The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires and displays 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 >36 completed weeks, in labor, 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 CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on 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

Device Description

The Monica Novii Pod Fetal-Maternal Monitor 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 Monica 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 the Bluetooth connection to the Monica Novii CTG Interface device that is a Monica Approved accessory to the Monica Novii Pod.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies that prove the Monica Novii Wireless Patch System meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides acceptance criteria for non-clinical tests (Data Transfer Validation and Data Extraction Validation).

Acceptance Criteria Category	Specific Metric	Acceptance Criteria	Reported Device Performance
Non-Clinical Testing
Data Transfer Validation	Bias difference for Fetal Heart Rate (FHR)	Less than 1 BPM	Demonstrated compliance (implies bias difference was < 1 BPM). The system achieves "reliability and accuracy of the data transfer... by demonstrating it meets pre-set thresholds i.e. a bias difference less of than 1 BPM for fetal heart rate and a maximum loss of transmitted to recorded data of 2%".
	Maximum loss of transmitted to recorded data	2%	Demonstrated compliance (implies loss was < 2%). Same as above.
Data Extraction Validation	Equivalence with predicate for FHR, MHR, UA data (via statistical analysis)	Demonstrated by statistical analysis including Positive Percent Agreement (PPA), Percentage Equivalence, and Sensitivity. Implicitly, these metrics met predefined thresholds for equivalence, though specific numerical thresholds are not provided in the summary.	The results of the extracted data from the Novii Pod were compared to the output of the predicate Monica AN24 device, and "demonstrate equivalence by statistical analysis including; Positive Percent Agreement (PPA), Percentage Equivalence and Sensitivity." This implies the device met the criteria for equivalence.
Clinical Testing	Equivalence in clinical performance of FHR, MHR, UA with predicate	Substantial equivalence to the Ambu electrodes attached to the Monica AN24 predicate device.	The results "demonstrated that the Monica Novii Patch is substantially equivalent to the Ambu electrodes attached to the Monica AN24 predicate device." (Specific quantitative metrics or detailed statistical results from the clinical study are not provided in this summary, but the conclusion states equivalence was demonstrated).

2. Sample Sizes Used for the Test Set and Data Provenance

Clinical Study (Test Set):
- Sample Size: 31 patients. The study was conducted in two stages:
  - 24 subjects recruited into three BMI groups.
  - 7 subjects where the Novii Patch was deliberately misplaced.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data but implies it was collected in a clinical environment. Given Monica Healthcare is based in the UK, it's probable the study took place there. The study was prospective in nature, comparing the Novii Patch directly against a predicate device in a clinical setting.
Non-Clinical Data Extraction Validation (Test Set):
- Sample Size: Ten (10) simulated data files.
- Data Provenance: The simulated data files were "based on data collected from the maternal abdomen in previous fetal ECG trials" of the predicate Monica AN24 device (K101801). This is retrospective in terms of the original data used to create the simulations, but the testing itself was performed using these pre-existing simulated data sets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Clinical Study: The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study. It mentions the study monitored "clinical performance" implicitly against the predicate device's readings, suggesting the predicate device served as the reference rather than independent expert adjudication of the Novii's output alone.
Non-Clinical Studies: Ground truth for the non-clinical tests (Data Transfer and Data Extraction) was established by comparing the device's output against known input signals or the predicate device's output. No human experts were involved in establishing ground truth for these simulated tests.

4. Adjudication Method for the Test Set

Clinical Study: The document does not describe a formal adjudication method by experts for the clinical study beyond comparing the Novii Patch's performance directly to that of the predicate device (Monica AN24 with Ambu electrodes).
Non-Clinical Studies: Adjudication was purely technical/automated, comparing device output to known inputs or predicate device output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. The studies described focus on the device's performance characteristics and its equivalence to a predicate device, rather than how human readers' diagnostic accuracy or efficiency might improve with or without AI assistance. The Monica Novii Wireless Patch System appears to be a monitoring device that outputs raw data (FHR, MHR, UA tracings) rather than an AI-driven interpretive tool requiring human reader studies.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone performance was assessed in the non-clinical "Data Extraction Validation." In this test, the Novii Pod's ability to extract FHR, MHR, and UA data from simulated electrophysiological signals was directly compared to the predicate device's output using the same inputs. This assesses the algorithm's performance in isolation from the clinical environment where a human might interpret the data.

7. Type of Ground Truth Used

Clinical Study: The ground truth was effectively the output of the predicate device (Monica AN24 with Ambu electrodes), as the study aimed to demonstrate substantial equivalence to this legally marketed device. This is a form of comparative ground truth against a recognized standard.
Non-Clinical Data Transfer Validation: Ground truth was the locally stored extracted data on the Novii Pod's Micro-SD card, compared against the transmitted data. This is a form of internal consistency ground truth.
Non-Clinical Data Extraction Validation: Ground truth was the output of the predicate Monica AN24 device when fed the same simulated inputs. This is also a form of comparative ground truth against a known standard.

8. Sample Size for the Training Set

The document does not provide any explicit details about a training set size. The Monica Novii Wireless Patch System's detection technology is explicitly stated to be "identical to the Monica AN24 predicate device in that it use the same electronic components, the same signal processing software." This suggests it reuses the established algorithms from the predicate device, rather than relying on a newly trained (e.g., machine learning) algorithm that would require a distinct training set. The simulated data used in testing was based on "previous fetal ECG trials" of the predicate, which could be considered data from which the original algorithms were developed, but not a "training set" in the context of a new algorithm.

9. How the Ground Truth for the Training Set Was Established

As there's no explicit mention of a new "training set" for a novel algorithm, the document doesn't detail how ground truth for a training set was established. The algorithms are inherited from the predicate device. The simulated data used for non-clinical testing was "based upon data collected in a trial of the predicate Monica AN24 device (K101801)" and "data collected from the maternal abdomen in previous fetal ECG trials" – these historical data sets would have had their own ground truth established via methods relevant to those original trials, likely involving expert review or known physiological parameters.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 27, 2014

Monica Healthcare Carl Barratt CEO BioCity, Pennyfoot Street Nottingham, NG1, 1GF, UK

Re: K140862

Trade/Device Name: Monica Novii Wireless Patch System Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: July 25, 2014 Received: July 28, 2014

Dear Carl Barratt,

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.

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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Monica Healthcare Limited Biocity, Pennyfoot Street, Nottingham, NG1 1GF, UK +44 (0)115 912 4540 / F +44 (0)115 912 4289 / E info@monicahealthcare.com www.monicahealthcare.com

Indications for Use Statement

510(k) Number (if known):

Device Name: Monica Novii Wireless Patch System

Indications For Use:

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 Pod maternal-fetal monitor and its accessories are intended for use by healthcare professionals in a clinical setting

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for Monica Healthcare. The word "Monica" is written in red, with the "i" replaced by a gray silhouette of a pregnant woman. Below the word "Monica" is the word "Healthcare" in gray.

Monica Healthcare Limited Biocity, Pennyfoot Street, Nottingham, NG1 1GF, UK T +44 (0)115 912 4540 / F +44 (0)115 912 4289 / E info@monicahealthcare.com www.monicahealthcare.com

510(k) Summary

Monica Novii Wireless Patch System

Submitters Name:	Carl BarrattMonica Healthcare LtdBiocityPennyfoot StreetNottingham NG1 1GFUKTel: +44 (0)115 912 4541Email: carl.barratt@monicahealthcare.com
Name of Device:	Monica Novii Wireless Patch System
Manufactured by:	Monica Healthcare LtdBiocityPennyfoot StreetNottingham NG1 1GFUK
Date of Summary:	25th July 2014
Classification Name:	21 CFR 884.270 System Monitoring Perinatal
Predicate Device:	Monica AN24 (K101801, K112390)Monica IF24 (K112163)Ambu Electrodes (K041026)

Device Description:

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Image /page/4/Picture/0 description: The image shows the logo for Monica Healthcare. The word "Monica" is written in red, with a stylized figure of a pregnant woman in gray forming part of the letter "i". Below "Monica" is the word "Healthcare" in a smaller, gray font. The logo is simple and modern, with a focus on the company's name and its association with women's health.

Intended Use:

The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetalheart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires and displays 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 >36 completed weeks, in labor, 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 NoviiPod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on 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

Technology Characteristics:

The Monica Novii Pod is a small battery powered electrophysiological monitor for the measurement of Maternal heart rate (MHR), Fetal heart rate (FHR) & Uterine activity (UA).

The electrical signals are passively monitored using five electrodes placed on the pregnant abdomen in a fixed array. From these electrical signals the Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Activity (UA) are continuously extracted and displayed in the same standard format as the predicate device.

The detection technology of the Monica Novii Pod is identical to the Monica AN24 predicate device in that it use the same electronic components, the same signal processing software and detects the electrical RR Intervals in the same way. Both devices produce the same output i.e. fetal heart rate (expressed as number of heart beats per minute), uterine activity and maternal heart rate.

For the actual detection of FHR, MHR and UA the Monica Novii Pod does not emit any energy into the patient, the same as the predicate device and hence the detection technology does not raise any new type of safety and effectiveness questions. In addition for FHR, MHR and uterine activity both the Monica Novii Pod and predicate device are external, skin contacting devices. The materials in contact with the patient are biocompatibility tested and comply with standards. To ensure clinical effectiveness the clinical performance data was collected as described in the "Clinical Study" section below. This study demonstrates that the Monica Novii Pod device is at least as accurate and reliable as the predicate device for monitoring FHR, MHR and UA.

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Image /page/5/Picture/0 description: The image shows the logo for Monica Healthcare. The word "Monica" is written in a bold, red font. Below the word "Monica" is the word "Healthcare" in a smaller, gray font. To the right of the word "Monica" is a gray silhouette of a pregnant woman.

Monica Healthcare Limited Biocity, Pennyfoot Street, Nottingham, NG1 1GF, UK T +44 (0)115 912 4540 / F +44 (0)115 912 4289 / E info@monicahealthcare.com www.monicahealthcare.com

Clinical Testing

The Monica Novii Patch was tested in a clinical environment in direct comparison to the AN24 predicate devices using individually placed Ambu electrodes used in accordance with the indications for use and Monica's AN24 user manual.

The clinical study monitored the clinical performance of the Monica Novii Patch and the predicate device for equivalence in 31 patients using a 60 minute recording for each participant, consisting of 30 minutes of data in stage 1 labor and 30 minutes of data in stage 2 labor (or late stage 1/stage 2 when stage 2 was shorter than 30minutes segments were chosen without bias to the Novii Patch or AN24 performance. The clinical study was in two stages, 24 subjects recruited into three BMI groups and 7 subjects where the Novii Patch was deliberately misplaced.

The results demonstrated that the Monica Novii Patch is substantially equivalent to the Ambu electrodes attached to the Monica AN24 predicate device.

Non-Clinical Test Summary

Extensive bench testing of the Novii Pod, Interface and Patch was undertaken to establish their equivalence to the predicate devices and detailed reports are included in Appendix F. An overview covering the key elements of the bench testing is outlined below:

트 Data Transfer Validation (Plan 107-TP-007 & Report 107-TP-007 01)

These tests confirm data transfer reliability and accuracy under normal conditions and for wireless coexistence using the following process, see Figure 1

Image /page/5/Figure/10 description: The image shows a block diagram of a fetal monitoring system. The system includes an MP3 player connected to an adaptor (100-EQ-065), which is connected to a Novii Pod. The Novii Pod is connected to a Novii Interface via Bluetooth. The Novii Interface is connected to a Fetal Monitor, which is connected to a computer via a serial link and a paper printout.

Figure 1: Data Transfer Validation

An MP3 player is used to simulate abdominal electrophysiological data on labouring patients. The simulated data is based upon data collected in a trial of the predicate Monica AN24 device (K101801). The audio MP3 output is fed into an adaptor (resistor network) to downsize the signals to microvolt levels in line with typical signal amplitudes recorded on the maternal abdomen. The Novii Pod detects the electrophysiological abdominal data and extracts FHR, MHR and Uterine Activity before transmitting it via Bluetooth to the Novii Interface. A Micro-SD card is fitted to the Novii Pod printed circuit board so that the Pod

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Image /page/6/Picture/0 description: The image shows the logo for Monica Healthcare. The word "Monica" is written in red, with the "o"s stylized. Above the "i" in Monica is a gray figure of a pregnant woman. Below the word "Monica" is the word "Healthcare" in a smaller font.

Monica Healthcare Limited Pennyfoot Street, Nottingham, NG1 1GF, UK 115 912 4540 / F +44 (0)115 912 4289 / E info@monicahealthcare.com www.monicahealthcare.com

can store the extracted data locally for later comparison with the transmitted signal. The transmitted Bluetooth data is converted back to analogue signals upon collection by the Novii Interface and fed into a fetal monitor through its standard DECG, MECG and TOCO inputs. The fetal monitor sends the data to its serial interface in the normal way, where it is collected in real time by a computer. At the end of the test the data stored on the micro-SD memory card is downloaded to the computer and compared to the transmitted data collected in real time from the serial COM port of the fetal monitor. Reliability and accuracy of the data transfer is confirmed in this way by demonstrating it meets pre-set thresholds i.e. a bias difference less of than 1 BPM for fetal heart rate and a maximum loss of transmitted to recorded data of 2%

■ Data Extraction Validation (Plan 107-TP-004, Report 107-TR-001 and App A 107-TR-001)

The real time patient data extraction is verified by comparing the output of the predicate Monica AN24 device to the output of the Novii Pod in respect of FHR, MHR and UA data using simulated electrophysiological data.

In the test, both devices are connected to the sound card of a computer using a resistor Bridge to reduce the voltage of the audio output of the PC soundcard down to the same level of amplitude recorded on the maternal abdomen. The data played through the PC sound card is simulated data based on data collected from the maternal abdomen in previous fetal ECG trials.

Ten (10) data files are then played into the inputs of both devices simultaneously and the results of the extracted data is then compared to demonstrate equivalence by statistical analysis including; Positive Percent Agreement (PPA), Percentage Equivalence and Sensitivity

■ Other Bench Validation

In addition, testing was also undertaken to validate;

Interface software functionality, including pairing with and charging the Novii pods
Hardware for both the Pod & Interface to demonstrate size, weight, connection, IP rating and other aspects of the physical design.
Patch Validation Testing was carried out in accordance with the ANSI/ AAMI EC12 standard for disposable electrodes, covering; Peel & Tact, patch aging & storage, transportation and electrical performance such as internal noise

. 3″d Party Testing

In addition, the full Monica Novii Wireless Patch system was demonstrated to comply with voluntary standards at accredited independent test facilities in the following areas:

Electrical Safety (IEC60601-1) .
EMC (IEC60601-1-2 & FCC CFR 47)

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Image /page/7/Picture/0 description: The image shows the logo for Monica Healthcare. The word "Monica" is written in red, with the "M", "o", and "n" in a bold, sans-serif font. The "i" is replaced by a stylized, silver-colored figure of a pregnant woman. Below the word "Monica" is the word "Healthcare" in a smaller, light gray font.

Monica Healthcare Limited Biocity, Pennyfoot Street, Nottingham, NG1 1GF, UK T +44 (0)115 912 4540 / F +44 (0)115 912 4289 / E info@monicahealthcare.com www.monicahealthcare.com

= IP (BSEN 60529)
Cleaning (Testing procedure is based on Ph Eur 2.6.13 / USP<61>)
. Biocompatibility (ISO10993)

Conclusion

The conclusions drawn from the non-clinical tests and clinical study demonstrate that the Monica Novii Wireless Patch System is as safe, as effective and performs as safely and effectively as the legally marketed predicate device.

Regulation Number and Section

§ 884.2720 External uterine contraction monitor and accessories.

(a)
Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.(b)
Classification. Class II (performance standards).