Who is the manufacturer of Neteera 130H/131H Vital Sign Monitoring Sensor?

Neteera Technologies , Ltd. filed the 510(k) submission for Neteera 130H/131H Vital Sign Monitoring Sensor (K212143).

What is the FDA product code for Neteera 130H/131H Vital Sign Monitoring Sensor?

DRT. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Neteera 130H/131H Vital Sign Monitoring Sensor?

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

What are the predicate devices for Neteera 130H/131H Vital Sign Monitoring Sensor?

Vital Sign Monitoring Sensor (Model: XK300) (K202464).

Who can help prepare an FDA 510(k) submission like Neteera 130H/131H Vital Sign Monitoring Sensor?

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.

Neteera 130H/131H Vital Sign Monitoring Sensor

K212143 · Neteera Technologies , Ltd. · DRT · Sep 28, 2022 · Cardiovascular

Device Facts

Record ID	K212143
Device Name	Neteera 130H/131H Vital Sign Monitoring Sensor
Applicant	Neteera Technologies , Ltd.
Product Code	DRT · Cardiovascular
Decision Date	Sep 28, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2300
Device Class	Class 2

Intended Use

The Neteera 130H/131H device is intended for spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring). The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care. The Neteera device is not intended to be used as an alarm system for potentially acute life-threatening situations in which medical intervention is necessary (e.g., ICU).

Device Story

Neteera 130H/131H is a contact-free vital signs monitor; utilizes high-frequency (122.25-123 GHz) micro-radar on-chip technology to detect micro-motions of skin (ballistocardiograph). Device operates in real-time, non-invasively, and non-contact; signals penetrate non-metallic materials like furniture and clothing. System measures heart rate and respiration rate during rest or mild body movement. Used in healthcare facilities and home monitoring; operated by healthcare professionals to inform patient care. Output displayed via cloud dashboard or USB connection. Provides clinicians with vital sign data to support patient monitoring; not intended for acute life-threatening alarm monitoring.

Clinical Evidence

GCP-compliant clinical study with 170 subjects (100 Israel, 70 US) including patients with cardiopulmonary/metabolic disorders. Evaluated HR and RR accuracy against FDA-cleared reference devices. Results showed high performance: HR accuracy under 10% error ranged from 97.06% to 98.7% across various setups (chair/bed); RR accuracy (5% or 5bpm criteria) ranged from 95.28% to 97.33%. No safety issues observed.

Technological Characteristics

Contactless micro-radar sensor (122.25-123 GHz). Components include sensor, USB cable, power supply. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366-1, and IEC 62304. Connectivity via USB and cloud dashboard. Software-based signal processing for ballistocardiograph motion detection.

Indications for Use

Indicated for spot and continuous measurement of heart rate and respiration rate in adult patients in healthcare facilities and home monitoring settings. Not for use as an alarm system for acute life-threatening situations requiring medical intervention (e.g., ICU).

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

Vital Sign Monitoring Sensor (Model: XK300) (K202464)

Reference Devices

MindRay Patient Monitor, model ePM 10M (K200015)

Related Devices

K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor · Neteera Technologies , Ltd. · Feb 9, 2024
K252676 — The Circadia C300 System (C300) · Circadia Health, Inc. · Feb 3, 2026
K251364 — Sleepiz One+ (2.5) · Sleepiz AG · Jul 29, 2025
K234003 — The Circadia C200 System · Circadia Technologies, Ltd. · May 30, 2024
K253388 — Sleepiz One+ (Model 2.5) · Sleepiz AG · Jan 28, 2026

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 28, 2022 Neteera Technologies Ltd. % Janice Hogan Official Correspondent Hogan Lovells US LLP Hebrew University Givat Ram Campus, High-tech Village - building 1.1/ P.O. Prof Rokah 2 Jerusalem, Jerusalem 9518702 Israel Re: K212143 Trade/Device Name: Neteera 130H/131H Vital Sign Monitoring Sensor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: DRT, BZQ Dated: August 29, 2022 Received: August 29, 2022 Dear Janice Hogan: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212143 Device Name Neteera 130H/131H Indications for Use (Describe) The Neteera 130H/131H device is intended for spot and continuous measurement of heart rate in adult patients (in healthcare facilities and home monitoring). The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care. The Neteera device is not intended to be used as an alarm system for potentially acute life-threatening situations in which medical intervention is necessary (e.g., ICU). | 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) Summarv # Device Name: Neteera 130H/131H Vital Signs Monitoring Sensor #### 1. 510K Submission Sponsor Neteera Technologies Ltd. High-Tech Village 1.1 The Hebrew University of Jerusalem PO Box 39088 Jerusalem 9139002, ISRAEL Company Phone No .: +972-2-5808733 Contacts: Janice M. Hogan, Consultant, Hogan Lovells US LLP a. - Email: mjanice.hogan@hoganlovells.com - b. Rakefet Shohat, VP Quality and Regulations, Neteera Technologies Ltd. Email: rakefet.shohat(@neteera.com ### 2. Date Prepared September 28, 2022 ### 3. Device Identification Trade/Proprietary Name: Neteera 130H/131H Common/Usual Name: Vital Signs Monitoring Sensor Classification Name: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) & Monitor, Breathing Frequency Regulation Number: 21 CFR 870.2300 (Product Code DRT) & 21 CFR 868.2375 (Product Code BZQ) Product Code: DRT & BZQ Device Class: 2 Classification Panel: Cardiovascular - 4. Legally Marketed Predicate Device(s): Vital Sign Monitoring Sensor (Model: XK300), 510(k) K202464, manufactured by Xandar Kardian Inc. - 5. Indication for Use Statement: The Neteera 130H/131H device is intended for spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring). {4}------------------------------------------------ The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care. The Neteera device is not intended to be used as an alarm system for potentially acute life-threatening situations in which medical intervention is necessary (e.g., ICU). - 6. Device Description: Neteera 130H/131H device is a contact-free vital-signs monitor based on a high frequency (122.25-123 GHz) micro-radar on-chip and algorithm, capable of detecting a variety of parameters: Respiration Rate (RR), Heart Rate (HR), during rest or subject's mild body movement. Neteera's micro radar-based solution enables measuring the micro-motions of the skin (BCG-Ballistocardiograph) remotely, in a real-time, non-invasive, and non-contact manner, through non-metallic materials such as furniture and clothing at a high resolution. # 7. Substantial Equivalence Discussion | | Subject Device | Predicate Device | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) Number Device Name | K212143 Neteera 130H/131H | K202464 Vital Sign Monitoring Sensor (Model: XK300) | | Common name | Heart Rate and Respiratory Rate Monitor | Heart Rate and Respiratory Rate Monitor | | Manufacturer | Neteera Technologies Ltd. | Xandar Kardian Inc. | | Intended Use | The Neteera System, Neteera 130/131H device, is intended for spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring). The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care. The Neteera device is not intended to be used as an alarm system for potentially acute life-threatening situations in which medical intervention is necessary (e.g., ICU). | The Vital Sign Monitoring Sensor (Model XK300) is intended to measure heart rate and respiration rate in adult patients in a general care hospital environment including nursing homes. The Vital Sign Monitoring Sensor can be used for home healthcare for data collection to inform patient care but not to acutely treat a patient. XK300 monitors presence or absence of a patient in a detection area of within 7 meters. The XK300 also monitors the length of continuous patient motion or absence of patient motion. | | Components | Sensor; USB Cable, Power Supply | Sensor; USB Cable | #### Table 5A – Comparison of Characteristics {5}------------------------------------------------ | Technology | Contactless, Radar-based measurement of micro-motions | Contactless, Radar-based measurement of micro-motions | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Medical Parameters Monitored and Displayer | Heart Rate; Respiratory Rate | Heart Rate; Respiratory Rate | | Patient Type | Adult | Adult | | Use Environment | Healthcare facilities and home monitoring. The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care. Not intended for potentially acute life-threatening situations. | General care hospital environment including nursing homes. The Vital Sign Monitoring Sensor can be used for home healthcare for data collection to inform patient care but not to acutely treat a patient. | | HR Measurement Range | 40 to 160 Beats Per Minute | 55-130 Beats Per Minute | | RR Measurement Range | 5 to 40 Breaths Per Minute | 5-60 Breaths Per Minute | | EMC Compliance | IEC 60601-1-2 | IEC 60601-1-2 | | Product Safety | IEC 60601-1; IEC 60601-1-6; IEC 60601-1-11 | IEC 60601-1; IEC 60601-1-6; IEC 60601-1-11 | | Data Display | Cloud Dashboard and/or USB connection to display | Cloud Dashboard | #### 8. Performance Testing (Non-Clinical) As part of demonstrating safety and effectiveness of the device and in showing substantial equivalence to the predicate devices, Neteera Technologies Ltd. completed a number of non-clinical performance tests. The device meets all the requirements of the overall design. Testing results confirm that the design output meets the design inputs and specifications for the device. The following testing has been performed using the Neteera 130H/131H Device: - IEC 60601-1:2005/A1:2012 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance {6}------------------------------------------------ - IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements . for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [tested as Class B, Group 2] - IEC 60601-1-6:2010/A1:2013 Medical electrical equipment Part 1-6: General ● requirements for safety - Collateral standard: Usability - IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General ● requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment - IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices - IEC 62304:2006/A1:2015 Medical device software Software life cycle processes ● - AIM 7351731 Rev. 2.00 (2017-02-23) Medical Electrical Equipment and System ● Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - IEEE/ANSI C63.27-2017- American National Standard for Evaluation of Wireless ● Coexistence - AAMI TIR69 2017 - Risk management of radio-frequency wireless coexistence for medical devices and systems. In addition to the testing above, software validation and usability testing were also conducted. This testing demonstrated that the Neteera 130H/131H performed and functioned as intended and according to the design specifications. Performance testing evaluated the performance of the Neteera device in comparison with data generated by the following Reference Device: MindRay Patient Monitor, model ePM 10M (K200015), manufactured by Shenzen Mindray Bio-Medical Electronics Co. # 9. Clinical Testing As part of demonstrating the safety and effectiveness of the device and in showing substantial equivalence to the predicate device, Neteera Technologies Ltd. completed a GCP-compliant clinical study with the device and FDA-cleared devices. Clinical validation was performed in two parts: - 100 subjects. Israel ● - . 70 Subjects, US population; specifically recruiting subjects with cardiopulmonary and metabolic medical disorders. {7}------------------------------------------------ | | | HR | RR (*) | SPOT | | | Continuous | | | |----------------------------|----------|----------------------|----------------------|-----------------------|---------------------------|--------------------------------|-----------------------|---------------------------|-----------------------------| | | | | | HR | RR | | HR | RR | | | Parameter | Subgroup | Num. Setups HR | Num. Setups RR | under 10% error | 5% or 5bpm Criteria | under 10% error or 2brpm | under 10% error | 5% or 5bpm Criteria | under 10% error or 2brpm | | Chair Back | Total | 130 | 130 | 98.46 | 96.92% | 96.15% | 97.44% | 95.96% | 93.1% | | Chair Front | Total | 130 | 131 | 98.46% | 96.92% | 96.95% | 98.7% | 97.33% | 93.52% | | Above Bed | Part 2 | 34 | 34 | 97.06% | 97.06% | 91.18% | 96.44% | 95.28% | 93.1% | | All Front (Chair & Bed) | | 164 | 165 | 98.17% | 96.95% | 95.76% | 98.26% | 96.94% | 93.44% | #### Performance Results of the overall ~170 Subjects mPP Version 4.0 No safety issues were observed during the study. ### Study population: Subject demographics and baseline characteristics are shown below. The mean age of the study population was 43.20 ± 14.37 years (range, 18-76 years). Ninety subjects (52.94%) were females. The mean BMI was 28.46 ± 6.93 kg/cm2 (range, 16.40-50.50 years). On average the subjects participating in Part 2 were older with a higher BMI. #### Subject baseline demographics | Parameter | Part 1 N=100 | Part 2 N=70 | Total N=170 | |------------------------------------------------|-------------------------|------------------------|-------------------------| | Age (years) | | | | | Mean $\pm$ SD | 39.03 $\pm$ 12.66 | 49.14 $\pm$ 14.65 | 43.20 $\pm$ 14.37 | | Median (range) | 39.5 (18-68) | 48 (18-76) | 42 (18-76) | | Sex, n (%) | | | | | Male | 52 (52%) | 28 (40%) | 80 (47.06%) | | Female | 48 (48%) | 42 (60%) | 90 (52.94%) | | Height, cm | | | | | Mean $\pm$ SD | 169.10 $\pm$ 9.56 | 168.73 $\pm$ 9.79 | 168.95 $\pm$ 9.63 | | Median (range) | 169.15 (141-194) | 168.75 (147-196.80) | 168.80 (141-196.80) | | Weight, kg | | | | | Mean $\pm$ SD | 75.15 $\pm$ 17.23 | 90.4 $\pm$ 23.65 | 81.43 $\pm$ 21.42 | | Median (range) | 72 (40-130) | 86.05 (53.70-152.40) | 79 (40-152.40) | | BMI, kg/cm2 | | | | | Mean $\pm$ SD | 26.2 $\pm$ 5.32 | 31.68 $\pm$ 7.68 | 28.46 $\pm$ 6.93 | | Median (range) | 25.24 (16.44- 47.07) | 29.45 (20.84-50.52) | 26.70 (16.40- 50.50) | | BMI = body mass index, SD = standard deviation | | | | {8}------------------------------------------------ | Source: NET-MED-002 CSR Post-Text Tables 14.1.2.1-14.1.2.5 | | |------------------------------------------------------------|--| |------------------------------------------------------------|--| # 10. Conclusion The device has the same intended use and similar indications for use and technological characteristics compared to the predicate device. The minor differences do not raise different questions regarding the safety and effectiveness of the device as compared to the predicate device. Therefore, based on the information provided in this 510(k) premarket notification, Neteera Technologies Ltd. concludes that the Neteera 130H/131H device is substantially equivalent to the Vital Signs Monitoring Sensor (Model: XK300; K202464) predicate device.