(90 days)
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No
The description focuses on pulse Doppler ultrasound and hardware/software for automatic detection and display, with no mention of AI or ML terms or concepts.
No
The device is intended for detection of fetal movement, not for treating any condition or alleviating symptoms.
No
The device detects fetal movements and displays them. It does not provide a diagnosis, but rather provides data that a healthcare professional might use as part of a diagnostic process.
No
The device description explicitly states it is a "modular hardware/software kit" and is installed in a Corometrics Fetal Monitor, indicating it includes hardware components.
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.
- Device function: The Corometrics Fetal Movement Detection (FMD) Kit uses pulse Doppler ultrasound to detect fetal movement within the body. It does not analyze samples taken from the body.
Therefore, based on the provided information, the Corometrics FMD Kit falls under the category of a medical device used for monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Corometrics Fetal Movement Detection (FMD) Kit is intended to detect gross fetal body movements and fetal body movements with associated limb movement. Corometrics defines "gross fetal body movement" as the extension, flexion, or rolling over of the fetal trunk about the longitudinal axis of the body and associated limb movements." Movement of the extremities alone may not be detected. Fetal eye movements will not be detected.
Product codes
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Device Description
The FMD Kit is a modular hardware/software kit that can be installed in a Corometrics Fetal Monitor. The FMD Kit provides the ability to automatically detect fetal movement via pulse Doppler ultrasound and to display the duration of such events on the fetal monitor's recorder strip chart as horizontal bars along the time scale (time axis) of the heart rate scale.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
pulse Doppler ultrasound
Anatomical Site
Fetal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing and clinical evaluations were performed and verified the equivalent performance of the Corometrics Fetal Movement Detection Kit with the Hewlett-Packard Fetal Movement Profile (FMP).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Hewlett-Packard Fetal Movement Profile (FMP) Option in the M1350A Fetal Monitor (K900480: clearance date - July 2, 1990)
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.
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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).
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§ 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
K
510(k)
Corometrics Fetal Movement Detection Kit 510(k) Summary
AR - 5 1996
Prepared: 30 November 1995
[807.92(a)1] Contact Information
Maria Vitug Fouts Regulatory Affairs/Compliance Specialist
Address: Corometrics Medical Systems, Inc. 61 Barnes Park Road North Wallingford, CT. 06492
Phone: 203-949-2538 Fax: 203-284-9465
[807.92(a)2] Device Name and Classification
The proprietary name of the modified device to be introduced into interstate commerce is the Corometrics Fetal Movement Detection Kit
Common names include: FMD Kit
As indicated in this premarket notification submission, the Corometrics Fetal Movement Detection Kit is a class II device. To date no formal classification name has been issued for similar devices. Applicable device classification names include: $ 884.2960 Obsteric ultrasonic transducer and accessories, and $884.2740, perinatal monitoring system.
[807.92(a)3] Identification of Legally Marketed Equivalent Devices (Predicate Systems)
Hewlett-Packard Fetal Movement Profile (FMP) Option in the M1350A Fetal Monitor (K900480: clearance date - July 2, 1990)
[807.92(2)4 & 807.92(a)5] Device Description & Intended Use
The FMD Kit is a modular hardware/software kit that can be installed in a Corometrics Fetal Monitor. The FMD Kit provides the ability to automatically detect fetal movement via pulse Doppler ultrasound and to display the duration of such events on the fetal monitor's recorder strip chart as horizontal bars along the time scale (time axis) of the heart rate scale.
The Corometrics Fetal Movement Detection (FMD) Kit is intended to detect gross fetal body movements and fetal body movements with associated limb movement. Corometrics defines "gross fetal body movement" as the extension, flexion, or rolling over of the fetal trunk about the longitudinal axis of the body and associated limb movements." Movement of the extremities alone may not be detected. Fetal eye movements will not be detected.
1
Corometrics Fetal Movement Detection Kit 510(k) Summary
- continued -
Prepared: 30 November 1995
[807.92(a)6| Predicate Device Comparison of Technological Characteristics
| Feature | (Predicate)
Hewlett-Packard Fetal Movement
Profile (FMP) | Corometrics
Fetal Movement Detection
(FMD) |
|-------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------|
| Detection method | Pulse Doppler Ultrasound Technique | Same |
| Detection of gross body
movements via ultrasound
transducer | Yes | Same |
| Annotated by bar/dot | Yes | Same |
| Annotated by spike waveform | No | Same |
| Optional function | Yes | Same |
[807.92(b)1, 807.92(b)2 & 807.92(b)3 | Performance Standards per the Food, Drug and Cosmetic Act
To date, no performance standards relating to devices of this type have been promulgated by the Food and Drug Administration.
[807.92(d)] Additional Information
Bench testing and clinical evaluations were performed and verified the equivalent performance of the Corometrics Fetal Movement Detection Kit with the Hewlett-Packard Fetal Movement Profile (FMP).