(34 days)
Not Found
No
The device description focuses on signal conversion and interface functionality, with no mention of AI/ML terms or capabilities.
No.
The document explicitly states that the Monica IF24 CTG Interface Device is an "accessory" and an "interface device" that converts a wireless digital signal to analog for display on a CTG Fetal Monitor. It does not exert a therapeutic effect or provide treatment.
No
The Monica IF24 CTG Interface Device is described as an "accessory" and an "interface device" that converts a wireless digital signal to analog for input into a CTG monitor. Its function is to enable signals collected by another device (Monica AN24) to be displayed, printed, and sent to a network. It does not collect data or perform any diagnostic analysis itself; it merely facilitates the transmission and display of data from a monitoring device.
No
The device description explicitly states it is a "small, low-voltage device" with a "touch screen" and performs hardware functions like converting a wireless digital signal to analog. It also mentions non-clinical tests for electrical safety, EMC, and biocompatibility, which are relevant to hardware components.
Based on the provided information, the Monica IF24 CTG Interface Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Monica IF24 Function: The Monica IF24 is an interface device that connects a wireless fetal monitor (Monica AN24) to a standard CTG fetal monitor. It receives and converts signals related to fetal heart rate and uterine activity, which are physiological measurements taken from the patient, not on a sample taken from the patient.
- Intended Use: The intended use clearly states it's an "accessory" to the Monica AN24 for "interfacing the wireless output" to a CTG monitor. This is about signal transmission and conversion, not diagnostic testing of a biological sample.
- Device Description: The description reinforces its role as an "interface device" that "receives the monitored parameters" and "converts the wireless digital signal to analogue."
The device facilitates the display and transmission of physiological data collected by another device (the Monica AN24), but it does not perform any diagnostic testing on a biological sample itself.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OSP, HGM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals in a clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Monica AN24 (K101801), Philips Avalon CTS (K023931)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for "Monica Healthcare". The logo features the word "Monica" in bold, sans-serif font, with the "i" replaced by a stylized figure of a person. Below the name is the word "Healthcare" in a smaller, less bold font. The logo is simple and professional, likely representing a healthcare-related business or organization.
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:
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
1
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
pg.2of3
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
2
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.
K112163
Pg. 3 of 3
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.
3
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
4
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/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
5
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)
(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
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K112163 |