(88 days)
No
The summary describes a passive, disposable device for blood handling during surgery, with no mention of computational or analytical capabilities.
No
The device is a reservoir and filter used during cardiopulmonary bypass surgery and for collecting and autotransfusing postoperative shed blood, which are supportive functions, not direct therapeutic interventions on the patient's condition.
No
The device text describes a storage reservoir and filter for blood during cardiopulmonary bypass surgery, and for collection and autotransfusion of postoperative shed blood. There is no mention of it being used to diagnose a medical condition.
No
The device description clearly indicates it is a physical, disposable device used in-line with an extracorporeal circuit, consisting of chambers and filtration layers. It is not software.
Based on the provided information, the Gish CAP VRF45 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device's function during cardiopulmonary bypass surgery and for collecting and autotransfusing blood. These are procedures performed on the patient's body or with blood collected from the patient for reinfusion, not for analyzing samples in vitro to diagnose a condition.
- Device Description: The description details the physical components and how it functions within an extracorporeal circuit. It focuses on blood handling and processing outside the body for therapeutic purposes.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of analytes, or diagnostic purposes.
Therefore, the Gish CAP VRF45 is a medical device used in surgical procedures and for blood management, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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