(280 days)
Not Found
No
The summary describes standard signal processing and calculation of physiological parameters without mentioning AI or ML techniques.
No.
The device is intended for continuous measurement and monitoring of patient parameters (respiration rate and heart rate), not for treating any condition.
No
Explanation: The device is intended for continuous measurement of respiration rate and heart rate, which is monitoring, not diagnosis. The data is to be analyzed by a healthcare practitioner, implying the device provides data for diagnosis rather than performing the diagnosis itself.
No
The device description explicitly lists hardware components: a Sensing Unit (containing a piezoelectric sensor) and a Control Unit (Bedside Unit), in addition to the software.
Based on the provided information, the EarlySense™ ES-16 system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- EarlySense™ ES-16 Function: The EarlySense™ ES-16 system measures physiological parameters (respiration rate and heart rate) directly from the patient's body in a contact-less manner. It does not analyze biological specimens.
The device is a physiological monitoring system, not an IVD.
N/A
Intended Use / Indications for Use
The 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 ES-16 System has been studied in children (weight ≥ 10 Kg) and adults (weight ≤111 Kg) during sleep and resting condition.
Product codes
BZQ
Device Description
The EarlySense™ ES-16 System consists of the following main components:
- . A Sensing Unit placed under the mattress pad.
- . A Control Unit (Bedside Unit).
- Proprietary recording and data analysis software operating under Microsoft® Windows™ CE.
The under mattress Sensing Unit includes a piezoelectric sensor, which converts the detected respiration- and heart beat-related mechanical movements into an electric signal. The Control Unit receives the electric signals, processes them and finally calculates, logs and displays the patient's respiration rate and hear rate.
The EarlySense™ System is designed for continuous and contact-less monitoring of respiration and heart rates during sleep or resting condition, and it automatically starts measuring whenever the patient is in bed under resting or sleeping conditions. The data acquired by the System should be analyzed by a health care practitioner either in realtime (e.g. when monitoring is performed in the clinic), or off-line, after the monitoring session (e.g. when monitoring is performed at home).
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 ES-16 System has been studied in children (weight ≥ 10 Kg) and adults (weight ≤111 Kg) during sleep and resting condition.
Intended User / Care Setting
health care practitioner, at 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
A set of software, bench and clinical testing was performed in order to demonstrate the performance and accuracy of the EarlySense™ ES-16 System and to verify that it does not raise any new safety and effectiveness issues in comparison to its predicate devices. The testing included the following:
- Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 (and amendments), and IEC 60601-1-2 standards.
- Software verification and validation testing .
- Bench testing including a comparison to a respiration and heart . beat simulator
- Clinical testing including simultaneous monitoring with the . EarlySense™ System and its predicate device
- Hazard analysis including risk level and solutions performed for . the entire system and for the software.
Tests results indicated that the EarlySense™ ES-16 System performs according to its specifications and accurately detects respiration rate and heart rate in comparison to its predicate devices.
Key Metrics
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
page 1 of 4
510(K) SUMMARY
510(K) Number K070375
Applicant's Name: EarlySense Ltd. 5.1 12 Tzvi St. Ramat Gan 52504, Israel Tel: +972-3-7522330 Fax: +972-3-7522340
NOV 1 5 2007
Dorit Winitz, Ph.D. 5.2 Contact Person:
Biomedical Strategy (2004) Ltd. 7 Jabotinsky Street. Ramat Gan 52520, Israel Tel: +972-3- 6123281 Fax: +972-3-6123282 Mail: dorit@ebms.co.il
Date Prepared: 5.3
Nov., 2007
5.4 Trade Name:
EarlySense™ ES-16 System
5.5 Common Name:
Breathing frequency monitor
1
5.6 Classification:
| Classification Name: | Breathing frequency monitor |
|---|---|
| Medical Specialty / Panel: | Anesthesiology |
| Product Code: | BZQ |
| Class: | II |
| Regulation Number: | 868.2375 |
5.7 Predicate Devices:
EarlySense Ltd. is relying on the combination of the following predicate devices and a standard procedure for the EarlySense™ ES-16 System substantial equivalence discussion:
- .. Embla N7000 [Embla Systems, Inc.] cleared under K024322 (breathing frequency monitor, Class II-MNR); hereinafter: Embla System, supplemented with Somnologica Studio Software [Ferguson Medical] cleared as part of Embla System under K971813 (Electroencephalograph, Class II-GWQ)
- LifeShirt System with VivoLogic Analysis Software (VivoMetrics ■ Inc.] cleared under K011903 (programmable diagnostic computer, Class II-DQK)
5.8 Device Description:
The EarlySense™ ES-16 System consists of the following main components:
- . A Sensing Unit placed under the mattress pad.
- . A Control Unit (Bedside Unit).
- Proprietary recording and data analysis software operating under 트 Microsoft® Windows™ CE.
The under mattress Sensing Unit includes a piezoelectric sensor, which converts the detected respiration- and heart beat-related mechanical movements into an electric signal. The Control Unit receives the electric signals, processes them and finally calculates, logs and displays the patient's respiration rate and hear rate.
The EarlySense™ System is designed for continuous and contact-less monitoring of respiration and heart rates during sleep or resting condition, and it automatically starts measuring whenever the patient is in bed under resting or sleeping conditions. The data acquired by the System should be analyzed by a health care practitioner either in realtime (e.g. when monitoring is performed in the clinic), or off-line, after the monitoring session (e.g. when monitoring is performed at home).
2
5.9 Intended Use / Indication for Use:
EarlySense™ ES-16 system is intended for continuous The 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 ES-16 System has been studied in children (weight ≥ 10 Kg) and adults (weight ≤111 Kg) during sleep and resting condition.
Performance Standards: 5.10
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the EarlySense™ ES-16 System complies with the following voluntary standards:
- . Medical electrical equipment- general requirements for safety. Part 1: General Requirements for Safety. IEC 60601-1(1988): +A1(1991) +A2(1995); UL 60601-1 (2003)
- Medical Electrical Equipment Part 1: General Requirements for ■ Safety; Electromagnetic Compatibility -- Requirements and Tests. EN/IEC 60601-1-2 (2001)
- Programmable electrical medical system Requirements for safety. 피 EN/IEC 60601-1-4 (2000)
- Medical devices Application of risk management to medical ■ devices. ISO 14971-1 (2003)
Substantial Equivalence: 5.11
The intended use and indications for use of the EarlySense™ ES-16 System are similar to or encompassed within the intended use and indications for use of its predicate devices. In addition, the basic design and principles of operation, specifically, the use of a sensing component including a piezoelectric sensor together with a recording and processing component, which uses proprietary algorithms to calculate the desired parameters, are similar in all the devices.
A set of software, bench and clinical testing was performed in order to demonstrate the performance and accuracy of the EarlySense™ ES-16 System and to verify that it does not raise any new safety and effectiveness issues in comparison to its predicate devices. The testing included the following:
3
- Electrical safety and electromagnetic compatibility testing I according to IEC 60601-1 (and amendments), and IEC 60601-1-2 standards.
- Software verification and validation testing .
- Bench testing including a comparison to a respiration and heart . beat simulator
- Clinical testing including simultaneous monitoring with the . EarlySense™ System and its predicate device
- Hazard analysis including risk level and solutions performed for . the entire system and for the software.
Tests results indicated that the EarlySense™ ES-16 System performs according to its specifications and accurately detects respiration rate and heart rate in comparison to its predicate devices.
5.12 Conclusion
EarlySense Ltd. believes that the EarlySense™ ES-16 System is as safe and effective as its predicate devices for its intended use and is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issues.
4
Image /page/4/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
NOV 1 5 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EarlySense Limited C/O Dorit Winitz, Ph.D. Regulatory Consultant BioMedical Strategy (2004) Limited 7. Jabotinsky Street Ramat Gan ISRAEL 52520
Re: K070375
Trade/Device Name: EarlySense™ ES-16 System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: BZQ Dated: November 5, 2007 Received: November 7, 2007
Dear Dr. Winitz:
We have reviewed your Scction 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.
5
Page 2 - Dr. Winitz
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) 276-0115. 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/industry/support/index.html.
Sincerely yours,
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
6
INDICATIONS FOR USE
510(k) Number (if known): K070375
EarlySense™ ES-16 System Device Name:
Indications for Use:
The 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 ES-16 System has been studied in children (weight ≥ 10 Kg) and adults (weight ≤111 Kg) during sleep and resting condition.
| 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 OF NEEDED)
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| ------------------------------------------------------- | -- |
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K070375