EarlySense Insight Sytem
Device Facts
| Record ID | K152911 |
|---|---|
| Device Name | EarlySense Insight Sytem |
| Applicant | Earlysense, Ltd. |
| Product Code | BZQ · Anesthesiology |
| Decision Date | May 6, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The EarlySense InSight System is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and resting condition.
Device Story
The EarlySense InSight System provides continuous, contact-free monitoring of heart rate, respiratory rate, and patient movement. It utilizes piezoelectric sensors placed under a mattress or in a chair to detect mechanical body signals (cardioballistic effect, breathing, and large body movements). These signals are converted to electrical signals, sampled, filtered, and analyzed by proprietary software to compute physiological parameters and detect bed/chair occupancy or exit. The InSight unit, located at the bedside, lacks a display; it communicates data and alerts via LAN or Wi-Fi to a remote control and display station (e.g., PC or central monitor). Healthcare practitioners at the remote station monitor the data, acknowledge alerts, and adjust settings. The system assists in patient management by providing automated, non-invasive monitoring, enabling timely clinical intervention.
Clinical Evidence
Bench testing only. Performance was validated by comparing the InSight device to the EarlySense 2.0 predicate using signals from children, adolescents, and adults. Accuracy of heart rate, respiration rate, and motion measurements was compared against a reference device (Embla Sleep lab System). Results demonstrated performance similarity between the subject and predicate devices.
Technological Characteristics
System uses piezoelectric sensors for contactless signal acquisition. Materials include ABS and polycarbonate for the InSight unit and bed/chair sensors, with 100% polyester chair covers. Connectivity via LAN/Wi-Fi. Power source is 100-240V AC. Software performs signal filtering and analysis to derive physiological rates. No internal battery. Dimensions: InSight unit 145.6 x 62 x 65.07 mm.
Indications for Use
Indicated for continuous measurement of respiration rate, heart rate, and movement in children (≥10 kg), adolescents, and adults (<111 kg) in hospital or clinic settings during sleep and resting conditions.
Regulatory Classification
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.
Predicate Devices
Reference Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2016
EarlySense Ltd. Ms. Dalia Argaman VP Clinical, Regulatory Affairs and QA 12 Tzvi Street Ramat Gan, 5250429 Israel
Re: K152911
Trade/Device Name: EarlySense Insight System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: BZO Dated: April 4, 2016 Received: April 5, 2015
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. 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.
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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 devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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.
Sincerely yours,
Tina Kiang -
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
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## Indications for Use
510(k) Number (if known) K152911
Device Name EarlySense InSight System
### Indications for Use (Describe)
The EarlySense InSight System is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in hospital or clinic setting. The system is indicated for use in children, add escents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and resting condition.
Type of Use (Select one or both, as applicable)
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(K) SUMMARY
## EarlySense InSight System
#### I. SUBMITTER
EarlySense Ltd. 12 Tzvi St. Ramat Gan 5250429, Israel Phone: +972-3-7522330 (ext.106); Fax: +972-3-7522340 Contact Person: Dalia Argaman E-mail: Dalia.Argaman@EarlySense.com Date Updated: May 5, 2016
#### II. DEVICE
Trade Name: EarlySense InSight System Classification Name: Breathing frequency monitor (21 CFR Sec. 868.2375) Regulatory Class: II Product Code: BZQ, There were no prior submissions for the subject device.
#### DEVICES III.
Primary Predicate:
EarlySense 2.0 System (K131379) manufactured by EarlySense Ltd, which can be used both with under the mattress bed sensing unit and with Chair Sensing Unit (K133661)
Secondary Predicate:
Wireless 2000 PAM™3000 (K082626) manufactured by Wireless 2000 These predicates have not been subjects to a design-related recall. Reference:
Chair Sensing Unit (K133661) can also be used with Insight Device as optional sensing unit.
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#### DEVICE DESCRIPTION IV.
A traditional 510(k) is submitted to clear the new EarlySense InSight System. The EarlySense Insight System developed by EarlySense Ltd. is designed for continuous and contact-free measurement of Heart and Respiratory Rate. In addition, the System tracks body motion; monitors patient movement and can notify users when the patient exits the bed or the chair. The device does not have a display and is controlled from a remote control and display station by the user. The measured data on Heart Rate, Respiratory Rate, Movement and alerts are communicated to a remote station that can communicate with the EarlySense device according to predefined protocol, to be displayed to users. The Remote Control and Display Device (RCD) can be computer or central monitoring device that can communicate with the InSight Unit through predefined standard protocol through LAN or Wi-Fi and is capable to remotely access the InSight Unit and display the information received from InSight Unit. All the settings and changing of configurations is performed by the user, via a Remote Control and Display Device (RCD device). The EarlySense Insight monitoring device can notify the Remote Control and Display device, when monitored parameters excurse above or below predefined limits. The user (Healthcare practitioner) receives the information and should actively acknowledge the alert notifications and adjust monitoring parameters as required.
## The EarlySense InSight device incorporates the following components:
- -EarlySense InSight Unit – placed at bedside (subject of this submission)
- EarlySense Bed Sensing Unit (K131379) placed under the mattress -
- Chair Sensing Unit (optional)(K133661)
#### V. INTENDED USE/INDICATIONS FOR USE
The EarlySense InSight Device is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense System has been
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studied in children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and resting condition.
The intended use of EarlySense InSight System is similar to its' primary predicate, EarlySense 2.0 System in all aspects, including clinical environment of usage and patient population.
EarlySense InSight has similar intended use as the cleared intended use for EarlySense System 2.0 (K131379) device that has already been cleared for usage in hospital and clinic environment for children, adolescents and adults. The intended use is also similar to the second predicate device, PAM™3000, the only difference is that in terms of patient population - the usage of the EarlySense Insight device is wider than PAM™3000 and includes children over the 2 years old, similar to the intended use of EarlySense 2.0 device.
### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The EarlySense InSight System shares the similar fundamental technology and functionality, similar types of components, similar intended use and indications for use with the predicate devices. The following table in details describes the similarities and differences between the submitted device and its predicate devices.
Table 5-1: Substantial Equivalence between the EarlySense InSight System and its' predicate devices
| | EarlySense InSight<br>System | EarlySense 2.0<br>System | PAM™3000 | | EarlySense InSight<br>System | EarlySense 2.0<br>System | PAM™3000 |
|------------------------|--------------------------------|--------------------------------|-----------------------------------------------------------------------|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K152911 | K131379 | K082626 | | | | breathing frequency<br>monitor |
| Product Code | BZQ | BZQ | DRT/BZQ | Manufacturer | EarlySense Ltd. | EarlySense Ltd. | Wireless 2000 |
| Regulation<br>Number | 868.2375 | 868.2375 | 870.2300/868.2375 | Intended Use<br>and Indications<br>for Use | The EarlySense InSight<br>Device is intended for<br>continuous<br>measurement of<br>respiration rate, heart<br>rate and movement, in<br>an automatic contact-<br>less manner, in<br>hospital or clinic<br>setting. The system is<br>indicated for use in<br>children, adolescents<br>and adults. The<br>operation of the<br>EarlySense has been<br>studied in children<br>(weight $≥$ 10 Kg) and<br>adults (weight $<$ 111<br>Kg) during sleep and<br>resting condition. | The EarlySense 2.0<br>System is intended<br>for continuous<br>measurement of<br>respiration rate, heart<br>rate and movement,<br>in an automatic<br>contact-less manner,<br>at home, hospital or<br>clinic setting. The<br>system is indicated<br>for use in children,<br>adolescents and<br>adults. The operation<br>of the EarlySense has<br>been studied in<br>children (weight $≥$ 10<br>Kg) and adults<br>(weight $<$ 111 Kg)<br>during sleep and<br>resting condition. In<br>addition, EarlySense<br>2.0 System can<br>continuously monitor<br>oxygen saturation of<br>arterial hemoglobin<br>(SpO2) using pulse<br>oximetry in pediatric<br>(ages 2 years and<br>older), adolescents,<br>and adults at home,<br>hospital or clinic<br>settings. | The PAM™3000 system<br>is intended to measure<br>heart rate and<br>respiration rate in adult<br>patients, in a general<br>care hospital<br>environment including<br>nursing homes. The<br>system monitors<br>presence or absence if<br>a patient in bed (bed<br>exit). The system also<br>times the length of<br>continuous patient<br>motion or absence of<br>patient motion. |
| Classification<br>Name | Breathing Frequency<br>Monitor | Breathing Frequency<br>Monitor | Monitor, Cardiac ( incl.<br>cardiotachometer<br>&rate alarm) monitor, | Sensing Unit | The Same<br>Contactless sensing<br>unit (Piezoelectric)<br>placed under the<br>mattress / on the chair | Contactless sensing<br>unit (Piezoelectric)<br>placed under the<br>mattress / on the<br>chair | Ultra Wide Band<br>motion sensor - Bed<br>sensor Panel (BSP),<br>placed under the bed<br>mattress |
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| | EarlySense InSight<br>System | EarlySense 2.0<br>System | PAM™3000 |
|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| | (Bed Sensing Unit<br>submitted as part of<br>EarlySense 2.0 System<br>(K131379) and Chair<br>Sensing Unit,<br>submitted separately<br>K133661) | (Bed Sensing Unit<br>submitted as part of<br>EarlySense 2.0 System<br>(K131379) and Chair<br>Sensing Unit,<br>submitted separately<br>K133661) | |
| Chair Sensing<br>Unit Cover,<br>Material | The Same<br>100% Polyester | 100% Polyester | |
| SpO2 module | Not supported by<br>InSight device | Is supported by<br>Earlysense 2.0 - as<br>optional module | Not used with the<br>system |
| Bedside Unit | Yes (processing unit).<br>No display and<br>graphical user<br>interface | Yes<br>Includes processing<br>unit, and graphical<br>User interface<br>Display. | No |
| Energy source | AC power source | AC power source | AC power source |
| Battery exist | No | Yes | No |
| Clinical<br>environment of<br>Use | Hospital, or clinic<br>environment | Home, Hospitals, or<br>clinic environment. | Hospital or hospital<br>type and clinic<br>environment |
| Patient<br>Population | Same<br>Children, adolescents<br>and adults | Children, adolescents<br>and adults | Adults |
| Visual and<br>Audio Indication<br>at bedside | Yes<br>LEDS and Buzzer | Yes.<br>LEDS, buzzer and<br>display | No |
| Software<br>Application and<br>Algorithms | Proprietary Software<br>developed by<br>Earlysense (Same) | Proprietary Software<br>developed by<br>Earlysense. | Proprietary Graphic<br>User Interface Software<br>on Central Computer<br>Station |
| | EarlySense InSight<br>System | EarlySense 2.0<br>System | PAM™3000 |
| User Interface<br>Display at<br>bedside | No | Yes | No |
| Network<br>Communication | Same<br>LAN and Wi-Fi | Yes<br>LAN and WI-FI | Yes<br>WI-FI |
| Communication<br>with Central<br>Station | Communication with<br>Central control and<br>display Stations (LAN<br>or Wi-Fi) according to<br>standard predefined<br>protocols | Communication with<br>EarlySense Central<br>Display Station (LAN<br>and/ or Wi-Fi) | Communication with<br>Central Computer<br>Station (that controls<br>operation and displays<br>monitoring information |
| Patient<br>monitoring | Same.<br>Monitoring<br>physiological<br>parameters:<br>- Heart Rate<br>- Respiration Rate<br>- Movement<br>- Occupancy and<br>- Exit (Bed /Chair)<br>Does not support<br>connection to Oxygen<br>Saturation monitoring<br>option and display. | Monitoring<br>physiological<br>parameters:<br>- Heart Rate<br>- Respiration Rate<br>- Movement<br>- Occupancy and<br>- Exit (Bed /Chair)<br>- Oxygen<br>- Saturation<br>(optional<br>external module<br>is supported), | Monitoring<br>physiological<br>parameters:<br>- Heart Rate,<br>- Respiration Rate<br>- Motion<br>- bed occupancy<br>data, patient<br>motion |
| Alerts | Same<br>(for parameters<br>crossing predefined<br>thresholds)<br>- Heart Rate<br>- Respiratory Rate<br>- Motion<br>- Bed / Chair<br>- Occupancy | (for parameters<br>crossing predefined<br>thresholds)<br>- Heart Rate<br>- Respiratory Rate<br>- Motion<br>- Bed / Chair<br>- Occupancy<br>- Oxygen<br>- Saturation | - Heart Rate<br>- Respiratory Rate<br>Alert<br>- Bed Occupancy<br>- Motion |
| Displayed<br>information | No Display Screen at<br>Bedside.<br>Monitoring data is<br>communicated to<br>remote control and | Parameters are<br>displayed at bedside<br>screen , and are<br>communicated to | The information<br>gathered by the system<br>(physiological<br>parameters and alerts)<br>are displayed on a PC |
| EarlySense InSight<br>System | EarlySense 2.0<br>System | PAM™3000 | |
| display station that<br>allows the user to<br>control bedside unit<br>operation and displays<br>monitoring data. | Earlysense Central<br>Station | monitor using Wireless<br>2000's proprietary<br>Graphic User Interface<br>(GUI) software. The<br>Central Computer<br>Station (CCS) is typically<br>placed at the nursing<br>station. | |
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# The following similarities are found between the EarlySense InSight System and its predicate devices:
The EarlySense Insight System share the same technological principle with its predicate devices and at the high level, the subject and predicate devices are based on the same technological features:
- EarlySense InSight System's performance is based on contactless . monitoring of Heart Rate, Respiration Rate and movement using piezoelectric sensors which were used and cleared in its predicate EarlySense 2.0 System- Bed Sensing Unit (K131379) and Chair Sensing Unit (K133661). The sensing units are used in exactly the same as cleared by FDA, no changes were performed.
- . The Bed or Chair Sensing Unit of the EarlySense System detects motion signals (mechanical movements) in a continuous contact-less manner. These signals are converted into an electric signal, which is transferred to the InSight Unit. In the InSight Unit the electric signal is sampled, filtered and analyzed by the System software to provide the respiration rate (RR), heart rate (HR), and movement level. The system's detection algorithms ( the same as those used in the predicate EarlySense 2.0 device) differentiate between large body movements, breathing movements and the cardioballistic effect, and thus compute the continuous heart and respiration rates and the body movement rate.
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- . The data is then transferred for display to a remote control and display device via LAN or Wi-Fi, similar to the predicate the EarlySense 2.0 System.
# The following differences exist between the EarlySense InSight System and its predicate devices:
- The EarlySense InSight Unit has no display (opposite to the EarlySense . 2.0 System) – the monitoring parameters and alerts can be viewed from the remote control and display system that can be placed on the nurse station. However, in this aspect, the Insight is similar to its second predicate, PAM™3000, which also has no display and no bedside unit.
- . EarlySense InSight Unit does not support monitoring and display of Sp02 measurement by external module, and in this aspect it is similar to PAM™3000, but different from EarlySense 2.0 device.
- . EarlySense InSight device does not have secondary power source – a battery, similar to PAM™3000, but different from EarlySense 2.0 device.
#### VII. PERFORMANCE AND NON CLINICAL TESTING
The EarlySense InSight System was subject to the verification and validation tests:
- 1. Risk analysis
- 2. Software Verification and Validation
- 3. EMC and Safety testing
- 4. Full load bench testing
5. Non Clinical Testing: EarlySense Insight Performance Verification Non-clinical tests included side by side performance testing of the InSight device vs. its predicate EarlySense 2.0. Signals from children, adolescents and adults' populations were tested. The accuracy of the InSight and EarlySense 2.0 in analyzing the signals and generating heart rate, respiration rate and motion measures were compared to results of reference device (Embla Sleep
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lab. System Medcare K024322). The devices' performance was found to be similar in respect to heart rate, respiratory rate and motion measurements.
Full load bench testing was also performed to examine the communication behavior aspects of EarlySense Insight units vs. EarlySense 2.0 predicate. The results of the bench tests showed that the InSight system performance is as good as the EarlySense 2.0, and thus concluded that it is substantially equivalent to the predicate device.
# Specification
| | Bed Sensing Unit | Chair Sensing<br>Unit | InSight Unit |
|------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Dimensions | Sensor: 300 X 210 X 6.45<br>mm | 300x210x6.45<br>mm | 145.6 x 62 x 65.07<br>mm |
| | With handles:<br>420.7X210X13.8 mm | | |
| Weight | 730 g | 482gr | 235 ± 10 gr |
| Materials | ABS + Poly carbonate | ABS+ Poly<br>carbonate<br>Inserted into<br>cushion:<br>Cushion : Visco<br>elastic<br>(dimension-<br>400 x 450 x 60<br>mm).<br>Cushion Cover:<br>100% Polyester | ABS + Poly<br>carbonate |
## Physical Characteristics
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## Electrical
| Voltage<br>Input Range | 100-240 V AC, 50-60 Hz, 0.9A max |
|------------------------|----------------------------------|
|------------------------|----------------------------------|
# Monitoring Range
| Respiratory Rate | Heart Rate | Movement |
|------------------|--------------|----------------|
| 6 – 45 Br./min | 30 - 170 BPM | 0, L, M, H, EH |
# Conclusions:
The conclusions drawn from the non-clinical tests demonstrate that the device can be considered substantially equivalent to its predicate devices: EarlySense 2.0 System (K131379) and Wireless 2000 PAM™3000 (K082626).
