(194 days)
The intrauterine pressure monitoring catheter (IUP) is for use on patients requiring intrauterine monitoring, amniofusion, and sampling of amniotic fluid.
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.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is a "Summary of Safety and Effectiveness" for an Intrauterine Pressure Transducer Catheter and focuses on describing the device and its equivalence to predicate devices, not on specific performance studies or acceptance criteria.
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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.
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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
§ 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).