INTRAN 500

K961424 · Utah Medical Products, Inc. · HFN · Jul 10, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K961424
• Device Name: INTRAN 500
• Applicant: Utah Medical Products, Inc.
• Product Code: HFN · Obstetrics/Gynecology
• Decision Date: Jul 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2700
• Device Class: Class 2

Intended Use

The UMP Intran 500 is a sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in “high risk” births.

Device Story

Sensor-tipped intrauterine pressure catheter; monitors uterine contraction frequency/duration during labor/delivery. Input: intrauterine pressure signals; amniotic fluid samples. Operation: catheter inserted into amniotic sac; pressure sensor transmits data to monitor; new molded clear plastic cylinder (View Port) and clip (Color Tab) added to amnio port for visual inspection of amniotic fluid color. Used in clinical labor/delivery settings by obstetricians. Output: pressure data for clinical monitoring; visual fluid sample for assessment. Benefit: facilitates contraction monitoring and fluid assessment in high-risk births.

Clinical Evidence

No clinical data provided. Safety inferred from historical usage data (1.4 million uses since 1991) and lack of product liability lawsuits.

Technological Characteristics

Sensor-tipped intrauterine pressure catheter. Features molded clear plastic cylinder (View Port) and plastic clip (Color Tab) for fluid visualization. Materials identical to predicate Intran-Plus. Sterilization and biocompatibility data maintained by manufacturer.

Indications for Use

Indicated for obstetricians monitoring frequency and duration of uterine contractions during labor and delivery, specifically for high-risk births.

Regulatory Classification

Identification

An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.

Predicate Devices

• Intran-400 (K961424)

Submission Summary (Full Text)

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JUL 10 1996
K961424

UTAH MEDICAL PRODUCTS INC.

SMDA 510(k) Summary

Trade Name: Intran Plus (Intran-500)
Common Name: Intrauterine Pressure Monitoring Catheter
Classification: Intrauterine Pressure Monitor and Accessories, 21 CFR §884.2700.

The UMP Intran 500 is the same device as Intran 400, Intran Plus, a sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in “high risk” births. Intran-500 adds a molded clear plastic cylinder component which is attached to the catheter’s amnio port, along with a plastic clip containing a color reference scale that fits over the plastic cylinder. The cylinder acts as a section in the liquid line that can be used by physicians for visualization of the color of a fluid sample drawn from the amniotic sac.

The safety of Intran Plus can be inferred directly from the fact that there have been no product liability lawsuits resulting from its use in an inherently risky procedure conducted by the most sued class of physicians in the U.S. in over 1.4 million uses since product introduction in 1991.

Both the Intran-500 and predicate Intran-400 devices are functionally identical and both have Amnio Ports that allow direct communication into the amniotic sac. The only difference between the two devices is the addition of a View Port and Color Tab Clip on the Intran 500, and the resulting package labeling and instructions for use.

Materials used in the Intran 500 that contact the patient are identical to materials used in the Intran-Plus. Biocompatibility and sterilization information is available from UMP upon request.

Kevin L. Cornwell
President & CEO

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UTAH MEDICAL PRODUCTS, INC • 7043 South 300 West • Midvale, Utah 84047-1046 • 801/566-1200 • FAX#[phone]