MINDCHILD MERIDIAN FETAL HEART RATE MONITOR

{0}------------------------------------------------ K120018 ## 510(k) Summary MindChild Medical Meridian Monitor SEP 1 9 2012 ## Submitter: ( , - 1 ) ( ﻣﯿﮟ ﺍﯾﮏ ﺭﮨﺘﮯ ﮨﯿﮟ۔ ﺗ ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ ﺎ 7 MindChild Medical 1600 Osgood Street, #2-17 North Andover, MA 01845 Phone: 978.975.1160 · Fax: 978.688.8875 Contact Person: Leo Basta NorthStar Biomedical Associates 755 Westminster St., Unit 120 Providence, RI, 02903 Phone: 617.834.9866 lbasta@northstarbiomedical.com | Date Prepared: | August 18, 2012 | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name: | MindChild Medical Meridian Monitor | | Regulation Name: | Perinatal monitoring system and<br>accessories | | Classification Number: | 21 CFR 884.2740 | | Product Code: | HGM | | Predicate Devices: | Monica Healthcare AN24 (K101801)<br>HP M1350A Fetal Monitor (K900480) | | Device Description: | The MindChild Medical Meridian Fetal Heart Rate Monitor<br>is an AC powered fetal heart rate (FHR) monitor. The<br>product consists of a signal processor containing hardware<br>circuitry and software which acquires and processes analog<br>signals using external, abdominal electrode sensors.<br>Software algorithms extract ECG morphology and monitor<br>fetal heart rate. Data is stored locally for retrieval in an off-<br>line mode. The patient data is displayed real time on a<br>touch screen LCD display monitor. Data may be printed<br>out offline for permanent hard copy records. The system<br>also possesses the ability to acquire and analyze signals | 84 {1}------------------------------------------------ from a fetal scalp electrode using the device's direct ECG (DECG) capability. The entire system is housed within a medical grade roll-up cart. The device is intended to be used in a hospital environment by trained medical staff. The MindChild Medical Meridian Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally or internally measures and displays fetal heart rate (FHR). The MindChild Meridian acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). The MindChild Meridian may also be used to measure and display fetal heart rate using direct ECG (DECG) with a fetal scalp electrode. The MindChild Meridian 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 MindChild Meridian is intended for use by healthcare professionals in a clinical setting. Descriptive information, laboratory bench testing, electrical safety/EMC screening, software validation, and a biocompatibility assessment were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use. In addition, a clinical validation of the Meridian algorithm responsible for calculating FHR from fECG signals was performed. For this validation of the algorithm, fetal ECG signals were acquired and recorded using the Meridian Monitor technology and HP M1350A Fetal Monitor/FSE simultaneously. The HP M1250A Fetal Monitor/FSE was the comparator for the clinical validation study. The Meridian Monitor signals were subjected to analysis by the Meridian algorithm to calculate fetal heart rate. The resulting heart rates were compared to heart rates calculated using HP M1350A Fetal Monitor/FSE. The analyses performed included FHR accuracy and percent successful recordings (i.e., # comparator signals/ # of Meridian signals x 100). This algorithm validation demonstrated that in either mode (abdominal electrode or DECG), the fetal heart rates calculated using the Meridian Monitor algorithm were close to the comparator's fetal heart rate calculations within a clinically acceptable number of beats per minute (BPM). There were no ## Intended Use: ### Functional Testing: {2}------------------------------------------------ statistically significant differences across different BMI groups analyzed. In addition, for all signals recorded with the comparator FSE device, the Meridian technology provided a successful signal reading on at least 94% of the signals. Lastly, a single Bland Altman (BA) difference plot was generated for the Meridian Monitor FHR calculations versus those calculated using the Gold Standard device for each patient and a root mean square (RMS) error was determined. A BA difference plot is a scatter plot of the difference between the device and Gold Standard measurements versus the Gold Standard measurement. RMS error is the square root of the mean of the squared differences. The mean RMS error of 5 BPM (Beats Per Minute) for the Meridian algorithm is similar to results observed in other FDA cleared fetal heart rate monitors. જર્ {3}------------------------------------------------ | Non-Resident | |--------------------------------------------------------------------------------------| | | | | | and the may been and the been and the been and the been and the best of the been and | | 10-40-40 10-40, 40- -- 4-4- 4-4 | | | | 1 | | | | 4.5 | | | | . FOR AND AND AND A | | 1 | | | | | | | | | | | | 1 | , | Characteristic | Proposed MindChild Meridian Device - K120018 | Monica AN24, Monica Healthcare - K101801 | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The MindChild Medical Meridian Fetal Heart Rate Monitor is an intrapartum<br>fetal monitor that externally or internally measures and displays fetal heart rate<br>(FHR). The MindChild Meridian acquires and displays the FHR tracing from<br>abdominal surface electrodes that detect the fetal ECG signal (fECG). The<br>MindChild Meridian may also be used to measure and display fetal heart rate<br>using direct ECG (DECG) with a fetal scalp electrode. The MindChild<br>Meridian is indicated for use on women who are at term (> 36 completed<br>weeks), in labor, with singleton pregnancies, using surface electrodes on the<br>maternal abdomen. The MindChild Meridian is intended for use by healthcare<br>professionals in a clinical setting. | The Monica AN24 is an intrapartum maternal-fetal monitor that non-invasively<br>measures and displays fetal heart rate (FHR) and uterine activity (UA). The<br>AN24 acquires and displays the FHR tracing from abdominal surface electrodes<br>that pick up the fetal EGG (fECG) signal. Using the same surface electrodes, the<br>AN24 also acquires and displays the UA tracing from the uterine<br>electromyography (EMG) signal. The AN24 is indicated for use on women who<br>are at term (>36 completed weeks), in labor, with singleton pregnancies, using<br>surface electrodes on the maternal abdomen. The AN24 maternal-fetal monitor is<br>intended for use by healthcare professionals in a clinical setting. | | Method | Acquisition of fetal ECG signals via external abdominal sensor electrodes.<br>From these signals the fetal heart rate is extracted. Also may use direct ECG<br>(DECG) acquisition using a fetal scalp electrode. | The electrical signals are passively<br>monitored on three channels using external sensor electrodes placed on the<br>pregnant abdomen. in specific locations. From these electrical signals the Fetal<br>Heart Rate (FHR) are continuously extracted and displayed. No DECG option. | | Software | Proprietary algorithm to calculate heart rate. | Proprietary algorithm to calculate heart rate. | | Signal<br>Processing | Analog to digital | Analog to digital | | Display | 24" diagonal real time LCD display (1900 x 1200 pixels) that graphically<br>displays clinical parameters received from signal processors. Touch screen<br>provides user with interface to control operation of unit. | Ability to download data to PC or view via optional 15" cart mounted monitor or<br>10" mobile touch screen. | | Controls | Power "On" button on control unit activates main operating screen on LCD<br>display. On-screen display buttons to adjust various parameters. | On/Off switch, "Event" button, battery status, signal quality, memory status. | | Connections | Five connectors for electrode leads and optional fetal scalp electrode, standard<br>USB connector,<br>standard AC plug and power connection | Electrode leads connector attaches to the top of the unit. | | Input Voltage<br>Range | 85 - 264 VAC | AN24 and optional mobile 10" viewing monitor (VS10) - Battery operated | | Frequency | 50/60 Hz | Battery operated | | Measurement<br>Range | 80 - 240 BPM; abdominal sensor mode, 30 - 50 BPM; DECG Mode | UNK | | Safety | Complies with FDA recognized standards pertaining to electrical safety.<br>Complies with FDA recognized standards pertaining to electrical safety and<br>EMC. | Complies with FDA recognized standards pertaining to electrical safety.<br>Complies with FDA recognized standards pertaining to electrical safety and<br>EMC. | MindChild 510(k) Rev. B 87 {4}------------------------------------------------ ## Summary of Substantial Equivalence: The design, intended use, principles of operation, and technological characteristics of the MindChild Meridian device are substantially equivalent to those of the predicate devices cited above. Substantial equivalence is based upon descriptive characteristics of the various cited predicate devices and upon the testing conducted to demonstrate that the subject device performs as intended and is substantially equivalent to the predicate devices in terms of its ability to monitor fetal heart rate using its abdominally placed external electrode sensors. In addition, fetal heart rate monitoring through the device's DECG mode was demonstrated to be substantially equivalent to that of marketed devices. MindChild 510(k) Rev. B 88 {5}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter. The logo is black and white. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MindChild Medical % Mr. Leo Basta Owner NorthStar Biomedical Associates 755 WestMinster Street, Unit 120 PROVIDENCE RI 02903 SEP 1. 9 2012 Re: K120018 Trade/Device Name: MindChild Meridian Fetal Heart Rate Monitor Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: September 14, 2012 Received: September 17, 2012 Dear Mr. Basta: We have reviewed your Section 510(k) premarket notification of intent to market the device indication We nave reviewed your Scellon >10(t) premierity is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosule) to regarly manated producal Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Medical Frederal Frederal Fred commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been recalismed in accession in a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a presisions of the Act . The and Costhere Act (Act) that do not require apple the general controls provisions of the Act. The Act. The Act. The Act. The You may, dielefone, market the device, basjever to the may begistration, listing of general condois provisions of the rice labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Flease note. ODIC access 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), If your device is classified (see above) and or regulations affecting your device can be it may be subject to additional controls. Existing major regulations affecting your it may be subject to adultional controls. Entraling migrid to 898. In addition, FDA may round in the Code of I cacial resgueening your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a buce complies with other requirements of the Act that FDA has made a determination that your device complies with other requiremen that FDA has made a decemination and regulations administered by other Federal and listing of any Federal Statutes and regulations annline, but not limited to: registration and listing of media comply with an the Act sTequilements, merading, outsist and the more of medical {6}------------------------------------------------ device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-leheu adverse events) (21 CFR 003); good many (21 CFR Part 820); and if applicable, the electronic forth in the quality Systems (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 IT you desire specific advice for your as nte coffices/CDRH/CDRHOffices/ucm115809.htm for go to mip.//www.ida.gov/rtoodid Drives/Health's (CDRH's) Office of Compliance. Also, please the Concer for Dorroos and reading by reference to premarket notification" (21CFR Part note the regulation emilied, "Misoranding of releases to presents 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 You may oodain outer general mormational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (000) 030-2011 01 (00:00)Devices/Resourcesfor You/Industry/default.htm. Sincerely yours, Benjamin R. Tucker 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 {7}------------------------------------------------ ## INDICATION FOR USE K120018 Not Assigned ## 510(k) Number (if known): Device Name: MindChild Meridian Fetal Heart Rate Monitor Indications for Use: The MindChild Medical Meridian Fetal Heart Rate Monitor is an intrapartum fetal monitor than The MindChild Wedical Meridian Peter Fetal heart rate (FHR). The MindChild Meridian externally of medially measures and displays from abdominal surface electrodes that detal acquires and displays the Prix training nominal may also be used to measure and display fetal heart rate using direct ECG (DECG) with a fetal scalp electrode. The MindChild Meridian is indicated for use on women who are at term (> 36 completed weeks), in labor, with singleton in indicated for use on women who are at term ( - 30 - 8 - 6 - 6 - 6 - 6 - 1 - MindChild Meridian is intended for use by healthcare professionals in a clinical setting. AND/OR X Prescription Use: _ (Per 21 CFR 801 Subpart D).................................................................................................................................................... Over-The Counter Use: (Per 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 Aogui M. Whim (Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number K120018 MindChild 510(k) Rev. A Confidential