(210 days)
Not Found
No
The description focuses on the physical components and function of a heat exchanger and fluid administration system, with no mention of AI or ML capabilities.
Yes
The device is used to control the temperature of fluids (blood or cardioplegia) in an extracorporeal circuit, which is a therapeutic intervention aimed at maintaining physiological conditions or inducing hypothermia/normothermia for patient treatment.
No
Explanation: The device is described as a heat exchanger and fluid administration set used to control fluid temperature in an extracorporeal circuit. Its function is therapeutic (heat exchange and fluid delivery), not diagnostic. It monitors pressure and removes air but does not provide diagnostic information about a patient's medical condition.
No
The device description clearly outlines physical components such as a heat exchanger, fluid administration set, stainless steel bellows, polycarbonate housing, bubble trap, filter, and pressure relief device. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes controlling the temperature of fluids like blood or cardioplegia in an extracorporeal circuit. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device is a heat exchanger and fluid administration set. It physically interacts with the blood to modify its temperature and deliver solutions. It does not perform any tests or analyses on the blood to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device analyzing blood components, detecting biomarkers, or providing any information for diagnostic purposes.
- Focus on Physical Function: The description emphasizes the physical aspects of heat exchange, fluid flow control, and safety features like bubble traps and pressure relief.
IVD devices are designed to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device operates in vivo (within the body's circulation) and performs a physical function.
N/A
Intended Use / Indications for Use
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 sıx hundred (600) milliliters per mınute for periods up to sıx (6 0) hours.
Product codes
DTR
Device Description
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.
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
The Gish Vision Blood Cardioplegia System with HA Coating has been subjected to extensive safety, performance, and validations prior to release Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications.
Key Metrics
Not Found
Predicate Device(s)
Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger, K020106, Vision Blood Cardiopleara System and Extracorporeal Heat Exchanger with GBS 110 Coating, K020106
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the text 'K081838' at the top, followed by the text '510(k) (Traditional) Submission' and 'Section 5, 510(k) Summary' below it. The text appears to be part of a document or submission related to the 510(k) process. The number at the top may be a reference or identification number for the submission. The text is black and the background is white.
Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807 92
1 Company making the submission
JAN 2 6 2009
| Name | Gish Biomedical, Inc |
|---|---|
| Address | 22942 Arroyo Vista |
| Rancho Santa Margarita, CA | |
| 92688-2600 | |
| Telephone | 949-635-6200 voice |
| 949-635-6291 fax | |
| martıns@gıshbıomedical com | |
| Contact | Martın Sellers |
| Director of Regulatory Affairs |
Device 2
| Proprietary Name | Vision Blood Cardioplegia System and
Extracorporeal Heat Exchanger with HA Coating |
|---------------------|---------------------------------------------------------------------------------------|
| Common Name | Cardioplegia Heat Exchanger |
| Classification Name | Cardiopulmonary Bypass Heat Exchanger |
3. Predicate Devices
Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger, K020106 and Vision Blood Cardiopleara System and Extracorporeal Heat Exchanger with GBS 110 Coating, K020106 Both manufactured by Gısh Bıomedical, Inc
ব Classifications Names & Citations
21 CFR 870 4240, Cardiovascular bypass heat exchanger, Class II, DTR, Cardiovascular
ਦ Description
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
1
(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
6 Indications for use
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 sıx hundred (600) milliliters per mınute for periods up to sıx (6 0) hours
7 Contra-Indications
For HA coated blood cardioplegia systems, no contra-indications have been noted
8 Comparıson
The Gish Vision Blood Cardioplegia System with HA Coating has the same device characteristics as the predicate devices
ਹੈ Test Data
The Gish Vision Blood Cardioplegia System with HA Coating has been subjected to extensive safety, performance, and validations prior to release Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications
10 Literature Review:
A review of literature pertaining to the safety and effectiveness has been conducted Appropriate safeguards have been incorporated in the design of Gish Vision Blood Cardioplegia System with HA Coating
11 Conclusions
Based upon the testing and comparison to the predict device the Gish Biomedical, Inc , Vision Blood Cardioplegia System with HA Coating has the same intended use, with similar technological characteristics Gish Biomedical, Inc , therefore posits that its device is equivalent in safety and effectiveness to predicate devices
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 6 2009
Gish Biomedical, Inc c/o Ms Janet Peets Regulatory & Clinical Affairs Specialist 22942 Arroyo Vista Rancho Santa Margarita, CA 92688
Re K081838
Vision Blood Cardioplegia and Extracorporeal Heat Exchanger with HA Coating Regulation Number 21 CFR 870 4240 Regulation Name Cardiopulmonary Bypass Heat Exchanger Regulatory Class Class II Product Code DTR Dated January 8, 2009 Received January 12, 2009
Dear Ms Peets
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA) You may, therefore, market the device, subject to the general controls provisions of the Act The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addition, FDA may publish further announcements concerning your device in the Federal Register
3
Page 2 - Ms Janet Peets
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies You must comply with all the Act's requrements, including, but not limited to registration and listing (21 CFR Part 807), labeling (21 CFR Part 801), good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050 This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours.
R. lo. Lunes
Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a cursive letter or a stylized mark, possibly part of a signature or a unique identifier. The symbol is drawn with a thick line, and it has a loop or curve at the top and a diagonal stroke at the bottom.
Bram D Zuckerman, M D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number K_081838
Device Name Gish Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger with HA Coating
Indications for use
The Vision Biood 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
Prescription Device
Federal Law (US) restricts this device to sale by or on the order of a physician
Prescription Use Yes
OR
Over-The-Counter Use No
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vahner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko81838