(196 days)
No
The summary describes a sensor and a bedside unit that receives and analyzes signals. There is no mention of AI, ML, or any related technologies in the description of the device's functionality or performance studies.
No
The device is described as a sensing unit for continuous measurement of physiological parameters (Respiration Rate, Heart Rate, Movement, SpO2) and does not perform any treatment or therapy.
No
The device measures physiological parameters like respiration rate, heart rate, movement, and oxygen saturation. While these measurements can be used by clinicians for diagnostic purposes, the device itself is described as a measurement and monitoring tool, not one that provides a diagnosis.
No
The device description explicitly states that the Chair Sensing Unit is comprised of a sensor (containing piezoelectric elements) and a cushion, which are physical hardware components. While it connects to a bedside unit with software, the core sensing mechanism is hardware-based.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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 about a person's health.
- Device Function: The EarlySense Chair Sensing Unit measures physiological parameters (Respiration Rate, Heart Rate, Movement, and SpO2) directly from the patient's body in a contact-less manner. It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring vital signs, not analyzing biological specimens for diagnostic purposes.
Therefore, the EarlySense Chair Sensing Unit falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EarlySense Chair Sensing Unit is intended to be used for continuous measurement of Respiration Rate, Heart Rate and Movement, in an automatic contact-less manner, at home, hospital or clinic setting. The sensor is indicated for use in children, adolescents and adults. The operation of the EarlySense system has been studied in children (weight >= 10 Kg) and adults (weight = 10 Kg) and adults (weight
§ 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).
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KI33661
Section 5 510(k) Summary
510(K) SUMMARY
JUN 1 3 2014
EarlySense Ltd.
EarlySense Chair Sensing Unit
Applicant's Name:
EarlySense Ltd. 12 Tzvi St. Ramat Gan 52504, Israel Tel: +972-3-7522330 Fax: +972-3-7522340
Contact Person:
Dalia Argaman, VP Clinical, Regulatory Affairs and QA EarlySense Ltd. 12 Tzvi Street. Ramat Gan 52504, Israel Tel: +972-3- 752-2330(ext.106) Fax: +972-3-752-2340 e-mail: Dalia.Argaman@EarlySense.com
Date Prepared:
June 12, 2014
Trade Name:
EarlySense Chair Sensing Unit
EarlySense Ltd. 12 Tzvi street, Ramat Gan, 52504, ISRAEL Tel: +972 3 7522330 (ext.106); Fax: +972 3 7522340; E-mail: Dalia.Argaman@Earlysense.com
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Classification Name:
Accessory for Breathing Frequency Monitor
Class: II
Regulation Number:
21 CFR Sec. 868.2375
Product Code:
BZQ, DRT
Predicate Device:
Bed Sensing Unit of EarlySense System (K120465)
Reason for Submission:
A traditional 510{k) is submitted for the addition of the optional accessory (Chair Sensing Unit) to be used with cleared EarlySense bedside units (K120465).
Intended Use/Indications for Use:
The EarlySense Chair Sensing Unit is intended to be used for continuous measurement of Respiration Rate, Heart Rate and Movement, in an automatic contact-less manner, at home, hospital or clinic setting. The sensor is indicated for use in children, adolescents and adults. The operation of the EarlySense system has been studied in children (weight ≥ 10 Kg) and adults (weight EarlySense Ltd. 12 Tzvi street, Ramat Gan, 52504, ISRAEL Tel: +972 3 7522330 (ext.106); Fax: +972 3 7522340; E-mail: Dalia.Argaman@Earlysense.com
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Differences:
-Accelerometer, rod and additional piezoelectric sensor (piezofilm) were added to the Chair Sensor
-Chair Sensor is placed under a specially-designed cushion, in order to avoid the direct contact between the patient and the sensor and to achieve the correct positioning of the sensor on the chair.
Substantial Equivalence
The EarlySense Chair Sensing Unit is similar to its predicate, the EarlySense Bed Sensing Unit. It has similar intended use and indications for use. The fundamental technology and mode of operation of the Chair sensing unit are similar as those of the Earlysense Bed Sensing unit. Similar to the cleared Bed Sensing Unit that is placed under the bed mattress and does not contact the patient, the Chair sensor is inserted into a specific cushion that mimics the bed mattress, so the chair sensor does not touch the patient. The Chair Sensing Unit performs similar functions as the Bed Sensing unit-in a contactless manner it monitors heart, respiration rate and motion. Similar to its predicate, the Earlysense Bed Sensing unit, the mechanical signals that are detected by the piezoelectric element of the sensors (Bed or Chair) are converted into an electric signal, which is then sampled and filtered and transferred to the EarlySense Bedside Unit, in order to be analyzed by the System's software to provide the respiration rate (RR), heart rate (HR), and movement rate. The system's detection algorithms differentiate between large body movements, breathing movements and the cardioballistic effect, and thus compute the continuous heart and respiration rates and the body movement.
The presented additional accessory, Chair Sensing Unit has similar functionality, the similar indications for use, technology, mode of operation and performance specifications as the Bed Sensing Unit.
EarlySense Ltd. 12 Tzvi street, Ramat Gan, 52504, ISRAEL Tel: +972 3 7522330 (ext.106); Fax: +972 3 7522340; E-mail: Dalia.Argaman@Earlysense.com
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Verification and Validation Activities:
The Chair Sensing Unit was subject to the following verification and validation tests to ensure correct performance:
-
Risk analysis
-
Bench Testing:
-
Performance tests were performed with signals simulating physiological patient signals to evaluate the measurement and compare those to the predicate device to show equivalent performance.
-
Theoretical assessment and bench tests were performed to assess the magnitude and effect of external sources of vibration and their effect on the chair sensing unit's functionality.
-
Environmental testing including: Random vibration (Non-Operational test), Sinusoidal vibration (Variable Frequency Operational)
- Complete software verification and validation testing performed to ensure proper functionality.
In addition, the Chair Sensing Unit as part of the EarlySense System was subject to complete set of testing (electrical safety, EMC and environmental testing) to ensure proper functionality.
The results of the bench tests showed, that the signals as detected by the chair sensing unit are similar to those that are detected by the predicate EarlySense Bed Sensor and thus the performance of the Chair Sensing Unit is equivalent to the performance of the Bed Sensing Unit and the performance of the chair sensor is not affected by the new design that includes insertion of the sensor into a cushion (rather than insertion of the sensor under a bed mattress). Therefore, it was concluded that the Chair Sensing Unit may be considered to be substantially equivalent to the previously cleared EarlySense Bed Sensing Unit (K120465).
EarlySense Ltd. 12 Tzvi street. Ramat Gan. 52504, ISRAEL Tel: +972 3 7522330 (ext.106); Fax: +972 3 7522340; E-mail: Dalia.Argaman@Earlysense.com
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2014
,
EarlySense Ltd. Ilana Shvorin RA Specialist 12 Tzvi St. Ramat Gan, Israel 52504
Re: K133661
Trade/Device Name: EarlySense Chair Sensing Unit Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: II Product Code: BZQ, DRT Dated: May 7, 2014 Received: May 15, 2014
Dear Ms. Shvorin:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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,
.
6
Page 2 - Ms. Shvorin
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Tejashri Purohit-Sheth. M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S.
Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Sincerely yours.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133661
Device Name EarlySense Chair Sensing Unit
Indications for Use (Describe)
The EarlySense Chair Sensing Unit is intended to be used for continuous measurement of Respiration Rate, Heart Rate and Movement, in an automatic contact-less manner, at home, hospital or clinic setting. The sensor is indicated for use in children, adolescents and adults. The operation of the EarlySense system has been studied in children (weight ≥ 10 Kg) and adults (weight Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRASIaff@ida.hhs.gov
*An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)