(58 days)
Koala Intrauterine Pressure Catheter is indicated for use on patients requiring intrapartum intrauterine pressure monitoring.
The Koala Intrauterine Pressure Catheter is a disposable, sterile, single patient use intrauterine pressure monitoring catheter, designed for measurement of intrauterine contraction pressures. The catheter is designed with a pressure-sensing membrane cavity at the tip (mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. The Koala Intrauterine Pressure Catheters utilizes a reusable cable with a reusable pressure transducer which is connected at the other end of the device. The sensor, located on the tip of the catheter is a 360° sensor that registers pressure in all directions. The tip is made of soft, malleable urethane. There are no electronics in the catheter. Clinicians can disconnect the catheter while it is in the uterus and zero the monitor while the transducer is exposed to atmospheric pressure, providing a true zero reading. The Koala Intrauterine Pressure Catheter has two different, clear lumens, one for the amnioinfusion, to confirm proper placement via amniotic fluid flashback, and another channel for sensor-charging. The amnioinfusion port has a hydrophobic and a tethered replacement cap.
The FDA Clearance Letter for the Koala Intrauterine Pressure Catheter (IPC-5000E) indicates that the device has met the requirements for substantial equivalence to a predicate device. However, the provided document does not contain information about clinical studies with specific acceptance criteria, sample sizes for test/training sets, or expert involvement for ground truth adjudication, particularly in the context of AI/ML performance. This is because the device is a physical medical device (catheter) for measuring intrauterine pressure, not an AI/ML-driven software device.
Therefore, many of the requested points related to AI/ML performance evaluation (e.g., sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance) are not applicable to this specific device as described in the provided clearance letter.
The document focuses on demonstrating substantial equivalence through:
- Comparison of intended use and technological characteristics with a predicate device.
- Non-clinical performance tests, including biocompatibility, sterility, shelf-life, and functional testing.
Below is a table summarizing the functional acceptance criteria that were met by the device during non-clinical testing, as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
While the document doesn't explicitly list a "table of acceptance criteria" with numerical values alongside "reported device performance" in the typical AI/ML sense (e.g., sensitivity/specificity targets), it states that "All device samples met their acceptance criteria" for various functional tests. These functional tests are the "performance" demonstrated.
| Acceptance Criteria Category | Specific Test | Reported Device Performance (as stated in document) |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Non-cytotoxic |
| Sensitization (ISO 10993-10) | Non-sensitizing | |
| Irritation/Intracutaneous Reactivity (ISO 10993-23) | Non-irritating | |
| Acute Systemic Toxicity (ISO 10993-11) | Not systemically toxic | |
| Material Mediated Pyrogenicity (ISO 10993-11, USP) | Non-pyrogenic | |
| Sterility & Shelf-life | Gamma Radiation Sterilization & Validation (ISO 11737-1, ISO 11737-2, ANSI AAMI ST67, FDA Guidance) | Achieved sterility. All samples met acceptance criteria. |
| Simulated Transportation & Package Integrity (ASTM D4169-22 DC-13) | Maintained package integrity. All samples met acceptance criteria. | |
| Accelerated Aging (ASTM F1980:21) including: |
- Package Integrity (ASTM F1929-15, ASTM F88/F88M-21, ASTM F1886/F1886M-16) | Maintained package integrity and functional performance for proposed 6-month shelf-life. All samples met acceptance criteria. |
| Functional Testing | Simulated Use (Balloon Pressure, Tip Pull-off force, Monofilament removal) | Functions as intended. All samples met acceptance criteria. |
| | Pressure Accuracy | Functions as intended. All samples met acceptance criteria. |
| | Leak Rate/Membrane Integrity | Functions as intended. All samples met acceptance criteria. |
| | T-connector Bond Strength | Functions as intended. All samples met acceptance criteria. |
| | Tip Bond Strength | Functions as intended. All samples met acceptance criteria. |
| | Catheter Flexibility | Functions as intended. All samples met acceptance criteria. |
| | Introducer Peel-force | Functions as intended. All samples met acceptance criteria. |
| Performance Specifications | Operation Pressure Range | -50 to +150mmHg (Same as predicate) |
| (with reusable cable) | Over-pressure Protection | -400 to +1200 mmHg (Same as predicate) |
| | Operating Temperature | 15º C to 40º C (Same as predicate) |
| | Amnio Lumen Flow | Min. 20 cc/min at a pressure of 65 mmHg (Same as predicate) |
Note: The phrase "All device samples met their acceptance criteria" is used consistently, indicating successful performance against predetermined thresholds, even if numerical specifics for each functional test aren't detailed in this summary.
2. Sample size used for the test set and the data provenance:
- The document mentions "All device samples" for functional and shelf-life testing without specifying exact numerical sample sizes per test. These were non-clinical bench and material tests, not human patient data or a clinical test set in the AI/ML context.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests conducted are laboratory-based, demonstrating physical and material properties of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this medical device (a catheter) is established through engineering specifications, material science, and established international standards (e.g., ISO, ASTM). It does not involve expert readers adjudicating clinical "ground truth" to evaluate an algorithm's performance on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This applies to expert review of clinical cases, which was not part of this device's non-clinical testing.
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:
- Not applicable. This device is a physical medical instrument, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm; it is a physical catheter designed for direct measurement.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on engineering specifications, material properties, and adherence to established international and national standards (e.g., ISO 10993 for biocompatibility, ISO 11737 for sterility, ASTM standards for package integrity and material testing). It's a "known" physical and chemical standard, not derived from expert consensus or patient outcomes data in a diagnostic sense.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires a training set. The device's design is based on engineering principles and previous iterations (as indicated by the predicate device K974389).
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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).