(210 days)
No
The description focuses on signal processing from a piezoelectric sensor and threshold-based alerting, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as a continuous and contact-less monitor of respiration and heart rates, providing alerts for threshold exceedances and detecting patient movement. It does not provide any form of therapy or treatment.
No
The EverOn system is described as being for "continuous measurement of respiration rate and heart rate" and providing "alert notification" based on these measurements. It aims to monitor physiological parameters but does not state that it is used to diagnose a specific disease, condition, or state of health.
No
The device description explicitly lists hardware components: a Sensing Unit (under mattress) and a Control Unit (Bedside Unit), in addition to the software.
Based on the provided information, the EverOn system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The EverOn system measures physiological parameters (respiration rate and heart rate) directly from the patient through a contact-less sensor placed under the mattress. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use is for monitoring physiological signs. The description clearly states the system is for "continuous measurement of respiration rate and heart rate." This falls under the category of patient monitoring devices, not diagnostic tests performed on samples.
- The device description focuses on sensing and processing mechanical movements. The core technology involves a piezoelectric sensor that converts mechanical movements into electrical signals for analysis. This is a physical measurement, not a chemical or biological analysis of a sample.
Therefore, the EverOn system is a patient monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EverOn (modified EarlySense™ ES-16) system is intended for continuous measurement of respiration rate and heart rate, in an automatic contact-less manner, at home, hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EverOn has been studied in children (weight ≥10 Kg) and adults (weight ≤111 Kg) during sleep and resting condition.
Product codes
BZQ
Device Description
The modified EarlySense™ EverOn System is designed for continuous and contact-less monitoring of respiration and heart rates. The system automatically starts measuring whenever the patient is in bed under resting or sleeping conditions. The EverOn enables the user to define upper and lower thresholds so an alert notification (audible and visible) is given to the user, if either heart rate or respiration rate exceed the thresholds set by the user. The EverOn also detects patient movement levels and provides patient out-of-bed (Bed Exit) notification to the user.
The EverOn System consists of the following main components:
- A Sensing Unit placed under the mattress or mattress pad.
- A Control Unit (Bedside Unit).
- Proprietary recording and data analysis software
The under mattress Sensing Unit includes a piezoelectric sensor, which converts mechanical movements into an electric signal. The Control Unit receives the electric signals, processes them and finally calculates, logs, displays the patient's parameters, and generates alerts as per set thresholds. when needed.
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
children, adolescents and adults. The operation of the EverOn has been studied in children (weight ≥10 Kg) and adults (weight ≤111 Kg) during sleep and resting condition.
Intended User / Care Setting
Home, hospital or clinic setting.
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)
Performance testing demonstrating the accuracy of the system (bench and clinical data)
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
510(K) SUMMARY
EarlySense Ltd.
MAR 2 5 2009
EverOn System
7.1.1 Applicant's Name:
EarlySense Ltd. 12 Tzvi st. Ramat Gan 52504, Israel Tel: +972-3-7522330 Fax: +972-3-7522340
7.1.2 Contact Person:
Dalia Argaman
7.1.3 Date Prepared:
March, 2009
.
7.1.4 Trade Name:
EverOn System
7.1.5 Classification Name: Breathing frequency monitor (868.2375)
7.1.6 Classification:
Class II; Product Code- BZQ
7.1.7 Predicate Devices
The ES-16 System, cleared under K070375.
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7.1.8 Device Description:
The modified EarlySense™ EverOn System is designed for continuous and contact-less monitoring of respiration and heart rates. The system automatically starts measuring whenever the patient is in bed under resting or sleeping conditions. The EverOn enables the user to define upper and lower thresholds so an alert notification (audible and visible) is given to the user, if either heart rate or respiration rate exceed the thresholds set by the user. The EverOn also detects patient movement levels and provides patient out-of-bed (Bed Exit) notification to the user.
The EverOn System consists of the following main components:
- A Sensing Unit placed under the mattress or mattress pad. 트
- A Control Unit (Bedside Unit). .
- Proprietary recording and data analysis software 트
The under mattress Sensing Unit includes a piezoelectric sensor, which converts mechanical movements into an electric signal. The Control Unit receives the electric signals, processes them and finally calculates, logs, displays the patient's parameters, and generates alerts as per set thresholds. when needed.
7.1.9 Intended Use:
(modified EarlySense™ ES-16) system is intended for The EverOn continuous measurement of respiration rate and heart rate, in an automatic contact-less manner, at home, hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EverOn has been studied in children (weight ≥10 Kg) and adults (weight ≤111 Kg) during sleep and resting condition.
7.1.10 Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the modified ES-16 System complies with voluntary standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, AAMI / ISO 14971-1.
7.1.12 Performance Data & Substantial Equivalence
The EverOn System is substantially equivalent in all aspects, e.g., technological characteristics (i.e., Piezo-electric sensing), mode of operation (contact-less monitoring), performance characteristics (accuracy), intended use, etc., to the ES-16 System cleared under K070375.
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The modifications involve the following main changes:
Software and User Interface
- An option was added enabling to notify the user (alert) when . certain heart rate and respiration rate thresholds, pre-defined by the user, have been crossed.
- An option of bed exit notice was added. The system detects, . records and reports body motion level and alerts upon bed exit.
- The user's interface was improved to include a clearer, more I interactive and user friendly interface to enhance presentation of information to the user and to allow the user to insert event into the system log-files.
Hardware
The design of the Control Unit has been changed as follows:
- The external design of the bedside Control Unit was changed to include a larger control unit that allows the presentation of larger icons and graphs, enabling a clearer and more convenient user interface.
- Control buttons and LEDs were added to the Control Unit, . allowing for more convenient and intuitive user interaction.
- A connector (relay) was added to allow for interface with existing ■ nurse call systems.
The modified System was subjected to the following testing:
- Electrical and electromagnetic testing 트
- Mechanical vibration and shock resistance testing I
- Operational Environmental testing
- Software verification and validation .
- Bench testing of alerting features 트
- Performance testing demonstrating the accuracy of the system I (bench and clinical data)
Based on the design verification and validation processes, performed as a result of risk analysis assessment, EarlySense Ltd. believes that the EverOn System, is substantially equivalent to the cleared ES-16, without raising new safety and/or effectiveness issues.
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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dalia Argaman Vice President, Clinical and Regulatory Affairs EarlySense Limited 12 Zvi Street Ramat Gan 52522 ISRAEL
MAR 2 5 2009
Re: K082465
Trade/Device Name: EverOn System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: BZQ Dated: February 5, 2009 Received: February 10, 2009
Dear Ms. Argaman:
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. Argaman
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Russo
Ginette Y. Michaud, M.D. Acting 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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):_
Device Name: EverOn System
Indications for Use:
The EverOn (modified EarlySense™ ES-16) system is intended for continuous measurement of respiration rate and heart rate, in an automatic contact-less manner, at home, hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EverOn has been studied in children (weight ≥10 Kg) and adults (weight ≤111 Kg) during sleep and resting condition.
Prescription Use _ V (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use_ (Part 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Susan Pearer
Sion Sign-Off) . vision of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K052465