SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)

K974730 · Graphic Controls Corp. · KXO · Jul 14, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K974730
• Device Name: SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
• Applicant: Graphic Controls Corp.
• Product Code: KXO · Obstetrics/Gynecology
• Decision Date: Jul 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2700
• Device Class: Class 2

Intended Use

The Softrans® Plus System is used to obtain direct internal measurements of the intensity, duration, and frequency of uterine contractions during labor and to provide continuous monitoring and display of patient intrauterine temperature. The catheter rests in the amniotic fluid between the fetus and uterine wall. During uterine contractions, the amniotic fluid is compressed; this pressure is transferred through the fluid and measured by the pressure transducer located at the tip of the catheter. The pressure signal is sent to the fetal monitor via the cable. The catheter also may be used for amnioinfusion of fluid into the uterus to enhance amniotic fluid volume, or for amniotic fluid sampling. Intrauterine temperature is sensed by a thermistor located in the catheter. The return signal from the thermistor is sent to the temperature display unit located on the cable.

Device Story

Softrans® Plus Intrauterine Pressure Catheter System (IUPC) consists of a catheter with a tip-mounted pressure transducer and thermistor, signal wires, and a removable introducer. System includes a reusable cable with a rezero mechanism, cable check, and temperature display unit. Used during labor; catheter placed in amniotic fluid between fetus and uterine wall. Pressure transducer measures contraction intensity, duration, and frequency; thermistor measures intrauterine temperature. Catheter port allows amnioinfusion or amniotic fluid sampling. Operated by clinicians in clinical settings. Output displayed on fetal monitor and cable-integrated temperature display unit. Provides continuous monitoring to assist clinical decision-making during labor.

Clinical Evidence

Bench testing only. Device specifications established by manufacturer; product meets or exceeds these specifications. Biocompatibility testing performed and found non-irritating, non-cytotoxic, and non-sensitizing.

Technological Characteristics

Catheter with tip-mounted pressure transducer and thermistor. Includes reusable cable with rezero mechanism and temperature display. Catheter packaged in PETG tray with Tyvek lid. Sterile (catheter), non-sterile (cable).

Indications for Use

Indicated for use during the intrapartum period to monitor intrauterine pressure, monitor intrauterine temperature, perform amnioinfusion, or perform 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

Reference Devices

• SureTemp Thermometer WelchAllyn(DIATEK) System

Submission Summary (Full Text)

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189 Van Rensse der Street PO Box 1274 Buffalo, New York 14240-1274 USA 716 853-7500

Customer Relations: 800 669-1009 Fax: [phone]

K974730
102

## 510(k) Summary

## Graphic Controls

Graphic Controls Corporation 189 Van Rensselaer Street P.O. Box 1271 Buffalo, NY 14240 Registration Number 1317188

Graphic Controls Corporation 1 Camegie Plaza Cherry Hill, NJ 08003 Registration Number 2243963

Isomedix 9 Apollo Drive Whippany, NJ 07981 Registration Number 2245604

[phone]

Kathleen H. Selover Regulatory Affairs Specialist PHONE [phone], ext. 7630 FAX [phone] E-Mail: [e-mail]

Softrans® Plus Intrauterine Pressure Catheter System (IUP 5000 Softrans® Plus IUPC)

Intrauterine Pressure Catheter with continuous temperature display

Catheter, Intrauterine and Introducer

85 KXO

Softrans® Intrauterine Pressure Catheter System

SureTemp Thermometer WelchAllyn(DIATEK) System.

Image /page/0/Picture/17 description: The image shows a stylized lowercase letter 'g' inside a black circle. The 'g' is white and has a distinctive, flowing design. Below the circle, there is a 'TM' symbol, indicating a trademark.

JUL 1 4 1998

Contract Sterilizer

Manufacturing Location

Manufacturer

Telephone

Contact Person

Device Trade Name

Common Name

Classification Name

Regulatory Reference

Predicate Device

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An intrauterine catheter with a pressure transducer at the tip, a thermistor Description located near 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 that contains a rezero mechanism, cable check and temperature display unit. An attachment strap is provided.

> Catheters are packaged within a PETG tray with a heat sealed tyvek lid. Unit of sale is a case of 10 IUPC's.

Cables are packaged in protective wrap and corrugated shippers.

The Softrans® Plus System is used to obtain direct internal measurements of Intended Use the intensity, duration, and frequency of uterine contractions during labor and to provide continuous monitoring and display of patient intrauterine temperature.

> The catheter rests in the amniotic fluid between the fetus and uterine wall. During uterine contractions, the amniotic fluid is compressed; this pressure is transferred through the fluid and measured by the pressure transducer located at the tip of the catheter. The pressure signal is sent to the fetal monitor via the cable. The catheter also may be used for amnioinfusion of fluid into the uterus to enhance amniotic fluid volume, or for amniotic fluid sampling.

> Intrauterine temperature is sensed by a thermistor located in the catheter. The return signal from the thermistor is sent to the temperature display unit located on the cable.

The intended use and application of Softrans® Plus IUPC System described Physical and Technical in this submission is substantially equivalent to Softrans® IUPC System currently manufactured and marketed by Graphic Controls. Both systems Comparison measure uterine pressure by means of a pressure transducer located at the tip of an intrauterine catheter. The patient contacting surfaces and materials of the predicate and Softrans® Plus are identical.

> In addition, Softrans® Plus has a temperature sensing mechanism near the catheter tip and a temperature display unit on the cable. The temperature sensing and display features of Softrans® Plus are substantially equivalent in technology and functionality to Welch Allyn (DIATEK) SureTemp Thermometer.

Performance FDA has not established special controls or performance standards for this Summary device. Graphic Controls has established its own specifications and the product meets or exceeds those specifications.

Biocompatibility This device was subjected to biocompatibility testing and the data was Testing submitted with the predicate device notification. The device was found to be non-irritating, non-cytotoxin and non-sensitizing.

- Sterility Softran® Plus catheter will be sold as a sterile unit. The reusable cable is and supplied non sterile. The expiration date is visible on the labeling for each Shelf Life catheter.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its head turned to the left, and three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the seal.

JUL 1 4 1998

Ms. Kathleen H. Selover Regulatory Affairs Specialist Graphic Controls Corporation 189 Van Renssalaer Street P.O. Box 1274 Buffalo, NY 14240-1274

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K974730 Softrans® Temp IUPC System Dated: April 15, 1998 Received: April 16, 1998 Regulatory Class: II 21 CFR 884.2700/Procode: 85 KXO

Dear Ms. Selover:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, narket the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vito diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrl/dsmaldsmamain.html".

Sincerely yours.

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Softrans® Temp UPC & System may be used during the intrapartum period to monitor intrauterine pressure, to monitor intrauterine temperature, to amnioinfuse or to perform amniotic fluid sampling.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Presecription Use (Per 21CFR 801.109)

OR Over-the-CounterUse _

Dand J. Ael for 44
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K974230