SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)

K964279 · Graphic Controls Corp. · KXO · Jan 22, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K964279
• Device Name: SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
• Applicant: Graphic Controls Corp.
• Product Code: KXO · Obstetrics/Gynecology
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2700
• Device Class: Class 2

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).

Indications for Use

Indicated for patients in labor requiring monitoring of uterine contraction intensity, duration, and frequency, or requiring amnioinfusion or amniotic fluid sampling.

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

• Softrans™ Intrauterine Pressure Catheter System

Submission Summary (Full Text)

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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: [phone]

JAN 22 1997

P192 K964279


## 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 | [phone] |
| Contact Person | Kathleen H. Selover
Regulatory Affairs Specialist
[phone], extension 7630
FAX Number [phone] |
| 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