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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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Avalon Fetal/Maternal Monitor FM20:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM30:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM40:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

Avalon Fetal/Maternal Monitor FM50:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

The legally marketed Philips Avalon fetal/maternal monitors FM20. FM30. FM40. and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal electrocardiography (ECG) wave, maternal noninvasive blood pressure (NIBP), oxygen saturation (SpO2) with pulse rate and temperature, during antepartum testing and labor and delivery.

The Avalon Fetal/Maternal Monitor FM20 provides the following external measurement parameters:

• Up to three Fetal Heart Rates (FHR) via Ultrasound (US) -
• Fetal Movement Profile -
• Uterine activity via external Toco -
• -Maternal nulse rate
• -Maternal Heart Rate via maternal ECG
• Noninvasive blood pressure (NBP) -
• Maternal temperature -
• Pulse oximetry (maternal SpO2) -

The Avalon Fetal/Maternal Monitor FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters:

• One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
• -Uterine activity via intrauterine pressure (IUP)
• -Maternal ECG (MECG) wave

*) Note: maximum three fetal heart rates can be monitored.

The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters:

• Up to three Fetal Heart Rates (FHR) via Ultrasound (US) -
• Fetal Movement Profile -
• Uterine activity via external Toco -
• -Maternal Pulse Rate
• Maternal Heart Rate via maternal ECG -
• -Noninvasive blood pressure (NBP)
• -Maternal temperature
• -Pulse oximetry (maternal SpO2)

The Avalon Fetal/Maternal Monitor FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters:

• One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
• Uterine activity via intrauterine pressure (IUP) -
• -Maternal ECG (MECG) wave

*) Note: maximum three fetal heart rates can be monitored.

This document describes the Philips Avalon Fetal/Maternal Monitors (FM20, FM30, FM40, and FM50) with software revision J.30.

The document does not explicitly list acceptance criteria in a table format with reported device performance alongside it. Instead, it states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices" and that "The test results are passed and showed substantial equivalence."

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

Based on the provided text, a specific table of acceptance criteria and reported device performance is not explicitly given. The document generally states that the device "passed" tests based on the specifications of predicate devices.

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

The document mentions "Bench testing included the use of previously recorded patient raw signals and traces." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

The document does not provide information regarding the number of experts, their qualifications, or how they established ground truth for any test set.

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

The document does not describe any adjudication method used for a test set.

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 document describes a medical device for monitoring physiological parameters, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

The document describes performance verification and validation. While software testing was performed ("Software verification and validation testing were conducted"), it primarily focuses on the device's functionality and safety in relation to its predicate devices, rather than a standalone algorithm performance in a diagnostic context. The device is a "monitor" and its modifications are related to interfaces and measuring capabilities. There is no explicit mention of a standalone algorithm-only performance study.

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

The document mentions "previously recorded patient raw signals and traces" were used for bench testing. The quality and origin of these 'raw signals' as ground truth are not further specified beyond being "previously recorded."

8. The sample size for the training set:

The document does not mention a training set as this is not an AI/machine learning device in the typical sense that would require a distinct training set.

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

As no training set is discussed, information on how ground truth was established for it is not applicable and not provided.

Summary of Acceptance Criteria and Study:

The primary "acceptance criteria" appear to be meeting the specifications cleared for the predicate devices, and the "study" involved a series of non-clinical verification and validation activities.

Verification and Validation Activities Included:

• Biocompatibility testing (Cytotoxicity, Irritation, Delayed Type Hypersensitivity, Chemical characterization)
• Testing of new or impacted hazards from risk management analysis
• Software performance and regression verification and validation
• Performance and regression verification testing of wireless functionality
• Verification according to applicable EMC, safety, and performance standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-37, ISO 80601-2-56, ISO 80601-2-61, IEC 62304, AAMI ANSI ISO 10993-1)
• Bench testing using previously recorded patient raw signals and traces.

The conclusion states that these non-clinical tests demonstrated that the modified devices are "as safe, as effective, and perform as well or better as the predicate devices" and "do not introduce new questions concerning the safety or effectiveness." No clinical studies were deemed necessary.

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The Philips Avalon FM20, FM30, FM40 and FM50 Fetal/Maternal Monitors are intended for non-invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery. All monitors are intended for monitoring fetal heart rates, fetal movement profiles, maternal heart rates, uterine activity, maternal noninvasive blood pressure, and additionally for the FM30, FM40 and FM50 maternal oxygen saturation (Sp02). The FM30 and FM50 are additionally intended for maternal ECG and for invasive monitoring of fetal Direct ECG and intrauterine pressure. All monitors are intended for generating alarms from fetal and maternal parameters, for displaying, storing and recording patient data and related waves, transmitting patient data to a patient information and surveillance system on a network, and for postpartum monitoring of the mother. All monitors are intended for use by trained health care professionals. They are intended for use in labor and delivery rooms, antepartum testing areas and during postpartum recovery in the hospital environment. They are not intended for use in intensive care units or operating rooms. The FM20 and FM30 are additionally intended for use in healthcare and for example in doctors' offices, and in private households.

The subject devices Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 are a modification of the legally marketed Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 and offer monitoring of fetal heart rates, fetal movement profiles, fetal Direct ECG, maternal uterine activity, maternal heart rates, maternal pulse rates, maternal ECG, maternal non-invasive blood pressure (NIBP) and maternal oxygen saturation (Sp02) during antepartum testing and labor and delivery. The modification of the Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 only permits specific Sp02 sensors, which are already cleared for the Philips picoSATIIplus SpO2 pulse oximetry module, the Philips Intellivue X2 (M3002A) multi measurement module and the Philips M1020B Sp02 plug-in module, to be also used with the Philips Avalon Fetal monitors FM30, FM40 and FM50.

The Philips Avalon Fetal Monitors (FM20, FM30, FM40, and FM50) are a modification of previously cleared devices, primarily to permit the use of specific SpO2 sensors already cleared for other Philips modules. The submission focuses on demonstrating substantial equivalence to these predicate devices.

Acceptance Criteria and Device Performance:

The document explicitly states that "hazard criteria were based on the Pass/Fail analysis. specifications cleared for the predicate devices and test results showed substantial equivalence." This implies that the acceptance criteria for the modified devices were the same performance specifications as those established for the predicate devices. The study concludes that the "results demonstrate that the Philips Avalon Fetal Monitors meet all reliability requirements and performance claims."

Study Details:

1. Sample Size and Data Provenance (Test Set):

   • The document does not specify the sample size used for the test set.
   • The data provenance (country of origin, retrospective/prospective) is not mentioned.

2. Number of Experts and Qualifications (Ground Truth for Test Set):

   • The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.

3. Adjudication Method (Test Set):

   • The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned. The submission focuses on device performance and substantial equivalence, not human reader improvement with AI assistance.

5. Standalone Performance Study:

   • A standalone performance study was implicitly done, as "Verification and Validation testing activities" were conducted to "establish the performance, functionality, and reliability characteristics of the modified devices." This testing was against predefined specifications, indicating an algorithm-only (device-only) performance assessment.

6. Type of Ground Truth Used:

   • The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The ground truth for the verification and validation appears to be the "specifications cleared for the predicate devices."

7. Sample Size for Training Set:

   • The document does not mention a training set, as the evaluation method described is primarily focused on verification and validation against pre-established specifications for the modified device, rather than training a new algorithm from data.

8. How Ground Truth for Training Set was Established:

   • Not applicable, as no training set is mentioned in the context of this submission. The device is a modification of an existing, cleared device, implying its core algorithms were already established and validated. The current submission focuses on verifying continued performance after a component modification.

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Avalon Fetal Monitor FM20:
Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.

Avalon Fetal Monitor FM30:
Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.

The Philips Avalon Fetal Monitors FM20 and FM30 are intended for noninvasive monitoring of parameters of pregnant women during antepartum testing and labor and delivery. The FM30 is additionally intended for invasive monitoring. All monitors are intended for monitoring fetal and maternal heart rates, uterine activity, maternal noninvasive blood pressure, and additionally for the FM30, oxygen saturation (SpO2). All monitors are intended for generating alarms for displaying, storing and recording patient data and related waves, transmitting patient data to a patient information and surveillance system on a network, and for postpartum monitoring of the mother.

The provided 510(k) summary (K071800) for the Philips Avalon Fetal Monitors FM20 and FM30 does not contain information related to specific acceptance criteria or details of a study proving device performance against such criteria.

This 510(k) is a premarket notification for a modification to an already cleared device: the Philips Avalon Fetal Monitors FM20 and FM30 (cleared under K052795 and K062137). The modification only introduces the capability for healthcare professionals to monitor pregnant women in private households.

Therefore, the submission relies on the substantial equivalence to the previously cleared devices and does not present new performance study data. The document focuses on regulatory classification, intended use, and substantial equivalence, rather than detailed performance metrics.

Based on the provided text, I cannot complete the requested information for the acceptance criteria and the study that proves the device meets them. The pertinent sections of the request that cannot be addressed due to the lack of information in the document are:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample sized used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
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/Available. (The device is not AI-assisted).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Available. (The device does not involve a standalone algorithm for diagnostic performance).
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

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Avalon Fetal Monitor FM30: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

Avalon Fetal Monitor FM20: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

The modified devices Philips Avalon Fetal Monitors FM20 and FM30 are intended for non-invasive and invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery. The Avalon FM20 and FM30 are intended for monitoring fetal and maternal heart rates, uterine activity, maternal non-invasive blood pressure (NIBP) and maternal oxygen saturation (SpO2). The Avalon FM20 and FM30 are intended for generating alarms, for displaying, storing and recording patient data and related waves.

The provided text describes a 510(k) summary for the Philips Avalon Fetal Monitors FM20 and FM30, specifically for a modification that introduces the capability of monitoring fetal heart rates of triplets. However, the text does not include detailed acceptance criteria or a specific study that quantitatively proves the device meets such criteria.

The information mainly focuses on establishing substantial equivalence to a predicate device, regulatory classifications, and the general scope of the device's intended use and functionality.

Here's a breakdown of what is and is not available in the provided text regarding your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Available. The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices" but does not provide details of these criteria nor specific reported performance metrics against them. It only states that "test results showed substantial equivalence" and "the results demonstrate that the Philips Avalon Fetal Monitors FM20 and FM30 meet all reliability requirements and performance claims." There are no quantitative performance numbers (e.g., sensitivity, specificity, accuracy, error rates) reported for the device, especially concerning the triplet monitoring capability.

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

• Not Available. The document mentions "performance tests, regression tests, and testing from hazard analysis" but does not specify the sample size (number of patients, records, or fetal heart rate traces) used for any of these tests. There is no information regarding the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable/Not Available. Since no specific performance study with a 'ground truth' is described (such as for diagnostic accuracy), there's no mention of experts establishing ground truth or their qualifications. The device is a physiological monitor, not typically one that requires expert-established ground truth for its core function in the same way an AI diagnostic tool would.

4. Adjudication Method for the Test Set:

• Not Applicable/Not Available. As no detailed performance study requiring adjudication is described, this information is not present.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• Not Available. The document does not describe any MRMC comparative effectiveness study, nor does it mention any AI component or the effect size of AI assistance on human readers. The device is a monitor, not an AI-assisted diagnostic tool in the sense of image analysis.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not Applicable/Not Available. This device is a monitor, not a standalone algorithm in the typical sense of AI/ML. Its function is to acquire and display physiological parameters. While it processes signals, the "algorithm only" performance metric as described for AI is not relevant here.

7. The Type of Ground Truth Used:

• Not Available. As no specific performance study requiring ground truth is described, this information is not present. For a physiological monitor, "ground truth" typically refers to the accuracy of the measurements against a gold standard instrument, but details of such testing are not provided beyond a general statement of meeting specifications.

8. The Sample Size for the Training Set:

• Not Applicable/Not Available. The document describes a traditional medical device (fetal monitor) and a modification for triplet monitoring. It does not indicate the use of machine learning or AI that would require a "training set."

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

• Not Applicable/Not Available. Since no training set for an AI/ML algorithm is mentioned, the method for establishing its ground truth is not applicable.

In summary, the provided 510(k) summary focuses on regulatory compliance through substantial equivalence, indicating that the device's modification (triplet monitoring) was verified through "performance tests, regression tests, and testing from hazard analysis" against existing predicate specifications. However, it does not provide the detailed, quantitative performance data, sample sizes, or specifics of ground truth establishment that you requested for a comprehensive understanding of the device's acceptance criteria and the study proving it.

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Avalon Fetal Monitor FM30: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rate in labor and delivery rooms and in antepartum testing areas.

Avalon Fetal Monitor FM20: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rate in labor and delivery rooms and in antepartum testing areas.

The subject devices Philips Avalon Fetal Monitors FM20 and FM30 are modification of the legally marketed Philips Series 50XM (M1350B) Fetal/Maternal Monitor (K954351) and offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG, maternal non-invasive blood pressure (NIBP) and oxygen saturation (Sp02) during antepartum testing and labor and delivery. The Avalon FM20 and FM30 are intended for non-invasive and invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery. The Avalon FM20 and FM30 are intended for monitoring fetal and maternal heart rates, uterine activity, maternal non-invasive blood pressure (NIBP) and oxygen saturation (SpO2). The Avalon FM20 and FM30 are intended for generating alarms, for displaying, storing and recording patient data and related waves.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

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

The provided text does not explicitly list specific quantitative acceptance criteria or detailed performance metrics. Instead, it makes a general statement:

Explanation: The submission is for a modified device (Philips Avalon Fetal Monitors FM20 and FM30) that is stated to have the "same technological characteristics" and "same intended use" as legally marketed predicate devices. The "acceptance criteria" here are implicitly tied to demonstrating that the modified device performs equivalently to the predicate devices and meets their established specifications. The text confirms that this equivalence was met.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not applicable. The submission describes verification, validation, and testing activities against predicate device specifications, not a clinical study involving experts establishing ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. The submission describes engineering and system-level testing, not a clinical study requiring adjudication of expert interpretations.

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 is not an AI-powered diagnostic device, and no MRMC comparative effectiveness study is mentioned. The device is a fetal monitor.

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

The device itself is a standalone fetal monitor designed to provide physiological data. Its "standalone" performance was assessed through system-level, performance, and safety tests against predicate device specifications. There is no "algorithm only" performance reported in the context of AI.

7. The type of ground truth used

The "ground truth" for the device's performance was established by the specifications cleared for the predicate device. The testing demonstrated that the modified device met these existing specifications.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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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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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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