(86 days)
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No
The summary describes a physical catheter and associated hardware for measuring uterine contractions and performing amnioinfusion/sampling. There is no mention of software analysis, algorithms, or any terms related to AI/ML. The performance study section also focuses on meeting established specifications rather than evaluating algorithmic performance.
No.
The device is used for measuring uterine contractions and for amnioinfusion or fluid sampling, which are diagnostic and procedural functions rather than therapeutic.
Yes
Explanation: The device is used to "measuring the intensity, duration, and frequency of uterine contractions during labor," which provides information about the patient's physiological state to help guide medical decisions.
No
The device description explicitly details hardware components such as a catheter, pressure transducer, cable, and introducer, 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 to measure uterine contractions, perform amnioinfusion, and sample amniotic fluid within the uterus. This is a direct interaction with the patient's body and physiological processes.
- Device Description: The device is an intrauterine catheter with a pressure transducer, ports, and associated components for insertion into the uterus.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device operates inside the body.
The device described is a medical device used for monitoring and intervention during labor, not for diagnostic testing of biological samples in a lab setting.
N/A
Intended Use / Indications for Use
Intended for use in measuring the intensity, duration, and frequency of uterine contractions during labor. Also, the catheter may be used for amnioinfusion of fluid into the uterus or to sample amniotic fluid.
Product codes
KXO
Device Description
An intrauterine catheter with a pressure transducer at the tip, a port for amnioinfusion and amniotic fluid sampling signal wires, and an introducer which is removed after placement. System includes a reusable cable with a zero mechanism and an attachment strap.
Catheters are packaged within a PETG tray with a heat sealed tyvek lid. Unit of sale is a case of 10 IUPC's.
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
Uterus
Indicated Patient Age Range
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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)
FDA has not established special controls or performance standards for this device. Graphic Controls has established its own specifications and the product meets or exceeds those specifications.
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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Graphic Controls Corporation
189 Van Rensselager Sireet PO Box 1274 Buffalo, New York 14240-1274 USA 716 853-7500
Customer Relations: 300 669-1009 Fax: 800-347-2421
JAN 22 1997
P192 K964279
510(k) Summary
Graphic Controls
Graphic Controls Corporation Manufacturer 189 Van Rensselaer Street P.O. Box 1271 Buffalo, NY 14240 Registration Number 1317188 Manufacturing Location Graphic Controls Corporation 1 Carnegie Plaza Cherry Hill, NJ 08003 Registration Number 2243963 Contract Sterilizer Isomedix 9 Apollo Drive Whippany, NJ 07981 Registration Number 2245604 (716) 853-7500 Telephone Contact Person Kathleen H. Selover Regulatory Affairs Specialist (716) 853-7500, extension 7630 FAX Number (716) 847-7531 Device Trade Name Softrans™ Intrauterine Pressure Catheter System (IUP 4000 Softrans™ IUPC Common Name Intrauterine Pressure Catheter Classification Name Catheter, Intrauterine and Introducer Regulatory Reference 82 KXO Predicate Device Softrans™ Intrauterine Pressure Catheter System
Image /page/0/Picture/8 description: The image shows a logo that consists of a white letter 'S' inside of a black circle. The 'S' is stylized with a curved, flowing design. The letters 'TM' are located in the bottom right corner of the circle, indicating that the logo is a trademarked symbol.
1
K96 42 29 12012
| Description | An intrauterine catheter with a pressure transducer at the
tip, a port for amnioinfusion and amniotic fluid sampling
signal wires, and an introducer which is removed after
placement. System includes a reusable cable with a zero
mechanism and an attachment strap. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Catheters are packaged within a PETG tray with a heat
sealed tyvek lid. Unit of sale is a case of 10 IUPC's. |
| Intended Use | Intended for use in measuring the intensity, duration, and
frequency of uterine contractions during labor. Also, the
catheter may be used for amnioinfusion of fluid into the
uterus or to sample amniotic fluid. |
| Physical/Technical
Comparison | Softrans™ is equivalent to the predicate device. Physical
and technical characteristics, including materials used in
construction, size and intended used of the predicate
device are comparable. |
| Performance
Summary | FDA has not established special controls or performance
standards for this device. Graphic Controls has
established its own specifications and the product meets
or exceeds those specifications. |
| Biocompatibility
Testing | This device was subjected to biocompatibility testing and
the data was submitted with the predicate device
notification. The device was found to be non-irritating,
non-cytotoxin and non-sensitizing. |
| Sterility and Shelf Life | Softrans™ will be sold as a sterile unit except for the
reusable cable. The expiration date is visible on the
labeling for each catheter. |