← Product Code [KXO](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KXO) · K964279 # SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) (K964279) _Graphic Controls Corp. · KXO · Jan 22, 1997 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KXO/K964279 ## Device Facts - **Applicant:** Graphic Controls Corp. - **Product Code:** [KXO](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KXO.md) - **Decision Date:** Jan 22, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.2700 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use Intended for use in measuring the intensity, duration, and frequency of uterine contractions during labor. Also, the catheter may be used for amnioinfusion of fluid into the uterus or to sample amniotic fluid. ## Device Story Softrans™ Intrauterine Pressure Catheter System (IUP 4000) monitors uterine contractions during labor; features tip-mounted pressure transducer, amnioinfusion/sampling port, signal wires, and removable introducer. System includes reusable cable with zeroing mechanism and attachment strap. Used in clinical labor/delivery settings by healthcare providers. Transducer converts mechanical uterine pressure into electrical signals transmitted via cable to monitoring equipment; provides real-time contraction data (intensity, duration, frequency) to clinicians for labor management. Amnioinfusion port allows fluid delivery or amniotic fluid sampling. Benefits include accurate, continuous monitoring of labor progress to guide clinical decision-making. ## Clinical Evidence Bench testing only. Biocompatibility testing performed; device found non-irritating, non-cytotoxic, and non-sensitizing. ## Technological Characteristics Intrauterine catheter with tip-mounted pressure transducer, amnioinfusion/sampling port, and introducer. Materials: PETG tray, Tyvek lid. Reusable cable with zeroing mechanism. Sterilization: Sterile unit (except reusable cable). ## 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 - Softrans™ Intrauterine Pressure Catheter System ## 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} Graphic Controls Corporation 189 Van Rensselaer Street PO Box 1274 Buffalo, New York 14240-1274 USA 716 853-7500 Customer Relations: 800 669-1000 Fax: 800-347-2421 JAN 22 1997 P192 K964279 ![img-0.jpeg](img-0.jpeg) ## 510(k) Summary ## Graphic Controls | Manufacturer | Graphic Controls Corporation 189 Van Rensselaer Street P.O. Box 1271 Buffalo, NY 14240 Registration Number 1317188 | | --- | --- | | Manufacturing Location | Graphic Controls Corporation 1 Carnegie Plaza Cherry Hill, NJ 08003 Registration Number 2243963 | | Contract Sterilizer | Isomedix 9 Apollo Drive Whippany, NJ 07981 Registration Number 2245604 | | Telephone | (716) 853-7500 | | Contact Person | Kathleen H. Selover Regulatory Affairs Specialist (716) 853-7500, extension 7630 FAX Number (716) 847-7531 | | Device Trade Name | Softrans™ Intrauterine Pressure Catheter System (IUP 4000 Softrans™ IUPC) | | Common Name | Intrauterine Pressure Catheter | | Classification Name | Catheter, Intrauterine and Introducer | | Regulatory Reference | 85 KXO | | Predicate Device | Softrans™ Intrauterine Pressure Catheter System | {1} K964279 p2012 ## Description An intrauterine catheter with a pressure transducer at the tip, a port for amnioinfusion and amniotic fluid sampling, signal wires, and an introducer which is removed after placement. System includes a reusable cable with a zero mechanism and an attachment strap. Catheters are packaged within a PETG tray with a heat sealed tyvek lid. Unit of sale is a case of 10 IUPC’s. ## Intended Use Intended for use in measuring the intensity, duration, and frequency of uterine contractions during labor. Also, the catheter may be used for amnioinfusion of fluid into the uterus or to sample amniotic fluid. ## Physical/Technical Comparison Softrans™ is equivalent to the predicate device. Physical and technical characteristics, including materials used in construction, size and intended used of the predicate device are comparable. ## Performance Summary FDA has not established special controls or performance standards for this device. Graphic Controls has established its own specifications and the product meets or exceeds those specifications. ## Biocompatibility Testing This device was subjected to biocompatibility testing and the data was submitted with the predicate device notification. The device was found to be non-irritating, non-cytotoxin and non-sensitizing. ## Sterility and Shelf Life Softrans™ will be sold as a sterile unit except for the reusable cable. The expiration date is visible on the labeling for each catheter. Revised Jan 20, 1997 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KXO/K964279](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KXO/K964279) **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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