COMPUMEDICS SOMTE PSG RECORDING SYSTEM

K072201 · Compumedics Limited · MNR · Apr 14, 2008 · Anesthesiology

Device Facts

• Record ID: K072201
• Device Name: COMPUMEDICS SOMTE PSG RECORDING SYSTEM
• Applicant: Compumedics Limited
• Product Code: MNR · Anesthesiology
• Decision Date: Apr 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

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 Story

Somté PSG System records, displays, and analyzes physiological signals including EEG, EOG, ECG, respiratory effort, airflow, and body position. Device consists of a Patient Input Box (PIB) and a Recorder connected by cable; powered by 2 AA batteries. Used in clinical or home settings by physicians or trained staff to aid in diagnosing sleep disorders. Data is stored on CF cards (up to 2GB) and transferred to a PC for review, analysis, and report generation via Somté ECG Analysis software. Remote surveillance capabilities allow monitoring of lead quality and recording parameters via broadband. Provides objective physiological data to assist clinicians in diagnostic decision-making, enabling investigation under realistic patient conditions.

Clinical Evidence

Bench testing only. Performance validation included internal and external sleep authority review (Woody Clinical Validation Report, Vampire Heart Rate Verification Report). Compliance testing performed for hardware, software, and firmware against design requirements. Safety and electromagnetic compatibility testing conducted per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Portable, battery-powered (2 AA) system with Patient Input Box and Recorder. Features monochrome graphic LCD with 3 push buttons. Supports up to 19 channels; 16-bit A/D resolution. Connectivity via IrDA and Bluetooth. Storage on CF card (up to 2GB). Sampling rates 1-1024 Hz. Software-based analysis for ECG and sleep parameters.

Indications for Use

Indicated for patients requiring diagnostic investigation of sleep disorders or sleep-related respiratory or cardiac disorders. Used in hospital or home environments under physician direction.

Regulatory Classification

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.

Predicate Devices

• Compumedics Sleep Monitoring System (K955841)
• Compumedics Somté Recording System (K021176)

Submission Summary (Full Text)

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K072201
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# 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,<br>Abbotsford, Victoria, 3067<br>Australia |
| CONTACT PERSON: | Gordon Ferguson |
| TELEPHONE NUMBER: | [phone] |
| FAX NUMBER: | [phone] |
| 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 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.

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# 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.

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# Technological characteristics, comparison to predicate device. 5.

# COMPARATIVE TABLE

| Characteristic | Compumedics<br>Somté PSG<br>Recording System | Compumedics<br>P-Series<br>Sleep Monitoring<br>System<br>(predicate device) | Compumedics<br>Somté Recording<br>System<br>(predicate device) |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended Use | Sleep/Respiratory<br>recording and<br>analysis,<br>Ambulatory ECG<br>recording and<br>analysis | Sleep/Respiratory<br>recording and<br>analysis | Sleep/Respiratory<br>recording and<br>analysis,<br>Ambulatory ECG<br>recording and<br>analysis |
| 510(k) number | | K955841 | K021176 |
| Environmental | 5 to 45 deg C<br>20 to 90 % relative<br>humidity<br>less than 3000m<br>altitude | 0 to 45 deg C<br>30 to 95% relative<br>humidity<br>less than 3000m<br>altitude | 0 to 45 deg C<br>30 to 95% relative<br>humidity<br>less than 3000m<br>altitude |
| Local User Interface | Monochrome graphic<br>LCD, 3 push buttons | Monochrome graphic<br>LCD, 3 push buttons | Monochrome graphic<br>LCD, 3 push buttons |
| Physical<br>dimensions | Recorder:113x65x30<br>mm<br>PIB: 53 x 133 x 25<br>mm | Recorder:<br>240x120x58mm<br>PIB: 127x66x27mm | Recorder:116x65x30<br>mm<br>PIB: 78 x 45 x 22<br>mm |
| Weight | 270 grams (including<br>batteries) | 1570 grams<br>(including battery) | 250 grams (including<br>batteries) |
| Number of Patients<br>Can Record<br>Simultaneously | 1 per Unit<br>2 Units per PC | 1 per Unit<br>2 Units per PC | 1 per Unit |
| Portable Design | Yes | Yes | Yes |
| Patient worn device | Yes | Yes | Yes |
| Main Recording unit | Yes | Yes | Yes |
| Patient Interface<br>Box | Yes | Yes | Yes |
| Use for in-lab<br>monitored studies | Yes | Yes | No |
| Use for ambulatory<br>studies at home | Yes | Yes | Yes |
| General<br>Functionalities: | | | |
| Data Collection | Yes | Yes | |
| Displays Raw Data<br>during Recording | Yes, PC during in-lab<br>use, or LCD on unit | Yes, PC during in-lab<br>use, or LCD on unit | Yes, on LCD on unit |
| Built in Display for<br>waveform preview | Yes - Integrated LCD<br>including full<br>disclosure waveform<br>preview | Yes - Integrated<br>LCD including full<br>disclosure waveform<br>preview | Yes - LCD |
| Characteristic | Compumedics<br>Somté PSG<br>Recording System | Compumedics<br>P-Series<br>Sleep Monitoring<br>System<br>(predicate device) | Compumedics<br>Somté Recording<br>System<br>(predicate device) |
| Data display on PC<br>for interpretation | Yes, during or after<br>recording | Yes, during or after<br>recording | Yes, after recording<br>only |
| Data Analysis | Optional | Optional | Optional |
| Report Generation | Optional | Optional | Optional |
| Capable of Data<br>Transfer for<br>Analysis and Report<br>Generation | Yes | Yes | Yes |
| Data Inputs | Generic and custom<br>sensors. Data inputs<br>as listed below | Generic and custom<br>sensors. Data inputs<br>as listed below | Generic and custom<br>sensors. Data inputs<br>as listed below |
| Signal Conditioning | Yes | Yes | Yes |
| Data Analysis<br>(Computer,<br>Computer-Assisted<br>or manual). | Optional | Optional | Optional |
| Comprehensive<br>Report Generation | Optional | Optional | Optional |
| Remote Sleep<br>Surveillance | Yes, via broadband | Yes, via dial-up | No |
| Remote Capability<br>to Monitor Lead<br>Quality | Yes | Yes | No |
| Remote Capability<br>to Monitor<br>Recording<br>Parameters | Yes | Yes | No |
| Look<br>Forward/Watch<br>Back Display | Yes | Yes | No |
| Data Recorded: | | | |
| # Channels of Data<br>Recorded | Up to 19 | Up to 18 | Up to 13 |
| Respiratory Effort<br>Channels | 2 Inductive<br>plethysmography | 2 Inductive<br>plethysmography | 2 Inductive<br>plethysmography |
| Airflow | 1 Nasal Cannula | 1 Nasal Cannula | 1 Nasal Cannula |
| Pressure | 1 Nasal Cannula | 1 Nasal Cannula | 1 Nasal Cannula |
| Snore<br>Body Position | From Cannula<br>1 built in | From Microphone<br>1 | From Cannula<br>1 |
| SaO2 | Yes | Yes | Yes |
| Heart Rate | Yes | Yes | Yes |
| Pulse Wave | Yes | No | Yes |
| Oximeter status<br>(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 | Compumedics<br>Somté PSG<br>Recording System | Compumedics<br>P-Series<br>Sleep Monitoring<br>System<br>(predicate device) | Compumedics<br>Somté Recording<br>System<br>(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 –<br>Alkaline or NiMh | 7.2V NiMh | 2 AA Batteries –<br>Alkaline or NiMh |
| Maximum recording<br>duration | 30 hours | 15 hours | 30 hours |
| Storage Media | CF Card up to 2Gb | CF Card up to<br>128Mb | CF Card up to 2Gb |
| Channel Sampling<br>Rates | 1-1024 Hz channel<br>dependent | 1-256 Hz channel<br>dependent | 1-1024 Hz channel<br>dependent |
| Channel Storage<br>Rates | 1-256 Hz channel<br>dependent | 1-256 Hz channel<br>dependent | 1-256 Hz channel<br>dependent |
| A/D Vertical<br>Resolution (in Bits) | 16 | 8 or 12 | 16 |
| Average study size<br>per 8 hour study | 100Mb | 30Mb | 42Mb |
| Ability to calibrate<br>DC channels | Yes | Yes | Yes |
| Communications to<br>PC | IrDA & Bluetooth | Comms port | Not applicable |
| When used for<br>ECG: | | | |
| Number of ECG<br>channels | 1 or 2 | Not applicable | 1 or 2 |
| Sensors | Standard ECG<br>electrodes | Not applicable | Standard ECG<br>electrodes |
| Sample rate | 1024 | Not applicable | 1024 |
| Recording rate | 256 | Not applicable | 256 |
| Frequency<br>response | 0.048Hz to 102Hz<br>(-3dB) | Not applicable | 0.05Hz to 100Hz<br>(-3dB) |
| Full scale range | 10mV p-p | Not applicable | 10mV p-p |
| ECG analysis<br>software | Somté ECG Analysis<br>V1.02 | Not applicable | Somté ECG Analysis<br>V1.02 |

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#### 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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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# 3 STATEMENT OF INDICATIONS FOR USE

510(k) Number: K072201

Device Name: SOMTÉ PSG SYSTEM

Indications for Use:

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

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: