The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.

Device Description

The Monica IF24 CTG Interface Device is an interface device that allows an AN24 to send data to a standard Fetal Monitor. 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 IF24 CTG Interface Device is a small, low-voltage device that receives the monitored parameters from the Monica AN24 Fetal Monitor and converts the wireless digital signal to analogue for inputting into a CTG Monitor. It has a touch screen for:

Selection of the appropriate CTG monitor
Calibration with the CTG Monitor
Display AN24 battery power
Display Bluetooth connectivity between the AN24 & IF24

AI/ML Overview

The Monica IF24 CTG Interface Device is an accessory designed to interface the wireless output of the Monica AN24 Fetal Monitor with a standard CTG (Cardiotocography) Fetal monitor. This allows signals collected by the AN24 to be displayed, printed, and potentially sent to a central network via the CTG monitor.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on non-clinical testing and substantial equivalence rather than explicit performance metrics with acceptance criteria for clinical efficacy. The acceptance criteria are broadly implied as compliance with relevant voluntary standards and accurate data reception/transmission.

Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety (Compliance with EN60601-1)	"The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: Electrical Safety." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were EN60601-1 electrical safety."
EMC (Electromagnetic Compatibility) (Compliance with EN60601-1-2, FCC CFR47)	"The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: EMC." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were EN60601-1-2 EMC, FCC CFR47 EMC."
Material Safety/Biocompatibility (Compliance with ISO10993)	"The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: Material Safety." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were ISO10993 Biocompatibility."
Software Validation (Compliance with EN 62304)	"The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: Software Validation." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were EN 62304 Software."
Usability (Compliance with IEC 62366)	"The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: Usability." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were IEC 62366 Usability."
Quality Management System (Compliance with ISO13485)	"The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were ISO13485 QMS."
Accurate data reception and transmission	"The Monica IF24 CTG Interface Device accurately receives and transmits the correct data." (Demonstrated through "software validation and performance bench testing").
Substantial Equivalence to predicate devices	"The conclusions drawn from the nonclinical tests, performance tests and the validation demonstrate that the Monica IF24 CTG Interface Device is substantially equivalent to the legally marketed predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a "test set" in the context of clinical data for the IF24 device. The regulatory submission is primarily based on non-clinical tests (electrical safety, EMC, material safety, software validation, usability, and performance bench testing) to demonstrate substantial equivalence to predicate devices (Monica AN24, Philips Avalon CTS).

Sample Size for Test Set: Not applicable or not specified in terms of patient data. The testing involves engineering and software validation tests.
Data Provenance: Not applicable in terms of patient data. The testing is described as non-clinical and performance bench testing, likely conducted in a laboratory or engineering environment. The manufacturer is Monica Healthcare Ltd, based in Nottingham, UK.

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

This information is not provided in the document. Given the non-clinical nature of the testing described, it's unlikely that "experts" (e.g., radiologists) in the typical sense for medical image interpretation were used for establishing ground truth for a clinical test set. The experts involved would likely be engineers, software testers, and regulatory compliance specialists responsible for executing and evaluating the non-clinical tests.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of an adjudication method for a clinical test set because the provided information focuses on non-clinical and bench testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence through non-clinical testing of the interface device itself, not on comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The concept of "standalone performance" as typically applied to an AI algorithm making a diagnosis or performing a task without human intervention doesn't directly apply here. The Monica IF24 is an interface device; its "performance" is in accurately receiving and transmitting data, not in making clinical interpretations. The "algorithm" in this context refers to the software controlling the device's functionality (e.g., conversion of wireless digital signal to analog), which was validated through "software validation and performance bench testing" to ensure accurate data handling.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests, the "ground truth" would be established by:

Compliance with published standards: For electrical safety, EMC, material safety, software, usability, and QMS, the ground truth is simply adherence to the requirements outlined in the specified standards (e.g., EN60601-1, IEC 62366).
Expected data values/behavior: For "accurate data reception and transmission," the ground truth would be the known input data values from the AN24 and the expected output values and waveform fidelity on the CTG monitor, verified through performance bench testing.

8. The Sample Size for the Training Set:

Not applicable. The Monica IF24 is an interface device, not an AI model that requires a training set in the conventional sense of machine learning for classification or prediction tasks. The software involved handles data conversion and communication, which is validated, not "trained."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no mention of a training set for an AI model.

Summary

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AUG 3 0 2011

510(k) Summary

Monica IF24 CTG Interface Device

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 IF24 CTG Interface Device

Manufactured by:

Monica Healthcare Ltd Biocity Pennyfoot Street Nottingham NG1 1GF UK

Date of Summary: 12 August 2011

Classification Name: 21. CFR 884.2740 System Monitoring Perinatal

Product Code: OSP

Secondary Product Code: HGM

Predicate Device: Monica AN24 (K101801) Philips Avalon CTS (K023931)

Reason for 510(K):

This 510(K) is to add the Monica IF24 Interface device as an accessory to the Monica AN24 Fetal Monitor previously granted market clearance under K101801

Device Description:

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Image /page/1/Picture/0 description: The image shows the logo for "Monica Healthcare". The logo features the word "monica" in a bold, sans-serif font, with a stylized figure of a pregnant woman positioned between the 'n' and 'i' of the name. Below the name, the word "Healthcare" is written in a smaller, lighter font.

K112163
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weeks gestation in laboring patients. The AN24™ is suitable for singleton pregnancies only.

Indications for Use:

The Monica IF24 CTG Interface Device is an accessory to the Monica AN24) which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.

Technology Characteristics:

· Selection of the appropriate CTG monitor
· Calibration with the CTG Monitor
· Display AN24 battery power
· Display Bluetooth connectivity between the AN24 & IF24

The technological characteristics of the Monica IF24 CTG Interface Device are the same in design, material, principle of operation and energy source as the predicates.

Monica IF24 CTG Interface Device has the same technological The characteristics as the base station for the wireless transducers in the Philips Avalon (K023931) predicate device. Both technologies have the same principle of operation and energy source, including

CPU (Microprocessor .
. LCD
Base station communication ●
EEPROM .
Flash memory .
Clock generator .
RF Transmitter (Bluetooth) ●

Non Clinical Test Summary

The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas:

Electrical Safety .
. EMC
Material Safety .
Software Validation ●
Usability

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Image /page/2/Picture/0 description: The image shows the logo for Monca Healthcare. The logo features the word "monca" in bold, black letters, with the "o" in "monca" replaced by a stylized image of a person. Below the word "monca" is the word "Healthcare" in a smaller, lighter font. The logo is simple and modern, and it conveys a sense of health and well-being.

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Conclusion

The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were

EN60601-1 electrical safety .
EN60601-1-2 EMC ●
FCC CFR47 EMC .
EN 62304 Software ●
IEC 62366 Usability .
ISO10993 Biocompatibility .
ISO13485 QMS .

The Monica IF24 CTG Interface Device has been subjected to the above non clinical tests combined with software validation and performance bench testing to demonstrate that the Monica IF24 CTG Interface Device accurately receives and transmits the correct data.

The conclusions drawn from the nonclinical tests, performance tests and the validation demonstrate that the Monica IF24 CTG Interface Device is substantially equivalent to the legally marketed predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference.

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

Monica Healthcare % Mr. William Sammons Senior Project Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road Unit B7 TWINSBURG OH 44087

AUG 3 0 2011

Re: K112163

Trade/Device Name: Monica IF24 CTG Interface Device Regulation Number: 21 CFR§ 884.2720 Regulation Name: External uterine contraction monitor and accessories Regulatory Class: II Product Code: OSP, HGM Dated: August 17, 2011 Received: August 18, 2011

· Dear Mr. Sammons:

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. 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

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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/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

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Indications for Use Statement

510(k) Number (if known): K112163

Device Name: Monica IF24 CTG Interface Device

Indications For Use:

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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(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and Urological Devices
510(k) Number	K112163

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).