(61 days)
K 961290, K 905563, K 955443, K 964279
None
No
The device description focuses on the physical components and function of a pressure monitoring catheter, with no mention of AI or ML capabilities.
No
The device is described as a monitoring catheter for intrauterine pressure and for fluid infusion/sampling, not for treating a condition or disease.
Yes
Explanation: The device is used for "intrapartum intrauterine pressure monitoring," which is the measurement of physiological parameters (intrauterine pressure) to assess the patient's condition. This falls under the definition of a diagnostic device as it provides information for diagnosis or monitoring of a physiological state.
No
The device description clearly details a physical catheter with a pressure transducer, leads, connectors, a fluid lumen, and an introducer. These are all hardware components, indicating it is not a software-only device.
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," "amniofusion," and "Amniotic fluid sampling." These are procedures performed in vivo (within the living body) to monitor physiological parameters and administer or collect substances directly from the uterus.
- Device Description: The device is a catheter with a pressure transducer designed to be inserted into the uterus. It measures pressure within the body. While it can be used for sampling amniotic fluid, the primary function described is monitoring pressure in vivo.
- Lack of In Vitro Testing: The description focuses on the device's physical characteristics and its function within the body. There is no mention of testing biological samples outside the body, which is the hallmark of an IVD.
In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The intrauterine pressure catheter is for use on patients requiring intrapartum intrauterine monitoring, amniofusion and amniotic fluid sampling.
Product codes
85 KXO
Device Description
This disposable device is a catheter with a pressure transducer located at the distal tip to monitor the intrauterine pressure. The sensor/transducer is a thick film/ceramic strain gage connected via 4 leads to a connector in proximal end. This end connector interfaces with a reusable cable designed for the proper connection to the monitor in use. The IUPC has a separate fluid infusion and sampling lumen with three holes near the distal end that terminates at the proximal end with a luer fitting/cap. Incorporated in the connector housing at the proximal end is a switch for electronic zeroing of the transducer. This switch can also be used for periodic rezeroing of the system during use without the need for removal and replacement of the catheter. The distal end of the catheter holding the sensor is rounded and blunt while the catheter is soft, flexible polyurethane. This design minimizes the possibility of perforating the uterus while at the same time providing maximum comfort to the patient. The introducer, is designed to ease the insertion of the flexible catheter and is of a split sheath design for easy removal from the catheter after insertion. A Velcro attachment devise is supplied to attach the catheter firmly in place on the patients thigh to prevent inadvertent slippage or dislodgment during use.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 961290, K 905563, K 955443, K 964279
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
Carl Schuh 10915 Lurline Avenue Chatsworth CA 91311 510(k) submittal REF K982565 IUPC
Addendum C:
510(k) Summary of Safety and Effectiveness
submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92
The assigned 510(k) number is: K__982565
Applicant information:
| Date Prepared: | July 17, 1998 | |
|---|---|---|
| Name: | Carl Schuh | |
| Address: | 10915 Lurline Avenue | |
| Chatsworth, CA 91311 | ||
| Contact Person: | Carl Schuh | |
| Phone #: | 818-882-6443 | Fax 818-882-5054 |
Device Information:
| Trade Name: | Easy Trans Tip |
|---|---|
| Common Name: | Intrauterine Pressure Transducer Catheter (IUPC) |
| Classification Name: | Intrauterine pressure Transducer |
Equivalent Device(s): 3
| Scientific Device Manufacturer, “Tip Trans” | 510(k) # K 961290 |
|---|---|
| Utah Medical, “IntransPlus IUP-400” | 510(k) #K 905563/A and |
| K 955443 | |
| Graphic Control, “Softrans 4000 IUPC” | 510(k) #K 964279 |
Classification:
It has been 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 the marketing introduction. This disposable device is a catheter with a pressure transducer located at the distal tip to monitor the intrauterine pressure. The sensor/transducer is a thick film/ceramic strain gage connected via 4 leads to a connector in proximal end. This end connector interfaces with a reusable cable designed for the proper connection to the monitor in use. The IUPC has a separate fluid infusion and
1
Carl Schuh 10915 Lurline Avenue Chatsworth CA 91311 510(k) submittal REF K982565 IUPC
Addendum C:
Page 2
sampling lumen with three holes near the distal end that terminates at the proximal end with a luer fitting/cap.
Incorporated in the connector housing at the proximal end is a switch for electronic zeroing of the transducer. This switch can also be used for periodic rezeroing of the system during use without the need for removal and replacement of the catheter.
The distal end of the catheter holding the sensor is rounded and blunt while the catheter is soft, flexible polyurethane. This design minimizes the possibility of perforating the uterus while at the same time providing maximum comfort to the patient.
The introducer, is designed to ease the insertion of the flexible catheter and is of a split sheath design for easy removal from the catheter after insertion. A Velcro attachment devise is supplied to attach the catheter firmly in place on the patients thigh to prevent inadvertent slippage or dislodgment during use.
Intended Use:
The intrauterine pressure catheter is for use on patients requiring intrapartum intrauterine monitoring, amniofusion and amniotic fluid sampling.
Comparison to Predicate Device:
This catheter is substantially equivalent to numerous currently marketed IUP devices with regard to:
- a) intended use, b) materials, c) dimensions, d) mechanical properties. Predicated devices include those made by Scientific Device Manufacturer (SDM), Utah Medical, Hewlett Packard, Graphic Control. No significant changes or modifications are being made from those predicate devices. Therefore, this device is substantially equivalent in safety and effectiveness to these devices and should be allowed to market this device.
Signed:
Carl Schuh
Owner
Position:
July 17, 1998
Date:
2
Image /page/2/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
SEP 2 2 1998
Mr. Carl Shuh 10915 Lurline Avenue Chatsworth, CA 91311-1638 Re: K982565 Easy Trans Tip (IUPC) Dated: August 31, 1998 Received: September 4, 1998 Regulatory Class: II 21 CFR 884.2700/Procode: 85 KXO
Dear Mr. Shuh:
We have reviewed your Section 510(k) notification of intent to market the clevice referenced above and we have determined 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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, 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 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 requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product 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 entitled, "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/cdrb/dsmaldsmamain.html".
Sincerely yours
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive
Director, Division of Reproductive, Abdominal, Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health .
Enclosure
3
Page __ of
510(k) Number (if known):K982565 Device Name: Indications For Use:
This intrauterine pressure monitoring catheter (IUPC) is for use on patients requiring intrapartum intrauterine pressure monitoring. Additionally it may be used for amniofusion and of Amniotic fluid sampling
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ ﮐﮯ ﻟﯿﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﻣﻄﺎﺑﻘﺖ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺷﮩﺮ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺷﮩﺮ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺷﮩﺮ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺷﮩﺮ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺷﮩﺮ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺷﮩﺮ ﺍﯾﮏ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Elamil A. Segger
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number K982565