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The Isolette® 8000 plus 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 neonatal incubator that provides a controlled environment for both premature and full-term infants up to a maximum of 10 kg (22lbs). It controls temperature, oxygen and humidity (both are optional).

The predicate device as cleared in K172154 is offered with the hood and shell assembly of the incubator mounted on a variable high adjustable (VHA) trolley. All components and accessories for the device were cleared as part of the system.

The modification of the device is the replacement of the variable height adjustable (VHA) trolley with a fixed-height cabinet stand trolley. All other components and accessories of the device are identical to those cleared under K172154.

The modification does not change the intended use or alter the fundamental scientific technology of the currently approved predicate device.

This document is a 510(k) premarket notification for a modification to an existing medical device, the Isolette® 8000 Plus Neonatal Incubator. The modification involves replacing the variable height adjustable (VHA) trolley with a fixed-height cabinet stand trolley. No AI/ML components are involved in this device, therefore, many of the requested fields are not applicable.

Here's a summary based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document focuses on demonstrating that the modified device remains substantially equivalent to its predicate device (Isolette® 8000 plus, K172154) despite the change in the trolley. The acceptance criteria essentially align with the predicate device's established performance and safety standards. The performance of the modified device is reported as "Same" for nearly all specifications, with "Different – No impact on effect on safety and effectiveness" for the few physical attribute changes.

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

This document describes a modification to an existing device, not a study involving human or animal subjects that would typically have a "test set" in the context of clinical data. The "test set" here refers to the engineering verification and validation activities. The document summarizes these activities as having been "carried out under well established methods." There is no information regarding the sample size of devices tested for Instability, Electrical Safety, and EMC, nor is there information on data provenance beyond being "non-clinical testing."

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)

This is not applicable to an engineering verification of a medical device modification. The "ground truth" for the tests performed (Instability, Electrical Safety, EMC) is established by the relevant international standards (IEC60601-1, IEC60601-1-2) which define the pass/fail criteria. Expertise would be in the form of qualified engineers and technicians performing the tests and reviewing the results against these standards.

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

Not applicable. This is not a study involving human reader interpretation or consensus on data. The verification activities are against predefined technical standards.

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

Not applicable. This device is a neonatal incubator, not an AI-powered diagnostic tool, and its modification does not involve human readers or AI assistance.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for the non-clinical testing refers to the established standards for medical device safety and performance, specifically IEC60601-1 (general medical electrical equipment safety), IEC60601-1-2 (electromagnetic compatibility), and IEC60601-2-19 (basic safety and essential performance of infant incubators). These standards define the acceptable limits and performance characteristics.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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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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