(280 days)
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.
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).
The provided text describes a 510(k) submission for the EarlySense™ ES-16 System, a breathing frequency monitor. However, it does not contain specific acceptance criteria or details of a study with reported device performance metrics against those criteria. The document focuses on establishing substantial equivalence to predicate devices.
Therefore, I cannot populate a table of acceptance criteria and reported device performance from this input. The text states: "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." but does not provide the specifications or quantitative accuracy results.
Below is a breakdown of what can be extracted from the document regarding the study and ground truth, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the provided document. The document mentions "performs according to its specifications" but the specifications themselves are not detailed.
- Reported Device Performance: Not explicitly stated in quantitative terms. The document concludes "accurately detects respiration rate and heart rate in comparison to its predicate devices."
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The document indicates the system "has been studied in children (weight ≥ 10 Kg) and adults (weight ≤111 Kg) during sleep and resting condition."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "simultaneous monitoring with the EarlySense™ System and its predicate device," implying a clinical setting. It does not specify if it was retrospective or prospective, but the nature of simultaneous monitoring suggests prospective data collection for the test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Ground Truth Establishment for Test Set: The ground truth for the test set was established by "simultaneous monitoring with the EarlySense™ System and its predicate device". The predicate devices (Embla N7000 and LifeShirt System) are widely recognized as established methods for monitoring breathing and heart rate, thus serving as the reference standard or "ground truth" for comparison.
4. Adjudication method for the test set
- Not mentioned. The comparison was directly against predicate devices.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This device is a monitor producing objective measurements, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done. The device, the EarlySense™ ES-16 System, is a "Breathing frequency monitor" 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 "Control Unit receives the electric signals, processes them and finally calculates, logs and displays the patient's respiration rate and hear rate." This describes a standalone algorithm-only performance, where human interaction primarily involves analysis of the already calculated data.
7. The type of ground truth used
- Comparative Ground Truth: The ground truth for the clinical testing was established by using "simultaneous monitoring with the EarlySense™ System and its predicate device". The predicate devices (Embla N7000 and LifeShirt System) served as the reference standard for respiration and heart rate measurements.
8. The sample size for the training set
- Not mentioned. The document does not distinguish between training and test sets in terms of sample size for human subjects. However, it does mention "bench testing including a comparison to a respiration and heart beat simulator" which could be part of development/training.
9. How the ground truth for the training set was established
- Not explicitly detailed. For human subject data, it would logically follow the method for the test set (comparison to predicate devices). For bench testing, a "respiration and heart beat simulator" was used as the ground truth.
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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
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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).
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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:
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- 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.
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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.
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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
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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
§ 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).