(87 days)
Not Found
Not Found
No
The device description and performance summary do not mention any AI or ML components or capabilities. The device appears to be a standard sensor-based system.
No.
The primary purpose of the device is monitoring (pressure and temperature) and aiding in procedures (amnioinfusion, sampling), not directly treating a medical condition.
Yes
Explanation: The device description states its purpose is "to monitor intrauterine pressure, to monitor intrauterine temperature, to amnioinfuse or to perform amniotic fluid sampling." Monitoring physiological parameters like pressure and temperature, as well as sampling fluids, are activities that provide information about the patient's condition, which is a core function of diagnostic devices.
No
The device description clearly outlines hardware components including an intrauterine catheter, pressure transducer, thermistor, signal wires, introducer, reusable cable, and attachment strap.
Based on the provided information, the Softrans Temp™ IUPC System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Softrans Temp™ IUPC System Function: The Softrans Temp™ IUPC System is a device that is inserted directly into the uterus to monitor pressure and temperature, perform amnioinfusion, and sample amniotic fluid. It is used in vivo (within the living body), not in vitro (outside the living body).
- Intended Use: The intended use clearly states it's for monitoring intrauterine pressure and temperature, amnioinfusion, and amniotic fluid sampling during the interpartum period. These are direct physiological measurements and procedures performed within the body.
Therefore, the Softrans Temp™ IUPC System is a medical device used for direct physiological monitoring and intervention within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for 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.
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.
Product codes
85 KXO
Device Description
An intrauterine catheter with a pressure transducer at the tip, a thermistor 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
FDA has not established special controls or performance standards for this device. Ludlow Technical Products has established its own specifications and the product meets or exceeds those specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Softans Temp™ Intrauterine Pressure Catheter System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2700 Intrauterine pressure monitor and accessories.
(a)
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.(b)
Classification. Class II (performance standards).
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JUL - 8 1999
(
Ludlow Technical Products
Two Ludlow Park Drive P.O. Box 297 Chicopee, MA 01021-0297 413-593-6400
510(k) Summary
| Manufacturer | Ludlow Technical Products
Two Ludlow Park Drive
Chicopee, MA 01022
Registration Number 9001764 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | (413) 593-6400 |
| Contact Person | Kathleen M. Murphy
Regulatory Affairs Manager
Phone: (413)-593-6400
Fax: (413) 593-6114 |
| Device Trade Name | Softans Temp™ Intrauterine Pressure Catheter
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
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. |
| 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. |
| Physical and
Technical Comparison | The intended use and application of the subject Softrans Temp™ described in
this submission is substantially equivalent to the predicate Softrans Temp™ currently
manufactured and marketed by Graphic Controls Corp (a division of Ludlow
Technical Products). |
| | In addition, the intended use of the subject Softrans Temp™ now includes the
addition of a claim in labeling stating that the intrauterine temperature measured by
the device is clinically equivalent to oral temperature and that intrauterine
temperature can be used in place of oral temperature measurements in laboring
patients. |
| Performance
Summary | FDA has not established special controls or performance standards for this
device. Ludlow Technical Products 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 Temp™ catheter will be sold as a sterile unit. The reusable cable is
supplied non sterile. The expiration date is visible on the labeling for each catheter. |
A LUCO INTERNATIONAL LTD. COMPANY
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Image /page/2/Picture/0 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. In the center of the seal is an abstract image of an eagle.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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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Page 1 of 1
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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 _