(89 days)
Not Found.
Not Found.
No
The summary describes a physical medical device (catheter) with a new component for visualizing fluid color. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for monitoring, not for treating or preventing disease.
Yes
The device monitors the frequency and duration of contractions during labor and delivery and allows for visualization of the color of a fluid sample, both of which provide information to aid in diagnosis or assessment of a medical condition.
No
The device description explicitly states it is a "sensor-tipped intrauterine pressure catheter" and includes physical components like a "molded clear plastic cylinder" and a "plastic clip." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is monitoring the frequency and duration of contractions during labor and delivery. This is a physiological measurement taken in vivo (within the body).
- Device Description: While the device has a feature for visualizing the color of amniotic fluid, this is a visual inspection of a sample, not a diagnostic test performed in vitro (outside the body) to detect specific substances or conditions. The core function remains the pressure monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples for diagnostic purposes, using reagents, or performing tests on bodily fluids to determine a disease state or condition.
The device is a monitoring tool used during a medical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The UMP Intran 500 is the same device as Intran 400, Intran Plus, a sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in "high risk" births. Intran-500 adds a molded clear plastic cylinder component which is attached to the catheter's amnio port, along with a plastic clip containing a color reference scale that fits over the plastic cylinder. The cylinder acts as a section in the liquid line that can be used by physicians for visualization of the color of a fluid sample drawn from the amniotic sac.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
obstetricians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 10 1996
Image /page/0/Picture/2 description: The image shows the logo for Utah Medical Products Inc. The logo features the company name in bold, uppercase letters at the top. Below the name is a stylized symbol that appears to be a combination of the letters 'U' and 'M', forming a unique emblem. The logo is simple and uses a black and white color scheme.
SMDA 510(k) Summary
Trade Name: Intran Plus (Intran-500) Common Name: Intrauterine Pressure Monitoring Catheter Classification: Intrauterine Pressure Monitor and Accessories, 21 CFR §884.2700.
The UMP Intran 500 is the same device as Intran 400, Intran Plus, a sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in "high risk" births. Intran-500 adds a molded clear plastic cylinder component which is attached to the catheter's amnio port, along with a plastic clip containing a color reference scale that fits over the plastic cylinder. The cylinder acts as a section in the liquid line that can be used by physicians for visualization of the color of a fluid sample drawn from the amniotic sac.
The safety of Intran Plus can be inferred directly from the fact that there have been no product liability lawsuits resulting from its use in an inherently risky procedure conducted by the most sued class of physicians in the U.S. in over 1.4 million uses since product introduction in 1991.
Both the Intran-500 and predicate Intran-400 devices are functionally identical and both have Amnio Ports that allow direct communication into the amniotic sac. The only difference between the two devices is the addition of a View Port and Color Tab Clip on the Intran 500, and the resulting package labeling and instructions for use.
Materials used in the Intran 500 that contact the patient are identical to materials used in the Intran-Plus. Biocompatibility and sterilization information is available from UMP upon request.
Kevin L. Cornwell
President & CEO
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