(47 days)
The KIMBERLY-CLARK* Patient Warming System is intended for monitoring and controlling patient temperature. The indications for use of the device include any condition where patient temperature control within the range covering mild hypothermia to normothermia is required.
The Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads is a device used to monitor and control patient temperature. It consists of single-use heat transfer pads, which are adhered to areas of the patient's skin, and a control module that circulates temperature-controlled water. The control module is connected to the pads by flexible tubing. A commercially available probe connected to the control module senses the patient's core temperature. The system can control the patient's core temperature by altering the temperature of the circulating water.
This submission is for a 510(k) premarket notification for the Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads. The submission claims substantial equivalence to a predicate device, the MediVance Inc. ARTIC SUN™ Temperature Management System - Model 100, which was cleared under 510(k) # K002577. The core argument for substantial equivalence is that the Kimberly-Clark device is "identical in design" to the previously cleared MediVance device, and Kimberly-Clark acquired all product rights related to it.
Therefore, the study proving the device meets acceptance criteria relies on the prior clearance of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
Since the submission states the device is "identical in design" to the predicate, and was previously cleared based on that predicate, the acceptance criteria and performance are implicitly met by virtue of the predicate device's clearance. There are no new performance metrics or acceptance criteria presented specifically for the Kimberly-Clark device.
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (Implied from Predicate) |
|---|---|
| Biocompatibility in accordance with ISO 10993-1 and/or USP | Met (as evidenced by predicate clearance) |
| Electrical safety in accordance with IEC601 | Met (as evidenced by predicate clearance) |
| Functional safety and safety performance | Met (as evidenced by predicate clearance) |
| Ability to monitor and control patient temperature within range of mild hypothermia to normothermia | Met (as evidenced by predicate clearance and identical design claim) |
2. Sample size used for the test set and the data provenance:
Not applicable. This 510(k) submission does not involve a new clinical study with a test set of data for the Kimberly-Clark device. The claim is based on the identical design to a previously cleared device. The "testing" mentioned refers to tests conducted for the original MediVance device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new ground truth for a test set was established for this submission.
4. Adjudication method for the test set:
Not applicable. No new test set requiring adjudication was performed.
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 thermal regulating system, not an AI-based diagnostic tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a thermal regulating system, not an algorithm, and intrinsically involves human interaction for setup and monitoring.
7. The type of ground truth used:
Not applicable for this submission. The "ground truth" for proving the device meets its intended use was established during previous testing of the predicate device, likely through:
- Engineering verification and validation (e.g., temperature accuracy, control algorithms).
- Biocompatibility testing against standards.
- Electrical safety testing against standards.
- Functional performance testing to demonstrate the ability to achieve and maintain target temperatures in vitro or in animal models (though details are not provided in this summary).
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
Summary of the Study Proving Acceptance Criteria:
The study proving the Kimberly-Clark Patient Warming System - Model 100 meets acceptance criteria is essentially the prior 510(k) clearance (K002577) of the MediVance Inc. ARTIC SUN™ Temperature Management System - Model 100.
According to the provided text:
- "The Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads is the exact same medical device as MediVance's Artic Sun™ Temperature Management System which obtained FDA clearance on October 26, 2000." (Section 14, Pg 2, Item 8. Conclusions)
- Kimberly-Clark "acquired all product rights related to the patient warming business from MediVance, Inc. on May 27, 2003." (Section 14, Pg 2, Item 6. Summary of technological characteristics)
- "Testing of the Kimberly-Clark Patient Warming System -- Model 100 Control Unit and Energy Transfer Pads [under MediVance's 510(k) # K002577], included: biocompatibility testing in accordance with ISO 10993-1 and / or USP, electrical testing in accordance with IEC601 and functional safety and safety performance testing." (Section 14, Pg 2, Item 7. Testing)
Therefore, the Kimberly-Clark device meets its acceptance criteria because it is a re-submission of a device that has already undergone and passed the required testing for safety and effectiveness, leading to its original clearance by the FDA. The identical design and acquisition of product rights mean no new testing was deemed necessary for this specific 510(k) submission (K033021) to demonstrate substantial equivalence to the predicate.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).