(185 days)
K980484, K001407, K003716, K023616, K033320, K033320/S002, K040212, K040212/S003, K050123/S001, K053306, K060241, K080442, K080442/S001, K082697, K083162, K090954, K092019, K092019/S001, K100481, K100481/S001, K101258, K101416, K101416/S001, K111979, K111979/S001, K112001, K112001/S001, K113063, K113426, K120422, K120422/S001, K120422/S002, K120422/S003, K120422/S004, K120422/S005, K120422/S006, K120422/S007, K120422/S008, K120422/S009, K120422/S010, K120422/S011, K130456/S001, K131362, K131362/S001, K131362/S002, K131362/S003, K140384, K140384/S001, K140384/S002, K140384/S003, K140384/S004, K140384/S005, K140384/S006, K142512, K142512/S001, K142512/S002, K142512/S003, K142512/S004, K142512/S005, K142512/S006, K142512/S007, K150616, K152562, K152562/S001, K160751, K160751/S001, K160751/S002, K160751/S003, K160751/S004, K160751/S005, K160751/S006, K160751/S007, K160751/S008, K160751/S009, K160751/S010, K172314, K172314/S001, K180493, K182811, K190691, K190691/S001, K191986, K192290
Not Found
No
The summary describes a standard fetal monitoring system that measures and displays physiological signals (FHR, MHR, UA) from surface electrodes. There is no mention of AI, ML, or any advanced data processing techniques beyond signal acquisition and display.
No.
The device is for monitoring and display, not for treatment or therapy.
No
The device measures and displays physiological parameters (FHR, MHR, UA) but does not provide a diagnosis or aid in making clinical decisions about a disease or condition. It is a monitoring device.
No
The device description explicitly states that it acquires signals from "abdominal surface electrodes" and displays them on a "primary fetal monitor," indicating the presence of hardware components beyond just software.
No, this 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.
- Meridian M110 Function: The Meridian M110 Fetal Monitoring System works by externally measuring physiological signals (ECG and uterine muscle signals) from the maternal abdomen using surface electrodes. It does not analyze samples taken from the body.
The device is a medical device used for monitoring physiological parameters, but it does not fit the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Meridian M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The Meridian M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals. Tracings of FHR and UA are displayed onto a primary fetal monitor.
Product codes
HGM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maternal abdomen
Indicated Patient Age Range
women who are at >= 37 completed weeks, in labor, with singleton pregnancies
Intended User / Care Setting
health care 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2017
Mindchild Medical % Leo Basta Owner Northstar Biomedical Associates 93 Benefit Street Providence, Rhode Island 02904
Re: K161902
Trade/Device Name: Meridian M110 Fetal Monitoring System Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: Class II Product Code: HGM Dated: December 16, 2016 Received: December 19, 2016
Dear Leo Basta:
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 (reporting of medical
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Benjamin R. Fisher -S
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
2
Indications for Use
510(k) Number (if known) K161902
Device Name Meridian M110 Fetal Monitoring System
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
The Meridian M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The Meridian M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals. Tracings of FHR and UA are displayed onto a primary fetal monitor.
The Meridian M110 Fetal Monitoring System is indicated for use on women who are at ≥ 37 completed weeks, in labor, with singleton pregnancies using surface electrodes on the maternal abdomen. The Meridian M110 Fetal Monitoring System is intended for use by health care professionals in a clinical setting.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."