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The Capnostream™35 monitor is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused.

The Capnostream™35 monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up . The OxiMax SPD™ alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The Nellcor™ respiration rate parameter is intended for the continuous, non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

Other than the OxiMax SPD™ alert and Nellcor™ respiration rate features, the device is intended for use in hospitals, hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed.

The microMediCO2 module provides the following inputs to the host monitor: EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).

The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2, Pulse Rate, Respiratory Rate, and saturation pattern detection (SPD) parameters to the host for display. The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI.

The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.

The device is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.

This document is a 510(k) summary for the Capnostream™ 35 Portable Respiratory Monitor. It details the device's indications for use, technological characteristics, and performance data from non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics like accuracy, precision, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices through validation of software functions, usability testing, and wireless connectivity.

• Software Validation: "to ensure that all modified software functions as intended."
  • Reported Performance: Passed. Implicitly, the software performed as expected and intended.
• Cybersecurity Documentation: "identified cybersecurity risks and summarized how they were mitigated."
  • Reported Performance: Cybersecurity risks were identified and mitigated.
• Usability Testing (per IEC 60601-1-6): "assessed the ability of 15 intended users with varying levels of experience to perform key tasks as well as understand Capnostream™35′s display."
  • Reported Performance: Passed.
• Wireless Connectivity Testing: "The wireless communication testing passed for all wireless key types compatible with the device."
  • Reported Performance: Passed.

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

• Usability Testing:

  • Sample Size: 15 intended users.
  • Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. It's implied to be prospective testing specific to this device.

• Other tests (Software, Cybersecurity, Wireless Connectivity): Sample sizes for data points are not specified, as these are typically functional or engineering tests rather than studies on a "test set" of patients or data records.

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

This information is not provided in the document. The listed tests (software validation, usability, wireless connectivity) do not typically involve establishing a clinical "ground truth" derived from expert consensus in the same way a diagnostic algorithm might. Usability testing relies on user feedback, and software/connectivity validation relies on engineering specifications.

4. Adjudication method for the test set

This information is not provided as it's not applicable to the types of tests described. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving expert interpretation, which is not what was performed for these non-clinical tests.

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

There is no indication that an MRMC comparative effectiveness study was done. The device description and performance data focus on device functionality and its equivalence to predicates, not on AI assistance to human readers or effect sizes of such assistance. The device is a monitor, not an AI diagnostic tool.

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

The performance data listed (software validation, usability, wireless connectivity) are for the device as a standalone product in terms of its functions. There is no mention of an "algorithm only" performance study separate from the device's integrated operation. The device itself performs continuous non-invasive monitoring and provides specific parameters and alerts.

7. The type of ground truth used

• Software Validation: The "ground truth" is adherence to predefined software requirements and specifications.
• Usability Testing: The "ground truth" is the successful and easy completion of key tasks by users and their understanding of the display, measured against usability objectives.
• Wireless Connectivity Testing: The "ground truth" is successful connection and data transmission/reception according to wireless communication standards and protocols.

These are functional and engineering "ground truths," not clinical ones like pathology or expert consensus on patient conditions.

8. The sample size for the training set

This information is not provided. The document describes non-clinical performance tests of a medical monitor, not the development or training of a machine learning algorithm.

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

This information is not provided, as there is no mention of a training set or ground truth establishment for algorithm training in the context of this device's K200594 submission.

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• Microstream™ Advance Neonatal-Infant Nasal Filter Line with O2 Tubing .
• Microstream™ Advance Pediatric Oral-Nasal Filter Line with O2 Tubing ●
• Microstream™ Advance Adult Oral-Nasal Filter Line with O2 Tubing 0

Used to conduct a sample of the subject's breathing to a gas measurement device (capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation. The device is to be used with monitors using Microstream™ technology.

o Microstream™ Luer Adult Oral-Nasal Sampling Line Used whenever the physician needs to collect a sample of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation.

Similar to their predicates, the Microstream non-intubated sampling line/Filter Line family is intended to conduct CO2 from the patient's breath to a gas measurement device (Capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation (when connected to an O2 source).

The proposed devices are a modification of their predicates' material compounds (not made with DEHP or PHT materials), a change of dryer location to off the patient's face, and the integration of softer face-contacting tubes, mainly to enhance patient comfort, increase flexibility and reduce smell.

The proposed devices are sampling lines which are intended to be used with Capnograph monitors using Microstream technology. These sampling lines incorporate a luer connector with a recognition system:

• Microstream™ Advance Neonatal-Infant Nasal Filter Line with O2 Tubing .
• . Microstream™ Advance Pediatric Oral-Nasal Filter Line with O2 Tubing
• Microstream™ Advance Adult Oral-Nasal Filter Line with O2 Tubing .

In addition, this sampling line which is intended to be used with any Capnograph monitor is proposed:

• Microstream™ Luer Adult Oral-Nasal Sampling Line .

The provided text describes a 510(k) premarket notification for a medical device (Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing and related products). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a clinical study establishing new performance metrics.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, provenance of data) are not applicable in this context, as this submission relies on bench testing and biocompatibility assessments to show the new device is as safe and effective as existing ones.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The "Substantial Equivalence Table" on page 6-7 serves as the primary source for acceptance criteria (implicitly, the values of the predicate devices) and the reported performance of the new devices.

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

N/A. This submission indicates the use of "bench testing" and "biocompatibility assessment" rather than clinical test data or real-world patient data. The purpose is to demonstrate that the physical and material properties of the new devices are substantially equivalent to existing ones.

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

N/A. Ground truth from experts is not relevant for bench testing and biocompatibility assessments of physical properties.

4. Adjudication method for the test set

N/A. Adjudication methods are typically used in clinical studies involving interpretation by multiple readers. This submission relies on objective physical measurements and material 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

N/A. This device is a passive CO2 sampling line, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.

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

N/A. This is a hardware device; there is no "algorithm" in the sense of AI or image analysis.

7. The type of ground truth used

The "ground truth" for this type of submission is based on engineering specifications and established standards (e.g., ISO 10993 for biocompatibility, and the performance characteristics of the predicate devices for physical parameters like rise time, pressure drop, leak tightness, and tensile strength).

8. The sample size for the training set

N/A. There is no "training set" in the context of this traditional 510(k) submission, as it does not involve machine learning or AI.

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

N/A. As there is no training set, this question is not applicable.

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Intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a gas measurement device for measuring the percentage of CO2 in the patient's exhaled breath. The set is intended for single patient use only. Intended population: Intubated Adult- Pediatric patients.

Similar to their predicates the devices are non-sterile, disposable, single patient use, intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a device for measuring the percentage of CO2 in the patient's exhalation when connected to a capnograph.

The device's main components are PVC tubing, airway adapter and a luer connector.

Microstream™ Advance Adult-Pediatric Intubated Filter Line can be used only with Microstream™ capnography technology.

Microstream™ Luer Adult-Pediatric Intubated Sampling Line can be used with any capnograph with a luer connection.

An Accessory (extension line) to the proposed devices: Microstream™ Advance Filter Line, MRI is composed of PVC tubing and a luer connector. It is Intended to be used when longer tubing is required to allow CO2 sampling for environments such as an MRI suite. The straight tubing is then connected to the FilterLine/ Sampling Line end from one side and from the other side to the monitor, which is placed outside of MRI suite.

The main reason for this submission is the modification of the CO2 tubing to material not made with phthalates.

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Microstream Luer Adult-Pediatric Intubated Sampling Line and Microstream Advance Adult-Pediatric Intubated Filter Line.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text outlines performance tests conducted, but it merges the acceptance criteria with the performance results. For clarity, I will present the acceptance criteria based on the "Same as predicate" statements and the performance reported when new criteria were established for the modified devices.

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

The document states that "Bench testing was conducted to ensure the devices' performance." This implies physical testing of the devices. However, the specific sample size (number of units tested) for the bench tests is not explicitly mentioned in the provided text.

The data provenance is laboratory-based bench testing of the physical devices. There is no indication of country of origin for the data or whether it was retrospective or prospective in the context of patient data, as this was a bench study.

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

This information is not applicable as the study described is a bench performance study and not a clinical study with a test set requiring expert ground truth establishment. The "ground truth" for these tests would be the established engineering and ISO standards for device performance (e.g., specific tensile strength, pressure drop limits).

4. Adjudication Method for the Test Set:

This information is not applicable as the study is a bench performance study and does not involve adjudication by experts for clinical outcomes or image interpretation.

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 information is not applicable as the device is a physical medical device (sampling line) and not an AI-powered diagnostic or assistive tool.

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

This information is not applicable as the device is a physical medical device and does not have an algorithm for standalone performance.

7. The Type of Ground Truth Used:

For this bench study, the "ground truth" refers to established engineering standards, regulatory requirements (e.g., ISO 10993 for biocompatibility), and performance specifications derived from the predicate devices. For example, for tensile strength, the ground truth is "at least 2kg," and for leak tightness, "2 mBar/sec leak rate @ 100 mBar."

8. The Sample Size for the Training Set:

This information is not applicable as the study is a bench performance study of a physical device and does not involve a "training set" in the context of machine learning or AI.

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

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

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The Capnostream™35 is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused.

The Capnostream™35 also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up.

The device is intended for use in hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed.

The microMediCO2 module provides the following inputs to the host monitor:

EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).

The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2 and Pulse Rate parameters to the host for display.

The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI.

The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.

The device is intended for use in hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for AI/Machine Learning devices. Instead, it describes a medical device (Capnostream™35 Portable Respiratory Monitor) undergoing a 510(k) submission for substantial equivalence to predicate devices, focusing on regulatory compliance, safety, and general performance testing.

Therefore, many of the requested fields regarding AI/ML study details (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) cannot be extracted from this document.

However, I can extract information related to the device's general performance testing and intended use, which are analogous to acceptance criteria and their verification in a non-AI/ML context.

Here's an interpretation based on the provided text, focusing on the closest available information to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed with numerical targets as they would be for an AI model's precision or recall. Instead, the device's "performance" is considered in relation to meeting standards and demonstrating substantial equivalence to predicate devices.

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

• Not applicable for AI/ML device. The document describes non-clinical performance and safety testing against engineering standards and comparison to predicate devices, not AI model evaluation with specific test sets of patient data.

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

• Not applicable. This pertains to clinical data labeling for AI/ML, which is not described here.

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

• Not applicable. This pertains to expert consensus for AI/ML ground truth, which is not described here.

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 such study was mentioned. This is not an AI-assisted device.

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

• No standalone algorithm performance study was described in the context of AI/ML. The device itself is a standalone monitor, and its "performance" was evaluated through engineering tests and comparison to predicates.

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

• Ground truth in this context typically refers to established engineering specifications, performance standards (e.g., ISO, IEC), and the known performance of the predicate devices. For instance, the accuracy of CO2 measurement would be validated against calibrated gas mixtures, and SpO2 against controlled hypoxia studies, which are the "ground truth" for those physiological parameters under specific test conditions. The document states "Appropriate safety, environmental and performance tests were conducted to ensure that the specifications of the Capnostream™35 were met."

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Summary of the Study (as described in the document):

The "study" described is a non-clinical performance testing and substantial equivalence assessment for product clearance. It involves:

• Performance Testing: Conducted according to specific ISO standards (ISO 80601-2-55, ISO 80601-2-61) for the respective measurement parameters (capnography and pulse oximetry).
• Electrical Safety Testing: Performed per IEC standards (IEC 60601-1, IEC 60601-1-8, IEC 60601-2-49, IEC 60601-1-12, IEC 60601-1-6).
• Electromagnetic Compatibility (EMC) Testing: Performed per IEC 60601-1-2.
• Environmental Testing: Verification of features like IP54 rating, shockproof status, sunlight readability, hot swap battery, and altitude capacity.
• Software Testing: To validate performance and substantial equivalence.
• Wireless Communication Testing: According to FDA guidance for wireless medical devices.
• Hazard Analysis: Conducted in compliance with ISO 14971:2012 to assess and mitigate risks.

The overarching goal was to demonstrate that the Capnostream™35 Portable Respiratory Monitor has the "same intended use, technological characteristics and performance as its predicate devices" and that its functionality in new intended environments (out-of-hospital EMS) was verified through testing against relevant standards. The document concludes that "Testing did not raise any concerns when compared to its predicate devices therefore the subject device is substantially equivalent to its predicate devices."

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The Capnostream®20p combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoqlobin (SpO2) and pulse rate. It is also indicated for continuous noninvasive monitoring of carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). It is intended for use with neonatal, pediatric, and adult patients in hospital-type facilities, intra-hospital transport and home environments.

Capnostream®20p is to be operated by qualified healthcare personnel only. The Capnostream®20p monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

The Capnostream20p HiFi mode provides a measurement of expired carbon dioxide and detects spontaneous breaths for infant/neonatal patients ventilated using high frequency oscillatory ventilation (HFOV).

The Capnostream20p bedside monitor is a two parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed.

The HiFi capnography software feature, presented in this submission, is intended to enable measurement of airway CO2 for infant/neonatal patients during high frequency oscillatory ventilation (HFOV) and detects spontaneous breaths for infant/neonatal patients ventilated using high frequency oscillatory ventilation (HFOV).

Here's an analysis of the acceptance criteria and study information for the Capnostream® 20p with HiFi CO2 monitoring, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance for the Test Set

• Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The testing was performed on a "lung simulator system."
• Data Provenance: The testing was conducted on a "lung simulator system," indicating it was not performed on human subjects. This suggests a controlled laboratory environment rather than retrospective or prospective clinical data from a specific country of origin.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Not applicable as the ground truth was established through a "lung simulator system" rather than expert interpretation of biological data. The "ground truth" would be the known, controlled CO2 and respiratory rate inputs of the simulator.

4. Adjudication Method for the Test Set

• Not applicable. Since the testing was done on a lung simulator, comparison would have been to the known, programmed values of the simulator, not requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This device is a measurement instrument, not an AI-assisted diagnostic tool that would involve human readers interpreting output. The study focused on the accuracy of the device's measurements.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The performance testing on the lung simulator system assessed the algorithm's (Capnostream20p with HiFi) ability to accurately measure CO2 and detect breaths independently of human interpretation.

7. Type of Ground Truth Used (Test Set)

• The ground truth used was the known, controlled parameters established by the "lung simulator system." This would include the programmed CO2 concentrations and respiratory rates (both passive and spontaneous).

8. Sample Size for the Training Set

• The document does not explicitly state a training set sample size. Given the nature of a capnograph/pulse oximeter, its core algorithms are typically based on physiological models and physical principles (e.g., infrared absorption for CO2). While there might be internal tuning or calibration processes that could be considered "training" in a broad sense, it's not described as a machine learning model with a distinct training dataset in the same way as an image recognition AI. The focus is on the validation of the HiFi software feature.

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

• Not explicitly described in the document. As mentioned above, for this type of device, "training" might not involve a distinct ground truth dataset in the way a modern AI algorithm would. Its development would likely rely on physical laws, engineering specifications, and possibly internal testing to refine signal processing and detection algorithms within the device.

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The Carinal VitaLine™ Set sampling line is intended to provide for CO2 measurement of intubated neonates and infants with a Microstream monitor. It enables either standard sampling via the airway adapter and main lumen of an endotracheal tube or sampling from the carina via the monitoring lumen of the same tube.

The set is intended for single patient use only.

The Carinal VitaLine Set comprises Microstream FilterLine ICU that is modified to enable the clinician to select between central monitoring from the trachea above the carina via the monitoring lumen of the ETT and traditional monitoring with a CO2 sampling airway adapter. The following components are included in the Carinal VitaLine Set:

• sampling line .
• airway adapter with tube and luer connected. .

The Carinal VitaLine Set is designed for use with an infant neonatal size uncuffed endotracheal tube equipped with a monitoring lumen. The endotracheal tube must be supplied by the end user and is not provided by Oridion as part of the Carinal VitaLine.

The tubing leading to the CO2 monitor includes two dryer sections to support use in high humidity environments and prevent rapid occlusion of the tubing.

This document describes the Carinal VitaLine™ Set, an accessory for capnographs designed to measure CO2 in intubated neonates and infants. The submission focuses on demonstrating substantial equivalence to a predicate device, the Microstream FilterLine ICU (K980327).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as pass/fail thresholds in this document for each performance characteristic. Instead, the document presents a comparison of the Carinal VitaLine™ Set's performance characteristics against the predicate device's characteristics to demonstrate similarity and thus substantial equivalence.

2. Sample Sizes and Data Provenance

The document states that bench tests were performed. It does not provide specific sample sizes (e.g., number of units tested) for each bench test. The data provenance is implied to be from internal testing conducted by Oridion Medical 1987 Ltd., based in Jerusalem, Israel. The study type is retrospective, as it involves testing a developed product to compare its performance against a predicate.

3. Number of Experts and Qualifications

This submission does not involve human readers or experts for establishing ground truth, as it is a technical performance comparison of a medical device accessory through bench testing.

4. Adjudication Method

Not applicable, as this is a technical performance comparison of a medical device accessory through bench testing, not a study involving human interpretation or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted. This device is a capnograph accessory, and the study focuses on its technical performance characteristics rather than diagnostic accuracy or human reader performance.

6. Standalone Performance Study

Yes, a standalone performance study was done in the form of bench tests. These tests evaluated the device's inherent performance characteristics (Tensile Strength, Leak Tightness, Pressure Drop, Rise Time, and Delay Time) independent of human operators, comparing them directly to the predicate device.

7. Type of Ground Truth Used

For the bench tests, the "ground truth" or reference for comparison was the performance specifications and characteristics of the predicate device (Microstream FilterLine ICU, K980327). The goal was to demonstrate that the Carinal VitaLine™ Set performed similarly enough to be considered substantially equivalent.

8. Sample Size for the Training Set

Not applicable. This submission describes testing for a medical device accessory, not a machine learning model that requires a training set.

9. How Ground Truth for the Training Set Was Established

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

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The Capnostream®20p combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is also indicated for continuous non-invasive monitoring of carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospitals, hospital-type facilities, intra-hospital transport and home environments.

The Capnostream®20p monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

The Capnostream20p bedside monitor is a two parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed.

The microMediCO2 module provides the following inputs to the host monitor:

FiCO2. EtCO2 numeric, EtCO2 waveform, Respiratory Rate, IPI (Integrated Pulmonary Index), Continuous CO2 numeric and waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).

The SpO2 module, integrated in the Capnostream20p monitor presented in this submission, provides the following parameters to the host for display: SpO2 (functional oxygen saturation of arterial hemoglobin), pulse rate, SpCO: carboxyhemoglobin saturation in blood (%SpCO), SpMet: methemoglobin saturation in blood (%SpMet), SpHb: total hemoglobin concentration in blood (g/dl SpHb). The SpO2 measurements are also provided to the microMediCO2 module enabling the calculation of the IPI and the ODI.

The host monitor will display this data to the user in numerics via a screen, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.

The Apnea per Hour (A/hr) is defined as the number of cessations of breathing of 10 seconds or more that have occurred per hour. The Oxygen Desaturation Index (ODI) is the number of desaturation events of 4% or more with a return to baseline within 240 seconds or less identified with pulse oximetry (following the AASM definitions)1. The values are updated once a minute.

The Smart A/hr & ODI™ feature presented in this submission is intended only for adult patients (age 22 and up) in hospital ICU and general floor environments. whilst the patient is being monitored using capnography and pulse oximetry as part of his medical care. The feature is not available for pediatric, infant and neonatal patients.

The provided text is a 510(k) Summary for a medical device (Capnostream20p with Smart A/hr & ODI™). It states that the device is substantially equivalent to a predicate device (Capnostream20p). However, it does not contain the specific details of a study that proves the device meets acceptance criteria.

The document states:

• "Software testing was performed to validate the performance of the new monitor and its substantial equivalence to the predicate device."
• "A hazard analysis was carried out on the Capnostream host monitor displaying the A/hr and ODI values. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the system."

These statements imply that testing was done, but the summary does not provide any quantitative acceptance criteria, reported performance values, sample sizes, data provenance, ground truth details, expert qualifications, adjudication methods, or effects of AI assistance.

Therefore, I cannot fulfill your request for the tables and detailed study information as the necessary data is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing a de novo study with specific performance metrics against pre-defined acceptance criteria.

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The Smart CapnoLine Guardian™ is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 60 fr. bite block, during upper endoscopy type procedures. The set is intended for single patient use only.

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I am sorry, but the provided text does not contain specific details about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) premarket notification letter from the FDA to Oridion Medical 1987 Limited regarding their Smart CapnoLine Guardian™ device, confirming its substantial equivalence to a legally marketed predicate device.

It primarily covers:

• Confirmation of substantial equivalence.
• Regulatory information and compliance requirements for the device.
• Contact information for regulatory questions.
• The product's indications for use.

Therefore, I cannot provide the requested table and study details based on the given input.

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The proposed device, Smart BiteBloc™, will be used during endoscopy procedures that require a bite block that enables and supports the convenient use of, and will not interfere with, an oral nasal cannula (K011536) for collecting samples of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose for inhalation. It can be used for non intubated patients who weigh more than 55 lbs (25 kg).

Bite blocks indicated for use as an endoscopy accessory are usually classified, according to 21CFR876.1500, as exempt from pre market notification. The submitted endoscopy accessory, Smart BiteBloc™, has been modified to allow the convenient use of an oral nasal cannula (K011536) for sampling of EtCO2 and administration of O2 during endoscopic procedures. Oridion considers this device to be a capnography accessory.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The document is a 510(k) summary for a medical device (Smart BiteBloc™), which focuses on establishing substantial equivalence to previously marketed predicate devices rather than detailing performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested table and information.

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The MicroCap Plus /NPB-75 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and of arterial oxygen saturation (SpO2) and pulse rate.

The Oridion MicroCap Plus/NPB-75 (the device being modified) (K964239) is an integrated instrument that measures end tidal CO2 (EtCO2) and saturated arterial oxygen (SpO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR) and as a derivative of the saturated arterial oxygen measurement the devices measure and display the pulse rate (PR). The capnograph section of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status. The pulse oximeter module in both devices measures the oxygenated hemoglobin (HbO>) and displays the results as a percent of oxygen and as a plethysmographic waveform.

The provided text describes the MicroCap Plus/NPB-75 device, a combination oximeter/carbon dioxide gas analyzer. The document is primarily a 510(k) summary for a modification to an existing device, specifically changing the pulse oximeter module. However, it does not contain specific acceptance criteria, study details, or performance data for demonstrating the device meets any acceptance criteria. It mainly focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, as these details are not present in the provided document.

The document only states:

• Device Description: The MicroCap Plus/NPB-75 measures end tidal CO2 (EtCO2), saturated arterial oxygen (SpO2), breath rate (BR), and pulse rate (PR).
• Substantial Equivalence: The modified device (using the NPB MP507 SpO2 module) is substantially equivalent to the predicate device (using the MP204 module) in terms of indications for use and technological characteristics. The MP507 is described as an "improved version" of the MP204.
• Intended Use: For continuous, non-invasive measurement and monitoring of CO2 concentration, respiration rate, arterial oxygen saturation (SpO2), and pulse rate by trained healthcare providers in various critical care settings.

Without a performance study section or specific testing results, it's impossible to derive the requested information.

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