(321 days)
THIS DEVICE IS INDICATED TO MAINTAIN PRESET BODY TEMPERATURE AS DETERMINED By THE PHYSICIAN. IT CAN ALSO BE UTILIZED TO MAINTAIN NORMAL BODY TEMPERATURE DURING SURCICAL PROCEDURES . IT IS INDICATED FOR USE IN HOSPITAL INVASIVE AND CORONARY CARD UNITS, IN OPERATING, RECOVERY AND EMERGENCY IN BURN UNITS, Rock's AND ON MEDICAL | SURGICAL floors
This device is an external thermal regulating system consisting of a mat that is placed in contact with the patient and a temperature controller and is to regulate the patient's temperature between 30 and 37.7 ℃ (86 and 100ºF), using carbon technology. The heating element and sensor are both embedded inside the mat. Two mat sizes are available: 1- 95 Watts, Standard 0.950 by 0.495 meters (3.1 by 1.6 ft) and 9mm high (0.35 inches) weighing 5 kg (11 lbs) (Product code 75/95/12M) for adult patients 2- 55 Watts, Pediatric 0.550 by 0.495 meters (1.8 by 1.6 ft) and 9mm high (0.35 inches) weighing 3.5 kg (7.7 lbs) (Product code 55/95/12M) for pediatric patients 75/95/12PRM consists of the Controller Micro 75-150 (product code 120/240/12PM) and mat 75/95/12M 55/95/12PRM consists of the Controller Micro 75-150 (product code 120/240/12PM) and mat 55/95/12M
The provided 510(k) summary for the Klimamed® Thermal Mat & Controller 95 & 55 Watts does not contain detailed information about specific acceptance criteria, a study proving device performance, sample sizes for test or training sets, expert qualifications, or adjudication methods.
Instead, the submission primarily focuses on demonstrating substantial equivalence to a predicate device (Allon 2001 by M.T.R.E Advanced Technology, Ltd, K001546) based on technological characteristics.
Here's a breakdown of the available information and what's missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as numerical targets or benchmarks that the device had to achieve. Instead, it relies on a comparative table to show that the Klimamed® device's characteristics are "Identical" or "Similar" to the predicate device.
| Characteristic | Comparison Result (Klimamed® vs. Predicate) |
|---|---|
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Identical |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Similar |
| Thermal safety | Similar |
| Radiation safety | Similar |
What's missing regarding "reported device performance":
The document states "Performance: Identical" in the comparison table, but it does not provide any specific performance metrics, data, or results from tests conducted on the Klimamed® Thermal Mat & Controller itself. It implicitly claims that because its performance is "Identical" to a legally marketed predicate, it meets an unstated, accepted level of performance.
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 510(k) summary. The submission does not describe a specific clinical or performance test set with a defined sample size. The equivalence is primarily based on a comparison of technological characteristics.
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 information is not provided. As no specific performance study on a test set is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This is not applicable to this device. The Klimamed® Thermal Mat & Controller is a thermal regulating system, not an AI-assisted diagnostic device that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. It is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. No specific test set or ground truth establishment is described. The "ground truth" for demonstrating substantial equivalence appears to be the established safety and effectiveness of the predicate device based on its prior market clearance.
8. The sample size for the training set
This information is not provided. This device is a physical medical device, not a machine learning model, so the concept of a "training set" in this context does not apply.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
In summary:
The 510(k) submission for the Klimamed® Thermal Mat & Controller relies on a comparison of technological characteristics to a predicate device to demonstrate substantial equivalence, rather than providing detailed acceptance criteria and the results of a specific performance study against those criteria. The argument is that since the device's characteristics (including "Performance") are "Identical" or "Similar" to a device already cleared by the FDA, it is considered safe and effective.
§ 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).