COMPASS M10 SYSTEM

K041724 · Medcare Flaga · MNR · Sep 28, 2004 · Anesthesiology

Device Facts

• Record ID: K041724
• Device Name: COMPASS M10 SYSTEM
• Applicant: Medcare Flaga
• Product Code: MNR · Anesthesiology
• Decision Date: Sep 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the Compass M10 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 M10 system is intended to be used for adult and pediatric patients.

Device Story

Ambulatory, battery-powered digital recorder; captures thoracic/abdominal respiratory effort, body position, movement (actigraphy), and optional blood oxygen saturation (oximetry) during sleep. System includes recording unit, signal adapter, respiratory sensors, and USB interface for PC-based Compass application. Physician/technician uses application to prepare device, download data, and review automated scan results. Software scans signals for abnormalities, generating summary report of event counts; clinician may manually overwrite or correct findings. Output assists in screening patients for further clinical polysomnography evaluation. Not intended for real-time monitoring or standalone diagnosis.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Pocket-sized, battery-powered digital recorder. Inputs: two respiratory channels (thoracic/abdominal), body position/actigraph sensor, optional oximeter. Connectivity: USB for data download to PC. Software: Compass application for data preparation, analysis, and reporting. No specific materials or sterilization standards cited.

Indications for Use

Indicated for adult and pediatric patients as a sleep screening device to record physiological signals, scan for abnormalities, and report event counts to determine the need for formal polysomnography diagnosis. Not for use as a monitor or diagnostic tool.

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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K041724

# Medcare

SEP 2 8 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

June 17, 2004

### Device

Trade Name: Classification Name: Regulation Number: Product Code: Device Class: Classification Panel:

Compass M10 system Ventilatory Effort Recorder 868.2375 MNR Class II 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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# Medcare

### Device Description

The Compass M10 system is an ambulatory recording system. It includes a recording device, a signal adapter, respiratory effort sensors, strap system for attaching of recording device to a patient, an USB cable for data download and the Compass application.

The Compass M10 device is a pocket size battery powered digital recorder that incorporates electronics to record and store one night of physiological parameters. It has two respiratory channels for measurement of thoracic and abdominal movements 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 M10 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 M10 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 M10 system has no significant differences from the predicate devices that would adversely affect product safety and effectiveness.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2004

Mr. Berglind Hallgrímsdóttir Quality Manager Medcare Flaga Sidumuli 24 108 Reykjavik Iceland EUROPE

Re: K041724

Trade/Device Name: Compass M10 System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: September 10, 2004 Received: September 15, 2004

Dear Mr. Hallgrímsdóttir:

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. Hallgrímsdóttir

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,

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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### Indication for Use

510(k) Number (if known): K041724

Device Name: Compass M10 System

Indications For Use:

The intended use of the Compass M10 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 M10 system 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)

Cunnyhrom

(Division Sign-Off Division of Anesthesionogy, General Hospital, Infection Control. Dental Devices

510(k) Number ._

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