(198 days)
Not Found
No
The summary describes a hardware modification (addition of load cells) to an existing sensing unit and focuses on verifying that this modification does not affect the performance of the system's existing algorithms. There is no mention of AI, ML, training data, or complex data analysis techniques typically associated with AI/ML.
No.
The device is described as an accessory for continuous measurement of respiration rate, heart rate, and movement for monitoring purposes, and does not mention any therapeutic intervention.
No
The device is described as an accessory for continuous measurement of physiological parameters (respiration rate, heart rate, movement) and bed exit detection. While it provides measurements, its intended use, as stated, is not for diagnosis but for monitoring. The "Indications for Use" section doesn't mention diagnosing any conditions.
No
The device description explicitly states it is a "Bed Sensing Unit" which is placed under a mattress and includes "load cells elements," indicating it is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The EarlySense Bed Sensing Unit measures physiological parameters (respiration rate, heart rate, movement) and detects bed exit contact-lessly by being placed under the mattress. It does not analyze any biological specimens taken from the patient.
- Intended Use: The intended use describes continuous measurement of vital signs and bed exit detection, not the analysis of in vitro samples.
The device is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The EarlySense Bed Sensing Unit is an accessory that is compatible with of EarlySense Systems (Models 2.0 and InSight) intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner. Environment of use for the accessory is defined as per compatible cleared bedside units labeling: EarlySense 2.0 - at home, in hospital or clinic setting and InSight - in hospital or clinic setting. The device 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
§ 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 4, 2018
EarlySense Ltd. Dalia Argaman VP Clinical, Regulatory Affairs and QA 7 Derech Zeev Jabotinsky Ramat Gan, 525007 ISRAEL
Re: K171836
Trade/Device Name: EarlySense Bed Sensing Unit Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BZQ Dated: November 30, 2017 Received: December 5, 2017
Dear Dalia 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 of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang -
s
Tina Kiang, Ph.D. Acting 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) K171836
Device Name EarlySense Bed Sensing Unit
Indications for Use (Describe)
The EarlySense Bed Sensing Unit is an accessory that is compatible with of EarlySense Systems (Models 2.0 and InSight) intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner. Environment of use for the accessory is defined as per compatible cleared bedside units labeling: EarlySense 2.0 - at home, in hospital or clinic setting and InSight - in hospital or clinic setting. The device 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 PRAStaff@fda.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."
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510(K) SUMMARY
EarlySense Ltd.
EarlySense Bed Sensing Unit (K171836)
I. SUBMITTER:
EarlySense Ltd. 7 Derech Zeev Jabotinsky Ramat Gan, 5252007, Israel Tel: +972-3-7522330 (106) Fax: +972-3-7522340
Contact Person:
Dalia Argaman, VP Clinical, Regulatory Affairs and QA EarlySense Ltd. Dalia.Argaman@earlysense.com Date Prepared: November 30th, 2017
II. DEVICE:
Name of device: EarlySense Bed Sensing Unit Classification Name: 21 CFR Sec. 868.2375 - breathing frequency monitor Regulatory Class: II Product Code: BZQ
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III.Predicate Devices:
EarlySense Bed Sensing unit cleared as component to EarlySense 2.0 System (K131379) and
EarlySense Bed Sensing unit cleared as component to EarlySense InSight System (K152911).
A Traditional 510(k) is submitted for the modifications made to the cleared EarlySense Bed Sensing Unit.
IV. Device Description:
EarlySense is submitting a new model for its Bed Sensing Unit to be used with cleared EarlySense bedside unit models (EarlySense 2.0 -K131379 and EarlySense InSight -K152911) which are intended for contactless measurement of heart rate (HR), respiratory rate (RR) and motion. Similar to the cleared Bed Sensing units, the subject device is placed under the bed mattress and connected to supporting bedside unit, to allow contactless measurements of HR, RR and motion and detection of bed exit. The modification of the cleared sensing unit includes addition of two load cells elements intended to be used in the Bed Exit feature of the system. The cleared and subject device share exactly the same intended use, the same fundamental functionality and similar types of components, and the same fundamental principles and mode of operation. As also described above, the modification that includes addition of load cells is not considered to affect the system performance. The subject device is also compatible with the existing optional accessories of the cleared sensor, i.e., extension cable and solid metal plate. Utilization of extension cable is to allow placing the sensing unit under the mattress farther than 3 meters from compatible bedside units. The solid metal plate can be used for beds that have un-flat surface (such as grid like).
V. Intended Use
The subject device is intended to be used as an accessory with EarlySense System (Models 2.0 -K131379 and InSight - K152911).
VI. Indications for Use
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The EarlySense Bed Sensing Unit is an accessory that is compatible with bedside units of EarlySense Systems (Models 2.0 and InSight) intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner. Environment of use for the accessory is defined as per compatible cleared bedside units labeling: EarlySense 2.0 - at home, in hospital or clinic setting and InSight - in hospital or clinic setting. The device 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