COMPASS F10 SYSTEM

K041904 · Medcare Flaga · MNR · Sep 7, 2004 · Anesthesiology

Device Facts

• Record ID: K041904
• Device Name: COMPASS F10 SYSTEM
• Applicant: Medcare Flaga
• Product Code: MNR · Anesthesiology
• Decision Date: Sep 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The intended use of the Compass F10 system is to record physiological signals during sleep, scan the signals for abnormalities and represent the count of abnormal events in a form of a summary report. The results of the scan may be manually overwritten or corrected by the physician. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's count of abnormal events. It is not intended for any diagnosis. It is not intended to be a monitor. The Compass F10 system is intended to be used for adult and pediatric patients.

Device Story

Compass F10 is an ambulatory, battery-powered digital recorder for overnight sleep studies. Inputs include nasal pressure/airflow, body position, actigraphy, and optional oxygen saturation (SpO2). Device stores data for download via USB to a PC. Compass application software processes recorded signals to automatically scan for and count abnormal respiratory events, generating a summary report. Physicians review, manually overwrite, or correct the automated analysis. Used as a screening tool to identify patients requiring formal polysomnography. Benefits include identifying potential obstructive sleep apnea (OSA) candidates in a home setting. Operation involves attaching the device to the patient via a strap system; data is analyzed by clinicians to inform clinical decision-making regarding further diagnostic testing.

Clinical Evidence

Bench testing and validation against manually scored full polysomnography (PSG) recordings. Study compared Compass F10 automated scoring to manual PSG scoring. Results: With oximeter, sensitivity 100%, specificity 87%, PPV 91.2%, NPV 100%, correlation 96.98%. Without oximeter, sensitivity 96.8%, specificity 82.6%, PPV 88.2%, NPV 95.0%, correlation 88.59%. Bland-Altman analysis showed high agreement with manual PSG. Performance compared favorably to ApLab predicate.

Technological Characteristics

Pocket-sized digital recorder; ABS plastic and aluminum construction; polyimide sensor adapter. Sensors: solid-state pressure, position/activity, optional oximetry. Power: 2 AA batteries. Connectivity: USB v1.1 for data transfer to PC. Software: Compass application for data preparation, download, and analysis. No galvanic connection to mains.

Indications for Use

Indicated for adult and pediatric patients requiring sleep physiological signal recording and screening for abnormal events to determine the need for clinical polysomnography diagnosis. Not for use as a diagnostic device or monitor.

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

• Embla N7000 (K024322)
• Rembrandt System (K962865)
• ApLab (K030379)

Submission Summary (Full Text)

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### SEP - 7 2004

#### 510(k) Summary

#### Submitter

Medcare Flaga Sidumuli 24 108 Reykjavik Iceland Europe

Tel: [phone] Fax: [phone]

Registration Number: 9611753

#### Contact person

Berglind Hallgrímsdóttir Email: [e-mail], [e-mail]

#### Preparation Date

July 9, 2004

#### Device

| Trade Name: | Compass F10 system |
|-----------------------|-----------------------------|
| Classification Name: | Ventilatory Effort Recorder |
| Regulation Number: | 868.2375 |
| Product Code: | MNR |
| Device Class: | Class II |
| Classification Panel: | Anesthesiology |

#### Predicate Devices

Embla N7000 from Medcare Flaga Product Code: MNR 510(k) Number: K024322

Rembrandt System from Medcare Flaga Product Code: FLS 510(k) Number: K962865

ApLab from Sector Medical Corp. Product Code: MNR 510(k) Number: K030379

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#### Device Description

The Compass F10 system is an ambulatory recording system. It includes a recording device, a signal adapter, strap system for attaching of recording device to a patient, an USB cable for data download and the Compass application.

The Compass F10 device is a pocket size battery powered digital recorder that incorporates electronics to record and store one night of physiological parameters. It has one respiratory channel for measurement of nasal pressure/airflow and a built-in body position and actigraph sensor for measurement of body position and movement. It also has an optional oximeter input to measure degree of oxygen saturation of the blood.

The Compass application provides the means to prepare the device for recording, download the recorded data, viewing and analyzing the recorded data on a PC.

#### Intended Use

The intended use of the Compass F10 system is to record physiological signals during sleep, scan the signals for abnormalities and represent the count of abnormal events in a form of a summary report. The results of the scan may be manually overwritten or corrected by the physician. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's count of abnormal events. It is not intended for any diagnosis. It is not intended to be a monitor.

The Compass F10 system is intended to be used for adult and pediatric patients.

#### Technological Characteristics

The comparison table is provided as a summary of the technological characteristics relative to the predicate devices. The summary demonstrates that the Compass F10 system has no significant differences from the predicate devices that would adversely affect product safety and effectiveness.

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| | Embla N7000 (K024322) | Rembrandt System (K962865) | ApLab (K030379) | Compass F10 system | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Number of acquisition units | Three units. | No hardware. | One unit. | One unit. | |
| Case | ABS Plastic (Patient Unit). | No hardware. | ABS Plastic. | ABS Plastic.<br>Aluminum. | |
| Sensor Adapter (Proxy) | Polyimide. | No hardware. | No proxy. | Polyimide. | |
| Dimension | 80mm (2.5") W, 111mm (4.9")H,<br>18.5mm(0.8") D (Patient Unit). | No hardware. | 81.3mm (3.2") W, 68.6mm (2.7")H,<br>25.9mm (1.02") D. | 65mm (2.5") W, 124mm (4.9")H,<br>20mm(0.8") D. | |
| Weight | 280g (Patient Unit). | No hardware. | 90.7g. | 100g. | |
| Power Source | 115/230V AC | No hardware. | 3V Lithium battery (Data Acquisition).<br>Host PC (Data Transfer). | 3V by 2 AA batteries (Data Acquisition).<br>Host PC (Data Transfer). | |
| Control | Data acquisition and data storage<br>microprocessor controlled.<br>Acquisition parameters set from<br>application SW. | Acquisition parameters set in<br>application SW.<br>No hardware. | Data acquisition and data storage<br>microprocessor controlled. | Data acquisition and data storage<br>microprocessor controlled.<br>Acquisition parameters set from<br>application SW. | |
| Data Interface | Ethernet. | No hardware. | USB v1.1. | USB v1.1. | |
| Patient isolation | Isolation between mains and applied<br>part. | No patient connection. | Device has no galvanic connections to<br>mains as it is a battery operated device.<br>Not possible to connect auxiliary devices<br>to the device. | Device has no galvanic connections to<br>mains as it is a battery operated device.<br>Not possible to connect auxiliary<br>devices to the device. | |
| Method of Connection to Patient | Elastic cloth material for support of<br>device.<br>RIP belts for respiratory effort.<br>Probes or Flexi Wrap for oximetry.<br>Plastic tubing and cannula for<br>pressure sensing.<br>Touch proof electrode cables.<br>Thermistor.<br>Snore Sensor. | No patient connection. | Elastic cloth material for support of<br>device.<br>Plastic tubing and cannula for pressure<br>sensing. | Elastic cloth material for support of<br>device.<br>Probes or Flexi Wrap for oximetry.<br>Plastic tubing and cannula for pressure<br>sensing. | |
| | Embla N7000 (K024322) | Rembrandt System (K962865) | ApLab (K030379) | Compass F10 system | |
| Single use | Disposable XactTrace Belts.<br>Flexi Wrap disposable.<br>Plastic cannula disposable.<br>Remaining portions require cleaning. | No hardware. | Plastic cannula and filter disposable.<br>Remaining portions require cleaning. | Flexi Wrap disposable.<br>Plastic cannula disposable.<br>Remaining portions require cleaning. | |
| Number of channels | Seven channels (Patient Unit).<br>40 channels (Bedside Unit).<br>Eight auxiliary channels (Communication Unit). | 8-64 channels. | One Channel. | Four channels. | |
| Signals recorded | Respiratory Effort (Abdomen and Thorax).<br>Body position.<br>Activity.<br>Oxygen Saturation.<br>Pulse<br>Nasal pressure.<br>Airflow.<br>Snore.<br>EEG, EOG, EMG, ECG. | Respiratory Effort (Abdomen and Thorax).<br>Body position.<br>Activity.<br>Oxygen Saturation.<br>Pulse<br>Nasal pressure.<br>Airflow.<br>Snore.<br>EEG, EOG, EMG, ECG.<br>Leg movement.<br>Upper airway resistance.<br>Body temperature.<br>Video.<br>No hardware. | Nasal Pressure. | Body position.<br>Activity.<br>Oxygen Saturation.<br>Pulse.<br>Nasal Pressure. | |
| Sensor Technology used in/with the system | Solid state pressure sensor.<br>Solid state position/activity sensor.<br>Respiratory Effort sensors based on respiratory inductive plethysmography.<br>Oximetry.<br>Thermistor.<br>Piezo snoring sensor.<br>Gold cup electrodes.<br>Ag/AgCL electrodes.<br>Piezobelts for respiratory effort. | No hardware. | Solid state pressure sensor. | Solid state pressure sensor.<br>Solid state position/activity sensor. | |
| Data validation | On-line in the application SW (not a part of the system).<br>Status light on Bedside Unit.<br>No software application. | On-line in the SW. | Visual verification of operating condition by light indicator on device. | Visual verification of the respiratory signals by light indicators on device. | |
| Operating System | No software application. | Microsoft Windows NT and 95. | Microsoft Windows ™ 2000 and XP. | Microsoft Windows™ 2000 and XP. | |
| Data review on screen | No software application. | Yes. | Yes. | Yes. | |
| | Embla N7000 (K024322) | lembrandt System (K962865<br>------------------------------------------------------------------------------------------------------------- | ApLab (K030379 | Compass F10 syste. | |
| Generate and<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>print of<br>reports | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>software application | (es. | .<br>Yes. | The Call Concession of Children Come of Children<br>(es. | |
| Patient data<br>entry | software application | es. | Yes. | Yes. | |
| Analysis | o software applicatior | Manual. | utomatic, result may be manipulated | utomatic, result may be manipulated | |

Medcare Flaga Sidumuli 24

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Medcare Flaga Sidumuli 24

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Medcare Flaga Sidumuli 24

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#### Testina

The Compass F10 system has been tested and verified in various phases, internal testing, verification and validation as well as external testing. The design was verified throughout the design process. Risk analysis was done, appropriate measures were implemented and their effectiveness verified. External test house, SEMKO, was used to confirm compliance to EMC requirements and standards for electrical safety.

#### Performance Data

The signals recorded with the Compass F10 system were compared to signals recorded with the predicate device Embla N7000 using the predicate Rembrandt software for review. The result demonstrates the reliability of all signals recorded with the Compass F10 system.

The Compass automatic scoring was compared to manually scored PSG to demonstrate the safety and effectiveness of the Compass automatic analysis. The validation data used was recorded with Embla N7000 using full polysomnography (PSG). The recordings were all hand scored by the same RPSG technician. The results are summarized in the following table:

| | Compass F10 + oximeter | Compass F10 (without oximeter) |
|-------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------|
| Sensitivity | 100% | 96.8% |
| Specificity | 87% | 82.6% |
| PPV | 91.2% | 88.2% |
| NPV | 100% | 95.0% |
| Correlation | 96.98% | 88.59% |
| Bland &<br>Altman | 95% confidence interval from -6.3 to<br>6.1 with an average of -0.1 | 95% confidence interval from -14.3 to<br>10.6 with an average of -1.8 |

The result summarized in the table above demonstrate that the Compass automatic scoring gives a good estimate of AHI values compared to manually scored AHI from a full Polysomnography. The results obtained when SpO2 data is present are significantly better than when SpO2 data is not present. The Compass F10 system, when used to distinguish between Normals and potential OSA's patient, performs very well in all cases.

The above performance test results were compared to a clinical study done with the predicate ApLab. In this study the ApLab automatic scoring was compared to a manually scored PSG. The clinical result show ApLab sensitivity of 89% compared to 100% for Compass F10 system with oximeter and 96.8% for Compass F10 system without oximeter.

#### Conclusion

The performance tests results confirm accuracy of the recorded data and the Compass automatic scoring. Based on the extensive testing, performance data and comparison to the predicate devices, it is the conclusion of Medcare Flaga that the Compass F10 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

Public Health Service

SEP = 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Berglind Hallgrimsdottir Quality Manager Medcare Flaga Sidumula 24 108 Reykjavik ICELAND

Re: K041904

Trade/Device Name: Compass F10 System Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: July 9, 2004 Received: July 15, 2004

Dear Mr. Hallgrimsdottir:

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. Hallgrimsdottir

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/dsma/dsmamain.html

Sincerely yours,

Charles

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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#### Indication for Use

510(k) Number (if known): K041904

Device Name: Compass F10 System

Indications For Use:

The intended use of the Compass F10 system is to record physiological signals during sleep, scan the signals for abnormalities and represent the count of abnormal events in a form of a summary report. The results of the scan may be manually overwritten or corrected by the physician. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's count of abnormal events. It is not intended for any diagnosis. It is not intended to be a monitor.

The Compass F10 device is intended to be used for adult and pediatric patients.

Prescription Use (Part 21 CFR 801 Subpart D) 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)

Aun C. Smlion

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

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510(k) Number: