MONICA IF24

K112163 · Monica Healthcare · OSP · Aug 30, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K112163
• Device Name: MONICA IF24
• Applicant: Monica Healthcare
• Product Code: OSP · Obstetrics/Gynecology
• Decision Date: Aug 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2720
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

The Monica IF24 CTG Interface Device acts as a bridge between the Monica AN24 fetal monitor and standard clinical CTG fetal monitors. It receives wireless digital signals (fetal heart rate and uterine activity) from the AN24 and converts them into analog signals compatible with standard CTG monitor transducer inputs. The device features a touchscreen for selecting monitors, calibration, and monitoring battery/Bluetooth status. It is used by healthcare professionals in clinical settings to allow data collected by the AN24 to be printed, displayed on existing hospital monitors, and transmitted to central networks. This integration facilitates continuous surveillance of fetal well-being during labor, enabling clinicians to view data on familiar hospital equipment and incorporate it into standard clinical workflows.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included electrical safety (EN60601-1), EMC (EN60601-1-2, FCC CFR47), software validation (EN 62304), usability (IEC 62366), and biocompatibility (ISO10993). Performance bench testing demonstrated accurate receipt and transmission of data.

Technological Characteristics

Low-voltage interface device. Components: CPU, LCD, EEPROM, Flash memory, clock generator, Bluetooth RF transmitter. Connectivity: Wireless digital input from AN24, analog output to CTG monitors. Standards: EN60601-1 (electrical), EN60601-1-2/FCC CFR47 (EMC), EN 62304 (software), IEC 62366 (usability), ISO10993 (biocompatibility).

Indications for Use

Indicated for use by healthcare professionals in a clinical setting as an interface accessory for the Monica AN24 fetal monitor to enable printing, display, and network transmission of fetal heart rate and uterine activity data collected from laboring patients.

Regulatory Classification

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.

Predicate Devices

• Monica AN24 (K101801)
• Philips Avalon CTS (K023931)

Submission Summary (Full Text)

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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: [phone] Email: [e-mail]

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:

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

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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:

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

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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## 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 [phone] or [phone] 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:

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.

Prescription Use ِ ‫( (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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