(88 days)
The Gish CAP VRF45 is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for venous return blood and to filter and defoam intrathoracic suctioned blood prior to the extracorporeal circuit. The CAP VRF45 is indicated for the collection and autotransfusion of the same patient's postoperative shed blood.
The Gish CAP VRF45 is a disposable device designed to be used in-line with an extracorporeal circuit during cardiopulmonary bypass surgery. The Gish CAP VRF45 Cardiotomy/Venous Reservoir is designed to be used in-line during cardiopulmonary bypass surgery as a storage reservoir for venous return blood and to filter and defoam intrathoracic suction blood. It is also to be used for collection and autotransfusion of postoperative shed blood. The device consists of a two (2) chamber or compartment configuration. The lower chamber is the venous return blood compartment, and the upper chamber is the intrathoracic suction blood compartment (cardiotomy). The device will be offered with or without a 20 - 28 micron filtration layer.
The provided text is a 510(k) Summary for a medical device (Gish CAP VRF45 Cardiotomy/Venous Reservoir). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive details about a device's performance against specific acceptance criteria in a study, especially concerning AI/ML aspects, human reader performance, or training/test set details.
Therefore, many of the requested categories are not applicable or not available in the provided document. The submission is not for a software or AI/ML device, but a physical medical device (blood reservoir).
However, I can extract the information that is present according to the spirit of your request, focusing on how the device demonstrates its safety and effectiveness (which is the goal of acceptance criteria in a broader sense for this device type).
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit acceptance criteria in a tabular format as one might see for a diagnostic device. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. The "performance" is inferred from this equivalence and the testing performed.
| Acceptance Criteria Category (Inferred from 510(k) Scope) | Reported Device Performance / Justification |
|---|---|
| Intended Use (Substantial Equivalence) | Intended use is substantially equivalent to predicate devices (K890504, K883923, K922799) for: - Storage of venous return blood - Filtering and defoaming intrathoracic suctioned blood - Collection and autotransfusion of postoperative shed blood |
| Technological Characteristics (Substantial Equivalence) | Design, construction, materials, and nominal specifications are either identical or substantially equivalent to predicate devices (K890504, K883923, K922799). A detailed comparison chart is referenced (Appendix III, not provided). |
| Biocompatibility (Safety) | Biocompatibility testing performed on sterilized product. Data supports that the device does not significantly affect safety. |
| In-vitro Bench Testing (Performance/Safety) | In-vitro bench testing performed on sterilized and accelerated aged product. Data supports that the device does not significantly affect safety and effectiveness. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as "test set" in the context of a diagnostic algorithm. For the biocompatibility and in-vitro bench testing, the specific number of units tested is not provided.
- Data Provenance: The testing appears to be conducted by the manufacturer, Gish Biomedical, Inc. The document does not specify a country of origin for data beyond this. The studies are prospective in the sense that they were conducted for this specific submission to demonstrate equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical blood reservoir, not an AI/ML diagnostic system requiring expert interpretation or ground truth establishment in that typical sense. Its function doesn't involve subjective interpretation by experts to determine "truth."
4. Adjudication Method
Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a physical medical device, 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 is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the typical sense of a diagnostic algorithm. For a physical device like this, "ground truth" implicitly refers to established engineering standards, material properties, and biological compatibility requirements that the device's performance in bench and biocompatibility tests is measured against. For example:
* Biocompatibility: Compliance with ISO standards for biological evaluation of medical devices.
* In-vitro bench testing: Meeting pre-defined performance specifications (e.g., filtration efficiency, defoaming effectiveness, structural integrity) which would be considered the "ground truth" for the device's functional attributes.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
COMPANY NAME AND CONTACT PERSON
Gish Biomedical, Inc. 2681 Kelvin Avenue Irvine, CA 92614-5821 714.756.5485 (Phone) 714.553.7330 (FAX)
MAR 1 0 1997
Jeff DuMontelle, P.E. Director of Engineering
DEVICE NAME
MODEL NUMBER
CAP VRF45 Cardiotomy/Venous Reservoir CAP VRF45
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
Gish Cardiotomy/Autotransfusion/Pleural Drainage Venous Reservoir; K890504 Gish Cardiotomy/Venous Reservoir: K883923 Terumo CAPIOX SX; K922799
DESCRIPTION OF DEVICE
Consistent with the intended use described in K883923 and K890504, the Gish CAP VRF45 is a disposable device designed to be used in-line with an extracorporeal circuit during cardiopulmonary bypass surgery. The Gish CAP VRF45 Cardiotomy/Venous Reservoir is designed to be used in-line during cardiopulmonary bypass surgery as a storage reservoir for venous return blood and to filter and defoam intrathoracic suction blood. It is also to be used for collection and autotransfusion of postoperative shed blood.
The device consists of a two (2) chamber or compartment configuration. See Figure 1 for diagrams of the device which demonstrate the compartmental configuration and indicate all component material compositions.
The lower chamber of the reservoir is the venous return blood compartment. The compartment functions to receive venous return blood by means of a central channel. The blood subsequently passes through an outer filter screen (160 micron) before deposition in the reservoir.
The upper chamber of the reservoir is the intrathoracic suction blood compartment (cardiotomy). The compartment functions as a cardiotomy to receive blood recovered by intrathoracic suction. The blood subsequently passes through two (2) defoamer layers and two (2) filtration layers (20 - 28 micron and 160 micron) before deposition in the reservoir. The central core of the filter assembly of the upper chamber is virtually identical in design, function and material composition the Gish Cardiotomy Venous Reservoir (K883923) and the Gish Cardiotomy/ Chest Drainage System (CAP35DF, K874924). In addition, the composition is also of similar construction to the Gish Cardiotomy/Autotransfusion Reservoir (ATR: K870792). The Gish CAP VRF45 will be offered with or without the 20 - 28 micron filtration layer.
510(k) NOTIFICATION GISH BIOMEDICAL, INC.
CONFIDENTIAL PAGE 101 of 203
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Consistent with the intended use described in K890504 and with other Gish reservoirs, specifically the Cardiotomy/Autotransfusion Reservoir (K870792) and Cardiotomy/Chest Drainage System (CAP35DF, K874924), the reservoir may be used postoperatively for collection and autotransfusion of the same patient's postoperative shed blood. Essentially, in the postoperative autotransfusion mode, the reservoir will function (just as in the operative mode) to collect, filter and defoam intrathoracic blood. In the autotransfusion mode, the blood is returned via the extracorporeal circuit to the same patient and essentially the reservoir (in conjunction with an appropriate manometer system (e.g. water or dry manometer)) functions in a chest drainage capacity.
STATEMENT OF INTENDED USE
The Gish CAP VRF45 is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for venous return blood and to filter and defoam intrathoracic suctioned blood prior to the extracorporeal circuit. The CAP VRF45 is indicated for the collection and autotransfusion of the same patient's postoperative shed blood.
STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES
The Gish CAP-VR (K890504) is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for venous return blood and to filter and defoam intrathoracic suction blood. Collection and autotransfusion of postoperative shed blood.
The Gish CVR (K883923) is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for venous return blood and to filter and defoam intrathoracic suction blood.
The Terumo CAPIOX SX (K922799) reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for venous return blood and to filter and defoam intrathoracic suction blood.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
This premarket notification submission provides substantial equivalence information and rationale which addresses the introduction to commercial distribution of the Gish CAP VRF45 Cardiotomy/Venous Reservoir. The Gish CAP VRF45 is substantially equivalent to other cardiotomy/venous reservoirs which are in commercial distribution These predicate/marketed devices include the Gish Cardiotomy/Venous Reservoir (K883923), the Gish Cardiotomy/Autotransfusion/Pleural Drainage Venous Reservoir (K890504) and the Terumo Medical Corporation CAPIOX SX (K922799, with the CAPIOX oxygenator).
The Gish CAP VRF45 has an intended use which is substantially equivalent to other cardiotomy/venous reservoirs which are in commercial distribution, such as the Gish Cardiotomy/Venous Reservoir, the Gish Cardiotomy/Autotransfusion/Pleural Drainage Reservoir and the Terumo Medical Corporation CAPIOX SX reservoir.
The Gish CAP VRF45 has technological characteristics which are substantially equivalent to the Gish Cardiotomy/Venous Reservoir, the Gish Cardiotomy/Autotransfusion/Pleural Drainage Reservoir and the Terumo CAPIOX SX reservoir. The design, construction, materials and nominal specifications of the Gish CAP VRF45 are either identical or substantially equivalent to the aforementioned reservoirs.
A Device Comparison Chart comparing the technological characteristics of the Gish CAP VRF45 with two substantially equivalent devices the Gish Cardiotomy/Venous Reservoir and the Gish Cardiotomy/Autotransfusion/Pleural Drainage Reservoir is provided in Appendix III.
510(k) NOTIFICATION GISH BIOMEDICAL, INC.
CONFIDENTIAL PAGE 102 of 203
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In addition to the above assessment of intended use and technological characteristics, Gish Biomedical, Inc. has provided additional information to support substantial equivalence of the Gish CAP VRF45. This includes biocompatibility testing on sterilized product and in-vitro beach testing on sterilized and accelerated aged product. These data support that the Gish CAP VRF45 Cardiotomy/Venous Reservoir does not significantly affect safety and effectiveness and is substantially equivalent to other marketed cardiotomy/venous reservoirs.
510(k) NOTIFICATION GISH BIOMEDICAL, INC.
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CONFIDENTIAL PAGE 103 of 203
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.