The Monica AN24 is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR) and uterine activity (UA). The AN24 acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the AN24 also acquires and displays the UA tracing from the uterine electromyography (EMG) signal. The AN24 is indicated for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.

The AN24 maternal-fetal monitor is intended for use by healthcare professionals in a clinical setting.

Device Description

The Monica AN24™ is a small, battery-powered device for L&D surveillance of fetal well-being. The AN24™ is designed to passively monitor Fetal Heart Rate (FHR) from the fetal electrocardiogram (fECG) and Uterine Activity (UA) from the Electrohysterogram (EHG) during pregnancy and can be used at any time from > 36 completed weeks gestation in laboring patients. The AN24™ is suitable for singleton pregnancies only.

The Monica AN24 is a small, battery powered electrophysiological monitor (specifically fetal ECG and uterine EMG). The electrical signals are passively monitored on three channels using five electrodes placed on the pregnant abdomen in specific locations. From these electrical signals the Fetal Heart Rate (FHR) and Uterine Activity (UA) are continuously extracted and displayed in the same standard format as the predicate device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Monica AN24 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct thresholds in the document, but rather implied by the non-inferiority comparison to the predicate device and the reported outcomes from the clinical study. The study aimed to demonstrate that the Monica AN24 is at least as accurate and reliable as the predicate device. Therefore, the "acceptance criteria" can be inferred as performance greater than or equal to the predicate device for each metric.

Metric	Implied Acceptance Criteria (relative to Predicate)	Reported Monica AN24 Performance	Reported Predicate Performance (Philips 50XM)
Fetal Heart Rate (FHR) Interpretability (PPA)	≥ 72%	85%	72%
FHR Accuracy (RMS Error)	≤ 12 bpm	5 bpm	12 bpm
Uterine Activity (UA) Interpretability (PPA)	≥ 67%	97%	67%
UA Sensitivity Accuracy (Sensitivity for Contractions)	≥ 55%	89%	55%
UA Timing Accuracy (Mean Timing Difference for Contractions)	≤ 3.3 seconds lag	2.5 seconds lag	3.3 seconds lag

2. Sample Sizes and Data Provenance

Test Set (Clinical Study):
- Total Subjects Enrolled: 60 women.
- Evaluable Data Subjects: 34 subjects.
- FHR Study Subjects: 33 women.
- UA Study Subjects: 30 women.
- Data Provenance: The study was conducted at two clinical sites: QHC, New York, and Temple University, Philadelphia. This indicates prospective data collection in the USA.
- Training Set Sample Size: Not explicitly stated. The document describes a "clinical equivalence trial" and a "subsequent Multi-Reader-Multi-Case (MRMC) study," which are generally used for validation/testing.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Number of Experts: Four.
Qualifications of Experts: Board Certified Obstetricians. (Specific years of experience are not mentioned).

4. Adjudication Method (Test Set)

Uterine Activity (UA): The uterine activity data was "independently reviewed in a Multi-Reader Study by four Board Certified Obstetricians who independently indicated on randomized trace segments." The results were "averaged" to establish the ground truth for UA. This aligns with a form of consensus-based adjudication, likely an average or 4/4 agreement model, though the exact decision rule isn't specified beyond "average of 4 board certified obstetricians."
Fetal Heart Rate (FHR): The ground truth for FHR was established directly by the "Direct fetal Scalp ECG (second Phillips Series 50XM device)," which served as the gold standard. No expert adjudication was mentioned for FHR.

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

Was an MRMC study done? Yes, a "Multi-Reader-Multi-Case (MRMC) study" was integral to the evaluation of Uterine Activity (UA).
Effect Size of Human Readers' Improvement with AI vs. without AI assistance: The document focuses on the performance of the device itself (Monica AN24 or predicate) compared to the gold standard, with human readers involved in establishing the ground truth for UA and in reviewing "False Positives." It does not describe a comparative effectiveness study where human readers interpret tracings with and without AI assistance to measure reader improvement. The MRMC study in this context refers to multiple readers evaluating the output of different devices (Monica AN24, TOCO, IUPC) to derive ground truth and compare device performance.

6. Standalone (Algorithm Only) Performance Study

Yes, the study primarily assessed the standalone performance of the Monica AN24 device (algorithm only), comparing its output directly against established gold standards (fetal scalp ECG for FHR, IUPC for UA). The metrics (PPA, RMS error, sensitivity, timing accuracy) are all measures of the device's inherent performance.

7. Type of Ground Truth Used

Fetal Heart Rate (FHR): Direct fetal Scalp ECG (from a second Philips Series 50XM device). This is a direct physiological measurement considered the gold standard.
Uterine Activity (UA): Intrauterine Pressure Catheter (IUPC) (from a Philips Series 50XM device), with expert consensus from four Board Certified Obstetricians used to interpret the tracings and mark contractions. This is a combination of direct physiological measurement and expert consensus/adjudication.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for training the Monica AN24 device's algorithms. The described study is a clinical equivalence trial used for validation of the device's performance against a gold standard and a predicate, not for training.

9. How Ground Truth for the Training Set was Established

The document does not provide information on how ground truth was established for the training set, as the focus is on the clinical validation study for regulatory submission.

Summary

{0}------------------------------------------------

11 January 2011

Image /page/0/Picture/1 description: The image shows the logo for "Monica Healthcare". The logo consists of the word "Monica" in bold, sans-serif font, with a stylized figure of a person with outstretched arms replacing the dot over the "i". Below the word "Monica" is the word "Healthcare" in a smaller, less bold font. The overall design is simple and professional, suggesting a focus on health and well-being.

K101801 510(K) Summarv

FEB - 3 201

Monica AN24

Submitters Name:

lan How Monica Healthcare Ltd Biocity Pennyfoot Street Nottingham NG1 1GF UK

Tel: +44 (0)115 912 4541 Email: ianhow@monicahealthcare.com

Name of Device: Monica AN24

Manufactured by:

Monica Healthcare Ltd Biocity Pennyfoot Street Nottingham NG1 1GF UK

Date of Summary: 40 January 2011

Classification Name: 21 CFR 884.270 System Monitoring Perinatal

Predicate Device: Philips 50XM (K954351)

Device Description:

Intended Use:

The AN24 maternal-fetal monitor is intended for use by healthcare professionals in a clinical setting.

Technology Characteristics:

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for "Monica Healthcare". The word "Monica" is in bold, black letters, with a stylized figure of a person extending upwards from the "i". Below "Monica" is the word "Healthcare" in a smaller, less bold font. The logo is simple and professional, likely representing a healthcare-related business.

Kioisoi page lot

Uterine Activity (UA) are continuously extracted and displayed in the same standard format as the predicate device.

The detection technology of the Monica AN24 differs from the predicate device which uses Doppler ultrasound to measure Fetal Heart Rate (FHR) and a tocodynamometer (TOCO) to measure Uterine Activity (UA). The predicate device detects the mechanical RR interval of the fetal heart whilst the Monica AN24 detects the electrical RR interval. However, from this data both instruments produce the same output i.e. fetal heart rate (expressed as number of heart beats per minute).

Uterine activity in the Monica AN24 is derived from the electrohysterogram which is the electric signal of the contracting/moving uterine muscle. The uterine activity in the TOCO predicate is derived from an external strain gauge to measure the abdominal pressure of the contracting/moving uterine muscle. However from this data both instruments produce the same uterine activity output trace.

For the actual detection of both FHR and UA the Monica AN24 does not emit any energy into the patient and hence the above differences in detection technology do not raise any new type of safety and effectiveness questions. In addition for FHR and uterine activity both the AN24 and predicate device are external, skin contacting devices. Differences in materials in contact with the patient are resolved with biocompatibility testing and compliance 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 AN24 device is at least as accurate and reliable as the predicate device for monitoring both FHR and UA.

In summary, the differences in technology between the AN24 and the predicate device do not affect safety or effectiveness.

Clinical Study

1. Introduction

This section summarizes the six-way clinical equivalence trial and subsequent Multi-Reader-Multi-Case (MRMC) studyl supporting the effectiveness of the Monica AN24. The study enrolled 60 women at term, in labor, at two clinical sites, of which 33 women contributed to the Fetal Heart rate (FHR) study and 30 to the Uterine activity (UA) study. Each study subject was instrumented with three technologies for measuring fetal heart rate (FHR) and with three technologies for measuring uterine activity (UA). These are:

Fetal Heart Rate (FHR):

Doppler ultrasound cardiotocograph (Philips Series 50XM) – predicate device
Monica AN24 abdominal fetal ECG - test device
Direct fetal Scalp ECG (second Phillips Series 50XM device) - gold standard (GS)

Uterine Activity (UA):

Tocodynamometry (Philips Series 50XM) - predicate device
Monica AN24 Electrohysterogram (EHG) - test device
Intrauterine Pressure Catheter (IUPC), Philips Series 50XM - gold standard (GS)

{2}------------------------------------------------

11 January 2011

Image /page/2/Picture/1 description: The image shows the logo for "Monica Healthcare". The logo consists of the word "Monica" in bold, block letters, with a stylized figure of a person replacing the dot over the "i". Below the word "Monica" is the word "Healthcare" in a smaller, less bold font. The logo is simple and modern, with a focus on the company name.

K101801 page 3 of 6

Using fetal scalp electrode and IUPC as the "gold standards", this study methodology allowed a six-way comparison for evaluating how well the Monica AN24 performed ys. Doppler for FHR measurement and Monica AN24 versus tocodynamometor for use in activity.

2. Study Design

2.1 Study Objective

The primary objective was to demonstrate that during the intrapartum period the Monica AN24 is equivalent to the Doppler FHR and tocodynamometer-derived uterine activity when both are compared simultaneously to direct scalp FHR and IUPC uterine activity, respectively.

Inclusion Criteria:

. Pregnant, age 15-40
Term gestation (>36 completed weeks)
Singleton fetus .
Active labor .
Vertex presentation
Requiring internal monitoring

Exclusion Criteria:

. Clinical contraindication for IUPC
Major fetal malformation �

2.2 Study Methodology

Each study subject agreed to be simultaneously instrumented with three different technologies for measuring FHR and with three different technologies for measuring uterine activity (UA). Sensors and/or catheters were applied and removed as clinically indicated. For the UA comparison, three 30-minute segments of data were randomly selected from the entire monitored period for each subject, two 30-minute tracings from Stage 1 and one 30-minute trace from Stage 2 of labor. Therefore, 90 minutes of recording was analyzed for each subject for UA. For the FHR comparison, all the FHR data was analyzed for the entire monitoring period when the direct scalp FHR data was present.

2.3 Outcome Measures

Both the Monica AN24 (FHR and EHG) and the predicate devices (Doppler or TOCO) were compared with the gold standard (GS) device (i.e. direct scalp fetal ECG or IUPC). Monica AN24 was tested against the predicates using null hypotheses of inferiority and alternative hypotheses of non-inferiority, for the measurement of FHR and UA in terms of: Interpretability and Accuracy - resulting in four separate endpoints as follows:

Fetal Heart Rate

The data from all 3 FHR instruments was processed into synchronized 0.25 second epochs. The following primary end points were calculated for FHR:

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Monica Healthcare. The word "Monica" is written in a bold, sans-serif font, with the "M" and "o" connected. To the right of the word "Monica" is a stylized graphic of a person. Below the word "Monica" is the word "Healthcare" in a smaller, sans-serif font.

vá

End Point 1: For FHR interpretability the Monica FHR (or the Doppler FHR) versus the GS was organized into a 2x2 table of interpretable and uninterpretable data, i.e., where uninterpretable data are defined as those where the device in question does not report a valid FHR reading. A positive percent agreement (PPA) with GS was generated for each patient giving two values per patient - one for Monica AN24 vs GS and one for Doppler vs GS. PPA is defined as the percent of epochs with valid GS figures that are interpretable by the device in question

End Point 2: For FHR accuracy, a single Bland Altman (BA) difference plot was generated for Monica FHR (or Doppler FHR) vs the GS for each patient and a root mean square (RMS) error was determined for each device comparison. A BA difference plot is a scatter plot of the difference between the device and GS measurements vs. the GS measurement. RMS error is the square root of the mean of the squared differences.

Uterine Activity

The uterine activity data were independently reviewed in a Multi-Reader Study by four Board Certified Obstetricians who independently indicated on randomized trace segments the following features: "Interpretable or Un-interpretable" data, and "Individual Contractions", with each individual contraction marked as "Good Quality" or "Bad Quality". The marking was blind with respect to the device that produced the tracing. The four sets of data were again processed in terms of interpretability and accuracy. The following primary end points were calculated for UA:

End Point 3: For UA interpretability, a 2x2 Table of interpretable/uninterpretable data of Monica EHG (or TOCO) vs GS (IUPC) was constructed and the PPA was determined in the same manner as for FHR.

End Point 4a: For UA sensitivity accuracy, a Table of individual contractions identified by both Monica AN24 (or TOCO) and GS (IUPC) and those detected only by GS (IUPC) was constructed. To determine sensitivity, the proportion of contractions as determined by GS that were detected within ± 30 seconds by the device in question were calculated

End Point 4b: A second UA accuracy parameter (UA timing accuracy) was calculated as the difference in timing of corresponding contractions between Monica AN24 (or TOCO) and the GS (IUPC).

3. Description of Study Population

Thirty-four of 60 subjects enrolled provided evaluable data. Mean gestational age was 39 weeks 3 days (37 w 2d to 42 w 0d). Mean age was 26 years (18 to 38). Mean body mass index (BMI) was 32 (19 to 54). Thirty-one subjects were successfully instrumented with all six technologies, two subjects were successfully instrumented with three FHR technologies and one subject was successfully instrumented with three uterine activity technologies.

4. Results

The following key statistical outcomes, all validated with 95% confidence limits, were:

{4}------------------------------------------------

Image /page/4/Picture/2 description: The image shows the logo for "monica Healthcare". The word "monica" is written in a bold, sans-serif font, with the "m" and "o" connected. Below "monica" is the word "Healthcare" in a smaller, less bold font. To the right of the word "monica" is a stylized graphic of a person.

FHR compared to fetal scalp ECG

1. FHR Interpretability: The mean positive percent agreement (PPA) for interpretable data for Monica was 85% compared with 72% for Doppler
1. FHR Accuracy: The mean RMS error from Bland Altman was 5 bpm for Monica compared with 12 bpm for Doppler, indicating than Was 5 Dpin 100 FHR output is more similar to the gold standard fetal scalp electrode measurement compared to Doppler.

Uterine Activity compared to IUPC (average of 4 board certified obstetricians):

1. UA Interpretability: The mean PPA for UA trace interpretability of Monica was 97% compared with 67% for TOCO
1. UA Sensitivity Accuracy: The mean sensitivity for detecting individual contractions observed on IUPC, within ± 30 seconds, was 89% (84% to 99%) for Monica compared with 55% (48% to 62%) for TOCO.
1. UA Timing Accuracy: The mean timing difference of corresponding contractions was 2.5 seconds lag (2.06 to 2.94 seconds lag) when coponaring Monica AN24 with IUPC and 3.3 seconds lag (2.92 to 3.69 seconds lag) when comparing TOCO with IUPC.

5. False Positives

When Monica AN24 or tocodynamometry tracings exhibit a deflection above baseline that does not have a corresponding deflection on the gold standard IUPC, that deflection may be considered a "False Positive" (FP). The Monica "Multi-Reader Study" evaluated the relative FP rate for Monica AN24 and tocodynamometry. The results of this analysis demonstrated that clinician judgement on individual deflections varied widely among the four clinical reviewers. Therefore, it is unclear whether comparison of the FP rate for Monica AN24 vs. tocodynamometry in the Multi-Reader Study is generalizable.

To illustrate how individual clinical judgment may vary, the following example displays a Monica AN24 tracing with two discernable deflections above baseline that do not correspond to deflections on the IUPC tracing:

Deflections do not correspond to a uterine contraction
Monica AN24 EHG trace:
Image: EHG trace graph




IUPC trace:
Image: IUPC trace graph





Deflections corresponding to uterine contraction

If most or all of the types of Monica AN24 deflections above are counted as contractions, then the Monica AN24 may display more FP contractions compared to

{5}------------------------------------------------

11 January 2011

Image /page/5/Picture/2 description: The image shows the logo for Monica Healthcare. The logo consists of the word "Monica" in a bold, sans-serif font, with the word "Healthcare" underneath in a smaller font. The "i" in Monica is replaced by a stylized figure of a person.

tocodynamometry. This difference, however, is unlikely to have an adverse impact on clinical outcomes in full term laboring patients.

5. Acknowledgements

Monica Healthcare Ltd, UK, would like to thank: the clinical teams at QHC, New York and Temple University, Philadelphia for undertaking this study and the USA mothers who kindly agreed to take part in the study.

Non Clinical Test Summary

The Monica AN24 and Accessories comply with voluntary standards. The standards were employed in the following areas:

Electrical Safety .
EMC
Material Safety
Software Validation

Conclusion

The non clinical tests used voluntary standards employed at accredited independent test facilities to demonstrate that the Monica AN24 is as safe and effective in performance to the predicate device, the main standards employed were

IEC60601-1 electrical safety .
IEC60601-1-2 EMC
IEC 60601-1-2-47 Performance standard for electrocardiographs
IEC60601-1-4 Software
ISO10993 Biocompatibility
ISO14385 QMS

To demonstrate that the Monica AN24 is as clinically safe and effective as the predicate device, the clinical study described above measured the clinical performance of the Monica AN24 and the predicate device against the gold standards fetal scalp ECG and IUPC. The outcomes showed that in a clinical setting the Monica AN24 achieved for FHR: a positive percent agreement (PPA) for interpretability of 85% compared to 72% for the predicate; whilst for accuracy a mean RMS error from Bland Altman of 5 bpm for Monica AN24 when compared with 12 bpm for the predicate. For Uterine Activity the Monica AN24 achieved: a mean PPA for interpretability of 97% compared with 67% for predicate (TOCO); whilst for accuracy the mean sensitivity for detecting individual contractions was 89% for Monica AN24 compared with 55% for the predicate (TOCO); further the mean timing difference of corresponding contractions was 2.5 seconds (lag) when comparing Monica AN24 with IUPC and 3.3 seconds (lag) when comparing TOCO with IUPC. The Monica AN24 had an increased false positive contraction count compared to the predicate however, this was not clinically significant.

The conclusions drawn from the nonclinical tests and clinical study demonstrate that the Monica AN24 is as safe, as effective and performs as safely and effectively as the legally marketed predicate device.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.

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

Mr. Ian How Regulatory Affairs Manager Monica Healthcare Biocity Pennyfoot Street Nottingham United Kingdom NG1 1GF

FEB - 3 201

Re: K101801

Trade Name: Monica AN24 Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM, OSP Dated: December 1, 2010 Received: December 3, 2010

· Dear Mr. How:

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 J 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. 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

{7}------------------------------------------------

Page 2

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):

Device Name: AN24

Indications For Use:

The AN24 maternal-fetal monitor is 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)

Page 1 of 1

hozu m whay

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K101801

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).