(309 days)
No
The document describes a physiological signal recording device and its added channels, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a "physiological signal recording device" intended for "testing patients suspected of having sleep-related breathing disorders" and measures and records various physiological data. It does not mention providing therapy or treatment.
Yes
The devices are "intended to be used for testing patients suspected of having sleep-related breathing disorders," which implies a diagnostic purpose. They also "measure and record oxygen saturation, pulse rate, body position, snoring, respiratory airflow, respiratory effort, PLM, EEG, EMG, EOG and ECG data," which are physiological signals collected for diagnostic assessment.
No
The device description explicitly states that the devices are "portable physiological signal recording devices" and mentions the addition of "AC channels" for recording various physiological signals (EOG, EMG, EEG, ECG). This indicates the presence of hardware components for signal acquisition and recording, which are not characteristic of a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SleepScreen and ApnoeScreen Cardio are described as "portable physiological signal recording devices." They measure and record physiological signals directly from the patient's body (oxygen saturation, pulse rate, body position, snoring, respiratory airflow, respiratory effort, PLM, EEG, EMG, EOG, and ECG data).
- No Sample Analysis: There is no mention of the device analyzing samples taken from the body. The data is collected directly from the patient.
Therefore, the device falls under the category of a medical device that records physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SleepScreen and ApnoeScreen Cardio are non-life-supporting portable physiological signal recording devices intended to be used for testing patients 7 years and older suspected of having sleep-related breathing disorders. The SleepScreen and ApnoeScreen Cardio are intended to measure and record oxygen saturation, pulse rate, body position, snoring, respiratory airflow, respiratory effort, PLM, EEG, EMG, EOG and ECG data. The devices may be used in the home, clinic, doctor's office or hospital.
The SleepScreen and ApnoeScreen Cardio are not intended for use as an apnea monitor or as a component in an apnea monitoring system. Additionally, the SleepScreen and ApnoeScreen Cardio are not intended to be used alone or in combination with another product as a life support device, a life support system, or as a critical component to a life support device or system. There is no claim of compatibility with diagnostic imaging equipment.
Product codes
MNR
Device Description
The ApnoeScreen Cardio is the ApnoeScreen Pro (K000396) with the addition of two AC channels. The additional AC channels may be used to record electro-oculargram (EOG), electromyogram (EMG), electroencephalogram (EEG) and/or electrocardiogram (ECG).
The SleepScreen is the ApnoeScreen Pro (K000396) with the addition of eight AC channels. The additional AC channels may be used to record electrooculargram (EOG), electromyogram (EMG), electroencephalogram (EEG) and/or electrocardiogram (ECG).
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
patients 7 years and older
Intended User / Care Setting
The devices may be used in the home, clinic, doctor's office or hospital.
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
Performance testing was conducted in the laboratory to confirm compliance to device specifications; all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies. Testing to internationally accepted standards for electrical safety and electromagnetic compatibility were performed: the SleepScreen/ApnoeScreen Cardio complied with the requirements of these standards.
Key Metrics
Not Found
Predicate Device(s)
ApnoeScreen Pro (K000396)
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
Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'KA21138'. The characters are handwritten in a dark ink, and they appear to be part of a code or identification number. The writing style is somewhat stylized, with distinct shapes for each character.
Summary of Safety and Effectiveness
FEB 1 2 2003
Date of Preparation: April 4, 2002
Submitter: Erich Jaeger GmbH Leibnizstrae 7 D-97201 Hoechberg Germany
Contact: Brian Long SensorMedics Corp. Phone: 800-231-2466 x8521 Fax: 714-283-8439
Device Trade Name: SleepScreen/ApnoeScreen Cardio
Device Common/Classification Name: The SleepScreen/ApnoeScreen Cardio is an Erich Jaeger GmbH device classified under 73MBZ, "Ventilatory Effort Recorder, per Requlation No. 868.2375.
Predicate Device: ApnoeScreen Pro (K000396)
Intended Use:
The SleepScreen and ApnoeScreen Cardio are portable physiological signal recording devices intended to be used for testing patients suspected of having sleep-related breathing disorders. They are intended to be used under the direction of a physician. The devices may be used in the home, clinic, doctor's office or hospital.
The SleepScreen and ApnoeScreen Cardio, or any of the accessories supplied with it, are not to be used, alone or in combination, as an apnea monitor or as a component in an apnea monitoring system.
The SleepScreen and ApnoeScreen Cardio, or any of the accessories supplied with it, are not to be used, alone or in combination, as a life support device, a life support system, or as a critical component in a life support device or life support system.
Device Description:
The ApnoeScreen Cardio is the ApnoeScreen Pro (K000396) with the addition of two AC channels. The additional AC channels may be used to record electro-oculargram (EOG), electromyogram (EMG), electroencephalogram (EEG) and/or electrocardiogram (ECG).
1
The SleepScreen is the ApnoeScreen Pro (K000396) with the addition of eight AC channels. The additional AC channels may be used to record electrooculargram (EOG), electromyogram (EMG), electroencephalogram (EEG) and/or electrocardiogram (ECG).
Comparison to Predicate Device:
The SleepScreen/ApnoeScreen Cardio is not significantly different from the predicate device. ApnoeScreen Pro (K000396). Simply, eight AC channels are now available for the SleepScreen and only two of the eight channels are available for the ApnoeScreen Cardio.
Summary of Performance Testing:
Performance testing was conducted in the laboratory to confirm compliance to device specifications; all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies. Testing to internationally accepted standards for electrical safety and electromaqnetic compatibility were performed: the SleepScreen/ApnoeScreen Cardio complied with the requirements of these standards.
2
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 features a stylized eagle with three heads, representing the department's commitment to health, human services, and the future. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2003
Erich Jaeger GmbH C/O Mr. Brian Long SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, California 92887-4645
Re: K021138
Trade/Device Name: SleepScreen and ApnoeScreen Cardio Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: December 23, 2002 Received: December 24, 2002
Dear Mr. Long:
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 vour 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. Long
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 vour 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 Purser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) NUMBER: K021138
DEVICE NAME: SleepScreen and ApnoeScreen Cardio
INDICATIONS FOR USE:
The SleepScreen and ApnoeScreen Cardio are non-life-supporting portable physiological signal recording devices intended to be used for testing patients 7 years and older suspected of having sleep-related breathing disorders. The SleepScreen and ApnoeScreen Cardio are intended to measure and record oxygen saturation, pulse rate, body position, snoring, respiratory airflow, respiratory effort, PLM, EEG, EMG, EOG and ECG data. The devices may be used in the home, clinic, doctor's office or hospital.
The SleepScreen and ApnoeScreen Cardio are not intended for use as an apnea monitor or as a component in an apnea monitoring system. Additionally, the SleepScreen and ApnoeScreen Cardio are not intended to be used alone or in combination with another product as a life support device, a life support system, or as a critical component to a life support device or system. There is no claim of compatibility with diagnostic imaging equipment.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
OR
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices |
| 510(k) Number | K021138 |
|---|---|
| --------------- | --------- |
| Over-The Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |