(217 days)
No
The summary describes a system for continuous measurement of vital signs and movement using sensing units and a remote display. There is no mention of AI, ML, or any algorithms that would typically be associated with these technologies for data analysis or interpretation beyond basic thresholding for alerts. The performance studies focus on comparing the device's measurements to a reference device and its predicate, not on evaluating the performance of any AI/ML models.
No.
The device is described as a monitoring system that measures physiological parameters (respiration rate, heart rate, movement) and provides alerts, but it does not specify any therapeutic or treatment function.
Yes
The device continuously measures vital signs (respiration rate, heart rate, and movement) and can notify users when parameters exceed predefined limits, which are all actions performed for diagnostic purposes (monitoring patient health to identify potential issues).
No
The device description explicitly lists hardware components: EarlySense InSight Unit, EarlySense Bed Sensing Unit, and Chair Sensing Unit.
Based on the provided text, the EarlySense InSight 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 about a person's health.
- EarlySense InSight System Function: The EarlySense InSight System measures physiological parameters (respiration rate, heart rate, movement) directly from the patient's body in a contact-less manner. It does not analyze samples taken from the body.
The device description and intended use clearly indicate that it is a patient monitoring system used in a clinical setting, not a device for analyzing biological specimens.
N/A
Intended Use / 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, adlescents and adults. The operation of the EarlySense has been studied in children (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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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 Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| 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