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

K991235 · Ludlow Technical Products · KXO · Jul 8, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991235
• Device Name: SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)
• Applicant: Ludlow Technical Products
• Product Code: KXO · Obstetrics/Gynecology
• Decision Date: Jul 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2700
• Device Class: Class 2

Intended Use

The Softrans Temp™ 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 amniotic fluid sampling. Intrauterine temperature is sensed by the thermistor located in the catheter. The return signal from the thermistor is sent to the temperature display unit located on the cable. Intrauterine temperature measurements correspond to oral temperature measurements and can be used in place of oral temperature measurements in laboring patients.

Device Story

Intrauterine pressure catheter (IUPC) with tip-mounted pressure transducer and thermistor; includes amnioinfusion/sampling port and introducer. System utilizes reusable cable with rezero mechanism, cable check, and temperature display unit. Used in clinical labor settings by healthcare providers. Pressure transducer measures amniotic fluid compression during contractions; signal transmitted to fetal monitor. Thermistor measures intrauterine temperature; display unit provides continuous readout. Intrauterine temperature serves as clinical equivalent to oral temperature. Benefits include direct, continuous monitoring of labor progress and patient temperature.

Clinical Evidence

No clinical data provided. Biocompatibility testing (non-irritating, non-cytotoxic, non-sensitizing) was submitted with the predicate device notification. Device meets internal manufacturer specifications.

Technological Characteristics

Catheter with tip-mounted pressure transducer and thermistor; PETG tray packaging with Tyvek lid. Reusable cable with rezero mechanism and temperature display. Sterilized unit (catheter).

Indications for Use

Indicated for use during the interpartum period to monitor intrauterine pressure, monitor intrauterine temperature, perform amnioinfusion, or perform amniotic fluid sampling in laboring patients.

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

• Softans Temp™ Intrauterine Pressure Catheter System

Submission Summary (Full Text)

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JUL - 8 1999

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## Ludlow Technical Products

Two Ludlow Park Drive P.O. Box 297 Chicopee, MA 01021-0297 413-593-6400

K991235

## 510(k) Summary

| Manufacturer | Ludlow Technical Products<br>Two Ludlow Park Drive<br>Chicopee, MA 01022<br>Registration Number 9001764 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Location | Graphic Controls Corporation<br>1 Carnegie Plaza<br>Cherry Hill, NJ 08003<br>Registration Number 2243963 |
| Contract Sterilizer | Isomedix<br>9 Apollo Drive<br>Whippany, NJ 07981<br>Registration Number 2245604 |
| Telephone | [phone] |
| Contact Person | Kathleen M. Murphy<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone] |
| Device Trade Name | Softans Temp™ Intrauterine Pressure Catheter<br>System (IUPC 5000 Softrans Temp™ IUPC) |
| Common Name | Intrauterine Pressure Catheter with continuous temperature display |
| Classification Name | Catheter, Intrauterine Pressure Catheter System |
| Regulatory Reference | 85 KXO |
| Predicate Device | Softans Temp™ Intrauterine Pressure Catheter System |
| Description | An intrauterine catheter with a pressure transducer at the tip, a thermistor located<br>near the tip, a port for amnioinfusion and amniotic fluid sampling, signal wires, and an<br>introducer which is removed after placement. System includes a reusable cable that<br>contains a rezero mechanism, cable check and temperature display unit. An<br>attachment strap is provided. |
| | Catheters are packaged within a PETG tray with a heat sealed tyvek lid. Unit of sale<br>is a case of 10 IUPC's. |
| | Cables are packaged in protective wrap and corrugated shippers. |
| Intended Use | The Softrans Temp™ System is used to obtain direct internal measurements of the<br>intensity, duration, and frequency of uterine contractions during labor and to provide<br>continuous monitoring and display of patient intrauterine temperature. |
| | The catheter rests in the amniotic fluid between the fetus and uterine wall. During<br>uterine contractions, the amniotic fluid is compressed; this pressure is transferred<br>through the fluid and measured by the pressure transducer located at the tip of the<br>catheter. The pressure signal is sent to the fetal monitor via the cable. The catheter<br>also may be used for amniotic fluid sampling. |
| | Intrauterine temperature is sensed by the thermistor located in the catheter. The<br>return signal from the thermistor is sent to the temperature display unit located on the<br>cable. Intrauterine temperature measurements correspond to oral temperature<br>measurements and can be used in place of oral temperature measurements in<br>laboring patients. |
| Physical and<br>Technical Comparison | The intended use and application of the subject Softrans Temp™ described in<br>this submission is substantially equivalent to the predicate Softrans Temp™ currently<br>manufactured and marketed by Graphic Controls Corp (a division of Ludlow<br>Technical Products). |
| | In addition, the intended use of the subject Softrans Temp™ now includes the<br>addition of a claim in labeling stating that the intrauterine temperature measured by<br>the device is clinically equivalent to oral temperature and that intrauterine<br>temperature can be used in place of oral temperature measurements in laboring<br>patients. |
| Performance<br>Summary | FDA has not established special controls or performance standards for this<br>device. Ludlow Technical Products has established its own specifications and the<br>product meets or exceeds those specifications. |
| Biocompatibility<br>Testing | This device was subjected to biocompatibility testing and the data was<br>submitted with the predicate device notification. The device was found to be non-<br>irritating, non-cytotoxin and non-sensitizing. |
| Sterility and<br>Shelf Life | Softrans Temp™ catheter will be sold as a sterile unit. The reusable cable is<br>supplied non sterile. The expiration date is visible on the labeling for each catheter. |

A LUCO INTERNATIONAL LTD. COMPANY

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 1999

Ms. Kathleen M. Murphy Regulatory Affairs Manager Ludlow Technical Products Two Ludlow Park Drive P.O. Box 297 Chicopee, MA 01021-0297

Re: K991235

Softrans Temp™ Intrauterine Pressure Catheter System (IUP 5000, Softrans_Temp™ IUPC) Dated: April 6, 1999 Received: April 12, 1999 Regulatory Class: II 21 CFR §884.2700/Procode: 85 KXO

Dear Ms. Murphy:

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 legally marketed predicate 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, market 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 III (Special Controls) or class III (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 (QS) 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 requlatory 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K991235

Device Name: Softtrans Temp™ IUPC System

Indications for Use:

The Softrans Temp™ IUPC System may be used during the interpartum 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)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991235

Prescription Use _X (Per 21 CFR 801.109)

OR

Over-The-Counter Use _