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The Isolette® 8000 plus incubator is indicated for thermoregulation and controlling oxygen (optional), and humidity (optional) for both premature and full-term infants up to a maximum of 10 kg (22lbs).

The Isolette® 8000 plus is not intended for home use.

The Isolette 8000 plus is a device used to maintain environmental conditions suitable for neonates. The Isolette 8000 plus incubator provides a controlled environment for both premature and full-term infants up to a maximum of 10 kg (22lbs). It controls temperature, oxygen (optional) and humidity (optional). It is a controller-based incubator featuring the ability to enable simultaneous control of temperature, and optional oxygen and humidity. The system operates on AC power. Data is provided on a liquid crystal display. It is operated in closed care therapy as an incubator according to IEC60601-2-19.

Components include hand ports or iris ports, access panel, serial port, trolley with height adjustment, castor wheels with brakes, power receptacle, a Trendelenburg bed-tilt mechanism (0° to 12°), softbed mattress, skin temperature probes, probe covers, oxygen inlet, sensor module, hose grommets, accessoryrail and cable wrap. Optional components include IV pole, drawers, water reservoir, collection bottler mount litter bag holder, basket for gloves, breathing hose holder kit, tray, high frequency ventilation (HFV) door with grommets, positioning aids, incubator cover, and monitor shelf.

The provided text describes the regulatory clearance of the Isolette® 8000 plus neonatal incubator and its comparison to a predicate device (Isolette® Infant Incubator, Model C2HS, K001242) for showing substantial equivalence. It does not contain information about an AI-powered device or a study involving human experts or a training set for machine learning. Therefore, many of the requested details are not applicable as this is a traditional medical device submission without AI.

However, based on the provided text, I can extract the acceptance criteria and a summary of the non-clinical studies performed to demonstrate that the device meets those criteria.

Acceptance Criteria and Device Performance for Isolette® 8000 plus (K172154)

This submission is for a traditional medical device (neonatal incubator) and does not involve AI. Therefore, numerous requested sections related to AI performance, human expert evaluation, and training sets are not applicable.

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

The acceptance criteria are generally implied by the stated specifications and compliance with recognized standards. The "Device Under Review" column effectively serves as the reported device performance compared to the predicate.

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

This information is not provided in the document. The studies were non-clinical bench testing, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a non-AI medical device submission, and the ground truth was established through engineering specifications, regulatory standards compliance, and bench testing, not human expert interpretation of data.

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

Not applicable. This is a non-AI medical device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a non-AI medical device submission.

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

Not applicable. This is a non-AI medical device submission. The device performs as a standalone incubator without human-in-the-loop performance in the context of an AI algorithm; however, human operators are inherently part of its use.

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

The "ground truth" for this device is based on engineering specifications, recognized international standards (e.g., IEC 60601-1, IEC 60601-2-19, IEC 60601-1-2, ISO-10993), and internal design control procedures. Performance benchmarks are set by these standards and the predicate device's capabilities.

8. The sample size for the training set

Not applicable. This is a non-AI medical device submission; there is no "training set" in the machine learning sense.

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

Not applicable.

Summary of Studies to Prove Acceptance Criteria are Met (Non-Clinical Testing):

The Isolette® 8000 plus underwent a series of non-clinical bench tests and evaluations to demonstrate its safety and effectiveness and substantial equivalence to the predicate device. These include:

• Performance Testing: Conducted in accordance with applicable standards and technical system requirements, as well as the device's Instructions for Use (IFU) Technical Data Section. This covers all the operational specifications listed in the table above (e.g., temperature control ranges, humidity accuracy, oxygen control, noise levels, warm-up times).
• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-2-19 (safety and performance), and IEC 60601-1-2 (EMC).
• Software Verification and Validation Testing: Conducted following FDA guidance for medical device software. The software was considered a "major" level of concern.
• Biocompatibility Testing: Conducted in accordance with FDA guidance on ISO 10993 standards. Tests included:
  • Integral Test for volatile organic compounds
  • Photogenic bacteria test
  • Emission of particles
  • Material characterization (ISO 10993-18)
  • Toxicological Evaluation (ISO 10993-17)
  • Cytotoxicity
  • Irritation
  • Sensitization
• Human Factors: Usability evaluation conducted in accordance with FDA guidance on Human Factors and Usability Engineering.
• Reprocessing: Assessed following FDA guidance ("Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling").
• Cleaning/Disinfection: Macroscopic and microbiological validation performed with Oxycide by an accredited laboratory (DIN EN ISO/IEC 17025).
• Kangaroo Mode Performance Testing: Performed according to the technical requirements for this new feature.
• Autohumidity Performance Testing: Performed according to technical requirements for the optional humidification system.
• Thermomonitoring Performance Testing: Performed according to technical requirements.
• External Communication (Serial data output or Medibus X) Performance Testing: Performed according to technical requirements.
• Trendelenburg (Tilt Mechanism) Regression Testing: Performed for mechanical changes compared to the predicate device.

No animal or clinical studies were conducted for this submission. The conclusion drawn from these non-clinical studies was that the Isolette® 8000 plus meets performance requirements and standards and is substantially equivalent to the predicate device K001242.

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The Infinity Delta Series Monitor (Delta/Delta XL/Kappa) are capable of

• monitoring:
• · Heart rate
• · Respiration rate
• · Invasive pressure
• · Non-invasive pressure
• · Arrhythmia
• · Temperature
• · Cardiac output
• · Arterial oxygen saturation
• · Pulse rate
• · Apnea
• · ST Segment Analysis
• 12-Lead ST Segment Analysis
• · tcp02/tcpC02
• · EEG signals
• · FiO2
• etCO2
• · Respiratory mechanics
• · Anesthetic agents
• · Neuromuscular transmission

The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians. Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The Infinity Delta Series (Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arthythmia which are intended for use in the adult and pediations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.

For combination with Scio gas module:

Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the Infinity monitors.

Infinity Delta and Kappa Series Monitors (Delta XL/ Kappa) are multi-parameter patient monitors intended for use at the patient bedside for the collection of physiological data. The intent of this 510(k) is to describe the proposed software and hardware modifications to the Infinity Delta and Kappa Series Monitors version VF9.1 which includes the integration of an alternative etCO2 solution for the Delta and Delta XL patient monitors as well as software enhancements for the Delta, Delta XL and Kappa patient monitors.

The provided text is a 510(k) summary for the Infinity Delta, Infinity Delta XL, and Infinity Kappa patient monitors. It describes software and hardware modifications to the existing devices, primarily the integration of an alternative etCO2 solution. However, it does not contain a study that proves the device meets specific acceptance criteria with detailed performance metrics, sample sizes, or ground truth establishment.

Instead, the summary states:

• "The substantial equivalence was assessed via internal verification tests, validation evaluations and external tests to FDA recognized consensus standards."
• "Performance data related to each proposed modification has been tested and evaluated."
• "High level summary reports are included in this special 510k demonstrate the changes to the monitors are substantially equivalent to the predicate devices."
• "The modified Infinity Delta and Kappa Series Monitors have been tested in accordance with applicable standards and internal design control procedures and were determined to be as safe and effective as the predicate device for its intended use."

This indicates that testing was performed, but the details of those tests, including specific acceptance criteria and detailed performance results, are not present in this document. The document focuses on demonstrating substantial equivalence to a predicate device (K070566) rather than providing a detailed performance study against specific acceptance criteria for a novel device.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, or adjudication methods from the provided text. The document asserts that testing was done to ensure substantial equivalence, but it does not present the results of such testing in the format you've requested.

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