(284 days)
The Somté System is a multi-functional ambulatory recording device intended to be used to collect and store signals related to sleep disorders, including respiratory signals, ECG signals and limb movement signals, to aid in the diagnosis of respiratory and/or cardiac related sleep disorders.
The Somté System is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
The Somté System is only to be used under the direction and supervision of a physician, technologist or clinician. It will not prevent or restore the interruption or loss of any physiological system.
The Compumedics Somté Patient Recording System is a multi-functional, ambulatory recording device. The Somté is used to collect and store a patient's ECG and respiratory signals, which are then used as an aid in the diagnosis of cardiac and/or respiratory related sleep disorders by qualified physicians.
The system is comprised of hardware and software, which provides up to 13 separate parameters for recording, review and analysis.
The data are acquired from a combination of electrodes, sensors and transducers. Signal types can include electrocardiogram (ECG), pressure, airflow, snore, respiratory effort, body position, limb movement, oxygen saturation, pulse rate and pulse waveform.
The electrodes and sensors used to acquire patient data are connected between the patient and the Somté System Recorder. Patient Studies are recorded using the Compumedics Somté Software which allows the user to view, print, summarise, analyse and create Patient Study reports.
The Somté Patient Recording Unit has a built in Compact Flash Disk interface for storage and convenient transfer to review workstations. There is no proprietary hardware required to transfer the study data.
This 510(k) summary for the Compumedics Somté Patient Recording Unit does not include acceptance criteria or detailed results from a study proving the device meets acceptance criteria.
The document primarily focuses on establishing substantial equivalence to previously cleared devices. It describes the device, its intended use, and lists predicate devices (Compumedics Limited E-Series System (K000068) and Oxford Instruments Medilog® Excel 3 Holter Management System (K002544)).
Therefore, I cannot provide the requested table or information about specific studies, sample sizes, ground truth establishment, or expert involvement based on the provided text.
What is present is a general description of the device's function: "The Somté is used to collect and store a patient's ECG and respiratory signals, which are then used as an aid in the diagnosis of cardiac and/or respiratory related sleep disorders by qualified physicians." This implies that the device is intended to accurately record these physiological signals, but specific performance metrics are not given.
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K021176
JAN 2 1 2003
510(K) SUMMARY
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the Compumedics Limited summary for the Compumedics Somté Patient Recording Unit.
| SUBMITTER'S NAME: | Compumedics Limited |
|---|---|
| ADDRESS: | 1 Marine ParadeAbbotsford, Victoria 3067Australia |
| CONTACT PERSON: | Constance Bundy, C.G. Bundy Associates, Inc. |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-571-2437 |
| DATE OF SUBMISSION: | April 10, 2002 |
1. Identification of device
Proprietary Name: Compumedics Somté System Common Name: Programmable Diagnostic Computer/EEG System Classification Status: Class II per 21 CFR Part 868.2375, Ventilatory Effort Recorder, Product Code: MNR
Equivalent devices 2.
Compumedics Limited believes the Compumedics Somté Patient Recording System is substantially equivalent to:
The Compumedics Limited E-Series System (K000068) (for the sleep/cardiorespiratory recording component); and the Oxford Instruments Medilog® Excel 3 Holter Management System, (K002544) (for the electrocardiograph (ECG) recording component).
Description of the Device 3.
The Compumedics Somté Patient Recording System is a multi-functional, ambulatory recording device. The Somté is used to collect and store a patient's ECG and respiratory signals, which are then used as an aid in the diagnosis of cardiac and/or respiratory related sleep disorders by qualified physicians.
The system is comprised of hardware and software, which provides up to 13 separate parameters for recording, review and analysis.
The data are acquired from a combination of electrodes, sensors and transducers. Signal types can include electrocardiogram (ECG), pressure, airflow, snore, respiratory effort, body position, limb movement, oxygen saturation, pulse rate and pulse waveform.
The electrodes and sensors used to acquire patient data are connected between the patient and the Somté System Recorder. Patient Studies are recorded using the
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Compumedics Somté Software which allows the user to view, print, summarise, analyse and create Patient Study reports.
The Somté Patient Recording Unit has a built in Compact Flash Disk interface for storage and convenient transfer to review workstations. There is no proprietary hardware required to transfer the study data.
Intended use 4.
The Somté System is a multi-functional ambulatory recording device intended to be used to collect and store signals related to sleep disorders, including respiratory signals, ECG signals and limb movement signals, to aid in the diagnosis of respiratory and/or cardiac related sleep disorders.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized design featuring three overlapping profiles of human faces, with flowing lines suggesting hair or fabric. The overall design is simple and conveys a sense of unity and service.
JAN 2 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Compumedics, Limited C/O Ms. Constance G. Bundy C. G. Bundy Associates, Incorporated 6470 Riverview Terrace Minneapolis, Minnesota 55432
Re: K021176
Trade/Device Name: Compumedics Somté System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: October 18, 2002 Received: October 23, 2002
Dear Ms. Bundy:
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 - Ms. Bundy
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 (OS) 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.
Susan Suarez
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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B. INDICATIONS FOR USE
510(k) Number K021176
Device Name: Compumedics Somté System
Indications for Use:
The Somté System is a multi-functional ambulatory recording device intended to be used to collect and store signals related to sleep disorders, including respiratory signals, ECG signals and limb movement signals, to aid in the diagnosis of respiratory and/or cardiac related sleep disorders.
The Somté System is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
The Somté System is only to be used under the direction and supervision of a physician, technologist or clinician. It will not prevent or restore the interruption or loss of any physiological system.
(Please do not write below 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
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: KO21176
§ 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).