(90 days)
This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.
An intrauterine pressure catheter with a pressure-sensing membrane cavity at the tip (either inside the catheter or mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. This product is a sterile, single patient use catheter. The system includes a reusable cable with a reusable pressure transducer.
The provided 510(k) summary for the Koala Intrauterine Pressure Catheter focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria through a specific performance study against defined metrics. Therefore, the information requested for a detailed acceptance criteria study is largely not present in the provided text.
However, based on what is available, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensor Accuracy | Verified in laboratory testing. (Specific numerical criteria or margin of error are not provided.) |
| Mechanical Integrity | Verified in laboratory testing. (Specific criteria are not provided.) |
| Overall Performance | Verified in laboratory testing. (Specific criteria are not provided.) |
| Biocompatibility | Materials used are safe for this application, as shown by biocompatibility testing. (Specific tests or metrics are not provided.) |
| Intended Use Equivalence | Same as predicate devices: intrauterine pressure measurement and monitoring, and amniotic fluid access. (Not a performance metric, but a claim of functional equivalence.) |
| Technological Equivalence | Same basic technological characteristics as predicate devices (e.g., pressure sensor at catheter tip, soft tip, markings, low-cost disposable, port for access, external zeroing). (Not a performance metric, but a claim of design equivalence.) |
Disclaimer: The document states that effectiveness is "the same as the predicate devices." This implies that the performance of the Koala IPC is expected to meet the established performance levels of the legally marketed predicate devices, but these specific levels are not quantified in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "clinical testing" but does not provide details on the number of patients or samples.
- Data Provenance: Not specified, but "clinical testing" generally implies prospective data collected from patients. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Not specified. The document only generically mentions "clinical testing."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study is not indicated or described in the provided text. This device is a measurement catheter, not an imaging interpretation or diagnostic aid system that typically involves human readers. The clinical testing mentioned would likely involve comparing pressure readings against a reference standard or assessing clinical outcomes, rather than human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- Yes, in a sense. The document states "The laboratory testing verified the performance in terms of sensor accuracy, mechanical integrity, and overall performance." This "laboratory testing" would represent a standalone evaluation of the device's technical specifications and function without direct human interpretation in the loop (beyond operating the equipment). However, it's not an "algorithm" in the typical sense of AI/software.
7. The Type of Ground Truth Used
- The ground truth for sensor accuracy would typically be established against a highly accurate reference pressure measurement system in a laboratory setting.
- For mechanical integrity, ground truth would be against engineering specifications and failure criteria.
- For the "clinical testing" mentioned, the ground truth would likely be physiologic pressure measurements and/or clinical outcomes. Specific details are not provided.
8. The Sample Size for the Training Set
- Not applicable. This device is a medical catheter with a pressure sensor; it is not described as having an AI algorithm that requires a "training set" in the machine learning sense. The "training set" concept is therefore irrelevant to the reported evaluations.
9. How The Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this device.
§ 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).