(27 days)
The WarmAir® 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-airheated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.
The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to a blanket that is placed over or under adult, pediatric or neonatal patients in order to warm them. The heated air is blown through connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air.
The provided document is a 510(k) summary for a Special 510(k) submission regarding a modification to the WarmAir® Model 135 Hyperthermia System. This type of submission is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
The core of this submission is to add a modified blanket to the family of WarmAir 135 blankets. The changes to the blanket are that it is now provided sterile, differs in size, and includes a flap for groin access.
Crucially, this document describes a modification to an existing device, and the evaluation focuses on showing that the modified device is "substantially equivalent" to an already cleared device, not on proving new clinical effectiveness or performance against specific, quantifiable clinical acceptance criteria through a full-scale clinical study for the entire system. The "study" mentioned here is primarily about verifying the effect of the modification (sterilization) on the blanket's ability to meet the same specifications as the non-sterile predicate.
Therefore, many of the requested items related to comprehensive clinical studies, such as multi-reader multi-case studies, standalone algorithm performance, large training/test sets, and expert adjudication, are not applicable or not present in this type of submission for this particular modification.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with reported numerical values for clinical performance as one might see in a de novo submission or a comprehensive clinical trial report. Instead, the "acceptance criteria" discussed are primarily related to design control verification and ensuring the modified sterile blanket still meets the same specifications as the non-sterile predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum temperature delivered to the patient (per ASTM F-2196) (for post-sterilization blanket) | "Testing showed the sterile blanket meets the specification for maximum temperature delivered to the patient (per ASTM F-2196) post sterilization." (Implies it met the pre-defined temperature limits as per the standard). |
| Material composition (compared to predicate) | "manufactured from the same materials" |
| Manufacturing methods (compared to predicate) | "using the same manufacturing methods" |
| Overall safety and effectiveness (compared to predicate) | "The modified device has the same intended use as the predicates and similar technological characteristics that do not raise different types of questions of safety and effectiveness and the modified device is therefore substantially equivalent to the predicate devices." (This is a regulatory conclusion, not a direct performance metric). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "test set" here refers to the modified blanket itself which underwent testing. It is not a patient cohort or a dataset in the context of an AI/algorithm study.
- Sample Size: Not specified in terms of numerical count for physical units tested, but it would have involved a sufficient number of blanket samples to perform the required ASTM F-2196 temperature testing effectively.
- Data Provenance: The testing was done internally by the manufacturer, Cincinnati Sub-Zero Products, Inc. (implied from the document). It is not country-specific in the way clinical trial data might be. The testing is likely prospective in the sense that the sterile blanket modification was created, then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This submission is for a medical device modification (blanket) and its performance is evaluated against engineering/material specifications (like temperature delivery), not against expert clinical diagnoses or ground truth established by medical experts for a diagnostic algorithm.
4. Adjudication Method for the Test Set
Not applicable. See point 3. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert-dependent diagnostic studies, not for evaluating the direct physical performance of a warming blanket.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating human reader performance with and without AI assistance in diagnostic tasks. This device is a warming blanket, not a diagnostic tool incorporating AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device does not incorporate an algorithm that operates in a standalone capacity.
7. The Type of Ground Truth Used
The "ground truth" for the blanket's performance is established by engineering specifications and recognized standards, specifically the "specification for maximum temperature delivered to the patient (per ASTM F-2196)". This is an objective, measurable physical property.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device modification. This is not an AI/machine learning device. The design and manufacturing processes are established based on engineering principles and prior device experience, not a data training set.
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).