(96 days)
No
The summary describes a device that records physiological signals and scans them for abnormalities, but it does not mention the use of AI, ML, or any related technologies in the scanning or analysis process. The analysis is described as a "scan" and the results can be manually overwritten, suggesting a rule-based or algorithmic approach rather than an AI/ML model.
No
The device is intended as a screening device to record physiological signals during sleep and determine the need for clinical diagnosis, but it is explicitly stated that "It is not intended for any diagnosis. It is not intended to be a monitor." and it does not treat or alleviate any condition.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not intended for any diagnosis." The device functions as a screening tool to determine the need for further clinical diagnosis.
No
The device description explicitly lists hardware components such as a recording device, signal adapter, sensors, strap system, and USB cable, in addition to the software application.
Based on the provided information, the Compass M10 system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The Compass M10 system records physiological signals from the body (respiratory effort, body position, movement, oxygen saturation). It does not analyze samples taken from the body.
- The intended use is to record and analyze physiological signals in vivo (within the living body). The device is attached to the patient to record these signals.
- The device description focuses on sensors and recording of physiological parameters. This aligns with devices used for monitoring or recording physiological activity, not for analyzing biological samples.
The Compass M10 system is a device used for physiological monitoring and screening, specifically for sleep-related issues. It falls under the category of medical devices that record and analyze signals directly from the patient's body.
N/A
Intended Use / 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.
Product codes
MNR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Medcare
SEP 2 8 2004
510(k) Summary
Submitter
Medcare Flaga Sidumuli 24 108 Reykjavik Iceland Europe
Tel: 011 354 510 2000 Fax: 011 354 510 2010
Registration Number: 9611753
Contact person
Berglind Hallgrímsdóttir Email: berglind@medcare.com, quality@medcare.com
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
1
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.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the left.
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.
3
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 (240) 276-0120. 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/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
4
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 ._
Page 1 of 1