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510(k) Data Aggregation
(187 days)
Cocoon Convective Warming System, Model CWS7000
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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(311 days)
Cocoon Convective Warming System
The Cocoon Convective Warming System is indicated for hyper or hypothermic patients for whom induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Cocoon Convective Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm. The Cocoon Convective Warming System can be used with adult and pediatric patients.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter for the "Cocoon Convective Warming System." It confirms the device's substantial equivalence to a legally marketed predicate device and outlines general regulatory information.
However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone) for an AI/device. These details are typically found in the clinical study report or performance testing documentation, which is not part of this 510(k) clearance letter.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text.
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(135 days)
COCOON CONVECTIVE WARMING SYSTEM
The Cocoon Convective Warming System is indicated for hyper or hypothermic patients or normothermic patients for whom induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Cocoon Convective Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm. The Cocoon Convective Warming System can be used with adult and pediatric patients.
The Cocoon Convective Warming system incorporates the Convective Warming Machine CWS4000, and the Cocoon Disposable Patient Warming Blankets. The Convective Warming Machine is a mains-powered, microprocessor-controlled device that delivers a continuous flow of temperature-controlled air through a flexible hose to the warming blanket. The temperature of the air delivered to the blanket can be set to one of six settings: Ambient, 34℃, 37℃, 40℃, 43ºC, or 46ºC. When a temperature of 46ºC is selected, the setting automatically drops to 43ºC after 10 minutes.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document describes a 510(k) summary for the Cocoon Convective Warming System, outlining its characteristics, intended use, and substantial equivalence to predicate devices.
Specifically, it states: "Care Essentials Pty Ltd did not conduct a clinical study as defined in the guidance for Industry Financial Disclosures by Clinical Investigators to determine substantial equivalence. Care Essentials Pty Ltd conducted performance testing with satisfactory results." This indicates that no human clinical study was performed to establish performance against acceptance criteria.
The non-clinical testing section mentions validation against "the company's specified design requirements" and conformance with voluntary standards (ANSI/AAMI/ES60601-1, IEC 60601-1-2, ISO 10993-1, ISO 14971). However, it does not provide specific acceptance criteria values or the results of these performance tests in a format that would allow for the table requested.
Therefore, I cannot provide the requested information.
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