(90 days)
Medex MX 4041 Intrauterine Pressure Catheter, Graphic Controls Life Trace 3000 Intrauterine Pressure Catheter System, Utah Medical Products Intran Plus IUP Catheter
Not Found
No
The summary describes a standard intrauterine pressure catheter and does not mention any AI or ML components or functionalities.
No.
The device is used for monitoring intrauterine pressure and for amnioinfusion/fluid sampling, which are diagnostic and procedural support functions, not therapeutic in nature.
No
The device is described as an intrauterine pressure catheter used for "intrapartum, intrauterine pressure monitoring" and it measures and monitors pressure. While monitoring can be part of a diagnostic process, the device itself outputs a measurement rather than a diagnosis. It does not perform image processing or AI/ML for diagnostic purposes. Its function is to provide real-time physiological data rather than to diagnose a condition.
No
The device description clearly outlines physical components like a catheter, pressure-sensing membrane, port, introducer, cable, and reusable pressure transducer, indicating it is a hardware device with potential software components for data processing or display, but not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intrapartum, intrauterine pressure monitoring." This is a physiological measurement taken directly from the patient's body, not a test performed on a sample of bodily fluid or tissue outside the body.
- Device Description: The description details a catheter for measuring pressure within the uterus, with features for amnioinfusion and fluid sampling. While fluid sampling is mentioned, the primary function is pressure monitoring in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing of biological specimens.
IVDs are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is direct physiological monitoring.
N/A
Intended Use / Indications for Use
This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.
Product codes
85 HFN
Device Description
An intrauterine pressure catheter with a pressure-sensing membrane cavity at the tip (either inside the catheter or mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. This product is a sterile, single patient use catheter. The system includes a reusable cable with a reusable pressure transducer.
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
Prescription Use
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)
The safety and effectiveness are similar to existing devices as demonstrated in the laboratory and in clinical testing. Biocompatibility testing shows that the materials used in the Koala IPC and the Koala External IPC are safe for this application. Effectiveness is the same as the predicate devices. The laboratory testing verified the performance in terms of sensor accuracy, mechanical integrity, and overall performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medex MX 4041 Intrauterine Pressure Catheter, Graphic Controls Life Trace 3000 Intrauterine Pressure Catheter System, Utah Medical Products Intran Plus IUP Catheter
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).
0
Section 6.0 510(k) Summary
K974389
Plnz
FEB 1 9 1998
510(k) Summary
| Submitter: | Clinical Innovations, Inc. |
|---|---|
| Name: | Wm. Dean Wallace |
| Address: | 6477 So. Cottonwood St., Murray, UT 84107 |
| Telephone: | (801) 268-8200 |
| Fax: | (801) 266-7373 |
Proprietary Names:
Common/Usual Name: Classification Name:
Koala Intrauterine Pressure Catheter and Koala External Intrauterine Pressure Catheter Intrauterine Pressure Monitor and Accessories Monitor, Pressure, Intrauterine
The legally marketed devices to which equivalence is claimed are the Medex MX 4041 Intrauterine Pressure Catheter, Graphic Controls Life Trace 3000 Intrauterine Pressure Catheter System, and Utah Medical Products Intran Plus IUP Catheter.
Description of the device: An intrauterine pressure catheter with a pressure-sensing membrane cavity at the tip (either inside the catheter or mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. This product is a sterile, single patient use catheter. The system includes a reusable cable with a reusable pressure transducer.
Intended use: This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.
The Koala IPC's are substantially equivalent to the predicate devices because: they have the same intended uses, namely, intrauterine pressure measurement and monitoring and amniotic fluid access, and
- they have the same basic technological characteristics as predicate devices, namely, . pressure sensor located at catheter tip,
- soft tip for low risk of perforation. .
- markings for catheter insertion,
- low-cost disposable in order to avoid cross contamination, ●
- . port and lumen with female luer connector for access to amniotic space, and
- external zeroing of pressure. ●
They use the same or similar materials, all of which have been shown to be biocompatible and to function well in the intended application.
The safety and effectiveness are similar to existing devices as demonstrated in the laboratory and in clinical testing. Biocompatibility testing shows that the materials used
1
in the Koala IPC and the Koala External IPC are safe for this application. Effectiveness is the same as the predicate devices. The laboratory testing verified the performance in terms of sensor accuracy, mechanical integrity, and overall performance.
Wm. Dean Wallace
Wm. Dean Wallace, M.D., Ph.D.
11-18-97
Date
K974389
P2092
Wm. Dean Wallace, M.D., Ph.D.
2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wm. Dean Wallace, M.D., Ph.D. President . Clinical Innovations 6477 S. Cottonwood Street Murray, UT 84107
Re: K974389
FEB 1 9 1998
Koala Intrauterine Pressure Catheters, Models 5000 and 5000E Dated: November 19, 1997 Received: November 21, 1997 Regulatory Class: II 21 CFR 884.2700/Procode: 85 HFN
Dear Dr. Wallace:
We have reviewed your Section 5 for the intent to market the device referenced above and we have there 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 requirement, 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 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 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 vitro diagnostic devices), please contact the Office of Compliance 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 of the regulation of the regulation of the regulation "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/dsmamain.html".
Sincerely yours,
Sincerely yours,
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
11.0 Indications For Use
Device Name: Koala Intrauterine Pressure Catheter and Koala External Intrauterine Pressure Catheter
510(k) Number: K974389
Indications for use: This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.
(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Sething
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices K 74389 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)