(48 days)
The device is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket to reduce cold discomfort during and after surgical procedures.
The Snuggle Warm® 4000 Convective Warming System consists of a Convective Warming Unit, a hose that connects to the Convective Warming Unit on one end and connects to a blanket on the other end. The forced warm air travels from the Warming unit through the hose to the blanket that is placed on the patient.
The provided document describes the regulatory submission for a Sterile Cardiac Blanket. It includes information about the device's characteristics, intended use, and performance testing designed to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum Temperature delivered to the patient: Maximum contact surface temperature not exceeding 48.0°C and average contact surface temperature not exceeding 46.0°C in normal condition, as per ASTM F 2196-02. | Maximum Temperature delivered to the patient: "The Sterile Cardiac Blanket was tested in accordance to the ASTM F 2196-02 Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices. This testing verified that the Sterile Cardiac Blanket maintained a maximum contact surface temperature of not exceeding 48.0℃ and an average contact surface temperature of not exceeding 46.0°C in normal condition." (This directly states the device met the criteria.) |
| Burst Pressure-Pre/post sterilization: Meet the same robustness requirements as the predicate non-sterile Convective Warming Blankets. | Burst Pressure-Pre/post sterilization: "The Burst Pressure of the Sterile Cardiac Blanket was tested in the same manner as the currently marketed non-sterile Convective Warming Blankets were inflated until bursting, and the burst pressure was measured. The Sterile Cardiac Blanket met the same robustness requirements, as do the predicate blankets." (This indicates the device aligned with the predicate's performance.) |
| Tape Strength-Pre and Post Sterilization: Sterilization to have minimal negative effects on the tape adhesive, even after a worst-case scenario of 3 levels of ethylene oxide exposure. | Tape Strength-Pre and Post Sterilization: "The tensile strength of the tape bond was measured pre and post sterilization, and after 3 levels of ethylene oxide exposure. While 3 levels of ethylene oxide dosage would represent a worst-case scenario. Test results indicate that sterilization have minimal negative effects on the tape adhesive." (This confirms the device met this criterion.) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (i.e., number of blankets tested) used for the performance tests (maximum temperature, burst pressure, tape strength). It refers to "testing" and "test results" without numerical quantities.
Regarding data provenance, the tests were conducted in-house by Smiths Medical ASD, Inc. and are described as "Proprietary and Confidential Information." There's no mention of external laboratory testing or specific geographic origin of the test data beyond the company's location in Rockland, MA, USA. The testing appears to be prospective in the sense that it was conducted specifically to evaluate the new sterile device against established standards and the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a physical medical device (a sterile cardiac blanket); therefore, the concept of "ground truth" established by experts in the context of diagnostic imaging or clinical interpretation does not apply. The acceptance criteria are based on quantifiable physical properties and performance standards (e.g., ASTM F 2196-02), and the evaluation is through objective measurements rather than expert consensus on a subjective interpretation.
4. Adjudication method for the test set
Not applicable. As described above, the evaluation involves objective physical measurements against predefined standards and comparison to a predicate device, not subjective interpretations requiring adjudication among experts.
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 physical sterile cardiac blanket, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical sterile cardiac blanket, not an algorithm, so the concept of standalone performance does not apply.
7. The type of ground truth used
The "ground truth" (or more appropriately, the standard of comparison) used for this device's acceptance was primarily:
- Established Performance Standards: Specifically, ASTM F 2196-02 for temperature delivery.
- Performance of a Predicate Device: The existing non-sterile Convective Warming Blankets (Model SW4000) served as the benchmark for burst pressure and robustness, as well as general performance expectations. The goal was to demonstrate "substantial equivalence."
8. The sample size for the training set
Not applicable. This is a physical device being evaluated for safety and performance against established standards, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 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).