Who is the manufacturer of EarlySense Bed Sensing Unit?

Earlysense, Ltd. filed the 510(k) submission for EarlySense Bed Sensing Unit (K171836).

What is the FDA product code for EarlySense Bed Sensing Unit?

BZQ. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for EarlySense Bed Sensing Unit?

510(k) clearance (submission type: Traditional).

What are the predicate devices for EarlySense Bed Sensing Unit?

EarlySense Bed Sensing unit (K131379); EarlySense Bed Sensing unit (K152911).

Who can help prepare an FDA 510(k) submission like EarlySense Bed Sensing Unit?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EarlySense Bed Sensing Unit

K171836 · Earlysense, Ltd. · BZQ · Jan 4, 2018 · Anesthesiology

Device Facts

Record ID	K171836
Device Name	EarlySense Bed Sensing Unit
Applicant	Earlysense, Ltd.
Product Code	BZQ · Anesthesiology
Decision Date	Jan 4, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	Pediatric

Intended Use

The subject device is intended to be used as an accessory with EarlySense System (Models 2.0 -K131379 and InSight - K152911).

Device Story

Accessory for EarlySense 2.0 and InSight systems; placed under mattress for contactless monitoring. Input: mechanical signals from body motion, heartbeats, and respiration detected via piezoelectric ceramic sensor and two load cells. Transformation: signals converted to electrical, filtered, and transmitted to bedside unit for algorithmic processing. Output: heart rate, respiratory rate, motion, and bed exit alerts. Used in home, hospital, or clinic settings by clinicians or patients. Output displayed on bedside unit to assist clinical decision-making regarding patient status and bed occupancy. Benefits: continuous, non-invasive monitoring without patient contact.

Clinical Evidence

Bench testing only. Comparison of signal parameters (amplitudes, SNR, time/frequency domain, spectral intensities) between subject and predicate sensors confirmed equivalence. Controlled experiments verified 'time to alert' for bed exit notifications were similar to predicate, confirming the addition of load cells does not negatively impact system performance.

Technological Characteristics

Materials: ABS/Polycarbonate plate. Sensing: Piezoelectric ceramic element for motion/HR/RR; two load cells for bed exit. Dimensions: 420 x 210 x 14 mm. Weight: 760g. Power: 5V from bedside unit. Connectivity: RS-232 protocol. Ingress protection: IP24. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 62366, IEC 62304, IEC 60601-1-2, IEC 60721-4-2, IEC 60721-4-3, IEC 60068-2.

Indications for Use

Indicated for continuous measurement of respiration rate, heart rate, and movement in children, adolescents, and adults. Compatible with EarlySense 2.0 (home, hospital, clinic) and InSight (hospital, clinic) systems. Studied in children (weight ≥10 Kg) and adults (weight <111 Kg) 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

EarlySense Bed Sensing unit (K131379)
EarlySense Bed Sensing unit (K152911)

Related Devices

K070375 — EARLYSENSE ES-16 SYSTEM · Earlysense, Ltd. · Nov 15, 2007
K152911 — EarlySense Insight Sytem · Earlysense, Ltd. · May 6, 2016
K092062 — EVERON 1.0 · Earlysense, Ltd. · May 24, 2010
K180079 — Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation · Hill-Rom, Inc. · May 7, 2018
K133661 — CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM · Earlysense, Ltd. · Jun 13, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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 <111 Kg) during sleep and resting condition. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | { Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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." {3}------------------------------------------------ # 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 {4}------------------------------------------------ ## 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 {5}------------------------------------------------ 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 <111 Kg) during sleep and resting condition. #### Comparison of technological characteristics with VII. the predicate device The cleared (AME-00200-K131379) and subject device share exactly the same intended use and indications for use. Piezoelectric sensor is the basic technological principle for both subject device and predicate Bed Sensing unit in order to monitor Heart Rate, Respiration Rate and motion in a contactless manner. The same piezoelectric sensor (located inside the both Bed Sensing units) is used to detect respiration related mechanical movement signals, heart beat-related mechanical movements and converts them into an electric signal that are sampled, filtered and transferred to the compatible EarlySense Bedside Unit where they are analyzed by algorithms to provide the respiration rate (RR), heart rate (HR), and motion measurements. The subject device consists of the following technological elements, which are identical to the cleared Bed Sensing Unit: - . Piezoelectric ceramic sensing element: detects gross body motion, heart and breathing rate motion related signals - . Sensor Plate: housing the piezoelectric sensing element - . Cable and connector: to allow connection to compatible bedside unit - Base plate with handles: to allow placing the sensor under the mattress The following technological differences exist between the subject device and predicate Bed Sensing Unit: - • Two load cell elements and supporting electronic circuit board added {6}------------------------------------------------ to the base plate of the sensor. The function of the modification is to be used in the detection of the Bed Exit function. The following table contains the summary of the substantial equivalence comparison. | | Predicate Device 1: Cleared Bed Sensing Unit (accessory to EarlySense 2.0 - K131379) | Predicate Device 2: Cleared Bed Sensing Unit (accessory to EarlySense InSight- K152911) | Subject Device | |-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K_number | K131379 | K152911 | K171836 | | Product Code | • BZQ | The Same | The Same | | Regulation | Accessory for: • 21 CFR Sec. 868.2375 Breathing frequency monitor | The Same | The Same | | Environment of use/care | At home, in hospital or clinic setting | In hospital or clinic setting | Environment of use 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. | | Sensor Technology | Piezoelectric ceramic sensing element is used to detect motion signals (mechanical movements) in a continuous contact-less manner. These signals are converted into | Identical | Identical | | | Predicate Device 1: Cleared Bed Sensing Unit (accessory to EarlySense 2.0 - K131379) | Predicate Device 2: Cleared Bed Sensing Unit (accessory to EarlySense InSight- K152911) | Subject Device | | | an electric signal, sampled, filtered and transferred to the Bedside Unit where they are analyzed by the Bedside unit's software (algorithms) to provide the respiration rate (RR), heart rate (HR), and motion. Bed exit signal is also detected and available. | | | | Bed Exit Function | Is performed by piezoelectric ceramic sensing element | Is performed by piezoelectric ceramic sensing element | Is performed by piezoelectric ceramic element as in the predicate and by addition of two load cells and supporting circuit board | | Sensor "housing" / material | ABS/Polycarbon ate plate | Identical | Identical | | Signals Detected | Pulse rate Respiration Rate Movement Bed occupancy/ exit | Identical | Identical Pulse rate Respiration Rate Movement Bed occupancy/ exit | | Technology | Detection of respiration mechanical signal and heart beat-related mechanical movements | Identical | Identical | | | Predicate Device 1: Cleared Bed Sensing Unit (accessory to EarlySense 2.0 - K131379) | Predicate Device 2: Cleared Bed Sensing Unit (accessory to EarlySense InSight- K152911) | Subject Device | | | (based on respiratory motion and cardioballistic effect motion) | | | | Patient Population | Adults, adolescents and children | Identical | Identical | | Mode of Operation | Connection to EarlySense Bedside unit | Identical | Identical | | Analysis (Signals processing and Display of parameters to user) | Connection to Earlysense bedside unit. Processing of signals by EarlySense proprietary algorithms which process the signals and GUI provided by bedside unit. | Identical | Identical | | SpO2 monitoring | Allows SpO2 monitoring by utilizing an off- the-shelf module (manufactured by Nonin Medical Inc.) | The design of the device (InSight) does not allow connection to off- the-shelf SpO2 module. | Identical to the predicate devices - the SpO2 monitoring is performed by separate off-the- shelf module while using EarlySense 2.0 model and is not performed, while connected to InSight device. SpO2 monitoring is not a function of the subject device | | Power Source | 5 Volt - received from EarlySense | Identical | Identical | | | Predicate Device 1: Cleared Bed Sensing Unit (accessory to EarlySense 2.0 - K131379) | Predicate Device 2: Cleared Bed Sensing Unit (accessory to EarlySense InSight- K152911) | Subject Device | | | bedside unit | | | | Way of connection / Communicat ion to the Bedside Unit | Communication protocol (RS- 232) and specific connector | Identical | Identical | | Sensor Dimensions | 420 X 210 X 14 mm | Identical | Identical | | Sensor Weight | 730 gr. | 730gr. | 760 gr | | Additional sensing element | No additional sensing element in the cleared bed sensing unit | No additional sensing element in the cleared bed sensing unit | Two load cell elements were added to the sensor's base plate (housed in specially designed niches) to be used in bed exit feature, supported by additional circuit board | | Method of Connection to patient | The Bed Sensing Unit is placed under the bed mattress - not touching the patient | Identical | Identical | | Optional accessories | Extension cable and metal plate | The same | The same | Substantial Equivalence Comparison subject device to its predicate devices {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ #### VIII. Performance data {10}------------------------------------------------ The subject device (as component to EarlySense System (Models 2.0 -K131379 and InSight - K152911) was subject to the verification, validation activities and bench testing, namely: - Risk analysis - · Electrical safety and electromagnetic compatibility - · Environmental Conditions Testing (Storage, Operation and Shipping,) - Performance Bench Testing #### Risk analvsis Risk analysis was performed as for the potential hazards that are relevant to the addition of load cells to the subject device, and required testing performed as mitigations. #### Electrical safety and electromagnetic compatibility Electrical safety and EMC testing, according to the IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 62366, IEC 62304 and IEC 60601-1-2 standards. Subject device was found to comply with the requirements of the standards, when connected to compatible bedside units. ### Environmental Conditions Testing The sensing unit was subject to storage, operation and shipping testing according to standards IEC 60721-4-2:2001+A1:03 (Class 2K4) and IEC 60721-4-3:2001+A1:03 (Class 3K3). In addition, Sinusoidal vibration, Bump, Free fall test were performed according to EC TR 6071-4-2:2001+A1:03(Class 2M2). Shock test (according to IEC 60068-2-27:2008), Broad-band random vibration test (according to IEC 60068-2-64:2008), Free fall test (according to IEC 60068-2-31:2008) were performed. Subject device successfully passed all the testing. Water and solid object ingress tests were performed and sensing unit was found to be IP24 protected. #### Performance Bench Testing {11}------------------------------------------------ Bench tests were performed to verify that the heart beat and respiration signals obtained from the subject device are similar to its predicate device, and to validate that the addition of load cells do not affect signal parameters as required by the EarlySense system's algorithms, to maintain specifications. The bench testing included comparison of parameters such as: signal's amplitudes, signal to noise ratios, time domain and frequency domain comparisons, signal spectral intensities. Bench testing results showed that in all relating parameters the signals from the sensing unit were similar to the predicate sensor and all parameters were within system's algorithms specification. In addition, tests were performed to compare performance of the sensing unit to predicate sensor in providing "time to alert" for bed exit notification. Controlled experiments showed that the time to alert for bed exit notifications are similar for both sensors, thus addition of the load cells does not affect system's performance and the sensing unit is substantially equivalent to the cleared sensor. ## IX. Conclusions The non-clinical tests demonstrate that subject device is substantially equivalent to the predicate device.