(210 days)
The Gish Vision Blood Cardioplegia System with HA coating is indicated for use in applications that require control of fluid temperature, such as blood or cardioplegia, typically in an extracorporeal circuit The device may be used for normothermic or hypothermic applications It is designed to operate at flow rates of one hundred (100) to six hundred (600) milliliters per minute for periods up to six (6 0) hours
The Gish Vision Blood Cardioplegia System with hyaluronan based coating (HA coating) consists of an extracorporeal heat exchanger and fluid administration set The heat exchanger consists of a one piece, stainless steel bellows, configured heat exchanger as the primary element to effect heat exchange This element is encased by a polycarbonate housing, which directs the blood through the outside convolutions of the stainless steel bellows, and therefore effects heat exchange while minimizing priming volume All materials of the heat exchanger are brocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air Additionally, the device includes an integral bubble trap, gross particulate filter (105 u) and pressure relief device designed to open in the event of excessive fluid pressure (600 mmHq) during use Solutions are delivered to the patient through the extension line and appropriate cannula Blood flow is driven by a roller pump connected through an extension line. The components of this system which have contact with the fluid path are sterle and nonpyrogenic. All blood contact materials of the Vision Blood Cardioplegia System with HA coatung are biocompatible and coated with a proprietary coating.
This document describes a 510(k) submission for the Gish Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger with HA Coating. It is a medical device, and the submission focuses on demonstrating its substantial equivalence to previously cleared predicate devices rather than proving its effectiveness through a new clinical study with specific acceptance criteria as you might see for a novel device.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typical for studies evaluating diagnostic accuracy or clinical outcomes of a novel device) is not explicitly present in this type of regulatory submission. The goal of a 510(k) is to show that the new device is as safe and effective as a legally marketed predicate device, often relying on engineering and performance testing.
However, I can extract the relevant information about the "Test Data" and "Comparison" sections to infer what the manufacturer claims regarding device performance and how it meets its functional requirements.
Here's an attempt to answer your questions based on the provided text, acknowledging the limitations inherent in a 510(k) summary for a "substantially equivalent" claim:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the format typically seen for rigorous clinical studies. Instead, it states that the device was subjected to various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications.
The functional requirements and specifications are implied by the device's intended use and comparison to the predicate devices. The key performance aspects mentioned are:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Control of fluid temperature | Confirmed (indicated for use) |
| Operable flow rates (Blood/Cardioplegia) | 100 to 600 ml/min |
| Operation duration | Up to 6 hours |
| Pressure monitoring capability | Yes |
| Air trapping and removal | Yes (includes integral bubble trap) |
| Gross particulate filtration | Yes (105 µ) |
| Pressure relief device activation | 600 mmHg |
| Biocompatibility of materials | All blood contact materials are biocompatible and HA coated. |
| Sterility and non-pyrogenicity | Components in fluid path are sterile and non-pyrogenic. |
| Overall Safety and Effectiveness | Equivalent to predicate devices (K020106) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of a clinical study or a specific number of devices tested. The testing mentioned appears to be engineering and performance validation rather than clinical trial data.
- Sample Size: Not specified. It refers generally to "the systems."
- Data Provenance: Not specified, but likely refers to internal testing conducted by Gish Biomedical, Inc. in the USA.
- Retrospective or Prospective: Not applicable in the context of device performance/engineering testing described.
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. The testing described is performance and functional verification, not a clinical study requiring expert ground truth establishment for a diagnostic output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human assessment or adjudication of outcomes for a test set.
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 cardiopulmonary bypass heat exchanger, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests, the "ground truth" would be the engineering specifications and established standards for heat exchangers in cardioplegia systems. For biocompatibility, it would be compliance with relevant biocompatibility standards.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/machine learning model.
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).