(173 days)
MX 4042 Series Intrauterine Pressure Catheter from Medex, Meditrace Disposable Intrauterine Catheter from Graphic Controls, Intrauterine Catheter from Telos, IUC -Intrauterine Catheter (INTRAN) from Utah Medical Products
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No
The summary describes a disposable catheter for pressure monitoring and does not mention any AI/ML components or capabilities.
No.
The device is used for monitoring, not for treating a condition or disease.
No
The device is described as "for use on patients requiring intrapartum, intrauterine pressure monitoring" and "evaluating the pressure within the uterus". This is a monitoring function, not a diagnostic one that aims to identify the nature or cause of a disease or condition. The performance studies also focus on safety and effectiveness in pressure monitoring, not on diagnosing a condition.
No
The device description explicitly states it is a "Disposable Intrauterine Pressure Monitoring System" and a "sterile, single patient use catheter," indicating it is a physical medical device, not software only.
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 involves monitoring a physiological parameter (pressure) directly within the body.
- Device Description: The device is a "Disposable Intrauterine Pressure Monitoring System" and a "catheter." Catheters are typically used for accessing or monitoring internal body spaces.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVDs are designed to perform tests on such specimens.
The device is a medical device used for direct physiological monitoring within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.
Product codes
Not Found
Device Description
STORC™ is a Disposable Intrauterine Pressure Monitoring System. This product is a sterile, single patient use catheter.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety
Laboratory testing has shown that in the following areas the STORC Intrauterine Pressure Catheter is safe:
- Perforation: bench testing on fresh placenta showed that the STORC . is less likely to perforate than predicate devices.
- Mechanical integrity: laboratory testing and basic design assure that . no parts will come loose and be left in the patient.
- . Biocompatibility and infection: independent lab testing show that the materials used in the STORC are safe for use in this application.
In addition, clinical studies including physician evaluation verified the safe nature of the STORC Intrauterine Pressure Catheter.
Effectiveness
The clinical trials showed that the STORC Intrauterine Pressure Catheter was as effective or more effective than the predicate devices in the following areas:
- integrity of intrauterine pressure signal ●
- . ease of use
- amniotic space access
- device retention ●
- . zeroing and drift signal stability
The laboratory testing verified the performance standards in terms of sensor accuracy, mechanical integrity, and overall performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MX 4042 Series Intrauterine Pressure Catheter from Medex, Meditrace Disposable Intrauterine Catheter from Graphic Controls, Intrauterine Catheter from Telos, IUC -Intrauterine Catheter (INTRAN) from Utah Medical Products
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
Image /page/0/Picture/1 description: The image shows the logo for Clinical Innovations. The logo consists of a stylized letter C made up of three curved lines inside of a black square. To the right of the symbol is the company name, "CLINICAL INNOVATIONS", in a simple sans-serif font.
510(k) Summary
APR 17 1996
Clinical Innovations, Inc. Submitter: Wm. Dean Wallace Name: 6477 So. Cottonwood St., Murray, UT 84107 Address: Telephone: (801) 268-8200
Trade Name: STORC Intrauterine Pressure Catheter Intrauterine Pressure Catheter Common Name: Classification Name: Catheter, Intrauterine and Introducer
The legally marketed devices to which equivalence is claimed include the MX 4042 Series Intrauterine Pressure Catheter from Medex, the Meditrace Disposable Intrauterine Catheter from Graphic Controls, the Intrauterine Catheter from Telos, and the IUC -Intrauterine Catheter (INTRAN) from Utah Medical Products.
Description of the device: STORC™ is a Disposable Intrauterine Pressure Monitoring System. This product is a sterile, single patient use catheter.
Intended use: This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.
The STORC Intrauterine Pressure Catheter is substantially equivalent to the predicate devices because:
It has the same intended uses, namely,
- intrauterine pressure measurement and monitoring .
- port for amniotic fluid access, ●
It has the same basic technological characteristics as predicate devices, namely,
- pressure sensor located at catheter tip, .
- . soft tip for lower 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, .
- external zeroing of pressure. .
It uses the same or similar materials, all of which have been shown to be biocompatible and to function well in the intended application,
1
The soft elastomeric tip is a further advantage that adds safety.
The safety and effectiveness are similar or better than existing devices as demonstrated in the laboratory and clinical testing.
Safety
Laboratory testing has shown that in the following areas the STORC Intrauterine Pressure Catheter is safe:
- Perforation: bench testing on fresh placenta showed that the STORC . is less likely to perforate than predicate devices.
- Mechanical integrity: laboratory testing and basic design assure that . no parts will come loose and be left in the patient.
- . Biocompatibility and infection: independent lab testing show that the materials used in the STORC are safe for use in this application.
In addition, clinical studies including physician evaluation verified the safe nature of the STORC Intrauterine Pressure Catheter.
Effectiveness
The clinical trials showed that the STORC Intrauterine Pressure Catheter was as effective or more effective than the predicate devices in the following areas:
- integrity of intrauterine pressure signal ●
- . ease of use
- amniotic space access
- device retention ●
- . zeroing and drift signal stability
The laboratory testing verified the performance standards in terms of sensor accuracy, mechanical integrity, and overall performance.
Wm. Dean Wallace
Wm. Dean Wallace, M.D., Ph.D.
10-23-95 Date