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K Number
K040392
Device Name
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
Manufacturer
AMERICAN I.V. PRODUCTS, INC.
Date Cleared
2004-09-14

(210 days)

Product Code
HFM
Regulation Number
884.2720
Type
Traditional
Panel
OB
Reference & Predicate Devices
K982651,K992811
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

These devices are intended to be used as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

AIV Transducer Model Numbers: FM10835 and FM10836. These devices are a direct replacement for the EPIC EFU200-20, Ultrasound Transducer for measuring fetal heart rate.

AIV Transducer Model Numbers: FM10839 and FM10840. These devices are a direct replacement for the Corometric's 2264LAX. TOCO Transducer for measuring uterine contractions.

AIV Transducer Model Number: FM10841. This device is a direct replacement for the EPIC EFT200-20, TOCO Transducer for measuring uterine contractions.

Device Description

AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors.

The US transducers are used to detect the fetal heart rate using Doppler shift technology. The TOCO transducers detect uterine activity using a strain gauge for evaluating contractions. These transducers are intended to be a direct replacement for the Corometrics, Hewlett Packard and Epic transducers.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the fetal monitoring transducers, formatted as requested:

Acceptance Criteria and Device Performance

Acceptance CriteriaReported Device Performance
Acoustic Output

§ 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).