(194 days)
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No
The description focuses on the physical components and function of a pressure monitoring catheter, with no mention of AI or ML for data analysis or interpretation.
No.
The device is used for monitoring and sampling, not for treating a condition or disease.
Yes
The device is used for monitoring intrauterine pressure, which is a diagnostic function to assess the condition of the patient during labor or other intrauterine events.
No
The device description clearly details physical hardware components including a catheter, pressure transducer, cable, connector, introducer, and attachment device. It is 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 "intrauterine monitoring, amniofusion, and sampling of amniotic fluid." This involves direct interaction with the patient's body and monitoring physiological parameters (pressure).
- Device Description: The description details a catheter designed for insertion into the uterus to measure pressure and facilitate fluid exchange. This is a medical device used in vivo (within the living body).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not analyze specimens in vitro.
The device is clearly designed for direct patient use and physiological monitoring, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intrauterine pressure monitoring catheter (IUP) is for use on patients requiring intrauterine monitoring, amniofusion, and sampling of amniotic fluid.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
This 510(k) Notification is being submitted prior to marketing introduction of Scientific Device Manufacturer's Intrauterine Tip Transducer Catheter and its insertion device. Two models will be offered, one with a pressure transducer located at the proximal end using a fluid column to transmit pressure waves, the ther has the pressure transducer located in the distal tip. In both cases the transducer is a thick film/ceramic strain gage connected to a proximal connector interfaces with a reusable cable which is designed for proper connection to the monitor being used. Both devices will also have a separate fluid infusion and sampling lumen terminating in the side of the catheter near the distal end and integral to the connector at the proximal end. Incorporated in the tip transducer catheter is a signal interruption switch for electronic zeroing of the system following insertion and prior to commencement of use. This switch is also used for periodic rezeroing of the system during use without the need for removal and replacement of the catheter. Both catheter tips have rounded, blunt ends while the catheter material is soft, flexible polyurethane. This design minimizes the possibility of uterine perforation while at the same time providing maximum comfort for the patient. The catheter introducer, made of a somewhat stiffer polypropylene, is designed for easy insertion of the flexible catheter. It is of a split sheath design for simple removal following insertion. Also, a hook and loop attachment device is supplied for fixing the connector end of the catheter to the thigh following placement in order to prevent inadvertent dislodgement during use.
Mentions image processing
Not Found
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
Not Found
Intended User / Care Setting
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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.)
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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.
IntranPlus (Utah Medical) Fetal Monitoring Intrauterine Pressure Kit, #14099C (Hewlett Packard)
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
Image /page/0/Picture/0 description: The image shows the text "scientific device manufacturer, inc." The text is written in a simple, sans-serif font and is horizontally aligned. The text appears to be part of a company name or description.
OCT 1 5 1996
999 Andersen Drive, Suite 110 San Rafael, California 94901 Phone 415-454-9370 Fax 415-454-9380
Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 1290
Applicant Information:
sdm
Date Prepared: Name: Address:
April 1, 1996 Scientific Device Manufacturer, LLC. 999 Andersen Drive, Suite 120 San Rafael, California 94901
Contact Person: Phone Number: Fax Number:
Richard C. Ball 415-454-9370 415-454-9380
Device Information:
SDM IUP-TipTrans and IUP-ProxiTrans Trade Name: Common Name: Intrauterine Pressure Transducer Catheter Intrauterine pressure Transducer Classification Name:
Equivalent Device:
IntranPlus (Utah Medical) Fetal Monitoring Intrauterine Pressure Kit, #14099C (Hewlett Packard)
Classification:
In preparation of this PreMarket Notification, it was determined that devices of this generic type have been previously classified as Class II devices.
Product Description:
This 510(k) Notification is being submitted prior to marketing introduction of Scientific Device Manufacturer's Intrauterine Tip Transducer Catheter and its insertion device. Two models will be offered, one with a pressure transducer located at the proximal end using a fluid column to transmit pressure waves, the ther has the pressure transducer located in the distal tip. In both cases the transducer is a thick film/ceramic strain gage connected to a proximal connector interfaces with a reusable cable which is designed for proper connection to the monitor being used. Both devices will also have a separate fluid infusion and sampling lumen terminating in the side of the catheter near the distal end and integral to the connector at the proximal end.
. .
1
Image /page/1/Picture/1 description: The image shows a symbol that appears to be related to a specific concept or term. The symbol consists of a circle enclosed within an oval shape, with the letters 'sdm' written inside the circle. The symbol is flanked by two parallel lines on either side, which may indicate an equivalence or relationship to other elements not shown in the image.
999 Andersen Drive, Suite 110 San Rafael, California 94901 Phone 415-454-9370 Fax 415-454-9380
Incorporated in the tip transducer catheter is a signal interruption switch for electronic zeroing of the system following insertion and prior to commencement of use. This switch is also used for periodic rezeroing of the system during use without the need for removal and replacement of the catheter.
Both catheter tips have rounded, blunt ends while the catheter material is soft, flexible polyurethane. This design minimizes the possibility of uterine perforation while at the same time providing maximum comfort for the patient.
The catheter introducer, made of a somewhat stiffer polypropylene, is designed for easy insertion of the flexible catheter. It is of a split sheath design for simple removal following insertion. Also, a hook and loop attachment device is supplied for fixing the connector end of the catheter to the thigh following placement in order to prevent inadvertent dislodgement during use.
Intended Use:
The intrauterine pressure monitoring catheter (IUP) is for use on patients requiring intrauterine monitoring, amniofusion, and sampling of amniotic fluid.
Comparison To Predicate Device:
Scientific Device Manufacturer's Intravascular Pressure Transducer Catheters are substantially equivalent to currently marketed IUP devices with regard to intended use, materials, dimensions and mechanical properties. Predicate devices include those made by Utah Medical, Corometrics, and Hewlett Packard. No significant changes or modifications were made from those predicate devices. SDM, LLC, therefore posits that its devices are equivalent in safety and effectiveness to those devices.
Signed:
Richard C. Ball
Name:
Richard C. Ball
Position: VP Regulatory Affairs and Quality Assurance
Date: April 1, 1996