(158 days)
The Novii+ Pod is an antepartum and intrapartum Maternal/Fetal Monitor that non-invasively measures fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii+ Pod acquires the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Pod is indicated for use on women who are at 34 weeks and 0/7 days and greater with singleton pregnancies, using surface electrodes on the maternal abdomen.
The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.
The Novii+ Interface is an accessory to the Novii+ Pod which provides a means of interfacing the wireless output of the Novii+ Pod to the transducer inputs of a Maternal/Fetal Monitor. The Novii+ Interface enables signals collected by the Novii+ Pod to be printed and displayed on a Maternal/Fetal Monitor and sent to a central network, if connected.
The Novii+ Pod Maternal/Fetal Monitor and its accessories are intended for use by healthcare professionals in a clinical setting.
The Novii+ Wireless Patch System (Novii+ system) is a battery-powered maternal-fetal monitoring system that measures abdominal fetal heart rate (FHR), abdominal uterine activity (UA), and abdominal maternal heart rate (MHR). The Novii+ Wireless Patch system is designed as an ambulatory device for the monitoring of a pregnant mother. The monitor enables the abdominal electrophysiological signal to be picked up from three different positions on the maternal abdomen using the 5 electrodes on the Novii Patch. The monitor filters the abdominal signals, converts the abdominal electrophysiological data into a digital format and then processes it in real time to extract the fetal heart rate, maternal heart rate and uterine activity. The result of the processing is transmitted via a Bluetooth connection to the Novii+ Interface device which is an accessory to the Novii+ Pod.
The Novii+ Pod (proposed device) is indicated for use on women who are at 34 weeks and 0/7 days and greater with singleton pregnancies with cephalic fetal presentation.
Here's a breakdown of the acceptance criteria and study details for the Novii+ Wireless Patch System, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
| Parameter (Metric) | Acceptance Criteria (Lower limit of 95% two-sided CI) | Reported Device Performance | Outcome |
|---|---|---|---|
| FHR (PA) | >80% | 83.45% | PASS |
| MHR (PA) | >80% | 97.26% | PASS |
| UA (RI) | >80% | 100% | PASS |
| UA (PPA) | >80% | 84.67% | PASS |
| FHR Deming Slope | 0.958 - 1.042 (95% two-sided CI) | 1.02 | PASS |
| FHR Deming Intercept | -10 to 10 BPM (95% two-sided CI) | -3.18 BPM | PASS |
| MHR Deming Slope | 0.958 - 1.042 (95% two-sided CI) | 1.01 | PASS |
| MHR Deming Intercept | -10 to 10 BPM (95% two-sided CI) | -1.18 BPM | PASS |
| MHR RMSE (Novii vs. GS) | < 2 BPM | < 2 BPM | PASS |
| MHR RMSE% (Novii vs. GS) | < 3.2 BPM | < 3.2 BPM | PASS |
| Ratio of RMSEs (Novii+ vs. Novii for MHR) | < 1.25 | (Implicitly passed) | PASS |
| MAE (Novii / Novii+ vs. GS for MHR) | < 1.6 BPM | < 1.6 BPM | PASS |
| MAE% (Novii / Novii+ vs. GS for MHR) | < 1.6 BPM | < 1.6 BPM | PASS |
Note:
- PA: Percent Agreement
- RI: Relative Interpretability
- PPA: Positive Percent Agreement
- RMSE: Root Mean Square Error
- MAE: Mean Absolute Error
- GS: Gold Standard
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study: 30 subjects
- 14 subjects with threatened pre-term labor (non-laboring)
- 16 subjects with pre-term labor and delivery
- Data Provenance: The document does not explicitly state the country of origin. Given that GE HealthCare is the submitter and their address is in Wauwatosa, WI, USA, it is likely the study was conducted in the United States. The study type is prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical study. Instead, the ground truth was established by comparator devices:
- FHR ground truth: Doppler Fetal Heart Rate device
- MHR ground truth: SpO2 Maternal Heart Rate device and 12-lead ECG data (Gold Standard)
- UA ground truth: TOCO Uterine Activity device
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1). The primary comparison was against established medical devices (Doppler, SpO2, TOCO, 12-lead ECG) which inherently serve as the reference/ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study's focus was on the Novii+ Wireless Patch System's equivalence to existing, established monitoring devices (Doppler, SpO2, TOCO, ECG) for capturing physiological data, not on how human readers' interpretations improve with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The study implicitly evaluated the standalone performance of the Novii+ Wireless Patch System. It directly compared the measurements generated by the Novii+ algorithms (FHR, UA, MHR) against the measurements from the comparator devices. There is no mention of human-in-the-loop performance evaluation in this specific context.
7. The Type of Ground Truth Used
- Fetal Heart Rate (FHR): Doppler Fetal Heart Rate device
- Maternal Heart Rate (MHR): SpO2 Maternal Heart Rate device, and a 12-lead ECG data (referred to as "MECG Gold Standard (GS)")
- Uterine Activity (UA): TOCO Uterine Activity device
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. This particular document focuses on the performance evaluation of the device in a clinical study for premarket notification, not the development or training of its underlying algorithms.
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 was established, as details about the training process are not included in this 510(k) summary.
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December 8, 2023
Datex Ohmeda Isabel McGann Director, Regulatory Affairs 9900 Innovation Drive Wauwatosa, WI 53226
Re: K231964 Trade/Device Name: Novii+ Wireless Patch System Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: II Product Code: HGM Dated: November 8, 2023 Received: November 8, 2023
Dear Isabel McGann:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Monica D. Garcia -S
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K231964
Device Name
Novii+ Wireless Patch System
Indications for Use (Describe)
The Novii+ Pod is an antepartum and intrapartum Maternal/Fetal Monitor that non-invasively measures fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii+ Pod acquires the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Pod is indicated for use on women who are at 34 weeks and 0/7 days and greater with singleton pregnancies, using surface electrodes on the maternal abdomen.
The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.
The Novii+ Interface is an accessory to the Novii+ Pod which provides a means of interfacing the wireless output of the Novii+ Pod to the transducer inputs of a Maternal/Fetal Monitor. The Novii+ Interface enables signals collected by the Novii+ Pod to be printed and displayed on a Maternal/Fetal Monitor and sent to a central network, if connected.
The Novii+ Pod Maternal/Fetal Monitor and its accessories are intended for use by healthcare professionals in a clinical setting.
| 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) Summary – K231964
In accordance with 21 CFR 807.92 the following summary information is provided:
| Date Prepared: | 07 DEC 2023 |
|---|---|
| Owner/Submitter:21 CFR 807.92(a)(1) | GE HealthCare (dba Datex- Ohmeda, Inc.)9900 Innovation DriveWauwatosa, WI 53226 |
| Primary ContactPerson: | Isabel McGannRegulatory Affairs DirectorGE HealthCareEmail: Isabel.mcgann@gehealthcare.com |
| Secondary ContactPerson: | Shiwani ZalpuriRegulatory Affairs Program ManagerGE HealthCareEmail: Shiwani.zalpuri@gehealthcare.com |
| Device Trade Name:21 CFR 801.92(a)(2) | Novii+ Wireless Patch System |
| Common/Usual Name: | Perinatal monitoring system and accessories |
| Regulation Name: | Perinatal monitoring system and accessories |
| Regulation Number: | 21 CFR 884.2740 |
| Classification: | II |
| Product Code: | HGM (System, Monitoring, Perinatal) |
| Predicate Device:21 CFR 807.92(a)(3) | Monica Novii Wireless Patch system (K140862)The predicate device has not been subject to a design-related recall. |
| Predicate DeviceManufacturer | Monica Healthcare Ltd |
| Device Description:21 CFR 807.92(a)(4) | The Novii+ Wireless Patch System (Novii+ system) is a battery-powered maternal-fetalmonitoring system that measures abdominal fetal heart rate (FHR), abdominal uterineactivity (UA), and abdominal maternal heart rate (MHR). The Novii+ Wireless Patchsystem is designed as an ambulatory device for the monitoring of a pregnant mother.The monitor enables the abdominal electrophysiological signal to be picked up fromthree different positions on the maternal abdomen using the 5 electrodes on the NoviiPatch. The monitor filters the abdominal signals, converts the abdominalelectrophysiological data into a digital format and then processes it in real time toextract the fetal heart rate, maternal heart rate and uterine activity. The result of theprocessing is transmitted via a Bluetooth connection to the Novii+ Interface devicewhich is an accessory to the Novii+ Pod.The Novii+ Pod (proposed device) is indicated for use on women who are at 34 weeksand 0/7 days and greater with singleton pregnancies with cephalic fetal presentation. |
| Indications for Use:21 CFR 807.92(a)(5) | The Novii+ Pod is an antepartum and intrapartum Maternal/Fetal Monitor that non-invasively measures fetal heart rate (FHR), uterine activity (UA) and maternal heart rate(MHR). The Novii+ Pod acquires the FHR tracing from abdominal surface electrodes thatpick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod alsoacquires the UA tracing from the uterine electromyography (EMG) signal and the MHRtracing from the maternal ECG signal (mECG). The Pod is indicated for use on women whoare at 34 weeks and 0/7 days and greater with singleton pregnancies, using surfaceelectrodes on the maternal abdomen. |
| The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Podand contains the surface electrodes that attach to the abdomen. | |
| The Novii+ Interface is an accessory to the Novii+ Pod which provides a means ofinterfacing the wireless output of the Novii+ Pod to the transducer inputs of aMaternal/Fetal Monitor. The Novii+ Interface enables signals collected by the Novii+ Podto be printed and displayed on a Maternal/Fetal Monitor and sent to a central network, ifconnected. | |
| The Novii+ Pod Maternal/Fetal Monitor and its accessories are intended for use byhealthcare professionals in a clinical setting. |
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COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE: 21CFR807.92(a)(6)
A comparison of the intended use and technological features of the subject and predicate device is provided in Table 1 below.
| Specification | Predicate DeviceMonica Novii Wireless PatchSystemK140862 | Subject DeviceNovii+ Wireless Patch SystemK231964 | Discussion of Differences |
|---|---|---|---|
| Indications for Use | The Monica Novii Pod is anintrapartum maternal-fetalmonitor that non-invasivelymeasures and displays fetalheart rate (FHR), uterineactivity (UA) and maternalheart rate (MHR). The NoviiPod acquires and displays theFHR tracing from abdominalsurface electrodes that pickup the fetal ECG (fECG) signal.Using the same surface | The Novii+ Pod is anantepartum and intrapartumMaternal/Fetal Monitor thatnon-invasively measures fetalheart rate (FHR), uterineactivity (UA) and maternalheart rate (MHR). The Novii+Pod acquires the FHR tracingfrom abdominal surfaceelectrodes that pick up thefetal ECG (fECG) signal. Usingthe same surface electrodes, | This difference does not raisedifferent questions of safety andeffectiveness and can beaddressed through performancetesting. |
| Specification | Predicate Device | Subject Device | Discussion of Differences |
| Monica Novii Wireless PatchSystem | Novii+ Wireless Patch System | ||
| K140862 | K231964 | ||
| electrodes, the Pod alsoacquires and displays the UAtracing from the uterineelectromyography (EMG)signal and the MHR tracingfrom the maternal ECG signal(mECG). The Pod is indicatedfor use on women who are at>36 completed weeks, inlabor, with singletonpregnancies, using surfaceelectrodes on the maternalabdomen. | the Pod also acquires the UAtracing from the uterineelectromyography (EMG)signal and the MHR tracingfrom the maternal ECG signal(mECG). The Pod is indicatedfor use on women who are at34 weeks and 0/7 days andgreater with singletonpregnancies, using surfaceelectrodes on the maternalabdomen. | ||
| The Novii Patch is anaccessory to the Novii Podthat connects directly to theNovii Pod and contains thesurface electrodes that attachto the abdomen. | The Novii Patch is anaccessory to the Novii+ Podthat connects directly to theNovii+ Pod and contains thesurface electrodes that attachto the abdomen. | ||
| The Novii Interface is anaccessory to the Novii Podwhich provides a means ofinterfacing the wireless outputof the Novii Pod to thetransducer inputs of a CTGFetal monitor. The NoviiInterface enables signalscollected by the Novii Pod tobe printed and displayed on aCTG Fetal Monitor and sent onto a central network, ifconnected. | The Novii+ Interface is anaccessory to the Novii+ Podwhich provides a means ofinterfacing the wireless outputof the Novii+ Pod to thetransducer inputs of aMaternal/Fetal Monitor. TheNovii+ Interface enablessignals collected by the Novii+Pod to be printed anddisplayed on a Maternal/FetalMonitor and sent to a centralnetwork, if connected. | ||
| The Novii Pod maternal-fetalmonitor and its accessoriesare intended for use byhealthcare professionals in aclinical setting. | The Novii+ Pod Maternal/FetalMonitor and its accessoriesare intended for use byhealthcare professionals in aclinical setting. | ||
| PatientPopulation | Intrapartum > 36 completedweeks for labor & deliverywith singleton pregnancies | 34 weeks and 0/7 days andgreater with singletonpregnancies | DifferentThe Novii+ Pod with its modifiedalgorithm can be used to monitor |
| Specification | Predicate DeviceMonica Novii Wireless PatchSystemK140862 | Subject DeviceNovii+ Wireless Patch SystemK231964 | Discussion of Differences |
| (34 weeks and 0/7 days andgreater), described as the pretermpatient population.This difference does not raisedifferent questions of safety andeffectiveness and can beaddressed through performancetesting. | |||
| Pod | The Novii Pod connects toeach electrode of the patchvia Pogo pins. The pod has ananalogue front end connectedto each electrode that is madeup of 4 instrumentationamplifiers and associatedelectronic bandpass filters.Original Novii pods are solidcolorNovii Pods are not compatiblewith Novii+ Interface | The Novii+ Pod connects toeach electrode of the patchvia Pogo pins. The pod has ananalogue front end connectedto each electrode that is madeup of 4 instrumentationamplifiers and associatedelectronic bandpass filters.The Novii+ Pod has a dualtone color (Purple and white)with slight dimensionaldifferenceThe Novii+ Pod is notbackward compatible | Similar |
| Patch | The Novii Patch is madeelectrodes that are holdtogether in place by asubstrate. The Patch has aplastic clip with magnets tohold in place the Novii Pod.Patch:- Single use- 5 electrodes on a substrate- Latex / PVC free- Gel quantity per electrode:300mg | The Novii Patch is madeelectrodes that are holdtogether in place by substrate.The Patch has a plastic clipwith magnets to hold in placethe Novii+ Pod.Patch:- Single use- 5 electrodes on a substrate- Latex / PVC free- Gel quantity per electrode:385mg | Similar |
| SupportedMonitors | GE Corometrics Maternal /Fetal Monitor (K072976)Philips Avalon Monitor(K140535) | GE Corometrics Maternal /Fetal Monitor (K072976) | SimilarNovii+ Wireless Patch Systemdoes not support Philips AvalonMonitor |
| Specification | Predicate DeviceMonica Novii Wireless PatchSystemK140862 | Subject DeviceNovii+ Wireless Patch SystemK231964 | Discussion of Differences |
| Alerts | The Interface alerts forconfirmation of features andconfirmation of charging. | The Interface alerts forconfirmation of features andconfirmation of charging.New Alert:- Patch electrode detached /broken pin | Different. The new alerts includedin the subject device do not raisedifferent questions of safety andeffectiveness. |
| Data Interface(Wireless)Interoperability | The Novii Pod and Interfaceconnect wirelessly usingBluetooth version 2.0.Input: Bluetooth Class 1.5,V2.0 real/time continuous,from Novii™ Pod. ModifiedSeries Protocol | The Novii+ Pod and Interfaceconnect wirelessly usingBluetooth version 4.0.Input: Bluetooth Class 1.5,V4.0 real/time continuous,from Novii™ Pod. ModifiedSeries ProtocolIrda interface to initiateauthentication and Bluetoothpairing | Similar |
Table 1: High-level Comparison of Subject Device to Predicate
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The subject and predicate device have similar indications for use statements and have the same intended use - non-invasive monitoring of fetal heart rate, maternal heart rate, and uterine activity. The Novii+ Pod software has been modified to work on patients who are at 34 weeks and 0/7 days and greater with singleton pregnancies with cephalic fetal presentation described as the preterm patient population as indicated in the modified indications for use. This difference in intended use population does not raise different questions of safety and effectiveness.
The proposed device (Novii+ Wireless Patch System) has similar fundamental scientific technology to the predicate device (Novii Wireless Patch system). It maintains the predicate device's functionality, performance and clinical workflows.
The Novii+ Wireless Patch System consists of minor updates to the existing version of the system (Novii system). Additionally non-significant changes were made the Novii system (e.g., update to the Pogo pin design, increase in quantity of gel in each electrode, changes in the patch PET shape, changes to the color, dimension and interface compatibility of the Pod). The different technological features of the subject device do not raise different questions of safety and effectiveness.
PERFORMANCE DATA: Determination of Substantial Equivalence 21 CFR 807(b)(1)
Summary of Non-Clinical Tests:
The Novii+ Wireless Patch System was tested to and complicable voluntary standards. The Novii+ Wireless Patch System was tested to assure that the device meets its design specifications. Testing included all new or modified features.
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Bench Testing
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the Novii+ Wireless Patch System demonstrating the design meets the pre-defined specifications.
Per the FDA guidance document entitled "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff, Document issued on December 20, 2019", the following was verified:
- . System Verification
- Pod and patch interface O
- O FECG/FHR quality indicator
- Confirmation of alerts O
- Bluetooth connectivity O
- Data transfer to GE HealthCare Corometrics monitors o
- Testing Wireless Interfaces ●
- Pod Algorithm Verification
- Hardware Bench Testing
- . Manuals Bench Testing
- Packaging Bench Testing ●
- Reprocessing Bench Testing ●
- Human Factors/Usability Testing
EMC/Electrical Safety/Wireless
The Novii+ Wireless Patch System meets the EMC requirements described in IEC 60601-1-2 Edition 4.0 2014-02 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests". Compliance according to the "Electromagnetic Compatibility (EMC) of Medical Devices Guidance for Industry and Food and Drug Administration Staff, issued on June 6, 2022". The Novii+ Wireless Patch System has been evaluated for electromagnetic compatibility and potential risks from common emitters in the Novii+ Wireless Patch System Solution environment, such as radio frequency identification readers, by testing per the AIM 7351731 Rev 2.00 "Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers" standard.
The Novii+ Wireless Patch System meets the electrical safety requirements of IEC 60601-1:2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Edition 3.1".
The Novii+ wireless patch system (the Novii+ Pod and Patch patient contact parts at the of defibrillation) was tested for misuse or emergency use of the defibrillator on patient as per the requirements of IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic
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Safety and Essential Performance clause 8.5.5 as applicable for the defibrillation. The device passed the applicable test cases such as common mode test and energy reduction mode tests with no impact to patient safety. The differential mode test at the higher voltage levels as prescribed by the standard protocol is not applicable based on the device intended use and hence was tested and found to be passing as per applicable test conditions. As the product is not designed to be completely defibrilation proof and also not intended to be used to monitor the maternal and fetal parameters at the time of defibrillation, the device is contraindicated for use with defibrillators.
Wireless performance data was provided related to:
- . Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff, Document issued on: August 14, 2013
- IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
Biocompatibility
The Novii+ Wireless Patch System follows the 2020 FDA Biocompatibility guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff" and ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. The testing data demonstrates that the subject device is not cytotoxic, non-sensitizing, and non-irritating.
Reprocessing
The Novii+ Wireless Patch System follows the 2015 FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff" and the following standards:
- . ISO 17664 Second edition 2017-10 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
- . 17664-2 First edition 2021-02 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.
Reprocessing efficacy validation has been conducted in accordance with the documented reprocessing instructions of the Novii+ Wireless Patch System. The reprocessing efficacy validation met the acceptance criteria for the reprocessing efficacy validation tests.
Human Factors
The Novii+ Wireless Patch System follows the 2016 FDA guidance – "Applying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration Staff", and the following standards:
- . IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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- IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
Software
The Novii+ Wireless Patch System adheres to FDA software guidance documents as outlined in this submission including the following:
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on May 11, 2005
- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on January 11, 2002
- Off-The-Shelf Software Use in Medical Devices; Guidance for Industry and Food and Drug ● Administration Staff, Document issued on September 27, 2019
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff issued April 8, 2022
- . FDA's Policy, Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act issued March 29, 2023
- Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, Document issued on September 6, 2017
Software testing was conducted, and documentation was provided per 2005 FDA Guidance- "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered as a "Major" level of concern. Software standard - "IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes" and risk management standard - "ISO 14971 Third Edition 2019-12, Medical devices - Application of risk management to medical devices" were also applied to the design.
Cybersecurity
Patient safety, security, and privacy risks have been addressed in the design and development of Novii+ Wireless Patch System including a Security Risk Assessment, Threat model and Penetration testing. This includes system integrity controls, access controls, network controls, and remote service controls which address the general principles and security capabilities outlined in the 2023 FDA guidance - "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". Additionally, in accordance with the FDA's Policy, Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act ", a plan to monitor, identify and address, in a reasonable time, postmarket vulnerabilities and exploits and an S-BOM is provided.
Summary of Clinical testing: 21 CFR 807.92(b)(2)
A clinical study was performed to determine the Novii+ Wireless Patch System's equivalence to Doppler Fetal Heart Rate (FHR), TOCO Uterine Activity (UA) and SpO2 Maternal Heart Rate (MHR) devices for preterm patients (≥34 weeks + 0/7 days) in terms of accuracy and reliability.
Overview of the Clinical study:
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30 subjects between 34 weeks + 0/7 days gestation through 36 weeks + 6/7 days gestation were enrolled: 14 subjects with threatened pre-term labor (non-laboring) and 16 subjects with pre-term labor and delivery. The acceptance criteria and results are summarized below.
FHR :
The mean percent agreement (PA) for FHR between the Novii+ Wireless Patch System and the predicate Doppler FHR was 88.08% with 95% lower limit confidence interval (CI) of 83.45%, above the 80% threshold set to demonstrate equivalence. In addition, for FHR the Deming Slope and Intercept were 1.02 and -3.18 Beats Per Minute (BPM), respectively. The 95% two-sided Cls for the slope fall within 0.958 and 1.042, and the intercept falls within -10 and 10 BPM which are the ranges set to demonstrate equivalence.
MHR:
The mean PA for MHR between the Novii+ Wireless Patch System and the comparator SpO2 MHR was 98.15% with 95% lower limit CI of 97.26%, above the 80% threshold set to demonstrate equivalence. In addition, for MHR the Deming Slope and Intercept were 1.01 and -1.18 BPM, respectively. The 95% two-sided Cls for the slope fall within 0.958 and 1.042, and the intercept falls within -10 and 10 BPM which are the ranges set to demonstrate equivalence.
The relative interpretability (RI) and mean positive percent agreement (PPA) for UA between the Novii+ Wireless Patch System and the TOCO UA were 100% and 89.5%, respectively. The 95% lower limit Cls were 100% and 85.48% for RI and PPA. These values are both above the 80% threshold set to demonstrate equivalence.
Additional re-assessment was done for the above clinical data, where bounds of the two-sided 95% confidence intervals, primary end point values and pass criteria are summarized below in Table 2.
| Criteria(Lower limit of 95%two-sided CI) | PA(Lower limit of 95%two-sided CI) | RI(Lower limit of95% two-sidedCI) | PPA(Lower limit of95% two-sided CI) | Summary | |
|---|---|---|---|---|---|
| FHR | >80% | 83.45 | -- | -- | PASS |
| MHR | >80% | 97.26 | -- | -- | PASS |
| UA/UC | >80% | -- | 100 | 84.67 | PASS |
Table 2: Lower Bounded Statistics
Further analysis is provided as follows:
Table 3: FHR Results with 2.5% Type 1 error with a two-sided interval
| Subject | Novii SR | Doppler SR | FHR PA | FHR RMSE | FHR MAE |
|---|---|---|---|---|---|
| Average | 88.81 | 88.24 | 88.08 | 5.7949 | 3.0346 |
| SD | 10.48 | 9.76 | 12.42 | 3.5692 | 2.0951 |
| Lower Cl two-sided 95% | 84.90 | 84.60 | 83.45 | 4.4642 | 2.2535 |
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510(k) Summary
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| Upper CI two-sided 95% | 92.72 | 91.87 | 92.71 | 7.1256 | 3.8157 |
|---|---|---|---|---|---|
| ------------------------ | ------- | ------- | ------- | -------- | -------- |
| Statistical Parameters | SPO2 SR | MHR SR | MHR (PA) | MHR RMSE | MHR MAE |
|---|---|---|---|---|---|
| Average | 95.96 | 99.96 | 98.15 | 2.6762 | 1.6695 |
| std | 10.17 | 0.12 | 2.01 | 1.1496 | 0.6401 |
| Lower Cl two-sided 95% | 91.47 | 99.90 | 97.26 | 2.1679 | 1.3864 |
| Upper Cl two-sided 95% | 100.46 | 100.01 | 99.04 | 3.1845 | 1.9525 |
Table 4: MHR Results with 2.5% Type 1 error with a two-sided interval
This study demonstrates that the data collected from Novii+ Pod is as accurate and as reliable as the data collected by Doppler ultrasound, TOCO transducer, and pulse oximetry (SpO2) devices for monitoring MHR, FHR and UA. The results of the clinical study demonstrate that the performance of Novii+ Wireless Patch System is equivalent to that of the Doppler/TOCO/ SpO2 devices for pre-term subjects (≥ 34 weeks + 0/7 days through 36 weeks + 6/7 days gestation) in terms of accuracy and reliability.
Additionally, the following clinical data was gathered in support of the Novii+ Wireless Patch system:
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- To support patients of different skin pigmentations, data was collected to demonstrate that there is no specific trend observed, indicating that the heart rate measurement from pulse oximetry sensors from the Corometrics device and Novii+ does not result in higher errors when used on subjects with darker skin pigmentation.
| Skin Pigmentation level | ||||||
|---|---|---|---|---|---|---|
| Light | Medium | Dark | ||||
| Fitzpatrick scoring level | I | II | III | IV | V | VI |
| Number of subjects | 4 | 9 | 3 | 1 | 3 | 0 |
| Percentage | 18.1 | 40.9 | 13.6 | 4.5 | 13.6 | 0 |
| Predicted valuesbased on trend | - | - | - | - | - | 2.573 |
| Mean RMSE | 2.05 | 2.58 | 1.68 | 2.29 | 2.99 | 2.573 |
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- To support the equivalence of the clinical performance of the Novii+ Wireless Patch System on patients with non-cephalic fetal presentations, additional bench testing data was provided. The results show that the polarity of the QRS complex does not impact the FHR output of the Novii+ algorithm.
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- To support the equivalence of the clinical performance of the MHR output of the Novii+ Wireless Patch System while using MECG Gold Standard (GS) (12-lead ECG data) as the comparator instead of a SpO2 device, additional bench testing data was provided to compare the mean Root
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Mean Square Error (RMSE) and Mean Absolute Error (MAE) results from the clinical study to that of the mean RMSE & MAE results from a standard ECG database of adult heart rates:
Mean RMSE value is less than 2BPM and mean RMSE% value is less than 3.2BPM for both Novii and Novii+ devices. Also, the ratio between two RMSEs are less than 1.25, which is a passing criterion for accepting the comparison between Novii+ MHR values. The MAE and MAE% values between Novii+ and GS and Novii and GS. MAE and MAE% values are less than 1.6BPM for both Novii and Novii+.
The results provided above demonstrate the equivalence of the Novii+ new algorithm to the predicate Novii algorithm-derived MHR in terms of accuracy and reliability as compared to a Gold Standard (12-lead ECG data).
CONCLUSION:
The results of the testing described above demonstrate that the Novii+ Wireless Patch System is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).