← Product Code [HFN](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFN) · K961424 # INTRAN 500 (K961424) _Utah Medical Products, Inc. · HFN · Jul 10, 1996 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFN/K961424 ## Device Facts - **Applicant:** Utah Medical Products, Inc. - **Product Code:** [HFN](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFN.md) - **Decision Date:** Jul 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.2700 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for 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. ## Regulatory 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](/device/K961424.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 28 UTAH MEDICAL PRODUCTS, INC • 7043 South 300 West • Midvale, Utah 84047-1046 • 801/566-1200 • FAX#801/566-2062 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFN/K961424](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFN/K961424) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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