(87 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The intended use of the subject device (monitoring uterine contractions, intrauterine temperature, amnioinfusion, amniotic fluid sampling) must be substantially equivalent to the predicate device. | The intended use and application of the subject Softrans Temp™ is substantially equivalent to the predicate Softrans Temp™. |
| Technological Characteristics Equivalence: The physical and technical characteristics (e.g., pressure transducer at tip, thermistor, amnioinfusion port, introducer, reusable cable with rezero/cable check/temperature display) must be substantially equivalent to the predicate device. | The physical and technical comparison confirms substantial equivalence. |
| Biocompatibility: The device materials must be biocompatible (non-irritating, non-cytotoxic, non-sensitizing). | Biocompatibility testing data was submitted with the predicate device notification and found the device to be non-irritating, non-cytotoxic, and non-sensitizing. (This data refers to the predicate, assumed to apply to the current device as it's the same design for these aspects). |
| Sterility & Shelf Life: The single-use catheter must be sterile with a visible expiration date. The reusable cable is non-sterile. | Catheter will be sold as a sterile unit with an expiration date on labeling. Reusable cable is non-sterile. (Assumed to meet established standards). |
| New Labeling Claim Validation (Temperature Equivalence): The intrauterine temperature measured by the device must be clinically equivalent to oral temperature, allowing its use in place of oral temperature measurements in laboring patients. | The document states: "the intended use of the subject Softrans Temp™ now includes the addition of a claim in labeling stating that the 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." However, the actual study proving this clinical equivalence is not detailed in this summary. It only states that the claim is now included. It implies a study was done to support this, but the details are absent. |
| Meets or Exceeds Manufacturer's Specifications: The product must meet or exceed internal specifications. | Ludlow Technical Products has established its own specifications and the product meets or exceeds those specifications. (General statement, no specific metrics provided). |
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 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).