(204 days)
Hypocore™ is a single-use device intended to cool sterile saline, lactated ringers and other comparable low viscosity inert fluids during intravenous administration where clinically indicated for reduction of patient temperature.
The Hypocore device is an inline chiller for IV (Intravenous) solutions that uses an endothermic reaction for cooling. The IV fluids enter the device through a Luer-lock connector on a standard IV tube, is cooled inside the device and exits through another Luerlock connector on a longer section of IV tube. During expected use, the device inlet is connected to an IV solution bag via an IV administration set, and its outlet is connected to an intravenous access port. It is powered by an internal non-rechargeable battery. The device has a handle to turn the device on and off. The entire device is disposable, single use and is provided pre-sterilized.
The provided text describes the acceptance criteria and a series of performance tests for the Novocor Medical Systems, Inc. Hypocore device.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 10 Minute Standard Device Performance - Level of cooling, fast flow | To cool 1 liter of fluid to an average temperature of 50% of the negative control per ASTM F2382. | The plasma exposed to the test article had an overall average clotting time of 235.9 seconds, which represented 79.9% of the negative control. The test article was considered a minimal activator, and therefore, met the requirements of the test. |
| Biocompatibility (Acute Systemic Toxicity) | Reference ISO 10993-11 (Section 5.3) - no mortality or evidence of systemic toxicity. | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. |
| Biocompatibility (Hemocompatibility) | Reference ISO 10993-4 - criteria for non-hemolytic/slightly hemolytic. | The hemolytic index for the test article in direct contact with blood was 2.0%, and the hemolytic index for the test article extract was 0.8%. The test article in direct contact with blood was slightly hemolytic and the test article extract was non-hemolytic. |
| Sterilization | Suitable to pass the acceptance criteria of ISO 11135 for a 1x10-6 SAL. | Testing demonstrated that the Hypocore device is suitable to pass the acceptance criteria of ISO 11135 therefore demonstrating substantial equivalence for sterilization compared to the predicate device. |
| Medical Electrical Safety | Meets the acceptance criteria of IEC 60601-1 and IEC 60601-1-2. | Testing demonstrated that the Hypocore device meets the acceptance criteria of IEC 60601-1 and IEC 60601-1-2 therefore demonstrating substantial equivalence to the predicate device with regard to electrical safety. |
| Human Factors Design Validation | All users safely complete all use tasks successfully. | All users safely completed all use tasks successfully. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific number of samples used for each test beyond indicating "All samples" met criteria. For some tests like "Strap Performance Test", it implies multiple tests were performed (e.g., three tests performed, "all samples met"). For the Biocompatibility tests, it refers to "test article extract" and "test article" but doesn't quantify the number of devices or extracts tested.
The data provenance (country of origin, retrospective/prospective) is not mentioned in the provided text. The tests appear to be laboratory-based performance and safety evaluations rather than clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this study. The study focuses on the physical and chemical performance, safety, and usability of a medical device, which are evaluated against predefined engineering specifications, international standards (ISO, IEC, ASTM, USP), and human factors guidance. There is no mention of expert consensus or interpretation required to establish a "ground truth" in the way it would be for diagnostic imaging or clinical assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints where agreement among observers is critical. This study involves objective measurements and adherence to engineering and safety standards.
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
This information is not applicable. The device (Hypocore) is a thermal regulating system, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study or assessment of AI's effect on human readers is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The Hypocore is a physical device, not an algorithm. Its "standalone" performance is assessed throughout the various performance and safety tests, which evaluate the device's ability to meet its specifications independently of human intervention during the measurement process. However, Human Factors Design Validation did evaluate user interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance tests (cooling level, time to cool, flow rate, environmental conditions, tilt, handle force, strap performance), the "ground truth" or reference was predefined engineering specifications and benchmark values, often based on "known published literature regarding IV fluid cooling" or "standard of care" (e.g., refrigerated IV fluid bag temperature, strength limits for a human wrist).
For the biocompatibility tests, the "ground truth" or reference was international standards such as ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ASTM F756, ASTM F2382, and USP General Chapter .
For sterilization, it was ANSI/AAMI/ISO 11135.
For electrical safety, it was IEC 60601-1 and IEC 60601-1-2.
For Human Factors, it was FDA Draft Guidance "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" and standards IEC 62366: 2007 + A1: 2014, IEC 60601-1-6: 2007 (3rd Ed.).
8. The sample size for the training set
This information is not applicable. This is a medical device performance and safety study, not an AI model development study that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for an AI model.
§ 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).