on standard Rechtscaffen and Kales (R&K) methodology (Rechtscaffen, A and Kales, A. A Manual of Standardised Terminology, Techniques and Scoring System for Sleep Stages of Human Subjects, United States National Instututes of Health publication No. 204, 1968).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

The placement of the electrodes and sensors depends on the parameter being monitored for the sleep study. The following are some examples of placement of sleep study monitoring devices used by all three Systems.
Position sensor: A transducer attached to the patient's clothing or skin over the sternum.
Leg Sensor: When placed on a leg muscle (anterior tibialis).
Thermistor: Taped just beneath the subject's nose and just above the upper lip to monitor airflow through the oral and nasal cavities.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

The use of this sleep monitoring system is to be under the supervision of a physician, sleep technologist or clinician.
The users of the Compumedics Sleep Monitoring System are medical professionals who have received training in the areas of hospital procedures, physiological monitoring of human subjects, and sleep disorder investigation.

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

Not Found

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

Clinical test: Clinical testing was performed using a side-by-side comparison of the Compumedics Sleep Monitoring System and the SensorMedics Series 4000 Sleep System (K915856).
Results: Sleep Staging of manually scored SensorMedics and Compumedics show similar appearance of traces. Distinguishable features appear in the same relative locations on the Compumedics Sleep Monitoring System when compared to the SensorMedics Sleep Monitoring System.
It has been noted that some of the traces output on the Compumedics Sleep Monitoring System have the reverse phase (i.e. opposite convention) than when compared to the SensorMedics Sleep Monitoring System. This difference in polarity does not influence the analysis performed by the Compumedics Sleep Monitoring System.
Concordance between manual and manual scoring, and manual and automatic scoring is within the range specified as being typical between two manual scorers within the article: "Sleep Stage Scoring Using the Neural Network Model: Comparison Between Visual and Automatic Analysis in Normal Subjects and Patients." Sleep (1996) 19(1): 26-35.

It has been shown that the Compumedics Sleep Monitoring System is substantially equivalent to the SensorMedics Sleep Monitoring System in the following areas:

  • Compumedics Manual Analysis and SensorMedics Manual Analysis
  • Compumedics Automatic Analysis and Compumedics Manual Analysis
  • Comparison of random epochs of raw data for visualisation of signal quality
  • Comparison of specific events (abnormal respiratory events, EEG arousal and different sleep stages)

This study shows that the Compumedics Sleep Monitoring System is substantially equivalent to the SensorMedics Sleep Monitoring System.

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.

K873535, K915856

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

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).

0

K955841/A4

MAR | | 1997

COMPUMEDICS SLEEP MONITORING SYSTEM

510(k) Summary

K955841

2017 2 Trip Trick State

February 1997 Issue 2

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Index

General Information3
Manufacturing Facility Address3
Trade/Proprietary Name3
Common/Usual Name3
Reason for Premarket Notification3
Device Classification3
Certification4
Predicate Devices4
Technological Characteristics Compared to Predicates4
Performance Standards4
Intended Use4
Device Description5
Overview5
Polysomnography7
System Description8
Compumedics Sleep Monitoring System Summary8
S-Series Hardware Overview9
S-Series Hardware Photograph9
S-Series System Diagram10
Patient Interface Box10
S-Series Preamplifier Module11
P-Series Hardware Overview12
P-Series Hardware Photograph12
P-Series System Diagram13
P-Series Portable Main Unit15
Electrodes and Sensors15
Example of Use16
Functions Performed16
Anatomical Sites16
Position sensor16
Leg Sensor16
Thermistor16
Target Population16
Summary of Technological Characteristics17
Comparison of Compumedics S-Series Sleep Monitoring System, SensorMedics 4100 Series and17
Nicolet Expert Sleep/Wake Analysis System17
Comparison of Compumedics P-Series Sleep Monitoring System and SensorMedics 4250 Series18
Performance Testing19
Physical Characteristics19
Safety Characteristics20
Design20
Materials20
Power Source and Energy Delivered20
Are the Descriptive Characteristics Precise Enough to Ensure Equivalence?21
Conclusions from Clinical Performance Data22
Clinical test22
Results22
Conclusion23

2

General Information

Manufacturing Facility Address

Compumedics Sleep Pty. Ltd 1 Marine Parade Abbotsford, Victoria, 3067 Australia A.C.N. 006 854 897

Tel: 011 61 3 9419 5433 Fax: 011 61 3 9419 5488

Contact Names: David Burton, Managing Director Lance Thomas, Operations Manager

Trade/Proprietary Name

Compumedics Sleep Monitoring System: S-Series P-Series W-Series

Common/Usual Name

Sleep Assessment Device

Reason for Premarket Notification

The Compumedics Sleep Monitoring System is a new device.

Device Classification

Sleep Assessment Equipment has been assigned FDA product code 73MNR (Ventilative effort recorder breathing frequency monitor).

At least two devices have received clearance for commercial distribution as Class II medical devices via substantial equivalence (510(k)) determinations under this designation. Those devices are the Farrall Instruments, Incorporated Sleep Assessment Device (K792305, December 20, 1979 determination) and Somnited Incorporated's Somnimic (K912817, July 26, 1991, determination).

Additionally, the Nicolet Expert Sleep/Wake System (K873535) and the SensorMedics Series 4000 Sleep System (K915856) have been cleared for commercial distribution through the determination of substantial equivalence under the 84GWQ product code (also under the Neurology panel designation).

In that all four of the above-named devices are sleep assessment equipment (like the subject Compumedics device), and all four of the above-named devices have been cleared for marketing through the substantial equivalence (510(k)) process, and as these latter two devices have been chosen as predicates for the subject device, we maintain that the Compumedics Sleep Monitoring System is similarly a Class II device, subject to market authorisation through the process of determination of substantial equivalence.

Certification

As the Compumedics Sleep Monitoring System is not claiming substantial equivalence to a Class III device, a certification statement is not required.

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510(k) Device Summary K955841

Predicate Devices

Predicate devices claimed:

Nicolet Expert Sleep/Wake Analysis System SensorMedics Series 4000 System

The Compumedics Sleep Monitoring System is substantially equivalent to currently marketed SensorMedics Series 4000 and Nicolet Expert Sleep/Wake System. The Nicolet Expert Sleep/Wake System, manufactured by Nicolet Biomedical Instruments, Madison, Wisconsin 53711-0287, was subject of an approved 510(k) notification on October 26, 1987, (Ref. No. K873535). The SensorMedics Series 4000, manufactured by SensorMedics Corporation, Yorba Linda, California 92687, was subject of an approved 510(k) notification on October 26, 1992, (Ref. No. K915856).

Technological Characteristics Compared to Predicates

There are no substantial distinctions in technological characteristics among the predicate and subject devices.

Performance Standards

To date, no performance standards or special controls applicable to this type of device have been promulgated by the Agency.

Intended Use

The Compumedics Sleep Monitoring System is used as an aid in the diagnosis of sleep and respiratory related sleep disorders. The use of this sleep monitoring system is to be under the supervision of a physician, sleep technologist or clinician. The Compumedics Sleep Monitoring System is an information management tool to record, display, organise, redisplay (retrieve) and generate user-defined reports based on the subject's data received from monitoring devices typically used to evaluate sleep and sleep related respiratory disorders.

The users of the Compumedics Sleep Monitoring System are medical professionals who have received training in the areas of hospital procedures, physiological monitoring of human subjects, and sleep disorder investigation.

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Device Description

Overview

Polysomnography involves recording of individual signals collected by various standard physiological monitoring and recording devices typically used for such studies. These include EEG, ECG, respiratory sensors, body position sensors, oximeters, etc. The Compunedics Sleep Monitoring System is a device which integrates the monitoring and recording function of these individual devices, and provides the means to gather all these signals simultaneously into a single "box" where these signals can be viewed, stored, and retrieved in formats selected by the clinician or sleep technologist.

Polysomnography

Polysomnography (PSG) involves the continuous, overnight monitoring and recording of selected physiological variables to assist in evaluation of sleep and sleep related respiratory disorders. These variables may include neurological activity, heart rate, body movements, nasal and oral airflow, snoring noises, eye movements, and others. Electrical signals are sent from specialised sensors applied to various body parts (e.g. head, chest, face) to an integrated recording and/or displaying instrument called a polygraph.

There are three generic types of signals collected:

  • a) Bioelectrical Potentials: These are signals produced by the body's own tissues, such as brain wave recordings felectroencephalogram (EEG)], eye movement recordings [electrooculogram [EOG]), muscle activity recordings [electromyogram (EMG)], and heart rate recordings [electrocardiogram (ECG)]. Bioelectrical potentials are recorded by placing sensors over the tissues generating these signals (e.g. on the scalp for EEG, chest for ECG, next to the eyes for EOG).
  • b) Non-electrical Physiologic Activity. Non-electric physiological activity is translated into electrical signals by transducers. For example: a thermistor or thermocouple measures change in temperature to monitor nasal or oral airflow (cool upon inhalation, warm upon expiration); inductive respiratory bands measure chest/abdominal effort in response to movement: and position sensors monitor body position.
  • c) Other signals: Other physiological activities translated into electrical signals by auxiliary devices. These may include devices such as oximetry to measure haemoglobin oxygen saturation (SaO2).

The patterns of these electrical signals are distinct in the different stages of sleep. At the onset of sleep, the brain's activity shifts into specific patterns. There are four stages of sleep: Stage 1 (light sleep), Stage 2, Stage 3/4 (slow wave), and REM (Rapid Eye Movement). Stages 1, 2, 3 and 4 are also collectively referred to as non-REM (NREM) sleep. Each stage is characterised by brain waves (EEG) of very specific frequencies and/or amplitudes. Stages of sleep may also be defined by certain types of eye movements (EOG) and muscle activities (EMG).

There is a regular progression of sleep stages for a normal sleep period. A sleep cycle is a period of REM sleep followed by NREM sleep. Typically, there are four to six sleep cycles per sleep period. Sleep disorders can cause disruptions in this normal pattern and their presence can be determined by monitoring changes in the sleep pattern. For example, when breathing through a blocked or partially blocked throat, the stress of this event may cause abrupt changes in brain activity, sometimes waking the person or moving them into a lighter stage of sleep. (e.g. Stage 1) prematurely. Often this results in a shorter total sleep time and reduced slow wave (Stage 3/4) and REM sleep. This sleep deprivation or fragmentation of normal sleep cycles may result in daytime sleepiness and poor daytime function.

Respiratory dysfunction occurring during sleep is referred to as sleep apnea and is a common condition contributing to sleep deprivation. When abnormal breathing episodes occur repetitively during a sleep period, a person is said to suffer from sleep apnea. An apnea episode or event occurs when the throat becomes totally blocked (obstructed) with complete or almost complete cessation of airflow lasting momentarily and is usually associated with oxygen desaturation or arousal. An hyponea occurs when

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510(k) Device Summary K955841

the throat is partially blocked, and when breathing continues but is diminished (about 70% reduction in airfow) and is also associated with oxygen desaturation or arousal. To resume breathing, hypopnea or apnea triggers increased inspiration efforts and within seconds, enough pressure builds up to open the obstructed throat, where a load snort or gasp may result. Alternatively, snoring may result when throat tissues vibrate while breathing through a partially blocked throat.

One obvious consequence of sleep apnea is disturbance of one's sleep an possibly that of a bed partner, which may result in diminished activity or capacity during the day, and possibly embarrassment or marital discord. However, a more serious consequence of these breathing disorders is in causing repeated, episodic drops in the body's oxygen levels. It is hypothesised that this causes stress on the heart, contributes to high blood pressure and other heart ailments (heart attacks, angina, irregular heart rhythms) or possibly stroke.

PSG is used to monitor and record physiological signals during sleep to permit evaluation of sleep patterns and aid in the diagnosis of sleep disorders. Apneas and hypopneas that last longer than ten seconds are characterised by a drop in oxygen and a change in brain wave pattern. If the incidence of apnea and hypopneas during sleep is greater than an established baseline, a diagnosis of sleep apnea is determined. For accurate assessments of these respiratory "events", the following parameters are monitored:

  • Brain activity (EEG) to determine the stage of sleep and arousals. .
  • Muscle activity (EMG) to determine the stage of sleep and arousals. .
  • Eye movements (EOG) to determine the stage of sleep and arousals. .
  • · Thermistors or thermocouples monitor oral/nasal airflow.
  • Sensors that measure thoracic and abdominal distension/movement with breathing monitor . respiratory effort.
  • Oximetry measures blood oxygen saturation levels (SaO2) by passing light through the . finger capillaries and measuring absorption patterns.
  • Body position is monitored (e.g. via position sensor and/or infrared video camera) to . determine if supine, upright, or side position is common during an event.
  • Heart rate (ECG) is monitored to evaluate stress related to breathing and arrhythmia . detection.

Historically, this monitoring has been performed by individual devices dedicated to one, or a few, of these physiological parameters. Only in recent years have integrated sleep monitoring systems been designed and commercialised to collect all of this data simultaneously. The subject device is one such device.

Following the collection of sleep data by PSG monitoring, the first step in processing the study data involves segregating the physiological data obtained through PSG into specific time intervals, called "epochs". A typical epoch used is 20 or 30 seconds. (Epochs longer than 30 seconds could introduce a bias against short-lived sleep changes.) Once epochs are established, the clinician scores each epoch into standard sleep stages using the obtained physiological data. Scoring the data is based on established methodology (Rechtscaffen, A and Kales, A. A Manual of Standardised Terminology, Techniques and Scoring System for Sleep Stages of Human Subjects, United States National Instututes of Health publication No. 204, 1968). Using the scored epochs, the clinician next noted the times occurrence, the duration, and the relative distribution of the Rechtscaffen and Kales (R&K) sleep stages.

Manual segregation of data accumulated from many independent monitoring devices into epochs and sleep stage scoring can be a labour intensive, tedious, and time-consuming process. Electronic recording, storage, retrieval and display of the monitored physiological parameters by a single integrated device offers many advantages over manual processing and evaluation of chart recorded outputs. The subject Compumedics Sleep Monitoring System offers this automatic organisation of data, in addition to the fundamental monitoring and collection function.

The automated display of the polysomnographic information is neither unique nor novel, and merely represents the application of automated, computer-assisted display and graphing functions to the physiological data collected by physiological activity monitoring devices. This permits faster evaluation of the data by the clinician and facilitates diagnosis.

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510(k) Device Summary K955841

System Description

The Compumedics Sleep Monitoring System consists of three sub-systems:

  • S-Series .
  • . P-Series
  • · W-Series

The S-Series is for monitoring multiple subjects simultaneously in the clinical setting. The P-Series allows for monitoring a single individual remotely, outside the clinical site (e.g. in their home). Both the S-Series and P-Series software modules operate using MS-DOS. The W-Series offers the user the capability to operate the Sleep Monitoring System in Windows (TM) instead of MS-DOS.

The Compumedics Sleep Monitoring System is comprised of hardware modules which allow for the collection and organisation of sleep study information. These modules have been expressly designed to be used in varying combinations to meet the wide range of needs of the sleep assessment device user. The minimum modules for the Compumedics Sleep Monitoring System consists of the following:

S-Series:

  • (1 to 8) Patient Interface Box(es) One for each patient
  • (1 to 8) Preamplifier Module(s) One for each patient
  • (1) Workstation Module using MS-DOS Software

P-Series:

  • (1) Patient Interface Box
  • Portable Main Unit (1)
  • Memory Card (1)
  • W-Series: Optional software for S-Series and P-Series to run Windows (TM)

The hardware and software modules are used in combinations to aquire, digitise, and record a variety of physiological signals during polysomnography (PSG) studies. Following the acquisition of the study data, the other hardware and software module combinations allow the sleep technician to review, process, generate reports, and archive all study information. The automated data processing functions the Compumedics Sleep Monitoring System can perform are:

  • . Sleep staging
  • Respiratory scoring .
  • . Detection of arousal events
  • Detection of periodic leg movement (PLM) events .

These sleep staging functions are based on standard Rechtscaffen and Kales (R&K) methodology (Rechtscaffen, A and Kales, A. A Manual of Standardised Terminology, Techniques and Scoring System for Sleep Stages of Human Subjects, United States National Instututes of Health publication No. 204, 1968).

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Compumedics Sleep Monitoring System Summary

Manufacturer NameCompumedicsCompumedicsCompumedics
Phone Number(613) 9419 5433(613) 9419 5433(613) 9419 5433
Model Names with Specific ModelS-Series SleepP-Series SleepW-Series Sleep
NumbersMonitoring System
V7Monitoring System
V2Monitoring System
V2
Comparison Categories
# Channels at (# per Patient)48 @ 24 per 1up to 36 per 1up to 64 per 1
Records EEG, EOG and EMGYYY
Records ECGYYY
Records Intercostal EMGYYY
Records EMG from both LegsYYY
Records Air FlowYYY
Records Respiratory EffortYYY
Records Snoring SoundsYYY
Accepts Ext. Capnograph SignalYYY
Accepts Ext. pH Monitor SignalYYY
Accepts Ext. NPT SignalsYYY
Oximeter (Built-In or External)ExternalBuilt-inExternal
Records Wrist Movement RatesN/AN/AN/A
Records Body Sleeping PositionYYY
Displays Raw Incoming DataYYY
Displays Raw Data for InterpretationYYY
A/D Vertical Resolution (in Bits)8 or 128 or 128 or 12
Sampling Rate/Channel Samples/secMax 500 per channelMax 250 per channelMax 500 per channel
Storage Rate/Channel Samples/secMax 500 per channelMax 250 per channelMax 500 per channel
Storage Medium Archive TypeMagneto Optical/ZipMagneto Optical/ZipMagneto Optical/Zip
Storage Medium Capacity (Supplied)1.7 Gb or greater20 - 80 Mb1.7 Gb or greater
Storage Required per 8 Hr Study20 to 30 Mb20 to 30 Mb20 to 30 Mb
Montage FlexibilityYYY
Sleep Stage ScoringYYY
Definable Sleep Event CriteriaYYY
Adjustable Sleep Scoring RulesYYY
Apnea /-Hypopnea ScoringYYY
Definable Flow/Effort CriteriaYYY
Adjustable Apnea/Hypopnea RulesYYY
Generates a Printed ReportYYY
CPU Type and Clock Speed
(Supplied)Pentium 166 or
greater16 Bit /14 MhzPentium 166 or
greater
Resolution (Width x Height [Pixels])1024 x 768 (MS-
DOS)1024 x 768 (MS-
DOS)1024 x 768 or greater
Type of Power RequiredACBattery or ACAC
Type of Low Level AmplifiersBuilt-in or externalBuilt-inBuilt-in or external
Ability to Do an In-Home StudyYYY
Number of Units Sold≈ 140 beds≈ 120≈ 10
Warranty on Parts and Labor12 Months12 Months12 Months
Price for Data Recording Unit* 44K AUS* 18K7 AUS* 44K AUS
Price for Data Analysis Workstation* 18K7 AUS* 18K7 AUS* 18K7 AUS
1-Bed Data collection/Playback* 60K AUS* 39K4 AUS* 60K AUS
2-Bed Data Collection/Playback* 84K AUS* 58K AUS* 84K AUS
  • Prices may vary with specialised configurations

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S-Series Hardware Overview

S-Series Hardware Creat voice voical configurations of the hardware modules. The photograph is
The diagrams of the S-Series departments of the S-Series The diagrams of the S-Bertes depted of problem the use of the S-Series.

S-Series Hardware Photograph

Image /page/8/Figure/7 description: The image shows a patient monitoring system with various sensors and components labeled. The labels point to different parts of the system, including the thoracic and abdominal respiratory bands, patient interface box, triple thermistor (air flow sensor), electrodes, position sensor, leg sensor (under clothing), and SaO2 probe. The image also shows the computer system (typically in another room) and the preamplifier module, along with the CM1160 rev. 1 label.

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Image /page/9/Figure/2 description: The image shows a diagram of a S-Series System. The diagram includes two patients, patient 1 and patient 2 (optional), each connected to a patient interface box. The patient interface boxes are connected to preamplifier modules, which are then connected to a workstation module. The workstation module is connected to modems (optional) via a telephone line, which is then connected to a remote monitoring station (optional).

S-Series System Diagram

S-Series Patient Interface Box

The S-Series Patient Interface Box (PIB) is designed to fulfil the following functions:

  • Electrode and sensor interface for the Compumedics Preamplifier Module Cards, as ● housed in the Compumedics Preamplifier Module.
  • Remote electrode impedance measurement. .

Image /page/9/Figure/8 description: The image shows a black and white drawing of a device with multiple buttons and ports. The device has a rectangular shape with rounded edges and appears to be made of plastic. On the top surface, there are several rows of circular buttons, along with labels and indicators. The sides of the device feature ports with multiple pins, suggesting connectivity options. The drawing is detailed and technical, possibly representing a schematic or product illustration.

S-Series Patient Interface Box

The following input connectors are provided on the S-Series PIB

  • · Preamplifier channels 1 to 11. These are differential input channels allowing connection to the channels 1 to 11 of the Compumedics Preamplifier Module.
  • Airflow Sensor .
  • · Position Sensor
  • Auxiliary input for Abdominal Respiratory Band (requires ACNONISO card in . Preamplifier Module)
  • Auxiliary input for Thoracic Respiratory Band (requires ACNONISO card in Preamplifier . Module)
  • Microphone. (The PIB also contains an internal microphone.) .

10

l

S-Series Preamplifier Module

o-other in the module The I realipinter Module is a compansion to Digital (A/D) cards in the computer.

The Preamplifier Module is located next to the patient and is connected to the computer by cable installations.

Image /page/10/Figure/6 description: The image is a black and white line drawing of a rectangular object, possibly a container or a piece of equipment. The object has a flat top and a side with a series of vertical bars or slats. The drawing is simple and technical in style, with clean lines and no shading. The text "CM1202" is visible in the lower right corner of the image.

S-Series Preamplifier Module

The complete range of Preamplifier Cards for each patient are housed in the Preamplifier Module. The I he complete fallge of Preampinier Cates to to to 20 innut cards and one supervisory processor card. All
Preamplifier Module has the provision for up to 20 innut cards and o Preamplifier Cards may be removed and replaced in the Preamplifier Module. The Preamplifier Cards Freampliner Caros may of removed aton op and one at the bottom of the respective front panel.

The Preamplifier Module and Preamplifier Cards have been designed to comply with the AS3200.1 medical standards.

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Image /page/11/Picture/0 description: The image shows a logo with a large, stylized letter 'C'. The 'C' is filled with a checkered pattern of alternating dark and light squares. To the right of the upper part of the 'C', there is a smaller, stylized letter 'E'. The overall design is simple and graphic, with a focus on the letterforms and the contrasting checkered pattern.

P-Series Hardware Overview

The diagrams of the P-Series depical configurations of the hardware modules. The photograph is
t the P-Series and adversetted worsession the use of the P-Series. The P-Series The diagrams of the P-Series depict typical continues of the P-Series Main Unit and a mock set-up of a sleep study demonstrating the use of the Posted on the Posted of the Pould not be
Patient Interface been arranged in this fashion for the photograph only a Patient Interiace Box nave boon arrang.
placed on the bed during the recording of an actual study.

P-Series Hardware Photograph

Image /page/11/Picture/6 description: The image shows a person in a medical setting with various sensors attached to their body. Labels point to the Triple Thermistor (Air Flow Sensor), Position Sensor Electrodes, Thoracic Respiratory Band, Abdominal Respiratory Band, Patient Interface Box, Analogue Lead, P-Series Main Unit, SaO2 Probe, and Leg Sensor (Under clothing). The image also contains the identifier "CM1159 rev. 1".

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Image /page/12/Figure/1 description: The image shows a black and white logo. The logo consists of a thick black circle with a small, lowercase letter 'm' inside the circle on the right side. The 'm' is also black, creating a contrast with the white space inside the circle.

Image /page/12/Figure/3 description: The image shows three system diagrams labeled as "P-Series System Diagram", "Remote Online Fullscreen Monitoring", and "Local Online Fullscreen Monitoring". Each diagram depicts a patient connected to a "Patient Interface Box", which is then connected to a "Main Unit". The first diagram shows the "Main Unit" connected to modems via a "Serial Cable" and "Telephone Line", which then connects to a computer, optical drive, and color printer. The second diagram shows the "Main Unit" connected to a computer, optical drive, and color printer via a "Serial Cable", while the third diagram shows the "Main Unit" connected to a computer, optical drive, and color printer via a "Memory Card".

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P-Series Patient Interface Box

Electrodes attached to the patient are connected to the P-Series Patient Interface Box (PIB). The PIB amplifies the signals and then the amplified signals are passed to the Portable Main Unit using an analogue cable.

Image /page/13/Figure/5 description: The image shows a diagram of a device with various sensors and inputs/outputs labeled. The device has sensors for airflow, abdominal respiratory, thoracic respiratory, position, internal light, external light, and internal microphone. It also has an electrode input and an analogue output, as well as the label CM1161.

P-Series Patient Interface Box

The following input connectors are provided on the P-Series PIB

  • · Airflow Sensor
  • Abdominal Respiratory Band .
  • Thoracic Respiratory Band ●
  • Position Sensor .
  • Brain activity (EEG and EEG/2) .
  • Heart activity (ECG) .
  • Leg movement sensor (LEG/L and LEG/R) .
  • . Muscle activity (EMG)
  • Eye movement (EOG/L and EOG/R) .
  • Microphone (MIC) .
  • Auxiliary input (AUX) .
  • Patient Reference (PAT/REF) t
  • · EEG/A
  • . EEG/B
  • EEG/C .
  • External LDR and Microphone ●
  • Internal Microphone .
  • . Internal Light Sensor

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Image /page/14/Picture/1 description: The image shows a black circle with a small letter 'm' inside the upper right quadrant. The circle is thick and solid, while the 'm' is smaller and positioned within the circle's boundary. The overall impression is a simple, graphic representation of a circle with an embedded letter.

P-Series Main Unit

The Main Unit is a key component of the Compumedics P-Series Sleep Monitoring System. It is used to digitise and record the patient's physiological signals onto a PCMCIA Memory Card.

Image /page/14/Figure/5 description: This image shows a device with labels pointing to different parts of the device. The labels include display screen, selection buttons, contrast, analogue input, oximeter input, air pressure input, serial port, power switch, auxiliary port, and DC power input. The device also has a CM1000 label.

P-Series Main Unit

Electrodes and Sensors

Compumedics supplies a kit containing PSG monitoring electrodes and sensors. This kit contains 6 types of sensors and 2 types of electrodes.

The following electrodes and sensors are manufactured by Compumedics:

  • · Leg sensors
  • Position sensors .
  • Triple thermistor (airflow sensor) .
  • Snap on electrode .

The following electrodes and sensors are purchased from vendors:

  • . Inductive respiratory band
  • Oral/nasal cannula sensor .
  • . Oximeter probe
  • Gold cup electrode .

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Image /page/15/Picture/1 description: The image shows a black circle with a small, lowercase letter 'm' inside the circle on the right side. The circle is thick and solid black, and the 'm' is also black. The 'm' is positioned so that it appears to be partially obscured by the edge of the circle.

Example of Use

The Compumedics Sleep Monitoring System provides menus from which the sleep technician may select/assign criteria for automated collection and organisation of specific events, or for off-line data summarisation. Importantly, such decisions made by the sleep technician do not change the raw data recorded during PSG. The Compumedics Sleep Monitoring System will automatically score the PSG data according to either R&K default values or clinician-selected criteria, and hence, eliminates the need to manually score PSG data. Thus analysis can be performed by the clinician more efficiently and expeditiously.

As an example, processing the data for respiratory scoring involves marking the occurrences of respiratory events which are defined by various parameters. These parameters have set default values which must be accepted by the operator or can be defined by the operator for different patients or different study parameters. Periodic Leg Movement (PLM) events, Arousal events, and Sleep Staging can be scored in a similar manner based on defined parameters using either default settings or operator defined values.

Compumedics provides User Guides that contain examples of how to use the Compumedics Sleep Monitoring System for a sleep study.

Functions Performed

The Compumedics Sleep Monitoring System performs the following functions:

  • Electronically records physiological parameters received by standard electrodes and . sensors during a subject's sleep to allow for recall and off-line (retrospective) data analysis
  • Permits on-line (real-time) display of data .
  • Allows operator to choose range for parameters for off-line (retrospective) data processing .
  • Automatically scores sleep stages, respiratory events, arousal events, and Periodic Leg ● Movement (PLM) events using either default values (based upon standard R&K scoring system) accepted, or those assigned by the sleep technician
  • Generates and prints study graphics and reports .

Anatomical Sites

The placement of the electrodes and sensors depends on the parameter being monitored for the sleep study The following are some examples of placement of sleep study monitoring devices used by all three Systems.

Position sensor

  • A transducer attached to the patient's clothing or skin over the sternum which indicates . whether the subject is lying prone (front), supine (back), or on their right or left sides.

Leg Sensor

  • When placed on a leg muscle (anterior tibialis), the sensor provides signal output . proportional to leg muscle movement.

Thermistor

  • . Measures change in air temperature and is taped just beneath the subject's nose and just above the upper lip to monitor airflow through the oral and nasal cavities.

Target Population

The target population of all three systems are subjects undergoing evaluations sanctioned by sleep disorder centers where this technology has been used to record and evaluate sleep disorders since the 1950's.

I

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Image /page/16/Picture/1 description: The image shows a black circle with a smaller white circle inside of it. The white circle is positioned on the right side of the black circle, creating a crescent shape. The image is simple and abstract, with no other details or elements present.

Summary of Technological Characteristics

The following comparison table outlines the similarities and difference between the Compunedics The following computison and the SensorMedics Series 4100 (Somnostar) and Series 4250 (Somnotrac) and the Nicolet Expert Sleep/Wake System.

Comparison of Compumedics S-Series Sleep Monitoring System, SensorMedics 4100 Series and Nicolet Expert Sleep/Wake Analysis System

| Features/Technical
Information | Compumedics
S-Series Sleep
Monitoring
System | SensorMedics
4100 Series
(Somnostar) | Nicolet Expert
Sleep/Wake
Analysis System |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------------|
| Intended Use | Sleep Analysis | Same | Same |
| Number of Patients Can
Monitor Simultaneously | 1 per Preamp, 2 per
Workstation
Module and up to 8
per Full System | Same | Up to 4 |
| Number of Hours of Monitoring | Limited by Storage | Same | Same |
| Data Inputs | From Existing
ECG or Polygraphs | Same | Same |
| Number of Channels/Patient | 20 Channels /
Patient Digital
Oversampling | 16 channels | 16 channels/patient |
| Automated Channel Calibration | Yes | Same | Semi-automated |
| General Software Capabilities | Operating, Analysis
and Report
Generation | Same | Same |
| Menu-Based Operations | Yes | Same | Same |
| Calibrate Input, User-Selectable
Sampling Rates and Montage
Library | Yes | Same | Same |
| Automated, Computer-Assisted
or Manual Analysis Sleep
Staging, Respiratory Scoring,
PLMS Scoring, SaO2 and Heart
Rate, User-Defined Formats and
Time Scales | Yes | Same | Same |
| Help-Menu with Glossary | Yes | Same | Same |
| Remote Telephonic Sleep
Surveillance | Yes | Same | Same |
| Electrical Isolation Transformer | Yes | Same | Same |
| Capable of Setting Recording
Parameters Remotely | Yes | Same | Same |
| Report Generation | Operator
configurable | Same | Same |
| Power Utilisation | 110/120VAC or
220/240VAC | $117\pm10$ VAC,
$220\pm20$ VAC | 110 or 220 VAC
+10%, 50 or 60 Hz |
| Computer Processor and
Operating System | 80486 or Pentium
CPU | Same | 68020 CPU |
| Monitor | Colour | Same | Same |
| Printer | Colour Inkjet | Same | Tektronix colour |
| Keyboard | Yes, and mouse | Same | Same |
| LAN and Modem Options | Yes | Same | Same |
| Features/Technical
Information | Compumedics
S-Series Sleep
Monitoring
System | SensorMedics
4100 Series
(Somnostar) | Nicolet Expert
Sleep/Wake
Analysis System |
| Built-In Data Storage System | 2.3 GB Magneto-
Optical Drive | 650 MB Optical
Disk | (2) 3 1/2" Floppy
Disks 80 MB Hard
Disk |
| Preamplifiers | Yes | Same | Same |

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Image /page/17/Picture/1 description: The image shows a black and white logo. The logo is a circle with a smaller circle inside of it. The letter 'm' is visible inside the smaller circle.

510(k) Device Summary K955841

Comparison of Compumedics P-Series Sleep Monitoring System and SensorMedics 4250 Series

| Features/Technical
Information | Compumedics P-Series Sleep
Monitoring System | SensorMedics 4250 Series
(SomnoTrac) |
|----------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------|
| Intended Use: Sleep Monitoring | Yes | Same |
| Number of Patients Can
Monitor Simultaneously | 1 per Unit | Same |
| Portable Design | Yes | Same |
| General Functionalities | Yes | Same |
| Data Collection | | |
| Data Analysis | Optional | Same |
| Report Generation | Optional | Same |
| Capable of Data Transfer for
Analysis and Report Generation | Yes | Same |
| Data Inputs | From Existing ECG or
Polygraphs, 16 Biophysical
Inputs, 24 or 36 Optional | Same |
| UltraShield Signal Conditioning | Yes | Same |
| Oximeter with Sat-Trac Signal
Technology | Yes | Same |
| Data Analysis (Computer or
Computer-Assisted). | Optional | Same |
| Comprehensive Report
Generation | Optional | Same |
| Remote Telephonic Sleep
Surveillance | Yes | Same |
| Remote Capability to Monitor
Lead Quality | Yes | Same |
| Remote Capability to Monitor
Recording Parameters | Yes | Same |
| Look Forward/Watch Back
Display | Yes | Same |

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Image /page/18/Picture/1 description: The image shows a black and white logo. The logo consists of a thick, black circle that is not fully closed. Inside the circle, on the right side, there is a small, lowercase letter 'm' in black. The 'm' is positioned so that it appears to be partially inside the circle.

Performance Testing

The Compumedics Sleep Monitoring System and other sleep assessment devices are information managers which display and record data received from routinely-used monitoring devices used to evaluate sleep and sleep related respiratory disorders. They do not treat or provide therapeutic effect to the subject administer any energy to the subject, or perform diagnoses of a subject's disorder or condition, and hence, the devices pose no risk whatsoever to subjects.

In that the Compumedics Sleep Monitoring System and the predicate devices pose to measurable risk to the monitored subject, it is our position that the device characteristics delineated in the Substantial Equivalency Information Tables the functional, material, and related characteristics of the device and the currently marketed predicates are well and sufficient to permit a determination of comparative performance.

The Compumedics Sleep Monitoring System and the predicate devices currently marked in the US are all intended for use with polysomnography for recording of selected physiological parameters monitored for the evaluation of sleep disorders and sleep-related respiratory disorders.

The Compumedics Sleep Monitoring System is used as an aid in the diagnosis of sleep and respiratory related sleep disorders. The use of this sleep monitoring system is to ne under supervision of a physician, sleep technologist or clinician. The Sleep Monitoring System is an information management tool so record, display, organise, summarise, redisplay (relative) and generate user-designed reports based on the subject's data received from monitoring devices typically used to evaluate sleep and sleep related respiratory disorders.

The Nicolet Expert Sleep/Wake Analysis System User Guide states this system "is intended for the acquisition, analysis, and reporting of electrophysiological signals. The system is specifically targeted for the automated analysis of polysomnographic recordings, that is, for the analysis of sleep and respiration."

The SensorMedics Series 4000 device offers "clinicians the flexibility of storing and analysing the sleep record in a variety of forms ... as data received from an Ampstar or other polygraph, it is digitally encoded on a laser-read optical disk ... a powerful report generator allows text, trends and graphic reports to be printed with laser printer quality. in user defined formats, or as an Epoch-By-Epoch disclosure." The indications for use of the SensorMedics Series 4000 device include monitoring and evaluation of respiratory disorders during steep; effectiveness of CPAP treatment; obstructive, central and mixed sleep apnea; insomnia and narcolepsy evaluation; nocturnal myoclonus; and other disorders of sleep.

The comparison of the predicate devices' indications, albeit not identical word for word with the indication claim for the Compumedics Sleep Monitoring System, cover both facets of the Compumedics Sleep Monitoring System data acquisition, processing and archiving directly from electrophysiological recordings of patient activity and from other recording instruments. Therefore, they support the substantial equivalence of the indications statement for the subject device for the Nicolet and SensorMedics predicate devices.

Physical Characteristics

Referring to the comparison tables, the subject system has the same physical characteristics as the named predicate devices.

All three Systems monitor and process input from routinely-used monitoring devices for sleep and sleep related respiratory disorders. Signals from these monitoring devices pass through preamplifiers, which modify signal strength and filter back ground noise through analog digital (A/D) converters. Signals am processed and archived using a computer processor and operating system (detail provided in tables) and displayed on a colour monitor, or printed.

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Image /page/19/Picture/1 description: The image shows a black circle with a small, indistinct text element inside it. The circle is thick and solid, creating a bold outline. The text is located within the right side of the circle's interior. Due to the image quality, the exact letters or words are not clearly discernible.

Safety Characteristics

The Compumedics Sleep Monitoring System and the other sleep assessment devices are information managers which display and received from routinely-used monitoring devices used to evaluate sleep and sleep related respiratory disorders. They do not treat or provide therapeutic: effect to the subject, administer any energy to the subject, or perform diagnoses of a subject's disorder or condition, and hence, the devices pose no risk whatsoever to subjects. Further, the subject device conforms to IEC 601.1. and hence, poses no electrical safety risk.

Design

The Compumedics Sleep Monitoring System consists of a computerised system for collecting data directly from the patient or from independent, and commercially available, monitoring devices, such as the predicate Nicolet and SensorMedics devices, and for collating, processing and presenting reports of this data in a variety of user selected formats. The data sources can include bioelectric monitoring (e.g. EEG, ECG, EOG and EMG), physiological monitoring via transducers (e.g. thermistors, inductance respiratory bands) and other sources, such as pulse oximetry. As such, the subject device and predicate devices serve purely as an information gathering and management tool.

As with the predicate devices, the Compumedics Sleep Monitoring System consists of a monitoring and data processing unit which receives information from external monitoring sources. The Sleep Monitoring System also has available a portable system (P-Series) providing remote monitoring where the data can be output to the larger monitoring and processing unit. The SensorMedics 4000 Series also contains a portable system (4520 Series SomnoTrac) with the same function as the Compumedics P-Series.

Both the Compumedics Sleep Monitoring System and the SensorMedics 4000 System are capable of remote sleep surveillance via telephone, and all three systems are capable of remotely setting recording parameters. Each system operates from standard 110 or 240 VAC power, and contains a 16 bit or 32 bit computer processor and operating system, a colour monitor, a keyboard, a printer, and preamplifiers. All have substantial data storage capacity using a variety of storage techniques.

As with the predicate Nicolet and SensorMedics devices, the Compumedics Sleep Monitoring System is capable of accepting data from multiple subjects simultaneously and multiple data input channels. Automated channel calibration is provided. The number of monitoring achievable is limited by the memory and data storage capabilities of these device types.

The subject device and the predicate Nicolet and SensorMedics devices contain software which include or facilitate menu-based operations for selection of manual or computer-assisted analysis of data (including sleep staging, respiratory event scoring, PLM event scoring, SaO2, and heart rate), input calibration with user selected data sampling rates, a Help Menu with Glossary, and user defined report generation.

Materials

Materials comprising the Compumedics Sleep Monitoring System and the predicate SensorMedics and Nicolet devices are substantially equivalent. These devices consist of hard cases of metal and/or plastics, within which reside integrated circuitry, mechanical and electrical apparatus, and software.

Power Source and Energy Delivered

The subject device and the named predicate devices an operate from standard 110 or 220 volt current and the portable system has the option of battery powered operation.

Neither the subject device, nor the predicate devices deliver any energy to the subject during operation.

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510(k) Device Summary K955841

Are the Descriptive Characteristics Precise Enough to Ensure Equivalence?

Comparing device characteristics delineated in the Substantial Equivalency Information Tables, the design, functional, material, and rated characteristics of the subject device and the currently marketed predicates are well identified, precise, and sufficient to permit a determination of substantial equivalence.

These and other sleep assessment devices are purely information managers which display and record data received from routinely used and commercially available polysomnography monitoring devices. They do not treat or provide therapeutic effect to the subject, administer any energy to the subject, or perform diagnoses of a subject's disorder or condition, and hence, the devices pose no risk whatsoever to the subjects.

In that the Compumedics Sleep Monitoring System and the predicate devices pose no measurable risk to the monitored subject, it is our position that the device characteristics identified in the Substantial Equivalency Information Tables permit sufficient characterisation and description of the significant functional and design aspects of the devices, and are adequate to permit a determination of substantial equivalence.

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Image /page/21/Picture/1 description: The image shows a black circle with a small, italicized letter 'm' inside the circle on the right side. The circle is thick and solid black, while the 'm' is smaller and also black. The 'm' is positioned in the upper right quadrant of the circle's interior. The image is simple and graphic, focusing on the contrast between the circle and the letter.

510(k) Device Summary K955841

Conclusions from Clinical Performance Data

Clinical test

Clinical testing was performed using a side-by-side comparison of the Compumedics Sleep Monitoring System and the SensorMedics Series 4000 Sleep System (K915856).

Even though the R&K definitions of sleep stages has been standardised, there is still variability of sleep stage scoring. The article below describes the expected variability of scoring between two human scorers.

Several studies have also evaluated agreement in human scoring. Agreement between scorers ranged from 88% to 85% according to Gailard and Tissot (2) and Smith et. al. (3), on the basis of 60 second epochs. Recently Stantus et. al. (7) obtained an 82% reliability using 20-second epoch definition, and Ferri et. al. (14) found and agreement rate of 91.3% between two independent readers. Agreement in visual scoring of sleep stages among 10 laboratories in Japan (16) showed values ranging from 67.3% to 75.3% for two healthy subjects. Inter-reader agreement between different laboratories is broadly similar. Variations are based on different time bases and on the number of readers for the validation. The difference between readers has three major causes: 1) the scoring of slow-wave sleep, which illustrates the human subjectivity introduced into the rules applied to the threshold of 75u V for delta wave recognition and in the detection of the percentage of delta waves in the epochs; 2) the scoring of stage 1 sleep, which is subject to great variation due to a lack of clearly characteristic features; and 3) application of "3-minute rules" in the standardized system (17).

Sleep Stage Scoring Using the Neural Network Model: Comparison Between Visual and Automatic Analysis in Normal Subjects and Patients. Sleep (1996) 19(1): 26-35

Results

Sleep Staging of manually scored SensorMedics and Compumedics show similar appearance of traces. Distinguishable features appear in the same relative locations on the Compumedics Sleep Monitoring System when compared to the SensorMedics Sleep Monitoring System.

It has been noted that some of the traces output on the Compumedics Sleep Monitoring System have the reverse phase (i.e. opposite convention) than when compared to the SensorMedics Sleep Monitoring System. This difference in polarity does not influence the analysis performed by the Compumedics Sleep Monitoring System.

Concordance between manual and manual scoring, and manual and automatic scoring is within the range specified as being typical between two manual scorers within the article: "Sleep Stage Scoring Using the Neural Network Model: Comparison Between Visual and Automatic Analysis in Normal Subjects and Patients." Sleep (1996) 19(1): 26-35.

It has been shown that the Compumedics Sleep Monitoring System is substantially equivalent to the SensorMedics Sleep Monitoring System in the following areas:

  • · Compumedics Manual Analysis and SensorMedics Manual Analysis
  • · Compumedics Automatic Analysis and Compumedics Manual Analysis
  • Comparison of random epochs of raw data for visualisation of signal quality
  • Comparison of specific events (abnormal respiratory events, EEG arousal and different sleep stages)

Ad. A Cahmian, 1007

This study shows that the Compumedics Sleep Monitoring System is substantially equivalent to the SensorMedics Sleep Monitoring System.

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Image /page/22/Picture/1 description: The image shows a black circle with a small, lowercase letter 'm' inside the circle, near the right edge. The circle is thick and solid, creating a strong contrast against the white background. The 'm' is significantly smaller than the circle, positioned to appear almost as if it's nestled within the circle's form.

Conclusion

As has been demonstrated by the descriptions and information contained within this document, the subject Compumedics Sleep Monitoring System is substantially equivalent to the predicate sleep assessment devices, the Nicolet Expert Sleep/Wake Analysis System and SensorMedics 4000 Series devices, currently marketed in the United States of America in terms of:

  • · Intended use and indications
  • Method of use .
  • . Effects
  • · Modes of operation
  • · Design
  • · Materials
  • Technological characteristics .
  • · Power source
  • Safety .