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The Softrans Temp™ IUPC System may be used during the interpartum period to monitor intrauterine pressure, to monitor intrauterine temperature, to amnioinfuse or to perform amniotic fluid sampling.

An intrauterine catheter with a pressure transducer at the tip, a thermistor located near 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 that contains a rezero mechanism, cable check and temperature display unit. An attachment strap is provided.

Catheters are packaged within a PETG tray with a heat sealed tyvek lid. Unit of sale is a case of 10 IUPC's.

Cables are packaged in protective wrap and corrugated shippers.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Softrans Temp™ Intrauterine Pressure Catheter System:

It's important to note right away that the provided 510(k) summary (K991235) is for a predicate device where the main change is the addition of a specific claim in labeling: "intrauterine temperature measured by the device is clinically equivalent to oral temperature and that intrauterine temperature can be used in place of oral temperature measurements in laboring patients."

The document heavily relies on the substantial equivalence to a previously marketed predicate device also named Softrans Temp™ Intrauterine Pressure Catheter System. This means that many of the original performance studies and acceptance criteria from the initial approval of the predicate device are not explicitly detailed in this specific 510(k) summary. The current submission is primarily about demonstrating that the new device (with the added temperature claim) is still substantially equivalent to the existing predicate.

Therefore, some of the requested information (like specific sample sizes, expert qualifications for the original device tests, etc.) is not present in this document because it defaults to the established equivalence of the predicate. The focus here is on the new claim about temperature equivalence.

Acceptance Criteria and Device Performance for K991235

The acceptance criteria for K991235 primarily revolve around the substantial equivalence to the predicate device and the validation of the new labeling claim regarding intrauterine temperature equivalence to oral temperature.

Study Details (based on available information):

Due to the nature of this 510(k) being a claim of substantial equivalence to a predicate device, the detailed study information for many aspects is not provided, as it would have been part of the original predicate device submission. The primary new aspect is the temperature equivalence claim.

1. Sample size used for the test set and the data provenance:

   • Not specified in this document. For the new temperature equivalence claim, a clinical study would have been required to compare intrauterine temperature readings to oral temperature readings. The number of patients, their demographics, country of origin, and whether it was retrospective or prospective data are not mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. For the temperature equivalence claim, the "ground truth" would likely be established through standard clinical thermometry (e.g., oral temperature taken with a validated thermometer) and, potentially, expert clinical assessment of patient condition. The number and qualifications of clinicians involved in such a study are not provided.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. For a temperature measurement equivalence study, adjudication methods like those used for image interpretation (2+1, etc.) are generally not relevant. The comparison would be between numerical measurements.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. An MRMC study is typically for evaluating diagnostic imaging devices where human readers interpret cases with and without AI assistance. This device is a direct physiological measurement device, not an imaging interpretation tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. The device itself is standalone in terms of generating the pressure and temperature measurements. The "performance" in this context is the accuracy and equivalence of these measurements. For the temperature claim, the device's measured intrauterine temperature would have been compared directly to an established reference (e.g., oral temperature). The document states the device provides "continuous monitoring and display" of temperature, implying autonomous measurement.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the temperature equivalence claim, the most likely ground truth would be clinical measurements from a recognized standard of care (e.g., oral temperature using a calibrated thermometer), and/or potentially comparison to core body temperature (though oral is specified in their claim).
   • For the pressure monitoring capabilities, the ground truth would be based on direct physiological measurement principles and validation against established pressure measurement standards.

7. The sample size for the training set:

   • Not applicable/Not specified. This device is hardware-based (catheter with transducers) and likely uses direct physical principles for measurement, rather than a machine learning algorithm that requires a "training set" in the conventional sense. If there were any internal calibrations or algorithms for temperature conversion, those details are not provided.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified. As above, a training set is not typically associated with this type of device. The ground truth for functional performance (pressure, temperature accuracy) would be established through engineering validation and, for the clinical equivalence claim, through direct comparative clinical studies against established methods.

Summary of Limitations in Information:

This 510(k) summary is very high-level regarding performance data, as is common for submissions based on substantial equivalence. It confirms that internal specifications are met and biocompatibility was previously established for the predicate. However, it does not provide detailed clinical study data (e.g., sample size, methodology, results) to support the specific new claim that "intrauterine temperature measurements correspond to oral temperature measurements and can be used in place of oral temperature measurements in laboring patients." This information would have been part of supporting documentation provided to the FDA but is not included in the public summary.

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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

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. 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.

The provided 510(k) submission for the "Easy Trans Tip" Intrauterine Pressure Transducer Catheter (IUPC) does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The document is a summary of safety and effectiveness, focused on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data from a specific study.

Therefore, I cannot populate the requested tables and sections. The submission primarily addresses:

1. Device Information: Trade name, common name, classification, and product description.
2. Equivalent Devices: Lists predicate devices with 510(k) numbers.
3. Intended Use: Specifies the medical applications of the device.
4. Comparison to Predicate Devices: Asserts substantial equivalence based on intended use, materials, dimensions, and mechanical properties.

To answer your request, the following information is not present in the provided text:

• Acceptance Criteria Table: No specific performance thresholds are mentioned.
• Reported Device Performance: No test results or performance metrics are provided.
• Sample Size for Test Set: No testing of the device performance is described.
• Data Provenance: Not applicable as no test data is presented.
• Number of Experts/Qualifications for Ground Truth: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No such study is mentioned or referenced.
• Standalone Performance Study: No specific performance study (beyond the claim of substantial equivalence) is documented.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set & How Ground Truth Established for Training Set: Not applicable, as this is related to studies validating specific performance metrics which are not present in this submission.

This 510(k) is a substantial equivalence submission, which means the manufacturer is asserting that their device is as safe and effective as existing legally marketed devices, primarily based on design and intended use similarities, rather than presenting a performance study with detailed acceptance criteria and results.

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The Softrans® Temp UPC & System may be used during the intrapartum period to monitor intrauterine pressure, to monitor intrauterine temperature, to amnioinfuse or to perform amniotic fluid sampling.

An intrauterine catheter with a pressure transducer at the tip, a thermistor located near 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 that contains a rezero mechanism, cable check and temperature display unit. An attachment strap is provided.

This 510(k) summary describes a medical device, the Softrans® Plus Intrauterine Pressure Catheter System (IUP 5000 Softrans® Plus IUPC), which is intended to monitor intrauterine pressure and temperature during labor, and to facilitate amnioinfusion or amniotic fluid sampling.

Here's an analysis of the provided information, structured according to your request:

Acceptance Criteria and Reported Device Performance

The provided document 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."

This indicates that external, regulatory acceptance criteria were not predefined by the FDA for this specific device at the time of submission. Instead, the manufacturer, Graphic Controls, developed its own internal specifications. The document does not explicitly list these internal specifications. Therefore, a table of acceptance criteria and reported performance cannot be fully constructed from the provided text.

However, based on the description of the device's functionality and the comparison to predicate devices, the implied performance criteria would be:

Study Details

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed performance statistics.

Here's how the other requested study information applies:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The 510(k) summary does not mention any specific clinical study sample sizes or patient data related to the performance of the device's pressure or temperature measurement functions. The primary "test set" for this submission appears to be comparisons of the device's design, technology, and functionality to predicate devices and established standards, rather than direct patient outcome data from a large cohort.
   • For biocompatibility, it states: "Biocompatibility This device was subjected to biocompatibility testing and the data was submitted with the predicate device notification." This implies a previous study with the predicate, but details are not provided here.

2. 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):

   • Not applicable in the context of this 510(k) summary, as it does not describe a clinical study requiring expert ground truth establishment for a test set. Substantial equivalence relies on comparing the new device's technical characteristics and intended use to a predicate.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as no clinical study with expert adjudication is described in the provided document.

4. 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:

   • Not applicable. This device is a medical monitoring instrument (catheter system), not an AI-assisted diagnostic tool involving human readers/interpreters.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent in its measurement capabilities, which would be validated through engineering tests and comparison to predicate devices, not algorithm-only performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the biocompatibility aspect, the ground truth was derived from specific biocompatibility tests (e.g., irritation, cytotoxicity, sensitization) following established standards.
   • For the functional performance of pressure and temperature measurement, the ground truth would typically be established by calibrated reference instruments or established measurement standards, against which the device's readings are compared. The document implies these internal tests were conducted as it states "the product meets or exceeds those specifications," but it doesn't detail them.
   • For substantial equivalence, the "ground truth" is the performance and safety profile of the legally marketed predicate device (Softrans® IUPC System and Welch Allyn (DIATEK) SureTemp Thermometer).

7. The sample size for the training set:

   • Not applicable within this 510(k) summary, as it describes a hardware medical device and not a machine learning model that would require a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set mentioned or implied for this device's submission.

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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.

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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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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