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510(k) Data Aggregation
(48 days)
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
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.
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(183 days)
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
The Snuggle Warm 4000 Convective Warming System is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
The Snuggle Warm consists of a disposable single use warming blanket that is placed in contact with the patient and a warming unit with a hose end temperature control connected to the blanket. The warming unit generates warm air that is distributed throughout the warming blanket to warm the patient during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
The provided text is a 510(k) Premarket Notification for the Snuggle Warm® 4000 Convective Warming System. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel technology.
Therefore, the information required to populate the requested table regarding acceptance criteria and device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for the Snuggle Warm® 4000 Convective Warming System is not present within the provided text.
The document explicitly states: "There are no significant changes in technological characteristics or intended use that impact the safety or effectiveness of these warming devices." This indicates that the submission relies on the established safety and effectiveness of the predicate device (Temp Marq™/ Snuggle Warm Convective Warming System, K904690) rather than new performance studies for the modifications made to the Snuggle Warm® 4000.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of acceptance criteria and the reported device performance:
- Not provided. The document focuses on demonstrating "substantial equivalence" to a predicate device, implying that the performance is expected to be similar, but it does not specify new acceptance criteria or report specific performance metrics for the modified device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. No new test data is presented for the Snuggle Warm® 4000.
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):
- Not applicable / Not provided. Since no new test set is described, there's no mention of experts or ground truth establishment for such a test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / 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:
- Not applicable. This device is a convective warming system, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is hardware, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided.
8. The sample size for the training set:
- Not applicable / Not provided. This document is for a hardware device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
In summary, the provided 510(k) notification focuses on the regulatory process of demonstrating substantial equivalence to a predicate device rather than presenting new performance data or detailed studies as would be expected for a novel device or AI algorithm.
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