(86 days)
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.
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.
The provided text describes a 510(k) Summary for a medical device called the Softrans™ Intrauterine Pressure Catheter System (IUP 4000 Softrans™ IUPC). This is a premarket notification for a Class II medical device, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specified acceptance criteria for novel performance metrics.
Based on the provided information, I can answer some of your questions and explain why others cannot be answered:
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "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."
Therefore, specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy, etc.) and their corresponding reported performance values are not provided in this document. The "performance summary" refers to the device meeting its internal specifications, which are not detailed here.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document | Not specified in this document |
| (Internal specifications met) | (Product meets or exceeds Graphic Controls' internal specifications) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes a "Performance Summary" and "Biocompatibility Testing," but these are general statements and do not detail the methodology, sample sizes, or provenance of any testing data beyond the biocompatibility section which refers to data submitted with the predicate device notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The device is an intrauterine pressure catheter, which measures physical parameters (uterine contraction intensity, duration, frequency). Its "ground truth" would be direct physical measurements by the device itself or comparison to other established measurement methods, not typically expert consensus on image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reviewing images), which is not the primary focus for validating this type of medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided and is not applicable to this device. This document is for a physical medical device (an intrauterine pressure catheter), not an AI-powered diagnostic or interpretive tool that would involve "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as this is not an algorithm-only device. It's a physical medical device for measuring physiological parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since the device measures physical parameters (uterine contractions), the "ground truth" would inherently be the physical measurement itself or comparison against a known, validated standard for pressure measurement. The document does not specify the exact type of ground truth used for any performance testing, other than stating internal specifications were met.
8. The sample size for the training set
This information is not provided. As this is a physical medical device and not an AI/machine learning system, the concept of a "training set" in the context of data for model development does not apply. If "training set" refers to samples used during the device's design verification, that detail is not included.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons stated in point 8.
Summary of Device and Performance Information Provided:
The Softrans™ Intrauterine Pressure Catheter System is intended for measuring uterine contractions during labor and for amnioinfusion/fluid sampling. Its performance summary states that "Graphic Controls has established its own specifications and the product meets or exceeds those specifications."
The document primarily focuses on demonstrating substantial equivalence to a predicate device (also named Softrans™ Intrauterine Pressure Catheter System) based on:
- Physical and technical characteristics: Stated as "comparable," including materials and size.
- Intended Use: Identical to the predicate.
- Biocompatibility: Testing was done, and data from the predicate device notification was submitted. The device was found to be non-irritating, non-cytotoxic, and non-sensitizing.
- Sterility: Sold as a sterile unit (except for the reusable cable).
This 510(k) summary is designed to show the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed clinical trials with acceptance criteria for novel performance claims.
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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.
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K96 42 29 12012
| Description | An intrauterine catheter with a pressure transducer at thetip, a port for amnioinfusion and amniotic fluid samplingsignal wires, and an introducer which is removed afterplacement. System includes a reusable cable with a zeromechanism and an attachment strap. |
|---|---|
| Catheters are packaged within a PETG tray with a heatsealed tyvek lid. Unit of sale is a case of 10 IUPC's. | |
| Intended Use | Intended for use in measuring the intensity, duration, andfrequency of uterine contractions during labor. Also, thecatheter may be used for amnioinfusion of fluid into theuterus or to sample amniotic fluid. |
| Physical/TechnicalComparison | Softrans™ is equivalent to the predicate device. Physicaland technical characteristics, including materials used inconstruction, size and intended used of the predicatedevice are comparable. |
| PerformanceSummary | FDA has not established special controls or performancestandards for this device. Graphic Controls hasestablished its own specifications and the product meetsor exceeds those specifications. |
| BiocompatibilityTesting | This device was subjected to biocompatibility testing andthe data was submitted with the predicate devicenotification. 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 thereusable cable. The expiration date is visible on thelabeling for each catheter. |
§ 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).