(80 days)
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.
§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.