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510(k) Data Aggregation
(114 days)
The Westmed nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases. Cumulative duration of use
Westmed has designed several 0%CO2 nasal cannula / exhaled gas sampling devices. They include:
- . Nasal cannula style that can provide supplemental O2 and sample exhaled gases at only the nares and
- Nasal cannula style that can provide supplemental O2 and sample exhaled gases at both ● the nares and at the mouth
The device configurations include nasal cannula that have a division to deliver oxygen through one nare and to sample exhaled gases through the other. There is also an oral sampling style which is positioned near the mouth to sample exhaled gases if the patient is a mouth breather.
The device includes a length of standard oxygen tubing and gas sampling lines.
This document describes Westmed's Gas Sampling Cannula with O2 delivery, which is intended to deliver supplemental oxygen and sample expired gases. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and performance through a dedicated study with a predefined test set. Therefore, some requested information may not be directly available from the provided text.
Here's an analysis based on the given document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it focuses on demonstrating equivalence to predicate devices through comparative testing. The performance is reported in terms of equivalence to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to measure a breath and a gas | Performed comparative CO2 sampling and waveform performance at 3 different breathing rates, CO2 concentrations (2% and 5%), and oxygen flow rates (1, 3, and 5 lpm). The results showed "equivalent" performance to the predicates. |
| Ability to breathe waveforms under several simulated breathing conditions | Performed comparative CO2 sampling and waveform performance at 3 different breathing rates, CO2 concentrations (2% and 5%), and oxygen flow rates (1, 3, and 5 lpm). The results showed "equivalent" performance to the predicates. |
| Environmental and Age resistance | Environmental and Age testing was performed. All testing demonstrated that the proposed devices are substantially equivalent to the identified predicate and reference. |
| Mechanical strength (e.g., connections, resistance to kinks) | Mechanical testing was performed, including Luer Fitting, Flow, Strength of bonds, and Resistance to kinks. All testing demonstrated that the proposed devices are substantially equivalent to the identified predicate and reference. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation) | ISO 10993 testing was performed on component materials, covering Cytotoxicity, Sensitization, and Intracutaneous Irritation. The device components are considered "Externally Communicating and Surface Contact with the patient." The results were acceptable given the device’s classification and intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of units, number of simulated breathing cycles) used for the bench testing. It only mentions "comparative testing" under "several simulated breathing conditions."
- Sample Size: Not explicitly stated for specific tests.
- Data Provenance: The testing was conducted as "Bench Testing" by Westmed, Inc. The document does not specify the country of origin of the data beyond implying it was performed by the submitting company. The tests were non-clinical (i.e., not performed on human subjects) and are therefore retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The "ground truth" for this device's performance is based on physical and chemical measurements (e.g., CO2 concentration, waveform characteristics, tensile strength) against engineering specifications or comparative performance with predicate devices, not subjective expert assessment of clinical data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As the testing involves objective measurements rather than subjective assessments requiring adjudication, no such method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or described. This type of study is typically relevant for interpretative devices (e.g., AI in radiology) where human readers interpret medical images or data. The Westmed device is a gas sampling and oxygen delivery cannula, not an interpretive device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not directly applicable to a physical medical device like a cannula. The device's performance is inherent in its physical and functional characteristics. The "bench testing" described evaluates the device in a standalone manner (without a human patient), but it's not an "algorithm only" study as understood in AI/software contexts.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation was based on:
- Objective Measurements: Such as CO2 concentrations, waveform characteristics, and mechanical properties (tensile strength).
- Comparison to Predicate Devices: Performance was deemed equivalent to the predicate devices (K010024 – Oridion and K011050 – Oridion). This implies that the performance of the predicate devices served as a de facto "ground truth" or benchmark for acceptable performance.
- Standardized Testing: Biocompatibility testing followed ISO 10993 standards, which define the "ground truth" for biological safety.
8. Sample Size for the Training Set
This information is not applicable. The Westmed device is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device.
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(105 days)
The Dispo-Med nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases.
The Dispo-Med gas sampling lines are intended to interface with the patient via nasal cannula, nares connector, or standard sampling port connectors to the expired gas monitor.
Environment of use - hospital, sub-acute, and pre-hospital settings
Patient population - Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics.
Dispo-Med has designed a series of exhaled gas sampling devices. They include:
- Nasal cannula styles that can provide supplemental O2 and sample exhaled gases
- Gas sampling only devices which sample the patient's exhaled gas at the nares or in the circuit
All of the devices have the same indications for use and therefore can be combined into a single submission.
We will present several different configurations which have been tested and compared to several predicates.
Gas sampling devices are not specific to a particular exhaled gas monitor. Almost all gas sampling design connect to the monitor via a standard luer fitting, whether it is a female or male fitting.
The provided text describes a 510(k) summary for DISPO-MED (MALAYSIA) SDN BHD regarding their Oxygen Delivery / CO2 Sampling Cannula Style and Gas Sampling Only Style devices. The document aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" with numerical targets in the same way one might find for a diagnostic test's sensitivity or specificity. Instead, it frames "acceptance" as demonstrating substantial equivalence to predicate devices through comparative performance testing and shared characteristics. The performance criteria are implicit within the comparative testing performed.
| Acceptance Criteria Category | Reported Device Performance (DISPO-MED) |
|---|---|
| Indications for Use | Oxygen Delivery / CO2 Sampling Cannula Style: "The Dispo-Med nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases." (Identical to predicates K010024 and K011050) |
| Gas Sampling Only Style: "The Dispo-Med gas sampling lines are intended to interface with the patient via nasal cannula, nares connector, or standard sampling port connectors to the expired gas monitor." (Identical to predicates K980325 and K980327) | |
| Environment of Use | "Hospitals, sub-acute, and pre-hospital settings." (Identical to predicates) |
| Patient Population | "Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics." (Identical to predicates) |
| Technology / Construction | Oxygen Delivery / CO2 Sampling Cannula Style: Design, fabrication, shape, size etc. are equivalent to predicates. Design incorporates several styles of split/channeled nasal cannula. |
| Gas Sampling Only Style: Design, fabrication, shape, size etc. are equivalent to predicates. Design incorporates simple means to interface with the patient or breathing/ventilator circuit. | |
| CO2 Sampling Performance | Oxygen Delivery / CO2 Sampling Cannula Style: Comparative CO2 sampling and waveform performance at breathing rates (12 bpm, 20 bpm), tidal volumes (300 ml, 500 ml), CO2 concentrations (1%, 5%), and oxygen flow rates (1 lpm, 5 lpm). "The results presented show that the proposed Dispo-Med Oxygen delivery / CO2 sampling cannula style devices performed equivalent to the predicates." Acknowledged that higher O2 flow (5 lpm) can cause lower CO2 values (washout), but "performance met the performance specifications" and differences "not considered clinically significant." |
| Gas Sampling Only Style: Comparative CO2 sampling and waveform performance at breathing rates (12 bpm, 20 bpm), tidal volumes (300 ml, 500 ml), CO2 concentrations (1%, 5%). "The results show that the proposed Dispo-Med CO2 sampling only style devices performed equivalent to the predicates." Noted "better performance of the proposed device vs. the predicates." | |
| Mechanical Testing | Resistance to flow, Tensile strength of connections, Luer fitting testing (per ISO 594-2), O2 Flow, Strength of bonds. (Performed and deemed equivalent to predicates for both styles.) |
| Environmental/Age Testing | Performed for both device styles; results not explicitly detailed but stated to support substantial equivalence. |
| Biocompatibility (Materials) | ISO 10993 testing performed for cytotoxicity, sensitization, and intracutaneous irritation for indirect and direct (skin) contact materials. (Performed, ensuring materials are appropriate.) |
| Single Patient Use, Disposable | Yes (Identical to predicates) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes (e.g., number of devices tested, number of simulated breaths, or duration of tests) for the comparative performance and mechanical testing. It mentions "several different configurations which have been tested".
- Data Provenance: The testing appears to be prospective (conducted specifically for this 510(k) submission) and simulated/laboratory-based. There is no mention of human subject data or data from a specific country of origin for the performance testing results themselves. The company, DISPO-MED (MALAYSIA) SDN BHD, is based in Malaysia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The "ground truth" for comparative performance data in this context would likely be derived from a validated capnometer or gas analyzer, rather than expert interpretation of data. The document focuses on the objective measurement and waveform equivalency.
4. Adjudication Method for the Test Set:
- This information is not applicable/provided. Since the testing is focused on objective measurements of gas sampling and mechanical properties, there wouldn't typically be a need for an adjudication method in the way one would for clinical 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. This submission is for a physical medical device (nasal cannula/gas sampling line), not an AI algorithm or a diagnostic imaging device requiring human reader interpretation. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This is not an AI algorithm. The device performance (standalone) was evaluated in laboratory settings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the CO2 sampling performance was the measured CO2 concentration and waveform generated by the simulated breathing conditions. This would be established by a reference gas analyzer or capnometer, which serves as the "gold standard" for measuring CO2.
- For mechanical and material testing, the ground truth refers to established standards and specifications (e.g., ISO 594-2 for Luer fittings, standard material properties, and mechanical limits).
8. The sample size for the training set:
- This information is not applicable. As this is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- This information is not applicable as there is no training set.
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(129 days)
The Polaris 2004 Capnograph is intended for the continuous, non-invasive measurement and monitoring or respiration rate and carbon dioxide concentration of the expired and inspired breath of neonatal, pediatric and adult patients wherever these measurements are required by attending medical personnel.
The Oridion Polaris Capnograph (the device being modified-K950388) is a device that measures end tidal CO2 (EtCO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR). The capnograph module 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.
This 510(k) summary does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as it primarily focuses on demonstrating substantial equivalence to a predicate device. However, it does reference compliance with a standard.
Here's an attempt to extract and infer information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Compliance with EN864 for Capnographs | "The Polaris 2004 Capnograph...meets the standard EN864 for capnographs that has been accepted by the FDA." (This implies the device performance met the technical specifications and accuracy requirements outlined in EN864 for parameters like EtCO2 measurement accuracy, breath rate accuracy, response time, etc., although specific numerical values are not provided in this document.) |
| Basic design, intended use, and indication remain the same as predicate device | "The basic design, intended use and indication of the Polaris 2004 remain the same..." |
| Design modifications do not alter fundamental technology, materials, or manufacturing processes. | "...the design modifications have not altered the technology, materials or manufacturing processes of the Polaris." |
| No new issues of safety or efficacy | "The changes pose no new issues of safety or efficacy." |
| Equivalent flow and gas sampling system to predicate | "The Polaris and the modified device (Polaris 2004) use the identical flow and gas sampling system and pneumatic system." |
| Equivalent CO2 module function to predicate (MiniMediCO2 vs. generic CO2 module) | "The modified device, the Polaris 2004 Capnograph, incorporates all the functions of the Polaris monitor. It is equivalent, in terms of indications for use and technological characteristics to the Polaris Capnograph K950388." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document primarily discusses device modifications and equivalence to a predicate, not performance testing on a specific "test set" of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. As no specific "test set" or clinical study with patient data results are detailed, there is no mention of experts establishing ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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 mention of an MRMC study. This device is a capnograph, a medical instrument that measures physiological parameters. It does not appear to involve image interpretation or AI for diagnostic assistance to human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly stated as a "standalone" study in the context of an algorithm. However, the device itself, the Polaris 2004 Capnograph, operates independently to measure and display CO2 and respiration rate. The document implies that its performance (e.g., accuracy of CO2 measurement) was validated against the EN864 standard. This standard would dictate the methods for testing the device's inherent measurement capabilities.
7. The Type of Ground Truth Used
The primary "ground truth" referenced for performance is the EN864 standard for capnographs. This standard likely specifies objective criteria and methods for evaluating the accuracy and performance of carbon dioxide analyzers, which would involve calibrated gas mixtures or other validated reference methods.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a hardware medical instrument for physiological measurement, not an AI/machine learning algorithm that requires a "training set" of data in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8.
Summary of what the document implies about validation:
The primary "study" proving the device meets acceptance criteria is the demonstration that the modified Polaris 2004 Capnograph conforms to the EN864 standard for capnographs. The 510(k) process for this device relies heavily on the concept of substantial equivalence to a previously cleared predicate device (Polaris Capnograph K950388). The document emphasizes that the modifications introduced (e.g., MiniMediCO2 module, aluminum manifold, removal of water trap with Filterline K980324) do not alter the fundamental safety, efficacy, or intended use, and leverage components or concepts already cleared by the FDA in other devices (e.g., MiniMediCO2 module in Microcap K981114, Filterline in K980324). Therefore, the "proof" is largely based on demonstrating that these changes maintain the performance characteristics of the predicate device and meet an internationally recognized standard.
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(250 days)
The Medley™ EtCO2 Module is a capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The monitor is intended for use by professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired. The Medley™ EtCO2 Module is indicated for use on adults, pediatrics and infant/neonates for both intubated and non-intubated patients.
The EtCO2 Module is the newest module to the currently marketed Medley™ Medication Safety System (Medley™ System). ALARIS Medical will incorporate currently marketed Oridion capnograph technology and accessories into the Medley™ EtCO2 Module. The Medley™ EtCO2 Module will be used to measure inspired and expired carbon dioxide (FiCO2 and EtCO2 respectively) and Respiration Rate (RR) on patients in the operating room, ICU, NICU, transport and emergency treatment. This capnograph technology originates from the MediCap/NPB-75 (K964239).
The provided text describes the Alaris Medical Systems Medley EtCO2 Module, a capnograph designed to continuously monitor end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The document is a 510(k) premarket notification summary.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, does not explicitly state specific numerical acceptance criteria or performance metrics (like accuracy, precision, or bias) for EtCO2, FiCO2, or RR measurements. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (typically quantitative thresholds for accuracy, precision, etc.) | "The performance data included in this submission indicate that the Medley™ EtCO2 Module meets specified requirements, and is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The evaluation appears to be based on demonstrating "substantial equivalence" to a predicate device and relies on the predicate's established performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not available in the provided text. No ground truth establishment by experts for a test set is described.
4. Adjudication Method for the Test Set
This is not applicable/not provided as no test set requiring expert adjudication for ground truth is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not mentioned in the document. The device is a monitor, not an AI diagnostic tool requiring human reader interpretation or assistance.
6. Standalone Performance Study (Algorithm Only)
The document does not describe a standalone performance study in the context of an algorithm's performance. The Medley EtCO2 Module is a hardware device that incorporates "currently marketed Oridion capnograph technology." Its performance is evaluated against (or shown to be equivalent to) an existing predicate device rather than undergoing a separate standalone algorithm performance study. The statement "The performance data included in this submission indicate that the Medley" EtCO2 Module meets specified requirements" suggests internal testing was done, but no details of such a study are provided.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any performance evaluation. Given it's a capnograph, ground truth would typically come from a gold-standard CO2 measurement method, but this is not detailed. The primary basis for approval appears to be substantial equivalence to a predicate device.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. As a hardware medical device based on existing technology, the concept of a training set for an algorithm is not directly applicable in the information provided.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as no training set is described.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Oridion MicroCap/NPB-75, K964239) rather than detailing specific standalone performance studies with quantitative acceptance criteria, test sets, or ground truth establishment relevant to AI/algorithm performance. The approval hinges on the assertion that the "technological characteristics" and "performance data" show the device is "substantially equivalent" to the predicate.
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