The Somté PSG is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders. The Somté PSG is designed for ambulatory and mobile operation and can be used in either the patient's home, the hospital or other environments, thus enabling patients to be investigated under as realistic conditions as possible. The Somté PSG is only to be used under the direction of a physician.

Device Description

The Somté PSG System comprises hardware and software which provides up to 27 separate parameters for recording, review and analysis of collected and stored physiological parameters, including EEG, EOG, ECG and respiratory signals, which are then used as an aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians. The Somté PSG device consists of two components permanently connected by a cable: the Patient Input Box (PIB) and the Recorder. The Somté PSG device is powered by 2 AA Batteries - Alkaline or NiMh.

AI/ML Overview

Acceptance Criteria and Device Performance for SOMTÉ PSG SYSTEM (K072201)

The provided 510(k) summary for the Compumedics SOMTÉ PSG SYSTEM primarily focuses on demonstrating substantial equivalence to predicate devices through a detailed comparison of technological characteristics and successful completion of various tests. It does not explicitly state specific quantifiable acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity for a particular sleep disorder). Instead, the performance validation relies on demonstrating the device's ability to accurately record and process physiological signals comparable to the predicate devices and conform to relevant safety and electromagnetic compatibility standards.

Therefore, the "acceptance criteria" can be inferred from the nature of the tests conducted and the general objective of demonstrating substantial equivalence for a medical device that aids in diagnosis.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Safety: Device meets international safety standards to prevent harm to users and environment. (IEC 60601-1)	Successfully completed Safety Tests to conform to IEC 60601-1.
Electromagnetic Compatibility: Device does not introduce intolerable magnetic disturbances and operates reliably within its electromagnetic environment. (IEC 60601-1-2)	Successfully completed Electromagnetic Compatibility Tests to IEC 60601-1-2.
Functional Performance Validation: Device accurately captures and processes physiological parameters as intended for sleep disorder diagnosis, comparable to predicate devices.	"Performance Validation was conducted, results were recorded and an internal and external Sleep authority generated a Somté PSG Performance Validation Report." Specific reports cited: AC550-01 Woody Clinical Validation Report, AD052-01 Vampire Heart Rate Verification Report and AC551-01 Report to EN60601-1-4 for Woody-Somte PSG.
Hardware, Software, and Firmware Compliance: Device components conform to design requirements.	Compliance tested to hardware, software, and firmware test specifications.
Substantial Equivalence: Device's technological characteristics and intended use are comparable to legally marketed predicate devices, posing no new safety or effectiveness concerns.	Demonstrated through a comprehensive comparative table and discussion with predicate devices (Compumedics Sleep Monitoring System K955841, Compumedics Somté Recording System K021176).

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

The document does not explicitly state the sample size for the test set used in the performance validation. It refers to a "Performance Validation Report" which would contain this information.

The data provenance is implicitly from "an internal and external Sleep authority" who generated the validation report. There is no mention of country of origin or whether the study was retrospective or prospective.

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

The document states, "an internal and external Sleep authority generated a Somté PSG Performance Validation Report."

Number of Experts: Not explicitly stated, but it implies at least two ("internal and external Sleep authority").
Qualifications of Experts: The term "Sleep authority" suggests expertise in sleep medicine, likely physicians qualified in sleep disorder diagnosis. No specific details like years of experience or board certifications are provided in this summary.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the performance validation. It simply mentions that a "Sleep authority" generated the validation report, implying their expert opinion served as the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed in the context of comparing human readers with and without AI assistance. The device in question is a physiological signal recording system, not an AI-powered diagnostic algorithm designed to assist human readers. Its purpose is to collect data for human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Somté PSG System is a data acquisition system, not a standalone diagnostic algorithm. While it collects data for analysis (which can be computer-assisted or manual), its primary function is accurate signal recording. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop directly assisting diagnosis does not apply in the typical sense for this device. Its performance validation is focused on the accuracy of data acquisition and signal processing.

7. The Type of Ground Truth Used

The ground truth for the performance validation was established by "an internal and external Sleep authority" as part of a "Clinical Validation Report." This indicates that the ground truth was based on expert consensus/clinical judgment from sleep experts, likely comparing the device's recorded signals and derived parameters against established clinical standards or other validated PSG systems. The "Vampire Heart Rate Verification Report" suggests physiological signal accuracy verification, which would use known physiological measurements as a reference.

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning components for which a training set would be required. The Somté PSG System is a medical device for acquiring physiological signals, not an AI/ML diagnostic algorithm.

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

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable to the information provided.

Summary

{0}------------------------------------------------

K072201
page 1 of 5

4 510(k) SUMMARY

APR 1 4 2008

In accordance with 21 CFR 807.92, the following information constitutes the Compumedics Pty Ltd summary for the SOMTÉ PSG SYSTEM.

SUBMITTER'S NAME:	Compumedics Pty Ltd
ADDRESS:	30-40 Flockhart Street,Abbotsford, Victoria, 3067Australia
CONTACT PERSON:	Gordon Ferguson
TELEPHONE NUMBER:	+61 3 8420 7300
FAX NUMBER:	+61 3 8420 7399
DATE OF SUBMISSION:	3May07

1. Identification of device

Proprietary Name:
Common Name:
Classification Status:
Product Codes:

Compumedics Somté PSG System SOMTE PSG SYSTEM Class II per regulations 868.2375 MINR

2. Predicate devices

Compumedics Limited believes the SOMTÉ PSG SYSTEM is substantially equivalent to:

Device name:	Compumedics Sleep Monitoring System
Supplier:	Compumedics Limited
510(k) number:	K955841.
Device name:	Compumedics Somté Recording System
Supplier:	Compumedics Limited
510(k) number:	K021176.

Description of the Device 3.

The Somté PSG device consists of two components permanently connected by a cable: the Patient Input Box (PIB) and the Recorder. The Somté PSG device is powered by 2 AA Batteries - Alkaline or NiMh.

{1}------------------------------------------------

4. Intended use

The Somté PSG is intended for use by or under the direction of physicians in private practices or hospital environments to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders.

: :

Technological characteristics, comparison to predicate device. 5.

COMPARATIVE TABLE

Characteristic	CompumedicsSomté PSGRecording System	CompumedicsP-SeriesSleep MonitoringSystem(predicate device)	CompumedicsSomté RecordingSystem(predicate device)
Intended Use	Sleep/Respiratoryrecording andanalysis,Ambulatory ECGrecording andanalysis	Sleep/Respiratoryrecording andanalysis	Sleep/Respiratoryrecording andanalysis,Ambulatory ECGrecording andanalysis
510(k) number		K955841	K021176
Environmental	5 to 45 deg C20 to 90 % relativehumidityless than 3000maltitude	0 to 45 deg C30 to 95% relativehumidityless than 3000maltitude	0 to 45 deg C30 to 95% relativehumidityless than 3000maltitude
Local User Interface	Monochrome graphicLCD, 3 push buttons	Monochrome graphicLCD, 3 push buttons	Monochrome graphicLCD, 3 push buttons
Physicaldimensions	Recorder:113x65x30mmPIB: 53 x 133 x 25mm	Recorder:240x120x58mmPIB: 127x66x27mm	Recorder:116x65x30mmPIB: 78 x 45 x 22mm
Weight	270 grams (includingbatteries)	1570 grams(including battery)	250 grams (includingbatteries)
Number of PatientsCan RecordSimultaneously	1 per Unit2 Units per PC	1 per Unit2 Units per PC	1 per Unit
Portable Design	Yes	Yes	Yes
Patient worn device	Yes	Yes	Yes
Main Recording unit	Yes	Yes	Yes
Patient InterfaceBox	Yes	Yes	Yes
Use for in-labmonitored studies	Yes	Yes	No
Use for ambulatorystudies at home	Yes	Yes	Yes
GeneralFunctionalities:
Data Collection	Yes	Yes
Displays Raw Dataduring Recording	Yes, PC during in-labuse, or LCD on unit	Yes, PC during in-labuse, or LCD on unit	Yes, on LCD on unit
Built in Display forwaveform preview	Yes - Integrated LCDincluding fulldisclosure waveformpreview	Yes - IntegratedLCD including fulldisclosure waveformpreview	Yes - LCD
Characteristic	CompumedicsSomté PSGRecording System	CompumedicsP-SeriesSleep MonitoringSystem(predicate device)	CompumedicsSomté RecordingSystem(predicate device)
Data display on PCfor interpretation	Yes, during or afterrecording	Yes, during or afterrecording	Yes, after recordingonly
Data Analysis	Optional	Optional	Optional
Report Generation	Optional	Optional	Optional
Capable of DataTransfer forAnalysis and ReportGeneration	Yes	Yes	Yes
Data Inputs	Generic and customsensors. Data inputsas listed below	Generic and customsensors. Data inputsas listed below	Generic and customsensors. Data inputsas listed below
Signal Conditioning	Yes	Yes	Yes
Data Analysis(Computer,Computer-Assistedor manual).	Optional	Optional	Optional
ComprehensiveReport Generation	Optional	Optional	Optional
Remote SleepSurveillance	Yes, via broadband	Yes, via dial-up	No
Remote Capabilityto Monitor LeadQuality	Yes	Yes	No
Remote Capabilityto MonitorRecordingParameters	Yes	Yes	No
LookForward/WatchBack Display	Yes	Yes	No
Data Recorded:
# Channels of DataRecorded	Up to 19	Up to 18	Up to 13
Respiratory EffortChannels	2 Inductiveplethysmography	2 Inductiveplethysmography	2 Inductiveplethysmography
Airflow	1 Nasal Cannula	1 Nasal Cannula	1 Nasal Cannula
Pressure	1 Nasal Cannula	1 Nasal Cannula	1 Nasal Cannula
SnoreBody Position	From Cannula1 built in	From Microphone1	From Cannula1
SaO2	Yes	Yes	Yes
Heart Rate	Yes	Yes	Yes
Pulse Wave	Yes	No	Yes
Oximeter status(signal quality)	Yes	Yes	Yes
ECG Channels	Up to 2	1	Up to 2
EEG Channels	2 or 3	Up to 2	Up to 2
Chin EMG	Up to 2	1	Up to 2
Diaphragmatic EMG	Up to 1	optional	Up to 2
EOG	2	2	Up to 2
Leg Movement	Yes 2 Piezo Electric	Yes 2 Piezo Electric	Yes 2 Piezo Electric
Characteristic	CompumedicsSomté PSGRecording System	CompumedicsP-SeriesSleep MonitoringSystem(predicate device)	CompumedicsSomté RecordingSystem(predicate device)
Aux AC	1 (or DC)	1	No
Aux DC	1 (or AC)	option	No
Impedance Check	Yes	Yes	No
Power Source	2 AA Batteries –Alkaline or NiMh	7.2V NiMh	2 AA Batteries –Alkaline or NiMh
Maximum recordingduration	30 hours	15 hours	30 hours
Storage Media	CF Card up to 2Gb	CF Card up to128Mb	CF Card up to 2Gb
Channel SamplingRates	1-1024 Hz channeldependent	1-256 Hz channeldependent	1-1024 Hz channeldependent
Channel StorageRates	1-256 Hz channeldependent	1-256 Hz channeldependent	1-256 Hz channeldependent
A/D VerticalResolution (in Bits)	16	8 or 12	16
Average study sizeper 8 hour study	100Mb	30Mb	42Mb
Ability to calibrateDC channels	Yes	Yes	Yes
Communications toPC	IrDA & Bluetooth	Comms port	Not applicable
When used forECG:
Number of ECGchannels	1 or 2	Not applicable	1 or 2
Sensors	Standard ECGelectrodes	Not applicable	Standard ECGelectrodes
Sample rate	1024	Not applicable	1024
Recording rate	256	Not applicable	256
Frequencyresponse	0.048Hz to 102Hz(-3dB)	Not applicable	0.05Hz to 100Hz(-3dB)
Full scale range	10mV p-p	Not applicable	10mV p-p
ECG analysissoftware	Somté ECG AnalysisV1.02	Not applicable	Somté ECG AnalysisV1.02

{2}------------------------------------------------

{3}------------------------------------------------

・

{4}------------------------------------------------

6. Discussion of performance testing.

An extensive collection of tests has been conducted and successfully completed, including:

Safety Tests to conform to IEC 60601-1, to ensure that there is no A potential for detrimental effects on patients, other persons, animals or the surroundings. (refer to IEC60601-1 rpt-46275.1-6Dec06-SomtePSG-IEC60601-1 rpt). - refer to Attachment F.
A Electromagnetic Compatability Tests to IEC 60601-1-2 to ensure no intolerable magnetic disturbances are introduced into its electromagnetic environment. (refer to IEC60601-1-2 rpt-M060825-21Sep06-SomtePSG-IEC60601-1-2 rpt). - refer to Attachment F.
Performance Validation was conducted, results were recorded and an A internal and external Sleep authority generated a Somté PSG Performance Validation Report (refer to AC550-01 Woody Clinical Validation Report, AD052-01 Vampire Heart Rate Verification Report and AC551-01 Report to EN60601-1-4 for Woody-Somte PSG). ). refer to Attachment D.
ﺮ ﺍﻟﻤﺮﺍﺟﻊ Compliance tested to hardware, software and firmware test specifications to ensure conformance to all design requirements. ). refer to Attachments C & D.

7. Conclusion

Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of Compumedics Limited that the SOMTE PSG SYSTEM is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gordon Ferguson Compumedics Pty Limited 30-40 Flockhart Street Abbotsford, Victoria 3067 AUSTRALIA

APR 1 4 2008

Rc: K072201

Trade/Device Name: Somté PSG System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: April 10, 2008 Received: April 11, 2008

Dear Mr. Ferguson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{6}------------------------------------------------

Page 2 - Mr. Ferguson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutte Y. Michael Davis

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

3 STATEMENT OF INDICATIONS FOR USE

510(k) Number: K072201

Device Name: SOMTÉ PSG SYSTEM

Indications for Use:

The Somté PSG is designed for ambulatory and mobile operation and can be used in either the patient's home, the hospital or other environments, thus enabling patients to be investigated under as realistic conditions as possible. The Somté PSG is only to be used under the direction of a

Prescription Use
(Per 21 CFR 801 Subpart D)

physician.

AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. N.

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

510(k) Number:

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

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