(496 days)
The device is intended to warming pre-set body temperature as determined by the physician. It can also be utilized to warming normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. The device has heating capability, not cooling.
This device is an external thermal regulating system consisting of blankets that are placed in contact with the patient, and a temperature controller and is to warming the patient's temperature using carbon technology between 30 and 40 ℃ (86 and 104ºF). The function of the device is heating, not cooling. The heating element and sensor are both embedded inside the blankets. Four blanket sizes are available: 11- 100 Watts, Pediatric: 1.0 by 0.65 meters (3.3 by 2.17) and 3mm high (0.12 inches) weighing 0.9 kgs (Product code WD-01-100); 2 140 Watts, Adult: 2.0 by 1.35 meters (6.6 by 4.5 ft) and 3mm high (0.12 inches) weighing 2.0 kgs (Product code WD-01-200); 3- 40 Watts, Arm Shoulder: 1.5 meters (5.0 ft) and 3mm high (0.12 inches) weighing 1.0 kg (Product code 150-AW); 4- 50 Watts, Leg Warmer: 0.95 meters (3.17 ft) and 3mm high (0.12 inches) weighing 1.2 kgs (Product code 100-DB).
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the new device.
However, based on the available information, I can extract and infer some points regarding the study and acceptance criteria as presented in a 510(k) context:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Claimed) |
|---|---|
| Indications for Use: Identical to predicate device | Identical |
| Target Population: Identical to predicate device | Identical |
| Design: Similar to predicate device | Similar |
| Materials: Similar to predicate device | Similar |
| Performance: Identical to predicate device | Identical |
| Biocompatibility: Similar to predicate device | Similar |
| Mechanical safety: Identical to predicate device | Identical |
| Chemical safety: Identical to predicate device | Identical |
| Anatomical sites: Identical to predicate device | Identical |
| Human factors: Identical to predicate device | Identical |
| Energy used and/or delivered: Identical to predicate device | Identical |
| Compatibility with environment and other devices: Identical | Identical |
| Where used: Identical to predicate device | Identical |
| Standards met: Identical to predicate device | Identical |
| Electrical safety: Identical to predicate device | Identical |
| Thermal safety: Identical to predicate device | Identical |
| Radiation safety: Identical to predicate device | Identical |
| Function: Heating the patient's temperature using carbon technology between 30 and 40 ℃ (86 and 104ºF). | The device's description states it performs this function. |
Explanation for "Inferred" Acceptance Criteria:
In a 510(k) submission, "acceptance criteria" are generally tied to demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This means the new device must perform as safely and effectively as the predicate, often by having the same technological characteristics or having different characteristics that do not raise new questions of safety or effectiveness and are demonstrated to be as safe and effective. The table above reflects the claims made in the "Summary comparing technological characteristics with other predicate device" section.
2. Sample Size for Test Set and Data Provenance:
- The document describes a comparison to a predicate device (Klimamed® Thermal Mats, 510k # K011859) rather than a clinical performance study with a distinct "test set" and a specified sample size.
- Data Provenance: Not explicitly stated. The comparison is based on the characteristics of the devices themselves, suggesting a technical and regulatory review rather than a new clinical study.
- Retrospective/Prospective: Not applicable in the context of the provided information, as it's a comparative analysis against an existing device's characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- This information is not provided in the document. The substantial equivalence claim is based on a comparison of technical and performance specifications, not on expert consensus or ground truth derived from clinical cases for a test set.
4. Adjudication Method for the Test Set:
- This information is not provided as there is no mention of a test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study is not mentioned in the provided text. This type of study is more relevant for diagnostic imaging devices where human reader performance with and without AI assistance is being evaluated. The Klimamed® Thermal Blankets are therapeutic devices (warming blankets).
6. Standalone (Algorithm Only) Performance Study:
- No, a standalone performance study is not mentioned. The device is a physical product (thermal blankets and a controller) for warming patients, not an algorithm, so this concept does not apply in the usual sense. The "performance" mentioned in the comparison refers to its functional performance as a warming device.
7. Type of Ground Truth Used:
- The concept of "ground truth" as typically used in AI/diagnostic device studies (e.g., pathology, outcomes data) is not directly applicable here. The "truth" in this context is the demonstrated safety and effectiveness of the predicate device, and the new device's characteristics are compared against that established benchmark.
8. Sample Size for the Training Set:
- Not applicable/Not provided. The device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 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).