(54 days)
Not Found
Unknown
The summary mentions "Compass automatic scoring" and "automatic analysis" which suggests algorithmic processing of the physiological signals to identify abnormal events. However, it does not explicitly state that AI or ML techniques are used for this analysis. The description of the validation process comparing automatic scoring to manual scoring is consistent with evaluating an automated algorithm, but doesn't confirm the use of AI/ML.
No
The device is intended for screening and recording physiological signals, not for treatment or therapy. It explicitly states it is "not intended for any diagnosis" and "not intended to be a monitor," further supporting its role as a screening tool rather than a therapeutic device.
No
Explanation: 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 clinical diagnosis by polysomnography.
No
The device description explicitly states that the system includes hardware components such as a recording device, signal adapter, strap system, and USB cable, in addition to the software application.
Based on the provided information, the Compass F10 system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Compass F10 Function: The Compass F10 system records physiological signals directly from the patient's body during sleep (nasal pressure/airflow, body position, movement, optional oxygen saturation). It does not analyze specimens derived from the body.
- Intended Use: The intended use explicitly states it's for recording physiological signals, scanning for abnormalities, and generating a summary report. It is used as a screening device to determine the need for further clinical diagnosis (polysomnography). It is not intended for any diagnosis.
Therefore, the Compass F10 system falls under the category of a physiological monitoring or recording device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
MNR
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.
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
The Compass F10 system is intended to be used for 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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 & Altman | 95% confidence interval from -6.3 to 6.1 with an average of -0.1 | 95% confidence interval from -14.3 to 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| 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 & Altman | 95% confidence interval from -6.3 to 6.1 with an average of -0.1 | 95% confidence interval from -14.3 to 10.6 with an average of -1.8 |
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
SEP - 7 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
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
1
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.
2
| 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. | |
| Aluminum. | |||||
| Sensor Adapter (Proxy) | Polyimide. | No hardware. | No proxy. | Polyimide. | |
| Dimension | 80mm (2.5") W, 111mm (4.9")H, | ||||
| 18.5mm(0.8") D (Patient Unit). | No hardware. | 81.3mm (3.2") W, 68.6mm (2.7")H, | |||
| 25.9mm (1.02") D. | 65mm (2.5") W, 124mm (4.9")H, | ||||
| 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). | ||
| Host PC (Data Transfer). | 3V by 2 AA batteries (Data Acquisition). | ||||
| Host PC (Data Transfer). | |||||
| Control | Data acquisition and data storage | ||||
| microprocessor controlled. | |||||
| Acquisition parameters set from | |||||
| application SW. | Acquisition parameters set in | ||||
| application SW. | |||||
| No hardware. | Data acquisition and data storage | ||||
| microprocessor controlled. | Data acquisition and data storage | ||||
| microprocessor controlled. | |||||
| Acquisition parameters set from | |||||
| application SW. | |||||
| Data Interface | Ethernet. | No hardware. | USB v1.1. | USB v1.1. | |
| Patient isolation | Isolation between mains and applied | ||||
| part. | No patient connection. | Device has no galvanic connections to | |||
| mains as it is a battery operated device. | |||||
| Not possible to connect auxiliary devices | |||||
| to the device. | Device has no galvanic connections to | ||||
| mains as it is a battery operated device. | |||||
| Not possible to connect auxiliary | |||||
| devices to the device. | |||||
| Method of Connection to Patient | Elastic cloth material for support of | ||||
| device. | |||||
| RIP belts for respiratory effort. | |||||
| Probes or Flexi Wrap for oximetry. | |||||
| Plastic tubing and cannula for | |||||
| pressure sensing. | |||||
| Touch proof electrode cables. | |||||
| Thermistor. | |||||
| Snore Sensor. | No patient connection. | Elastic cloth material for support of | |||
| device. | |||||
| Plastic tubing and cannula for pressure | |||||
| sensing. | Elastic cloth material for support of | ||||
| device. | |||||
| Probes or Flexi Wrap for oximetry. | |||||
| Plastic tubing and cannula for pressure | |||||
| sensing. | |||||
| Embla N7000 (K024322) | Rembrandt System (K962865) | ApLab (K030379) | Compass F10 system | ||
| Single use | Disposable XactTrace Belts. | ||||
| Flexi Wrap disposable. | |||||
| Plastic cannula disposable. | |||||
| Remaining portions require cleaning. | No hardware. | Plastic cannula and filter disposable. | |||
| Remaining portions require cleaning. | Flexi Wrap disposable. | ||||
| Plastic cannula disposable. | |||||
| Remaining portions require cleaning. | |||||
| Number of channels | Seven channels (Patient Unit). | ||||
| 40 channels (Bedside Unit). | |||||
| Eight auxiliary channels (Communication Unit). | 8-64 channels. | One Channel. | Four channels. | ||
| Signals recorded | Respiratory Effort (Abdomen and Thorax). | ||||
| Body position. | |||||
| Activity. | |||||
| Oxygen Saturation. | |||||
| Pulse | |||||
| Nasal pressure. | |||||
| Airflow. | |||||
| Snore. | |||||
| EEG, EOG, EMG, ECG. | Respiratory Effort (Abdomen and Thorax). | ||||
| Body position. | |||||
| Activity. | |||||
| Oxygen Saturation. | |||||
| Pulse | |||||
| Nasal pressure. | |||||
| Airflow. | |||||
| Snore. | |||||
| EEG, EOG, EMG, ECG. | |||||
| Leg movement. | |||||
| Upper airway resistance. | |||||
| Body temperature. | |||||
| Video. | |||||
| No hardware. | Nasal Pressure. | Body position. | |||
| Activity. | |||||
| Oxygen Saturation. | |||||
| Pulse. | |||||
| Nasal Pressure. | |||||
| Sensor Technology used in/with the system | Solid state pressure sensor. | ||||
| Solid state position/activity sensor. | |||||
| Respiratory Effort sensors based on respiratory inductive plethysmography. | |||||
| Oximetry. | |||||
| Thermistor. | |||||
| Piezo snoring sensor. | |||||
| Gold cup electrodes. | |||||
| Ag/AgCL electrodes. | |||||
| Piezobelts for respiratory effort. | No hardware. | Solid state pressure sensor. | Solid state pressure sensor. | ||
| Solid state position/activity sensor. | |||||
| Data validation | On-line in the application SW (not a part of the system). | ||||
| Status light on Bedside Unit. | |||||
| 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 | ||||
| ------------------------------------------------------------------------------------------------------------- | ApLab (K030379 | Compass F10 syste. | |||
| Generate and |
print of
reports | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
software application | (es. | .
Yes. | The Call Concession of Children Come of Children
(es. | |
| Patient data
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
3
Medcare Flaga Sidumuli 24
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Medcare Flaga Sidumuli 24
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5
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 & | ||
| Altman | 95% confidence interval from -6.3 to | |
| 6.1 with an average of -0.1 | 95% confidence interval from -14.3 to | |
| 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.
6
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.
7
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 (301) 594-4646. 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,
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
8
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: