COMPUMEDICS SUMMIT IP

K040194 · Compumedics USA, Ltd. · MNR · Apr 23, 2004 · Anesthesiology

Device Facts

• Record ID: K040194
• Device Name: COMPUMEDICS SUMMIT IP
• Applicant: Compumedics USA, Ltd.
• Product Code: MNR · Anesthesiology
• Decision Date: Apr 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

The Summit IP is intended for use in private practices or hospital environments for the detection of human respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. Signals from patient worn thoracic and abdominal sensors are demodulated, amplified and summed to provide electrical signals suitable for connection to the inputs of physiological recording equipment. The Summit IP unit is only to be used under the direction and supervision of a physician. The Summit IP unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units. The Summit IP unit is not intended for use on infant or pediatric patients.

Device Story

Device is a respiratory effort module for sleep studies; inputs are thoracic and abdominal respiratory effort bands. Device demodulates, amplifies, and sums signals; produces three output channels (thoracic, abdominal, and weighted sum) for connection to external physiological recording equipment. Used in hospitals or private practices under physician supervision. Operates via 1.5V battery; automatically activates upon sensor connection. Sum channel output assists clinicians in identifying paradoxical (out-of-phase) respiratory effort. Benefits patient by facilitating diagnostic data collection for sleep-related respiratory disorders.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through safety testing to IEC60601-1, electromagnetic emission/immunity testing to IEC60601-1-2, and compliance with CDRH guidance for lead wires and patient cables. Hardware and firmware verified against design requirements.

Technological Characteristics

Small plastic enclosure; 2 input sockets for respiratory effort bands; 3 output channels (1.5mm touch-proof connectors). Powered by 1.5V user-replaceable alkaline battery. Sensing principle: linear response to stretch. Connectivity: analog output to external physiological recorders. Firmware-controlled calibration and status monitoring via 3 LEDs. Dimensions: 59x41x21mm.

Indications for Use

Indicated for adult patients undergoing sleep disorder studies to assist in the diagnosis of sleep-related respiratory disorders. Not for use on infant or pediatric patients or as life support/vital signs monitoring in intensive care units.

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

• Synchrony™ summing amplifier (K013905)
• Compumedics Somté System (K021176)

Submission Summary (Full Text)

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# APR 2 3 2004

## SECTION 4. 510(k) SUMMARY

In accordance with 21 CFR 807.92, the following information constitutes the Compurnedics Limited summary for the Compumedics Summit IP.

SUBMITTER'S NAME: Compumedics Limited

ADDRESS:

7850 Paseo del Norte El Paso, TX 79912 USA

Elvira Garcia

915-225-0303

915-845-2965

January 22, 2004

CONTACT PERSON: TELEPHONE NUMBER: FAX NUMBER: DATE OF SUBMISSION:

#### 1. Identification of device

| Proprietary name: | Compumedics Summit IP |
|----------------------|-----------------------------------|
| Common name: | respiratory effort module |
| Classification name: | Ventilatory Effort Recorder |
| Class: | Class II per regulations 868.2375 |
| Product Code: | MNR |

#### 2. Predicate devices

Compumedics Limited believes the Compumedics Summit IP is substantially equivalent to:

| Device name: | Synchrony™ summing amplifier |
|----------------|------------------------------|
| Supplier: | Pro-Tech Services, Inc. |
| 510(k) number: | K013905 |

The sensors used by the Summit IP are identical to those used by the respiratory effort part of the Compumedics Somté System.

Device name: Compumedics Somté System Supplier: Compumedics Limited 510(k) number: K021176

#### 3. Description of the Device

The Compumedics Summit IP consists of a small plastic enclosure with two input sockets for connection to Compumedics respiratory effort bands (Thoracic and Abdominal), and output sockets for the Thoracic, Abdominal and Sum channels. The Sum channel is a weighted surn of the Thoracic and Abdominal signals. The output channels may be connected to the inputs of standard physiological equipment for the purpose of recording or monitoring respiratory effort.

The Summit IP is powered by a user-replaceable 1.5 volt battery and automatically switches on when any or both sensors are connected.

### 4. Intended Use

The Summit IP is intended for use in private practices or hospital environments for the detection of human respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. Signals from patient worn thoracic and abdominal sensors are demodulated, amplified and summed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.

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The Summit IP unit is only to be used under the direction and supervision of a physician.

The Summit IP unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units.

The Summit IP unit is not intended for use on infant or pediatric patients.

·

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### Technical characteristics, comparison to predicate device ട.

| Characteristic | Compumedics Summit IP | Pro-Tech Synchrony™ Summing Amplifier |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Intended Use | Intended for use during sleep<br>disorder studies to acquire<br>respiratory effort suitable for<br>recording using a physiological<br>recorder for diagnostic<br>purposes. | same |
| Number of inputs | 2 | same |
| Sensor location | Around thorax and abdomen | same |
| Sensor type | Linear response to stretch | same |
| Output channels | 3 (thoracic, abdominal, sum) | same<br>(Qsum is name of sum channel) |
| Output connectors | 1.5mm touch-proof safety<br>connectors | same |
| Output Signal size, typical | 1mVpp for all channels | 0.6mVpp for thoracic and<br>abdominal, 1.2mVpp for Qsum |
| Equipment outputs to be<br>connected to | Physiological recorder | same |
| Physiological recorder high<br>pass frequency | <0.3Hz | same |
| Physiological recorder low<br>pass frequency | 5Hz to 20 Hz | 5Hz to 15Hz |
| Function of sum channel | To more easily identify thoracic<br>and abdominal effort signals<br>that are out of phase<br>(paradoxical) | same |
| Power | Internal 1.5V alkaline battery,<br>user replaceable | Internal 3.6V lithium battery, not<br>user replaceable |
| Controls | None | One, cal switch |
| Indicators | 3 (red, amber, green) LEDs | 1 bicolor(red/green) LED |
| Indicator functions | Calibration, battery condition,<br>operating status | Calibration, battery condition |
| Method of reducing battery<br>consumption when not in use | Disconnection of sensors | same |
| Calibration initiation | Automatic after connection of<br>both sensors | Press red "cal" button |
| Maximum calibration time | 10 minutes | 3 minutes |
| Calibrating indication | Fast Flashing Green LED | Green LED |
| Failed calibrating indication | Flashing Amber LED | Red LED |
| Purpose of calibration | Measure amplitudes of<br>Thoracic and Abdominal<br>signals to set mix of these<br>signals used by Sum channel | Same |
| Operating indication | Slow flashing Green LED | none |
| Size, mm | 59 L x 41 W x 21 H | 70 L x 51 W x 20 H |

### COMPARATIVE TABLE

### NOTE

There is no comparative table for the respiratory effort sensors used in the Compumedics Somté System, K021176, as the sensors used by Summit IP are identical.

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### Discussion of performance testing 6.

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

Safety tests to IEC60601-1 (1988 +A1:1999+ A2:1995), Medical Electrical Equipment, Safety tests to iEO000 >> (role to ensure there are no detrimental effects on patients, operators or the surrounding environment.

Electromagnetic emission tests to JEC60601-1-2 (2001) Medical Electrical Equipment, Electromagnetic emission tests to fE06001 + + 2 = 0 = Flectromagnetic compatibility – General Nequirements for Salety, on intolerable electromagnetic disturbances are introduced to the environment.

Electromagnetic immunity tests to IEC60601-1-2 to ensure safe and effective operation in the presence of electromagnetic interference.

Safety tests to U.S. and Canadian deviations from IEC60601-1.

Cables and leads confirm to CDRH Guidance Document on the "Performance Standard for Lead Wires and Patient Cables" March 9 1998.

Compliance tested to hardware and firmware test specifications to ensure conformance to all design requirements.

#### Conclusion 7.

Based on extensive performance testing and comparison to the predicate device, it is Based on extensive performance tooting that the Compumedics Summit IP is the conclusion of Ocumpanouse = already on the market (cleared by the 510(k) substantially equivalient to do noon concerns about safety and effectiveness.

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Image /page/4/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. Inside the circle is an abstract image of an eagle or other bird-like figure.

### Public Health Service

APR 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elvira Garcia Compumedics USA, LTD. 7850 Paseo Del Norte El Paso, Texas 79912

K040194 Rc:

Trade Name: Compumedics Summit IP Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: March 31, 2004 Received: April 1, 2004

Dear Ms. Garcia:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your secures is see is substantially equivalent (for the referenced above and have determined the ta heally marketed predicate devices marketed in indications for use stated in all 28, 1976, the enactment date of the Medical Device interstate connitetee pror to that have been reclassified in accordance with the provisions of Amendments, of to devices that have been rockers to not require approval of a premarket the Federal Food, Drug, and Cosment Tre (res) ................................................................................................................................ approval appreation (1 Mr.). I The general controls provisions of the Act include confors provisions of the Fiel. "The given of devices, good manufacturing practice, requirements prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Spccial Controls) or class III If your device is classified (see ao) into seating major regulations affecting (PMA), it may be subject to suen additions, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.

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### Page 2 - Ms. Garcia

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled of a bases and its with other requirements mean that FDA has made a decembination administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other started to registratio of the Act of ally rederal statutes and regulations, but not limited to: registration You must comply with an the Fee brequire of the Part 801); good manufacturing practice and ifsung (21 CFR Pat 607), laoolity systems (QS) regulation (21 CFR Part 820); and if requirements as sectionin the quality bystems (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) This letter whi anow you to begin mationing your device of your device to a premarket notification. The PDF Imaling or celessification 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), If you desire specific advice to: your de records of the splease note the regulation in please contact the Other or Comphanes are (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miorination on Journational and Consumer Assistance at its toll-free Division of Di638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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# SECTION 3. STATEMENT OF INDICATION FOR USE

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Device Name: Compumedics Summit IP

Indications for use:

The Summit IP is intended for use in private practices or hospital environments for the The Summit IP is intended for use in private practiced is of sleep disorders of sleep disorders of sleep detection of numan respiratory offert to assist in worn thoracic and abdominal sensors
related respiratory disorders. Signals from patient worn is note with work with he for related respiratory disorders. Bignals from partical signals suitable for are demodulated, anputs of physiological recording equipment.

The Summit IP is only to be used under the direction and supervision of a physician.

The Summit IP unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units.

The Summit IP unit is not intended for use on infant or pediatric patients

(Please do not write bclow this line – continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

Cinh

510(k) Number: K040194