Search Results

The RPI heating elements are used to emit infrared radiant heat in an infant radiant warmer to maintain an infant's body temperature. The heating elements are identical to those supplied as original equipment as part of the infant radiant warmer.

The RPI Replacement Heating Elements are intended to be used as replacement parts for the Hill-Rom Air Shields infant radiant warmers. The RPI heating elements are used to emit infrared radiant heat in an infant radiant warmer to maintain an infant's body temperature. The Replacement Heating Elements are available in different outputs (wattage) and terminations. The heating elements are provided nonsterile.

This 510(k) summary (K020966) describes RPI Replacement Heating Elements, which are replacement parts for infant radiant warmers. The submission states that "No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Replacement Heating Elements. The design, form, and materials of the probes are identical to their predicate devices." Therefore, the document leverages substantial equivalence to predicate devices rather than presenting a study where the device itself meets specific performance criteria.

As such, acceptance criteria and device performance as typically understood for new medical devices or software algorithms are not applicable or provided in this 510(k) submission.

Here's an breakdown based on the information provided and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission asserts substantial equivalence based on identical design, form, and materials to existing predicate devices. There are no performance metrics or acceptance criteria reported for the RPI Replacement Heating Elements themselves.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable, as no specific performance testing on a "test set" for the RPI Replacement Heating Elements is described. The basis for clearance is manufacturing the replacement parts to be identical to existing, already cleared components.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no mention of expert involvement in establishing ground truth, as the device is a replacement part asserting identicality to existing parts.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a heating element, not an interpretive system that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical heating element, not a software algorithm.

7. Type of Ground Truth Used

Not applicable. No ground truth is established or used for performance evaluation of the RPI Replacement Heating Elements in this submission. The "ground truth" for regulatory clearance is the established performance and safety of the predicate devices to which these parts are identical.

8. Sample Size for the Training Set

Not applicable. This device is a physical replacement part, not an AI or machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set or ground truth for algorithmic development is mentioned.

Summary of the K020966 Submission for RPI Replacement Heating Elements:

This 510(k) submission for RPI Replacement Heating Elements is a premarket notification asserting substantial equivalence to several predicate infant radiant warmer heating elements. The key argument for approval is that the RPI heating elements are identical in design, form, materials, and intended use to existing, legally marketed predicate devices.

The submission explicitly states:

• "No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Replacement Heating Elements."
• "The design, form, and materials of the probes are identical to their predicate devices."
• "The heating elements are identical to those supplied as original equipment as part of the infant radiant warmer."

Because the device is a replacement part claimed to be identical to already approved components, a detailed performance study with specific acceptance criteria, test sets, expert ground truth, or algorithm-specific metrics (like those relevant to AI/ML devices) is not presented or required for this type of submission. The 'proof' of meeting acceptance criteria is the demonstration of identicality to already approved predicate devices.

Ask a specific question about this device