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The Air Shields ISOLETTE® Infant Incubator is designed to care for the smaller premature baby as well as the healthier full term baby. It does this by providing a controlled environment, one in which the baby can be provided with the necessary care as well as being left undisturbed in the security of the incubator.

It is to this end that the product can be used in any department of the hospital that provides neonatal and infant care. One would typically expect the ISOLETTE® to be used in the NICU/SCBU (Neonatal Intensive Care Unit and/or the Special Baby Care Unit). The design lends itself to all levels of care in the NICU making it suitable for use in level I, II, III, and IV where applicable. Other departments would include the Step Down Nursery, Newborn Nursery and Pediatrics.

This device, when fitted with the battery backup feature, may be used to move the infant from one area of the hospital to another while maintaining the controlled environment.

This device is not intended for home use.

This is a prescription device.

The C2000e is an enhancement to the currently marketed C2000 Isolette Infant Incubator originally cleared under 510(k) K960980. The features, functions, and performance of the C2000 incubator remain the same. The C2000e enhancements are additions to the C2000 product features. These additions are a horizontal rail system for attachment of accessories and a battery back up for the unit to maintain the controlled environment in the event of a power failure or to move the infant within the hospital environment.

The provided text describes a 510(k) submission for the C2000e Isolette® Infant Incubator, an enhancement to an already marketed device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a new, high-risk device might.

Therefore, the document does not contain the kind of information requested in the prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.). The focus is on the modifications made and how they relate to the predicate device.

Here's why the requested information is absent and what the document does provide:

• No Acceptance Criteria or Reported Device Performance Table: The document doesn't define specific performance metrics or acceptance criteria for the C2000e beyond the general statement that "The features, functions, and performance of the C2000 incubator remain the same." The enhancements are merely additions (horizontal rail and battery backup).
• No Clinical Study Details: There is no mention of a formal clinical study to prove the device meets acceptance criteria. The 510(k) process for device enhancements often relies on engineering testing and comparison to the predicate, not clinical trials with human subjects to establish diagnostic performance.
• No Sample Sizes, Data Provenance, Expert Ground Truth, Adjudication, MRMC, or Standalone Performance: These are all concepts related to clinical performance studies, typically for diagnostic or predictive AI/ML devices. An infant incubator, particularly an enhanced version of an existing one, would not undergo such evaluation in a 510(k) submission.
• No Training Set Information: As there's no AI/ML component described, there's no training set.
• No Ground Truth Type: Similarly, ground truth is a concept for evaluating diagnostic accuracy, which is not applicable here.

What the document does provide in relation to regulatory approval:

• Predicate Device: K960980 C2000 Isolette® Infant Incubator. The C2000e is an enhancement, meaning its substantial equivalence hinges on the original C2000's proven safety and effectiveness.
• Modifications: Addition of a horizontal rail system and a battery backup.
• Intended Use Statement: Describes the incubator's purpose (controlled environment for infants) and where it can be used (NICU, SCBU, Step Down Nursery, Newborn Nursery, Pediatrics). It also clarifies that the battery backup allows for safe transport within the hospital.
• Regulatory Classification: Class II device, specifically a Neonatal Incubator (21 CFR 880.5400).
• Performance Standards: "None applicable" (referring to specific mandatory standards for the device's original submission, though general requirements like GMP still apply).

In summary: The nature of this 510(k) submission for an enhanced infant incubator does not require or include the detailed performance study information requested in your prompt. The regulatory approval is based on demonstrating that the new features do not raise new questions of safety or effectiveness and that the device as a whole is substantially equivalent to a legally marketed predicate.

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