(446 days)
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).
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.
The Neteera 130H/131H Vital Signs Monitoring Sensor is intended for "spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring)." The following details describe the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the performance metrics reported, specifically the percentage of measurements falling "under 10% error" or meeting "5% or 5bpm Criteria" for HR, and "under 10% error or 2brpm" for RR. These thresholds represent the satisfactory performance levels.
| Parameter | Subgroup | Num. Setups HR | Num. Setups RR | Spot HR under 10% error | Spot HR 5% or 5bpm Criteria | Spot RR under 10% error or 2brpm | Continuous HR under 10% error | Continuous HR 5% or 5bpm Criteria | Continuous RR 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% |
2. Sample Size for the Test Set and Data Provenance
The clinical validation study involved 170 subjects in total across two parts.
- Part 1: 100 subjects from Israel.
- Part 2: 70 subjects from the US population, specifically recruiting subjects with cardiopulmonary and metabolic medical disorders.
The study was prospective as it was a "GCP-compliant clinical study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
No information is provided about the number of experts or their qualifications used to establish ground truth.
4. Adjudication Method for the Test Set
No information is provided about an adjudication method for the test set. Given that the ground truth for vital signs is typically established through direct measurement with reference devices, complex adjudication methods like 2+1 or 3+1 are typically not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The Neteera 130H/131H is a direct measurement device for vital signs, rather than an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance study was done. The performance results presented in the table are for the Neteera device's measurements compared to a reference device, indicating its standalone accuracy in measuring HR and RR. The device is described as "a high frequency (122.25-123 GHz) micro-radar on-chip and algorithm," implying autonomous measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance testing was established using a reference medical device. Specifically, the "MindRay Patient Monitor, model ePM 10M (K200015)," which is an FDA-cleared device.
8. The sample size for the training set
The document does not specify the sample size for the training set. The provided clinical study data (170 subjects) appears to be for validation/testing, not training.
9. How the ground truth for the training set was established
The document does not provide information on how the ground truth for the training set, if any, was established. It only mentions the reference device used for validation.
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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.
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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) 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
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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) |
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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
-
- Legally Marketed Predicate Device(s): Vital Sign Monitoring Sensor (Model: XK300), 510(k) K202464, manufactured by Xandar Kardian Inc.
-
- 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).
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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 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.
- 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.
7. Substantial Equivalence Discussion
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) NumberDevice Name | K212143Neteera 130H/131H | K202464Vital 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
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| 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
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- 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.
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| HR | RR (*) | SPOT | Continuous | ||||||
|---|---|---|---|---|---|---|---|---|---|
| HR | RR | HR | RR | ||||||
| Parameter | Subgroup | Num.SetupsHR | Num.SetupsRR | under10%error | 5% or5bpmCriteria | under 10%error or2brpm | under10%error | 5% or5bpmCriteria | 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 1N=100 | Part 2N=70 | TotalN=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 |
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| 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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
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.(b)
Classification. Class II (performance standards).