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510(k) Data Aggregation
(203 days)
Draegerwerk AG & Co. KGaA
VentStar Resus heated (N) (MP17030): VentStar Resus heated (N) with manual PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source (resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient.
The product allows short-term ventilation with humidified breathing gas and additional PEEP.
It can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port.
The product is suitable for patients with a maximum body weight of 10 kg (22 lb).
VentStar Autobreath heated (N) (MP17031): VentStar AutoBreath heated (N) with automatic PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient.
The product allows automatic short-term ventilation with humidified breathing gas and additional PEEP.
The valve is controlled via the AutoBreath function of the resuscitation module. The product can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port.
The product is suitable for patients with a maximum body weight of 10 kg (22 lb).
The subject devices, VentStar Autobreath heated (N) (MP17031) and VentStar Resus heated (N) (MP17030), are two heated disposable single limp breathing circuits with humidifier chamber for connection to the humidifier MR850 by Fisher and Paykel (K073706), for neonatal patients with a maximum body weight of 10 kg for use with the Dräger BabyRoo TN300 (K230278) and Dräger Resuscitaire (K120642).
The VentStar Resus heated (N) MP17030 is equipped with a manual PEEP valve which enables the setting of a PEEP by the operator directly. The operator can control the inhalation and exhalation.
The VentStar Autobreath heated (N) MP17031 is equipped with an automatic PEEP valve. With the Autobreath function a respiratory rate can be adjusted on the resuscitation module and a machine controlled consistent inspiration rate can be applied to the patient.
The heated breathing circuits are intended for conveying breathing gases (air and/or oxygen) from a breathing gas source (resuscitation module) to the humidifier chamber and finally to the patient.
Both breathing circuits are designed for a flow range from 5 to 15 L/min.
The heating of the hoses is done by using electrical heating wires inside the wall of the hoses. These wires have specific electrical resistances to generate a specific heating power. The heating plate of the humidifier chamber is positioned at the heater of the humidifier.
The provided FDA 510(k) Clearance Letter for the VentStar Resus and Autobreath Heated Devices (K242769) outlines the regulatory approval process for these medical devices. However, it does not contain information related to software, artificial intelligence (AI), diagnostic studies, or the acceptance criteria for such studies.
The document pertains to the physical characteristics, safety, and functionality of heated disposable breathing circuits for neonatal ventilation. The performance data section refers to non-clinical testing covering mechanical, thermal safety, environmental conditions, electrical safety, electromagnetic compatibility, functional verification, and performance capacity and accuracy, all conducted against established medical device standards.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance related to AI, ground truth, expert consensus, sample sizes for training/test sets, or MRMC studies, as none of this information is present in the provided text.
The information primarily focuses on:
- Device Description: Heated disposable breathing circuits for neonatal patients.
- Intended Use: Conveying humidified breathing gas from a resuscitation module to a patient.
- Comparison to Predicate Devices: Demonstrating substantial equivalence based on physical and functional characteristics.
- Performance Data: References to compliance with various ISO and IEC standards for electrical safety, EMC, functional performance, and biocompatibility.
**To directly answer your numbered points based solely on the provided document: **
- A table of acceptance criteria and the reported device performance: Not provided in the document in the context of diagnostic performance or AI. The performance section mentions compliance with various standards (e.g., IEC 60601-1, ISO 5367), implying that the acceptance criteria are adherence to these established engineering and safety standards, rather than diagnostic accuracy metrics.
- Sample sizes used for the test set and the data provenance: Not applicable or not provided. The testing discussed is non-clinical (mechanical, electrical, etc.), not a data-driven diagnostic study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI models (e.g., expert reads of medical images) is not relevant to the described device testing.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance, often with AI assistance, in diagnostic tasks. The device is a breathing circuit, not a diagnostic AI tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no mention of an algorithm or AI.
- The type of ground truth used: Not applicable in the context of diagnostic accuracy. Ground truth for this device would be defined by engineering specifications and physical measurements (e.g., resistance levels, heating efficiency, material composition).
- The sample size for the training set: Not applicable, as there is no AI/machine learning component mentioned.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance of a physical medical device (breathing circuits) and its compliance with safety and performance standards for hardware, not a software/AI driven diagnostic tool. Therefore, the questions related to AI performance, ground truth establishment, and clinical study methodologies are not addressed by the provided text.
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(268 days)
Draegerwerk AG & Co. KGaA
VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
The subject devices (VentStar Helix Dual Heated N Exten. Kit and VentStar Helix Heated (N) Plus), two inspiratory (and expiratory) heated disposable breathing circuits with humidifier chamber are designed for neonatal patients with a tidal volume of up to 100 mL, for conduction of humidified breathing gas from the humidifier to the patient. VentStar Helix Dual Heated N Exten. Kit is a dual heated breathing circuit and VentStar Helix Heated (N) Plus is a single heated breathing circuit to be connected to a humidifier MR850 by Fisher and Paykel, both tested for system compatibility and released for use with Dräger Babylog VN-Series ventilators.
Additionally, this submission comprises a neonatal humidifier chamber and a double connector for connection to the ventilators as accessories to the above mentioned medical devices.
This is a 510(k) premarket notification for breathing system heaters, not an AI/ML device. Therefore, the requested information about acceptance criteria for AI performance, sample sizes for test/training sets, ground truth establishment, expert consensus, MRMC studies, or standalone algorithm performance is not applicable.
The document discusses the substantial equivalence of the VentStar Helix Dual Heated N Exten. Kit (MP02280) and VentStar Helix Heated (N) Plus (MP02608) to previously cleared predicate devices. Substantial equivalence is determined by demonstrating that the new devices are as safe and effective as the predicate devices, despite some technological differences.
Here's the relevant information about the device's technical specifications and the non-clinical studies performed to demonstrate its safety and effectiveness:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides extensive comparison tables (Table 1 and Table 2) between the new devices and their predicate devices. These tables list various technical characteristics and performance parameters, indicating whether they are "Same," "Similar," or "Different" compared to the predicate. For characteristics marked "Different," numerical values are provided for both the subject device and the predicate device. These differences were evaluated through non-clinical testing to ensure they do not raise new questions of safety or effectiveness.
Due to the extensive nature of the comparison, which lists numerous parameters like hose diameter, length, resistance, compliance, leakage, volume, warm-up time, humidification output, and electrical data, a comprehensive reproduction of all "acceptance criteria" (which are implicitly the performance of the predicate device or established standards) and "reported device performance" in a single table format is beyond the scope of a short answer. However, the tables clearly highlight these comparisons.
For example, for VentStar Helix Dual Heated N Exten. Kit (MP02280) compared to predicate RT265 (K103767):
| Characteristic | Subject Device Performance | Predicate Device Performance | Comment |
|---|---|---|---|
| Hose diameter (ID) | 11 mm ID | 10 mm ID | Different |
| Resistance | Inspiratory: at 2.5 L/min 33 mg/L. Non-invasive ventilation at 2 to 60 L/min > 12 mg/L. | Invasive ventilation up to 60 L/min > 33 mg/L. Non-invasive ventilation up to 120 L/min > 10 mg/L. | Same / Different |
The document states that "Performance data related to each proposed modification has been tested and evaluated" and "High level summary reports included in this 510(k) demonstrate that the subject devices are substantially equivalent to the predicate device." This implies that the acceptance criteria are met if these differences do not negatively impact safety and effectiveness, as determined by the non-clinical testing against relevant standards.
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device that uses test sets of data in the common understanding for AI performance evaluation. The "test set" here refers to the physical devices and materials subjected to non-clinical laboratory testing. The provenance of these physical samples is from the manufacturer, Drägerwerk AG & Co. KGaA (Germany). The studies are prospective in the sense that they are conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., expert annotations on medical images) is not relevant for this type of device submission, which relies on engineering and biocompatibility testing against established standards.
4. Adjudication method for the test set: Not applicable. This concept is not relevant for the type of non-clinical testing performed for this device.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used: For this device, "ground truth" refers to the established requirements and performance limits defined by international consensus standards and the performance characteristics of the predicate devices. For example, specific thresholds for electrical safety, biocompatibility, resistance, and humidification output are defined by standards like IEC 60601-1, ISO 5367, and ISO 18562. The device's performance is measured against these objective, quantifiable benchmarks.
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.
Summary of Non-Clinical Studies and Standards:
The study that proves the device meets the acceptance criteria is a series of non-clinical tests covering various aspects:
- Mechanical Performance: Demonstrated conformance to ISO 5367 (Breathing sets and connectors) and ISO 80601-2-12 (Critical care ventilators).
- Thermal Safety: Implied by testing against the aforementioned standards and the device's function as a heated breathing circuit.
- Environmental Conditions: Not explicitly detailed beyond compliance with relevant standards.
- Electrical Safety and Electromagnetic Compatibility (EMC): Tested according to IEC 60601-1 (basic safety and performance) and IEC 60601-1-2 (EMC).
- Functional Verification and Performance Capacity and Accuracy: Demonstrated through compliance with ISO 5367, ISO 80601-2-12, ISO 5356-1 (Conical connectors), and ISO 80601-2-74 (Respiratory humidifying equipment).
- Biocompatibility Testing: Materials and completed products were evaluated through biological qualification safety tests as outlined in ISO 10993-1 ("Biological Evaluation of Medical Devices") and ISO 18562 series ("Biocompatibility evaluation of breathing gas pathways in healthcare"). Specific tests included:
- Emissions of particulate matter (ISO 18562-2)
- Emission of VOC with additional humidity (ISO 18562-3)
- Leachables in condensate (ISO 18562-4)
- Extraction (ISO 10993-18)
- Material characterization (ISO 10993-18)
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Irritation (ISO 10993-10)
The "acceptance criteria" are implicitly defined by the requirements of these recognized consensus standards and the performance characteristics of the predicate devices, which the subject devices "meet all applicable requirements of" and are found to be "substantially equivalent" to. The testing demonstrates that despite some technological differences, no new safety or effectiveness concerns are raised compared to the predicate devices.
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(295 days)
Draegerwerk AG & CO KGaA
The Babylog intensive care Ventilator (Babylog VN600) is intended for the ventilation of neonates with a body weight of 0.4 kg (0.88 lb) to 10 kg (22 lb) and for pediatric patients with an IBW of 5.2 kg (11.5 lb) to 20.1 kg (44.3 lb).
This device provides mandatory pressure-controlled ventilation modes for supporting spontaneous breathing, and ventilation monitoring.
The intensive care ventilators Babylog VN800 and Babylog VN600 were developed and are manufactured by Dräger in Lübeck, Germany.
Babylog VN800 and Babylog VN600 are specified for the ventilation of pediatric patients and neonates. These devices provide mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring.
Babylog VN800 and Babylog VN600 are available in different device variants and can additionally be upgraded by software and hardware options as well as attachable accessories.
Babylog VN800 and Babylog VN600 are available with a basic device configuration that comprises the following:
- Trolley with four castors and brakes
- Display unit (graphical user interface)
- Ventilation unit
The changes have been made in the device design including functional integration of the Infinity series C cockpit into the device by changing "PC based Cockpit technology" to an "Embedded Control Display (ECD) technology" including a visually updated (color) in the graphical user interface. The hardware complexity has been reduced. In addition, a Gas supply Unit has been added as well as the Power supply Unit as an option. The device software and firmware have been redesigned. The functionality and features of Babylog VN800 / VN600 are identical to the predicate device.
It appears the provided text describes a 510(k) premarket notification for a medical device, the Babylog VN800/VN600 ventilator. However, the document focuses on demonstrating substantial equivalence to a predicate device based on technical specifications, intended use, and adherence to consensus standards. It does not present a clinical study to prove the device meets acceptance criteria related to its performance in a clinical setting with human subjects or a clinical outcome.
Specifically, the document lists "Non-clinical Testing" including:
- Sterilization
- Biocompatibility
- Software, including cybersecurity
- Electrical safety
- Electromagnetic compatibility (EMC)
- Alarm Systems in medical electrical equipment
- Respiratory gas monitors
- Waveforms, including comparisons to the predicate device and performance
- Technical System Requirements
- Accessories compatibility
- Human factors engineering, usability
The "Conclusion" states that "The conclusions drawn from non-clinical tests and the comparison of intended use and technological characteristics with its predicate demonstrate that the new product Babylog VN800 / Babylog VN600 is substantially equivalent to the predicate device... and does not raise new questions of safety or effectiveness."
Therefore, based solely on the provided text, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The document does not describe specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical application. The "performance" mentioned refers to technical performance related to waveforms, not clinical outcomes.
- Sample size used for the test set and data provenance: There is no mention of a human test set. The testing described is non-clinical.
- Number of experts used to establish the ground truth: Not applicable as there is no clinical test set requiring ground truth established by experts.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable, as this is a physical ventilator device, not an AI algorithm for diagnosis/detection.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as this is not an AI/ML-based device requiring a training set in the typical sense.
- How ground truth for the training set was established: Not applicable.
The document demonstrates that the device functionally meets standards and is similar to a previously cleared device, but it does not detail a study proving clinical performance against specific acceptance criteria in the way you've outlined for an AI-powered diagnostic or similar product.
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(309 days)
Draegerwerk AG & Co. KGaA
The Evita intensive care ventilator (Evita V800 / Evita V600) is intended for the ventilation of adults, pediatric patients and neonates weighing a minimum of 0.4 kg (0.88 lb). The device is indicated for patients who require temporary or longer-term breathing support for different medical reasons. The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport. The device is intended to be used by qualified and trained medical personnel. The device is indicated to provide critical care specific therapy. The device provides ventilation monitoring and modes for volume controlled, pressure controlled and spontaneous breathing.
The intensive care ventilators Evita V800 and Evita V600 were developed and are manufactured by Dräger in Lübeck, Germany. Evita V800 and Evita V600 are specified for the ventilation of adults, pediatric patients and neonates. These devices provide mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring. Evita V800 and Evita V600 are available in different device variants and can additionally be upgraded by software and hardware options as well as attachable accessories. Evita V800 and Evita V600 are available with a basic device configuration that comprises the following: Trolley with four castors and brakes, Display unit (graphical user interface), Ventilation unit. The changes have been made in the device design including functional integration of the Infinity series C cockpit into the device by changing "PC based Cockpit technology" to an "Embedded Control Display (ECD) technology" including a visually updated (color) in the graphical user interface. The hardware complexity has been reduced. In addition, a Gas supply Unit has been added as well as the Power supply Unit as an option. The device software and firmware have been redesigned. The functionality and features of Babylog VN800 / VN600 are identical to the predicate device.
The provided text is a 510(k) Premarket Notification Summary for the Dräger Evita V800 and Evita V600 ventilators. It details the device's characteristics and its substantial equivalence to predicate devices. However, the document does not contain information regarding an acceptance criteria table, device performance report, details of a study with sample sizes, data provenance, expert ground truth, adjudication methods, MRMC comparative effectiveness study, standalone algorithm performance, or training set details.
The document focuses on demonstrating substantial equivalence to predicate devices (Infinity Acute Care System Workstation Critical Care K093633 and Puritan Bennett™ 980 Series Ventilator System K193056) through comparison of intended use, technological characteristics, and non-clinical testing.
The "Discussion of Non-clinical Testing" section lists various tests performed, such as sterilization, biocompatibility, software, electrical safety, EMC, alarm systems, respiratory gas monitors, waveforms, technical system requirements, accessories compatibility, and human factors engineering. It states that results were summarized in "Test Summary tables" and "evidence included in this submission," but these summaries and evidence are not present in the provided text.
Therefore, I cannot fulfill the request for information on acceptance criteria, device performance, or study details as this information is not included in the provided 510(k) summary.
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(352 days)
Draegerwerk AG & Co. KGaA
Intended use The Dräger CO2 Mainstream Sensor for measuring the CO2 concentration in breathing gas (CO2 mainstream sensor).
Indications The CO2 mainstream sensor enables the diagnosis and monitoring of patients by measuring CO2. The use of the medical device is limited to one patient at a time.
The CO2 Mainstream Sensor is designed for continuous, non-invasive mainstream measurement of Carbon Dioxide. The sensor is able to monitor CO2 using an infrared absorption technique and measures end tidal CO2 and inspired CO2 and calculates the respiratory rate. The data are processed by a microcontroller and provided to the parent device via a serial interface.
The sensor is adapted to the breathing system by airway adapters (CO2 measuring cuvettes).
Here's a summary of the acceptance criteria and study information for the CO2 Mainstream Sensor, based on the provided FDA 510(k) premarket notification:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics of the CO2 Mainstream Sensor with corresponding reported values in a consolidated format. However, it mentions extensive testing against various standards, which imply certain performance criteria. The key performance-related mention is the "Measuring range," which has been slightly extended compared to the predicate device.
| Performance Metric | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance |
|---|---|---|
| Measuring range | 0 to 13.2 Vol.%, 0 to 13.3 kPa, 0 to 100 mmHg | 0 to 15.8 Vol% (at 1013 hPa), 0 to 16.0 kPa, 0 to 120 mmHg |
| Respiratory Rate Range | 0 to 150 /min | 0 to 150 /min |
| Operating Temperature | -20 to +50 °C (-4 to 122 °F) | -20 to +50 °C (-4 to 122 °F) |
| Operating Humidity | 5 to 95 %, non-condensing | 5 to 95 %, non-condensing |
| Operating Ambient Air Pressure | 57 - 110 kPa (K100941) / 570 to 1100 hPa (428 to 825 mmHg) | 570 to 1100 hPa (428 to 825 mmHg) |
| Protection against penetrating liquids | IP64 | IP64 |
| Electrical Safety | Conformance to IEC 60601-1-6, IEC 60601-1-12 | Tested and Conforms |
| EMC | Conformance to IEC 60601-1-2, IEC/TR 60601-4-2 | Tested and Conforms |
| Biocompatibility | Conformance to ANSI AAMI ISO 10993-1 | Tested and Conforms |
| Software | Conformance to ANSI AAMI IEC 62304 | Tested and Conforms |
| Usability | Conformance to IEC 60601-1-6, AAMI / ANSI / IEC 62366-1 | Tested and Conforms |
| Risk Management | Conformance to ANSI AAMI ISO 14971 | Tested and Conforms |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for specific performance tests or studies like clinical trials in terms of the number of patients or specific data points. The testing mentioned is primarily bench testing and in vitro evaluations against technical standards and requirements.
The data provenance is not specified beyond indicating "extensive testing" and "well-established methods." It's reasonable to infer these tests were conducted by the manufacturer (Drägerwerk AG & Co. KGaA) in Germany, given the submitter's location. The studies appear to be retrospective in nature, drawing from the predicate device's established performance and applying new testing to demonstrate equivalence or improvement.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for testing in the context you describe (e.g., radiologists for image interpretation). The testing conducted is primarily objective, technical verification and validation against pre-defined standards and specifications for a CO2 sensor. Therefore, the "ground truth" for the test set would be derived from:
- Reference gases with known concentrations for CO2 measurements.
- Calibrated instruments for temperature, humidity, pressure, and electrical measurements.
- Standardized test procedures and benchmarks for software, EMC, and safety.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned, as this type of human expert consensus is not typically applicable to the kind of technical and bench testing described for this device. Test results would be compared directly to the specified standards and requirements.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. The CO2 Mainstream Sensor is a measurement device where its output is directly read rather than interpreted by multiple human readers in a comparative setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described appears to be primarily standalone performance testing, focusing on the algorithm (implicitly, the sensor's measurement principle and data processing) and hardware of the device itself. The "Discussion of Non-clinical Testing" section lists various technical evaluations, including software, electrical safety, EMC, and specific performance requirements from ISO 80601-2-55 for respiratory gas monitors. These are conducted on the device's inherent capabilities without human intervention for interpretation as part of the performance evaluation.
7. The Type of Ground Truth Used
The ground truth used for the technical testing would be:
- Reference Standards: Such as known concentrations of CO2 for accuracy testing, established environmental conditions (temperature, humidity, pressure), and defined electrical safety limits.
- Calibration Standards: High-precision instruments used to calibrate and verify the accuracy of the sensor's measurements.
- Compliance to Standards: The device's performance is measured against predefined thresholds and specifications outlined in the various IEC and ISO standards listed (e.g., ISO 80601-2-55 specific requirements for respiratory gas monitors).
8. The Sample Size for the Training Set
This device appears to be based on an established measurement principle (infrared absorption), and the submission focuses on demonstrating substantial equivalence through non-clinical testing rather than development of a novel algorithm that would require a "training set" in the machine learning sense. Therefore, there is no mention of a training set sample size as it's not applicable to the development verification of this type of device.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" mentioned in the context of machine learning, this question is not applicable to the information provided. The principles the device operates on are well-understood physics, and the validation relies on meeting established technical specifications and standards rather than learning from a dataset.
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(259 days)
Draegerwerk AG & Co. KGaA
Babyleo TN500 is intended for use with premature babies and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.Neonates are kept warm in the patient with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: - Temperature - Humidity - Oxygen (option)
The device Babyleo TN500 is a medical device used to maintain environmental conditions suitable for preterm babies and neonates. The important features are temperature and humidity. The operational principle is a combination of a neonatal incubator and an open warmer.
Babyleo TN500 can be operated in closed care therapy as an incubator according to IEC60601-2-19 or in open care therapy as a warmer according to IEC60601-2-21. Additionally, an optional x-ray translucent heated mattress is intended to provide sensible heat to the preterm babies and neonates.
The device consists of the following components: Incubator (=bassinet) with a convection heater and closed humidification system for the patient, trolley, radiant warmer, display, mattress, x-ray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package.
This document is a 510(k) Premarket Notification for the Babyleo TN500, a neonatal incubator and radiant warmer. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The information provided heavily focuses on design verification and validation testing, and therefore, does not contain the details on acceptance criteria and study proving performance in the context of an AI/ML medical device that would typically involve clinical studies, multi-reader multi-case studies, and explicit ground truth establishment with expert consensus.
Given the document talks about a physical medical device (neonatal incubator/radiant warmer) and not an AI/ML diagnostic or prognostic tool, the questions posed about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or AUC, multi-reader multi-case studies, expert consensus for ground truth, effect size for human reader improvement with AI assistance, and training/test set sample sizes and provenance for AI/ML models are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this conventional medical device primarily revolve around safety and performance standards, electrical safety, EMC, software verification, biocompatibility, human factors, and reprocessing validation.
Here's how to address the prompt based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document lists compliance with various standards and provides specifications that serve as performance criteria.
| Acceptance Criteria (Standard Compliance / Performance Spec) | Reported Device Performance (Compliance / Value) |
|---|---|
| Electrical Safety: IEC 60601-1, IEC 60601-2-19, IEC 60601-2-21, IEC 60601-2-35 | Device complies with all listed standards. |
| Electromagnetic Compatibility (EMC): IEC 60601-1-2 | Device complies with the standard. |
| Software Verification and Validation: FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (2005) | Software verification and validation testing conducted; documentation provided; considered "major" level of concern. |
| Biocompatibility: ISO 10993, ISO 10993-1, ISO 10993-17, ISO 10993-18 | Evaluation conducted in accordance with FDA guidance; battery of testing included: Integral Test for volatile organic compounds, Photogenic bacteria test, Emission of particles, Material characterization, Toxicological Evaluation, Cytotoxicity, Irritation, Sensitization. |
| Human Factors: FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff, 2016 | Usability evaluation conducted in accordance with FDA guidance. |
| Reprocessing: FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff, 2015 | Reprocessing validation conducted in accordance with FDA guidance. |
| Operating Noise Volume in Patient Compartment | Typically 40 dB(A) (Measured without oxygen application) - _(Compared to predicate |
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(127 days)
Draegerwerk AG & Co. KGaA
The Infinity Acute Care System Workstations Critical Care consist of monitoring and control displays and additional therapy units. They are intended to be used as integrated, networked, and configurable workstations to provide critical care specific therapy. The Infinity Acute Care System Workstations Critical Care are intended to be used by qualified and trained medical personnel.
The Infinity C Series Medical Cockpits, consisting of the C500 and the C700, are monitoring and control displays for the Infinity Acute Care System (IACS). Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings. The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.
The Evita V500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of adult, pediatric and neonatal patients. Evita V500 offers mandatory ventilation modes and ventilation modes for spontaneous breathing support and airway monitoring. The Evita V500 ventilation unit is used with Infinity C Series Dräger Medical Cockpits. The Evita V500 ventilation unit is intended for use in different medical care areas.
Evita V500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.
The Infinity Acute Care System Workstation Critical Care provides critical-care specific functionality. It is made up of the Infinity Medical Cockpit C500 and the ventilation unit Evita Infinity V500. The optional gas supply unit GS500 can be added. The ventilation unit provides critical-care specific ventilation and monitoring data of ventilation parameters. The Infinity Medical Cockpit is the control and display unit witch runs a ventilation application. The patient monitoring data are displayed on the Infinity Medical Cockpit, which is also used to control ventilation settings including alarms. The optional gas supply unit provides compressed air to the ventilation unit in case of central gas failure or in house transport.
This document is a 510(k) summary for the Dräger Infinity Acute Care System Workstation Critical Care. It does not contain the detailed information required to describe acceptance criteria and a study that proves the device meets those criteria, as typically found in a clinical study report or validation protocol.
The document primarily focuses on:
- Device Description: What the device is and its components (Infinity Medical Cockpit and Evita Infinity V500 ventilator).
- Operating Modes/Features: Detailed list of ventilation modes (VC, PC, Spn, and special modes).
- Regulatory Information: Applicant details, date of submission, device name, and the FDA's 510(k) clearance letter (K093633).
- Standards Compliance: A list of performance testing standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-12, IEC 60601-1-6, IEC 60601-1-8, EN ISO 14971, EN ISO 17664) and the FDA Guidance for Ventilators: 1995.
- Indications for Use: The intended purpose and patient population for the device.
Therefore, I cannot provide the requested information from the provided document.
The document states that "Performance was tested in compliance with following standards," and lists various IEC and ISO standards, along with the FDA Guidance for Ventilators: 1995. However, it does not include:
- A table of specific acceptance criteria and reported device performance values. The standards listed usually define general safety and essential performance requirements, but the specific, quantitative acceptance criteria for this particular device are not detailed here, nor are the actual performance results (e.g., measured accuracy of a parameter, response time, etc.).
- Details of any specific studies conducted to demonstrate clinical performance or effectiveness. This document is a regulatory submission for substantial equivalence based on technical standards and predicate devices, not a report of a clinical efficacy or performance study. As such, it lacks information on:
- Sample sizes (for test sets or training sets)
- Data provenance
- Number and qualifications of experts for ground truth
- Adjudication methods
- MRMC comparative effectiveness study results or effect sizes
- Standalone algorithm performance
- Type of ground truth used
- How ground truth was established for any training data.
In summary, the provided text describes regulatory compliance through adherence to standards but does not detail the specific performance acceptance criteria or the study data that would demonstrate the device meets those criteria in a quantitative sense.
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