(151 days)
Not Found
No
The device description focuses on standard Doppler and strain gauge technology for fetal monitoring, and there is no mention of AI, ML, or related concepts in the provided text.
No.
The device measures fetal heart rate and uterine contractions, which are diagnostic measurements, not therapeutic interventions.
No
The device is described as an accessory to monitors designed to measure fetal heart rate and uterine contractions. Its function is to detect and provide data (fetal heart rate using Doppler shift technology and uterine activity using a strain gauge) rather than to provide a diagnosis or interpret medical conditions.
No
The device description explicitly states that the devices are "ultrasound and tocodynamometer (toco) transducers," which are 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: This device measures fetal heart rate and uterine contractions by applying transducers to the outside of the maternal abdomen. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for measuring physiological parameters (fetal heart rate and uterine contractions) in a gravid patient, not for analyzing biological samples.
- Device Description: The description details the use of Doppler shift technology and strain gauges applied externally, not laboratory analysis of samples.
Therefore, based on the provided information, this device falls under the category of a medical device used for monitoring physiological functions, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These devices are intended to be used as replacement transducer accessories for Corometrics and Hewlett Packard monitors, for use in measuring fetal heart rate and uterine contractions.
Product codes (comma separated list FDA assigned to the subject device)
85 HFM, 85 HEL
Device Description
Epic's ultrasound and tocodynamometer (toco) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The ultrasound transducers are used to detect the fetal heart rate using Doppler shift technology and the toco transducers detect uterine activity using a strain gauge for evaluating the fetal heart rate during a contraction. These transducers are intended to be a direct replacement for the OEM transducers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler shift technology (for ultrasound transducers)
Anatomical Site
The ultrasound transducer is placed on the maternal abdomen aimed at the fetal heart and the toco transducer is placed on the maternal abdomen over the fundal area of the uterus.
Indicated Patient Age Range
Gravid patients, especially during labor
Intended User / Care Setting
Not Found
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)
- Acoustic output testing shows
§ 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).
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Providing Solutions Through Innovation and Creativity
Image /page/0/Picture/2 description: The image shows the logo and address of Epic Medical Equipment Services. The address is 1800 10TH STREET, SUITE 300, PLANO, TEXAS 75074. The image also shows the date JAN 1 8 2000.
Appendix C Page 1 of 2
510(k) Summary
Submitter Information:
Epic Medical Equipment Services, Inc. 1800 E. 10th Street, Suite 300 Plano, TX 75074
Contact:
Krista Oakes Vice President, Regulatory Affairs and Quality Assurance Telephone: (972) 801-9854 Fax: (972) 801-9859
Date Prepared:
August 17, 1999
Product Name:
Classification Name: Perinatal Monitoring System Accessories Common Name: Transducers for ultrasound and tocodynamometer fetal monitoring
Predicate Device:
These devices are equivalent to the following legally-marketed devices: Corometrics Models FM (US & TOCO) 115 (5600 & 2260) - K843385 116 (5700 & 2260) - K891595 118 (5700 & 2260) - K934959 120 (5700 & 2260) - K964770
Hewlett Packard Models 8040 (15245 & 15248) - 510(k) unknown 1350 (1356 & 1355) - K900480
Description:
Epic's ultrasound and tocodynamometer (toco) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The ultrasound transducers are used to detect the fetal heart rate using Doppler shift technology and the toco transducers detect uterine activity using a strain gauge for evaluating the fetal heart rate during a contraction. These transducers are intended to be a direct replacement for the OEM transducers.
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Appendix C Page 2 of 2
Intended Use:
These devices are intended to be used as replacement transducer accessories for Corometrics and Hewlett Packard monitors, for use in measuring fetal heart rate and uterine contractions.
| Epic | Corometrics | Hewlett Packard | |
|---|---|---|---|
| Intended use | Measure fetal heart rate and uterine | ||
| contractions in the gravid patient. | Same | Same | |
| Anatomical | |||
| sites | The ultrasound transducer is placed on the | ||
| maternal abdomen aimed at the fetal heart and | |||
| the toco transducer is placed on the maternal | |||
| abdomen over the fundal area of the uterus. | Same | Same | |
| Target patient | |||
| population | Gravid patients, especially during labor | Same | Same |
| FHR Range | Dependent upon monitor specifications | Same | Same |
| Uterine | |||
| Activity Range | Dependent upon monitor specifications | Same | Same |
| Patient | |||
| use/reuse | Reusable | Same | Same |
| Sterility | Non-Sterile | Same | Same |
| Description of | |||
| patient | |||
| attachment | These devices attach to the patient with elastic | ||
| straps around the mother. | Same | Same | |
| Cable length | 8 feet | Same | Same |
| Accessories | Transducer Belts and Ultrasonic Gel | Same | Same |
| Connector | |||
| design | Transducer connectors are color- coded and | ||
| keyed to fit into the appropriate fetal monitors. | Same | Same | |
| Acoustic output |