(197 days)
No
The summary describes software algorithms for signal processing and extraction of ECG morphology and heart rate, but there is no mention of AI or ML techniques. The performance studies focus on traditional validation methods and compatibility, not AI/ML specific metrics or training/test data.
No.
The device is a monitor that measures and displays fetal heart rate; it does not provide any therapy or treatment.
Yes
The device measures and displays fetal heart rate (FHR) using abdominal surface electrodes, which is a physiological measurement used to assess fetal well-being, thus serving a diagnostic purpose.
No
The device description explicitly states that the product consists of a signal processor containing hardware circuitry and software, and it acquires and processes analog signals using external, abdominal electrode sensors. This indicates the presence of hardware components beyond just software.
Based on the provided information, the MindChild Medical Meridian M100 Fetal Heart Rate Monitor 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 M100 Function: The Meridian M100 is an external device that measures fetal heart rate by detecting the fetal ECG signal from electrodes placed on the maternal abdomen. It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor fetal heart rate during labor, which is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, the Meridian M100 falls under the category of a medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MindChild Medical Meridian M100 Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR). The MindChild Meridian M100 acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). FHR tracings are displayed onto a primary fetal monitor. In addition, the M100 synchronizes the TOCO transducer signal which is also displayed to the primary fetal monitor.
The MindChild Meridian M100 is indicated for use on women who are at >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.
Product codes
HGM
Device Description
The Meridian M100 Fetal Heart Rate Monitor is a modification of the cleared M1000 Fetal Heart Rate Monitor (K120018). The modifications are ones that do not affect the intended use or the fundamental scientific technology. The M100 Fetal Heart Rate Monitor is an AC powered fetal heart rate (FHR) monitor. The product consists of a signal processor containing hardware circuitry and software which acquires and processes analog signals using external, abdominal electrode sensors. Software algorithms extract ECG morphology and monitor fetal heart rate.
The M100 connects to existing cleared fetal heart rate monitors with DECG (i.e., primary monitor) using the primary monitor's screen for display of fetal heart rate. The patient data is displayed real time on the primary monitor's display. The Meridian M100 is used as an accessory to a main/primary fetal monitor replacing the Doppler sensor on those monitors. The M100 is for use with the GE Corometrics 120 and the GE Corometrics 250 Fetal Monitors.
The M100 differs from the cleared M1000 in the following ways:
-
- The M100 has connection ports for connection of the M100 to existing cleared fetal heart rate monitors. Through these connections, the M100 uses the existing primary monitor's display for fetal heart rate whereas the M1000 incorporates a 24" LCD display,
-
- The M100 incorporates a standard input connection for a uterine contraction device. The M100 acts as a pass-through of this signal allowing for the uterine contraction data to be displayed on the primary monitor screen along with the fetal heart rate. The M1000 did not include this feature. Instead, viewing uterine contraction data required a separate monitor placed beside the M1000 device and viewing data on two screens. The M100 does not process uterine contraction signals but only synchronizes them to the fetal heart rate data.
-
- The primary monitor, to which the M100 is connected, is used for DECG measurements using a fetal scalp electrode should that be necessary. The M1000 had a dedicated DECG connection and adapter for a fetal scalp electrode.
-
- The M100 is set on a table top whereas the M1000 is housed within a rollup cart.
The algorithm used in the M100 to acquire and process fetal ECG signals through externally placed abdominal electrodes is the same as that used and clinically validated in the cleared M1000 device.
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
36 completed weeks (gestational age)
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)
Descriptive information, laboratory bench testing, electrical safety/EMC testing, and software validation were provided to demonstrate the device meets its design specifications, performs as intended, is safe for its intended use and that the modifications made from the M1000 device do not adversely affect safety and effectiveness.
The following testing was performed and met design specifications or criteria:
- Dimensional Verification: To verify products meets specified dimensions and weight.
- Fetal Heart Rate Output: Verify FHR output waveform for both minimum and maximum amplitude fetal heart output.
- TOCO Output: Verify Toco output voltage for pressure application.
- Packaging Testing: Verification of packaging and labeling.
- Cable Pull Strength: Verify the cable connections are maintained when a 5 ft/lb. load is applied.
- Drop Test: Verification that unit could sustain drop.
- Push Test: Verify mechanical strength of enclosure by applying a 250N force to all sides and bottom of enclosure.
- Cleaning: Verify that cleaning, disinfecting, and sterilizing the monitor in accordance with the instructions for doing so in the Operator's Manual and Service Manual do not create any hazards or hazardous situations. Ensure that cleaning substances are compatible with the M100.
- Software Validation: Verify that all software modifications made performed as intended. Complete re-validation of the software was performed. Software validation demonstrated that the software performed according to design specifications, met requirement specifications and that there were no unintended effects due to any software modifications made.
Biocompatibility testing was not required as the M100 uses the same patient contacting materials as the cleared M1000 device.
Primary Monitor Compatibility: The M100 Monitor is intended to be used with the currently marketed GE Corometrics 120 and 250 Fetal Monitors. Compatibility testing was performed using the M100 monitor with each of the marketed primary monitors. Testing demonstrated the M100 is compatible with each of these monitors.
Electrical Safety and EMC: Electrical safety, electromagnetic compatibility, and usability testing was performed in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-49, and IEC 62366. The M100 monitor met all test criteria.
Clinical Validation: The algorithm responsible for calculating fetal heart rate in the M100 Monitor is the same as that used in the cleared M1000 monitor. Further, the signal acquisition components (external electrodes) and signal processing software remain the same. The clinical validation of the software responsible for calculating FHR from fECG signals was performed in support of the cleared 510(k) for the M1000. This clinical validation is directly applicable to the modified design as the signal acquisition components (external electrodes) and the signal processing software and algorithm remains the same in the modified M100 device. Therefore, further clinical validation was not necessary for the modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Meridian M1000 Monitor (K120018)
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 and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2015
Mindchild Medical % Leo Basta Owner NorthStar Biomedical Associates 93 Benefit Street Providence. RI 02904
Re: K142883
Trade/Device Name: MindChild Meridian M100 Fetal Heart Rate Monitor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: Class II Product Code: HGM Dated: September 30, 2014 Received: October 2, 2014
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 device
1
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 yours,
Benjamin R. Fisher -S
Benjamin Fisher, PhD. 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) K142883
Device Name MindChild Meridian M100 Fetal Heart Rate Monitor
Indications for Use (Describe)
The MindChild Medical Meridian M100 Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR). The MindChild Meridian M100 acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). FHR tracings are displayed onto a primary fetal monitor. In addition, the M100 synchronizes the TOCO transducer signal which is also displayed to the primary fetal monitor.
The MindChild Meridian M100 is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The MindChild Meridian is intended for use by healtheare 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)
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3
510(k) Summary MindChild Meridian M100 Fetal Heart Rate Monitor
| Submitter: | MindChild Medical
1600 Osgood Street, #2017
North Andover, MA 01845
Phone: 978.975.1160
Fax: 978.688.8875 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leo Basta
Northstar Biomedical Associates
93 Benefit St.
Providence, RI, 02904
Phone: 617.834.9866
lbasta@northstarbiomedical.com |
| Date Prepared: | March 14, 2015 |
| Trade Name: | MindChild Meridian M100 Fetal Heart Rate Monitor |
| Regulation Name: | Perinatal monitoring system and
accessories |
| Classification Number: | 21 CFR 884.2740 |
| Product Code: | HGM |
| Predicate Devices: | Meridian M1000 Monitor (K120018) |
Device Description:
The Meridian M100 Fetal Heart Rate Monitor is a modification of the cleared M1000 Fetal Heart Rate Monitor (K120018). The modifications are ones that do not affect the intended use or the fundamental scientific technology. The M100 Fetal Heart Rate Monitor is an AC powered fetal heart rate (FHR) monitor. The product consists of a signal processor containing hardware circuitry and software which acquires and processes analog signals using external, abdominal electrode sensors. Software algorithms extract ECG morphology and monitor fetal heart rate.
4
The M100 connects to existing cleared fetal heart rate monitors with DECG (i.e., primary monitor) using the primary monitor's screen for display of fetal heart rate. The patient data is displayed real time on the primary monitor's display. The Meridian M100 is used as an accessory to a main/primary fetal monitor replacing the Doppler sensor on those monitors. The M100 is for use with the GE Corometrics 120 and the GE Corometrics 250 Fetal Monitors.
The M100 differs from the cleared M1000 in the following ways:
-
- The M100 has connection ports for connection of the M100 to existing cleared fetal heart rate monitors. Through these connections, the M100 uses the existing primary monitor's display for fetal heart rate whereas the M1000 incorporates a 24" LCD display,
-
- The M100 incorporates a standard input connection for a uterine contraction device. The M100 acts as a pass-through of this signal allowing for the uterine contraction data to be displayed on the primary monitor screen along with the fetal heart rate. The M1000 did not include this feature. Instead, viewing uterine contraction data required a separate monitor placed beside the M1000 device and viewing data on two screens. The M100 does not process uterine contraction signals but only synchronizes them to the fetal heart rate data.
-
- The primary monitor, to which the M100 is connected, is used for DECG measurements using a fetal scalp electrode should that be necessary. The M1000 had a dedicated DECG connection and adapter for a fetal scalp electrode.
-
- The M100 is set on a table top whereas the M1000 is housed within a rollup cart.
The algorithm used in the M100 to acquire and process fetal ECG signals through externally placed abdominal electrodes is the same as that used and clinically validated in the cleared M1000 device.
Indications for Use:
The MindChild Medical Meridian M100 Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR). The MindChild Meridian M100 acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). FHR tracings are displayed onto a primary fetal
5
monitor. In addition, the M100 synchronizes the TOCO transducer signal which is also displayed to the primary fetal monitor.
The MindChild Meridian M100 is indicated for use on women who are at >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.
6
Device Characteristic Comparison
| Characteristic | M100 Fetal Heart Rate Monitor
[current 510(k)] | M1000 Fetal Heart Rate Monitor
- K120018 | Substantial
Equivalence |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Photograph | Image: M100 Fetal Heart Rate Monitor | Image: M1000 Fetal Heart Rate Monitor | Different footprint of the M100 allows for
placement on the table top. Firmware for
the M1000 is contained within a roller cart
with drawer and display monitor. M100
device uses the display of the primary fetal
heart rate monitor to which it is connected.
The software and firmware of the M100
and M1000 is identical varying only in
regard to the system administrative
software. The fetal heart rate algorithm
remains the same. |
| Intended Use | A fetal cardiac monitor used to monitor fetal heart
activity during pregnancy and labor. | A fetal cardiac monitor used to monitor fetal heart
activity during pregnancy and labor. | Identical |
| Indications for
Use | The MindChild Medical Meridian M100 Fetal Heart
Rate Monitor is an intrapartum fetal monitor that
externally measures and displays fetal heart rate
(FHR). The MindChild Meridian M100 acquires
and displays the FHR tracing from abdominal
surface electrodes that detect the fetal ECG signal
(fECG). FHR tracings are displayed onto a primary
fetal monitor. In addition, the M100 synchronizes
the TOCO transducer signal which is also displayed
to the primary fetal monitor. The MindChild
Meridian M100 is indicated for use | 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 | Very similar. The differences don't affect the
or effectiveness as all of the same functions
can be operated either through the M100 or
the primary monitor (should the invasive
DECG using a fetal scalp electrode be
clinically indicated. |
| Characteristic | M100 Fetal Heart Rate Monitor
[current 510(k)]
on women who are at >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. | M1000 Fetal Heart Rate Monitor
– K120018
MindChild Meridian is intended for use by
healthcare professionals in a clinical setting. | Substantial
Equivalence |
| Regulation
Number | 884.2740 | 884.2740 | Identical |
| Display | 2 inch LCD screen on front of unit for system
only information. The M100 uses the display of
the primary fetal heart monitor to display the fetal
heart rate. | 24" diagonal real time LCD display (1900 x 1200
pixels) that graphically displays clinical parameters
received from signal processors. Touch screen
provides user with interface to control operation of
unit. | Identical information displayed. M100
utilizes the primary monitor to display fetal
heart rate calculated from ECG signals
collected via abdominal electrodes and
calculated using the Meridian algorithm.
The algorithm remains the same as the
M1000. |
| Controls | Power "On" button on rear side of the M100 to
activate. | Power "On" button on front side of M1000 to
activate. The LCD display incorporates "Action"
buttons that are touch sensitive to control operation
of the unit. | Each unit has a power "On/Off" switch to
activate the monitor. The M100 switch is
located on the rear of the unit, whereas the
M1000 is on the front of the unit. The
M1000 also has control buttons on the
display screen that operates certain
functions of the M1000. The M100 utilizes
the primary monitor to control the same
functions when the M100 is attached. |
| Printer | The M100 does not include an integrated printer;
however, patient data including graphical display
may be downloaded via the primary monitor to
which the M100 is attached. | The Meridian Monitor does not include an
integrated printer; however, patient data including
graphical display may be downloaded via integral
USB port to a standard USB jump drive for
printing or transfer of data. | Both systems allow for the same function.
The M100 and the M1000 allow for
downloading patient data and transfer of
information. The proposed M100
accomplishes this through use of the
primary monitor to which it is attached,
whereas the cleared M1000 possesses this
capability through a USB jump drive. |
| Front or top
Connections | There are six connectors on the front of the unit.
Five of the connectors are for cable connections to
the external electrode sensors including reference
and ground. The sixth connector is for the
connection of cleared TOCO uterine contraction
devices. | There are five connectors on the front of the unit.
All five of the connectors are for cable connections
to the external electrode sensors including
reference and ground. The fifth connector is also
used for the connection to the optional fetal scalp
electrode. | Similar. Each unit has connections for the
externally placed maternal abdominal
electrodes used to acquire bioelectric
signals of the fetal heart. The M100
provides a connection to TOCO uterine
contraction accessories whereas the M1000
incorporates a connection for an optional |
| Characteristic | M100 Fetal Heart Rate Monitor | M1000 Fetal Heart Rate Monitor | Substantial |
| | [current 510(k)] | - K120018 | Equivalence
fetal scalp electrode. These differences do
not affect substantial equivalence as the
M100 does not process uterine contraction
data but instead passes the information on
to the primary monitor whereas the M1000
was used in conjunction with a TOCO
monitor and the user was required to
review the FHR data on the M1000 in
parallel with the uterine contraction data.
Functionally Identical.
Although the M100 does not incorporate
the fetal scalp electrode connection, it does
allow for the use of a fetal scalp electrode if
indicated using the connection on the
primary monitor. Functionally Identical.
Because the M100 utilizes the display of the
primary monitor for displaying fetal heart
rate and uterine contraction information,
the device incorporates connection ports to
couple the two monitors. Functionally, the
M100 and M1000 are very similar and
allow for the provision of the identical
information to the user. |
| Rear Connections | Power connection and connections to the primary
monitor. | Power connection. | Because the M100 utilizes the display of the
primary monitor for displaying fetal heart
rate and uterine contraction information,
the device incorporates connection ports to
couple the two monitors. Functionally, the
M100 and M1000 are very similar and
allow for the provision of the identical
information to the user. |
| Side Connections | No connections | No connections | No impact on substantial equivalence. |
| Input Voltage
Range | 120 VAC ±10% | 120 VAC ±10% | No impact on substantial equivalence. |
| Characteristic | M100 Fetal Heart Rate Monitor | M1000 Fetal Heart Rate Monitor | Substantial |
| | [current 510(k)] | - K120018 | Equivalence |
| Frequency | 60 Hz | 60 Hz | No impact on substantial equivalence. |
| Method | Acquisition of fetal ECG signals via multiple
external abdominal sensor electrodes, which are
then processed on the signal processor which is
comprised of the signal processing card and
system controller.
Direct ECG (DECG) acquisition using FDA
cleared fetal scalp probes composed of a reusable
DECG leg plate cable, leg plate attachment
electrode and Philips Spiral Electrode.
Connection on the primary monitor is used for the
fetal scalp electrode.
TOCO connection is incorporated in the M100.
The M100 does not process the uterine contraction
information. It syncs the information with the
fetal heart rate and passes the information on to
the primary monitor. | Acquisition of fetal ECG signals via multiple
external abdominal sensor electrodes, which are
then processed on the signal processor which is
comprised of the signal processing card and system
controller.
Direct ECG (DECG) acquisition using FDA
cleared fetal scalp probes composed of a reusable
DECG leg plate cable, leg plate attachment
electrode and Philips Spiral Electrode.
M1000 monitor used in parallel while the physician
looks at a TOCO monitor while reviewing the fetal
heart rate on the M1000. | The changes made resulting in the M100
device have no adverse impact on
substantial equivalence. |
| Measurement
Range | 50 - 240 BPM; abdominal sensor mode
DECG Mode dependent on primary monitor. | 50 - 240 BPM; abdominal sensor mode
50 - 240 BPM; DECG Mode | No impact on substantial equivalence. |
| Signal Processing | Analog to digital | Analog to digital | No impact on substantial equivalence. |
7
8
9
10
| Characteristic | M100 Fetal Heart Rate Monitor
[current 510(k)] | M1000 Fetal Heart Rate Monitor
- K120018 | Substantial
Equivalence |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Safety | Patient protection isolation barrier provides
4KVDC of galvanic isolation for all patient input
connections. The cables that connect directly to
the patient pass through this isolation barrier.
Will be certified to comply with FDA recognized
standards pertaining to electrical safety and EMC. | Patient protection isolation barrier provides
4KVDC of galvanic isolation for all patient input
connections. The cables that connect directly to the
patient pass through this isolation barrier.
Will be certified to comply with FDA recognized
standards pertaining to electrical safety and EMC. | No impact on substantial equivalence. |
| Software | Microsoft Windows 7 embedded operating system
customized to support specific Meridian
hardware. Proprietary MindChild ECG algorithm
provides processing and filtering to extract fetal
ECG and calculate fetal heart rate. Software
modification allowing for syncing uterine
contraction signal with fetal heart rate (does not
alter or manipulate uterine contraction data). | Microsoft Windows 7 embedded operating system
customized to support specific Meridian hardware.
Proprietary MindChild ECG algorithm provides
processing and filtering to extract fetal ECG and
calculate fetal heart rate. | No impact on substantial equivalence. |
| | Graphical and numeric data displayed on primary
monitor display. Patient data may be stored on
primary monitor and downloaded or printed using
primary monitor's functions. | Graphical and numeric data display on touch screen
monitor. Individual patient data may be stored on
the unit and downloaded via user supplied USB
Jump drive for inclusion into hospital electronic
records. Hard copies of graphical display may be
printed in standard format. | No impact on substantial equivalence. |
11
Performance Testing:
Descriptive information, laboratory bench testing, electrical safety/EMC testing, and software validation were provided to demonstrate the device meets its design specifications, performs as intended, is safe for its intended use and that the modifications made from the M1000 device do not adversely affect safety and effectiveness.
The following testing was performed:
| Test | Purpose | Results |
|---|---|---|
| Dimensional Verification | To verify products meets | |
| specified dimensions and weight | Met design specification | |
| Fetal Heart Rate Output | Verify FHR output waveform for | |
| both minimum and maximum | ||
| amplitude fetal heart output. | Met design specification | |
| TOCO Output | Verify Toco output voltage for | |
| pressure application | Met design specification | |
| Packaging Testing | Verification of packaging and | |
| labeling. | Met design specification | |
| Cable Pull Strength | Verify the cable connections are | |
| maintained when a 5 ft/lb. load is | ||
| applied. Results are force applied to | ||
| each of the patient cable connector | ||
| extraction. | Met design specification | |
| Drop Test | Verification that unit could | |
| sustain drop | Met specification | |
| Push Test | Verify mechanical strength of | |
| enclosure by applying a 250N force | ||
| to all sides and bottom of enclosure | Met specification | |
| Cleaning | Verify that cleaning, disinfecting, and | |
| sterilizing the monitor in accordance | ||
| with the instructions for doing so in | ||
| the Operator's Manual and Service | ||
| Manual do not create any hazards or | ||
| hazardous situations. Ensure that | ||
| cleaning substances are compatible | ||
| with the M100. | Met specification | |
| Software Validation | Verify that all software modifications | |
| made performed as intended. | ||
| Complete re-validation of the | ||
| software was performed. | Software validation demonstrated | |
| that the software performed | ||
| according to design | ||
| specifications, met requirement | ||
| specifications and that there were | ||
| no unintended effects due to any | ||
| software modifications made. |
Hardware
12
Biocompatibility Testing
Biocompatibility testing was not required as the M100 using the same patient contacting materials as that used in the cleared M1000 device.
Primary Monitor Compatibility
The M100 Monitor is intended to be used with the currently marketed GE Corometrics 120 and 250 Fetal Monitors. Compatibility testing was performed using the M100 monitor with each of the marketed primary monitors. Testing demonstrated the M100 is compatible with each of these monitors.
Electrical Safety and EMC
In addition, electrical safety, electromagnetic compatibility, and usability testing was performed in accordance with the following standards. The M100 monitor met all test criteria.
-
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance; IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)
-
- IEC 60601-1-2: ed3.0 (2007-03), Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (FDA recognized number: 19-1)
-
- IEC 60601-1-6:2010 (Third Edition), Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Usability (FDA recognized number: 5-85)
-
- IEC 60601-2-49 (Second Edition): 2011, Medical electrical equipment Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
-
- IEC 62366:2007(ed.1), Medical devices Application of usability engineering to medical devices (FDA recognized number: 5-67)
Clinical Validation
The algorithm responsible for calculating fetal heart rate in the M100 Monitor is the same as that used in the cleared M1000 monitor. Further, the signal acquisition components (external electrodes) and signal processing software remain the same. The clinical validation of the software responsible for calculating FHR from fECG signals was performed in support of the cleared 510(k) for the M1000. This clinical validation is directly applicable to the modified design as the signal acquisition components (external electrodes) and the signal processing software and algorithm remains the same in the
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modified M100 device. Therefore further clinical validation was not necessary for the modified device.
Summary of Substantial Equivalence:
The design, intended use, principles of operation, and technological characteristics of the MindChild Meridian M100 device are substantially equivalent to those of the already cleared M1000 device. Substantial equivalence is based upon descriptive characteristics of the modifications and upon the testing conducted and summarized in this 510(k). The changes made resulting in the M100 device do not change the device's intended use or the fundamental scientific technology used and the testing performed in support of this notification demonstrate that the M100 device is substantially equivalent to the M1000 device.