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510(k) Data Aggregation
(187 days)
The Cocoon Convective Warming System, Model CWS7000, is indicated for patient warming. The Cocoon Convective Warming Unit, Model CWS7000 has been designed for use with Cocoon Disposable Patient Warming Gown Blankets. It is intended for use with children, adolescent, and adult patients.
The Cocoon Convective Warming System, Model CWS7000 is part of the Cocoon family of temperature management systems that consists of portable forced-air temperature management units, Cocoon™ Disposable Patient Warming Gown Blanket.
The Cocoon Convective Warming System, Model CWS7000 comprises of the Cocoon Convective Warming Unit, Model CWS7000 unit and the Cocoon™ Disposable Patient Warming Gown Blankets. The Cocoon Convective Warming System, Model CWS7000 can be used in preoperative and postoperative settings. In a preoperative setting, the warming system provides prewarming and comfort warming. In a postoperative setting, the warming system provides comfort warming only. The Cocoon Convective warming system should be used by trained medical professionals only.
The Cocoon™ Convective Warming System, Model CWS7000 is not intended for use in the operating room.
The provided text describes the regulatory clearance for the Cocoon Convective Warming System, Model CWS7000. It includes a summary of nonclinical testing but explicitly states that clinical testing is not applicable. Therefore, I can provide information based on the nonclinical testing, but there is no study described that proves the device meets acceptance criteria through clinical performance.
Here's an analysis based on the provided text, focusing on what's available and noting what is not applicable:
Acceptance Criteria and Reported Device Performance (Nonclinical)
The acceptance criteria for the Cocoon Convective Warming System, Model CWS7000 are based on compliance with various international standards for medical electrical equipment, electromagnetic compatibility, software life cycle processes, heating devices, biological evaluation, and risk management. The reported performance is simply "Pass" or "Meets requirements" for each of these standards.
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Basic Safety & Performance | AAMI/ANSI ES60601-1: Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance (Edition 3.1; FDA rec. # 19-46) | Pass |
| EMC | IEC 60601-1-2: Medical electrical equipment - Part 1-2: Collateral Standard: Electromagnetic Compatibility - Requirements and tests (Edition 4.1; FDA rec. # 19-36) | Pass |
| Software Life Cycle | IEC 62304: Medical Device Software - Software Life Cycle Processes (Edition 1.1; FDA rec. # 13-79) | Pass |
| Heating Devices | IEC 60601-2-35: Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use. (Edition 2.0; FDA rec. # 6-483) | Pass |
| Biocompatibility | ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process (Edition 5.0; FDA rec. # 2-258) | Pass |
| Risk Management | ISO 14971: Medical devices - Application of risk management to medical devices (Edition 3.0; FDA rec. # 5-125) | Meets requirements |
Study Details (for nonclinical testing as clinical testing was not applicable)
- Sample size used for the test set and the data provenance: Not specified in terms of patient data, as clinical testing was deemed not applicable. The sample size for nonclinical engineering and safety tests would refer to the number of units or components tested, which is not detailed but assumed to be sufficient for compliance with the listed standards. Data provenance is not applicable as it's not a study involving human or animal data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For nonclinical standards compliance, "ground truth" is established by the specifications and requirements of the standards themselves. The testing would be conducted by qualified engineers and technicians.
- Adjudication method for the test set: Not applicable for nonclinical standards testing. Compliance is determined by whether the device meets the specified parameters and requirements of each standard.
- If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating observer performance with medical images or clinical judgment, which is not relevant to a convective warming system.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The provided information refers to the device itself (hardware and embedded software), not a standalone algorithm. The device's performance was evaluated independently against the standards.
- The type of ground truth used: For this device, the "ground truth" for demonstrating performance is derived from the requirements and specifications of the referenced international technical and safety standards (e.g., IEC 60601-1, IEC 60601-2-35, ISO 10993-1). These standards define acceptable levels for electrical safety, electromagnetic compatibility, temperature control accuracy, biocompatibility, and risk management.
- The sample size for the training set: Not applicable, as this is not an AI/ML-based device that undergoes a training phase with a dataset.
- How the ground truth for the training set was established: Not applicable, as there is no training set for this device.
In summary, the provided document focuses on the regulatory clearance of a medical device based on its compliance with established nonclinical safety and performance standards, rather than clinical efficacy studies or AI performance metrics.
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