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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.

• 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.

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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

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.

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This accessory is used with a Koala Intrauterine Pressure System and is used in priming the catheter.

The pre-filled Syringe is 10 cc syringe filled with 0.9% isotonic saline and is an accessory to the Koala Intrauterine Pressure System used in priming the catheter. This product is a sterile, single-use device.

This submission is for a medical device (pre-filled syringe) and does not involve AI/ML. Acceptance criteria and study details as requested for AI/ML devices are not applicable.

Here's a summary of the information provided in the document:

Device: Pre-filled Syringe for Koala Intrauterine Pressure Catheter

Intended Use: To prime the catheter in an intrauterine pressure monitoring system.

Predicate Devices: Pre-filled syringes used with the Medex MX 4042 Series Intrauterine Pressure Catheter and the Quest (formerly Healthdyne Cardiovascular) ISOFLO Intrauterine Pressure Monitoring & Amnio.

Basis for Substantial Equivalence:

• Same intended uses: Priming catheters in intrauterine pressure monitoring.
• Same basic technological characteristics: A syringe pre-filled with saline.
• Same or similar materials: All materials are biocompatible and function well in the intended application.

Safety and Effectiveness Documentation:

• Safety and effectiveness are similar to existing devices as demonstrated in the laboratory.
• Biocompatibility testing shows that the materials used in the pre-filled syringe are safe for this application.
• Effectiveness is stated to be the same as the predicate devices.

Regulatory Classification: Class II, 21 CFR §884.2700, Product code: 85 HFN.

Note: The document is a 510(k) summary for a relatively simple medical device (a pre-filled syringe). It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and materials, rather than detailed performance metrics or clinical study data typically associated with more complex or AI-driven devices. Therefore, many of the specific questions regarding acceptance criteria and studies (e.g., sample size for test/training sets, expert consensus, MRMC studies, standalone performance for AI) are not applicable to this type of submission.

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a sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in "high risk" births.

The UMP Intran 500 is the same device as Intran 400, Intran Plus, a sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in "high risk" births. Intran-500 adds a molded clear plastic cylinder component which is attached to the catheter's amnio port, along with a plastic clip containing a color reference scale that fits over the plastic cylinder. The cylinder acts as a section in the liquid line that can be used by physicians for visualization of the color of a fluid sample drawn from the amniotic sac.

The provided K961424 document, dated July 10, 1996, is a SMDA 510(k) Summary for a medical device. This type of document is a pre-market notification to the FDA, demonstrating that the device is substantially equivalent to a legally marketed predicate device.

It's crucial to understand that this document does not describe a study involving algorithms, AI, or advanced statistical analysis as typically seen in modern device submissions for AI/ML-enabled devices. Instead, it's concerned with showing substantial equivalence to a previously cleared device for a relatively simple medical instrument. Therefore, many of the requested categories related to acceptance criteria, AI performance, and AI-specific study details are not applicable to this 1996 submission.

Here's an attempt to address the requested information based on the content of the document, highlighting where information is not present or not relevant to this type of submission:

1. A table of acceptance criteria and the reported device performance

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

• Not Applicable. This submission is for substantial equivalence of a physical medical device, not an AI/ML algorithm or a complex diagnostic test requiring a "test set" in the computational sense. The "safety" claim uses retrospective market data on the predicate device.
• Data Provenance: The safety claim refers to "over 1.4 million uses" of the predicate device since 1991, presumably in the U.S. market since it mentions "physicians in the U.S."

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)

• Not Applicable. No ground truth needed for a "test set" in this context. The "safety" claim relies on the absence of product liability lawsuits during the real-world use of the predicate device, which isn't a "ground truth" establishment in the typical sense.

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

• Not Applicable. No "test set" or adjudication method described for this type of device submission.

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

• No. This device is a passive monitoring catheter; it does not involve "readers" or "AI assistance."

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

• No. There is no algorithm or AI component to this device.

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

• The primary "evidence" for substantial equivalence and safety relies on:
  • Functional comparison to a predicate device itself (no "ground truth" beyond design specifications).
  • Material comparison to a predicate device.
  • Real-world outcomes data (absence of product liability lawsuits) for the predicate device, which serves as a proxy for safety validation rather than a formally established "ground truth" in clinical trials.

8. The sample size for the training set

• Not Applicable. No training set for an AI/ML algorithm.

9. How the ground truth for the training set was established

• Not Applicable. No training set for an AI/ML algorithm.

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This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.

STORC™ is a Disposable Intrauterine Pressure Monitoring System. This product is a sterile, single patient use catheter.

This document, K954952, describes a 510(k) premarket notification for a medical device called the STORC Intrauterine Pressure Catheter. The submission aims to demonstrate substantial equivalence to predicate devices already on the market.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a quantitative table of acceptance criteria with specific thresholds (e.g., "accuracy > 95%"). Instead, it
qualitatively describes areas where the STORC catheter's performance was compared to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "clinical studies" and "clinical trials" but does not specify the sample size for the test set (number of patients or cases).

The provenance of the data is limited to "clinical studies" and "laboratory testing." It does not specify the country of origin of the data or explicitly state whether the clinical data was retrospective or prospective. Given the context of a 510(k) for a new device, it is most likely that the clinical studies were prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document mentions "physician evaluation" as part of the safety verification in clinical studies. However, it does not specify the number of experts used to establish ground truth for the clinical effectiveness assessments, nor does it detail their specific qualifications (e.g., "obstetrician with X years of experience").

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the assessment of the clinical studies. The mention of "physician evaluation" suggests subjective assessment, but the process for resolving discrepancies or reaching consensus is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focuses on comparing the device's performance to predicate devices, but there's no indication of a structured MRMC design to measure human reader improvement with or without AI assistance, as AI is not a component of this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable as the STORC Intrauterine Pressure Catheter is a physical medical device, not an AI algorithm. Therefore, there is no "algorithm-only" performance to assess.

7. The Type of Ground Truth Used:

For safety, the ground truth appears to be based on:

• Bench testing results (e.g., direct measurement of perforation likelihood on fresh placenta).
• Clinical physician evaluation (qualitative assessment of safety in a real-world setting).
• Biocompatibility test results from an independent lab.

For effectiveness, the ground truth appears to be based on:

• Clinical trial results and physician evaluation: Assessing attributes like signal integrity, ease of use, access, retention, and signal stability, likely through direct observation, patient outcomes, and user feedback.
• Laboratory testing: Verifying sensor accuracy and overall performance against established standards for pressure measurement.

8. The Sample Size for the Training Set:

This question is not applicable as the STORC Intrauterine Pressure Catheter is a physical medical device. It does not use machine learning or AI, and therefore, there is no "training set" in the context of data used to train an algorithm.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as point 8.

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