(205 days)
DWF, DTL
Not Found
No
The device description and performance studies focus on the physical components and their function in extracorporeal blood flow, with no mention of AI or ML capabilities.
No
The device provides a conduit for extracorporeal blood flow, connecting components of a bypass circuit. It does not actively treat a disease or medical condition.
No
This device is described as tubing and connectors used to provide a conduit for extracorporeal blood flow in surgical procedures, not to diagnose a condition. Its function is to facilitate blood flow between components of a bypass circuit.
No
The device description clearly states it is comprised of physical components like tubing (polyvinyl chloride) and connectors (polycarbonate), which are hardware. It is used as a conduit for extracorporeal blood flow, a physical function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for use in surgical procedures to provide a conduit for extracorporeal blood flow. This involves handling blood outside the body during a medical procedure, not for diagnostic testing of samples.
- Device Description: The description focuses on the physical components (tubing, connectors) used to connect other devices in a bypass circuit. It describes the materials and function of transporting blood.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood or other biological samples for diagnostic purposes (e.g., detecting diseases, measuring substances).
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and related to facilitating blood flow during surgery.
N/A
Intended Use / Indications for Use
The Gish Tubing and Connectors with HA Coating are indicated for use in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass cırcuit it is designed to operate at flow rates of one (1 0) to six (6) liters per minute for periods up to six (6) hours
Product codes
DWF, DTL
Device Description
The Gish Tubing and Connectors with HA Coating are used in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass cırcuit - Specifically they are used in connecting oxygenators, reservoirs, filters, heat exchangers and other devices used in surgical procedures The tubing is polyvinyl chloride (PVC) The connectors are polycarbonate of various configurations such as straight, "Y", Luer and reducer types. The components of this system which have contact with the fluid path are sterle and nonpyroqenic. All materials of the Gish Tubing and Connectors are biocompatible and coated with a proprietary coating. The Gish Tubing and Connectors with HA Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.
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 Tubing and Connectors with HA Coating has been subjected to extensive safety, performance, and validations prior to release Final testing for the systems ıncludes vanous performance tests designed to ensure that the device meets all of its functional requirements and performance specifications.
Key Metrics
Not Found
Predicate Device(s)
Gish Tubing and Connectors
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
Kort/881
510(k) (Tradıtıonal) Submıssıon Section 5, 510(k) Summary
JAN 2 3 2009
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
| Name | Gish BioMedical, Inc |
|---|---|
| Address | 22942 Arroyo Vista |
| Rancho Santa Margarita, | |
| CA 92688-2600 | |
| Telephone | 949-635-6200 voice |
| 949-635-6299 fax | |
| edw@gishbiomedical.com | |
| Contact | Edward F Waddell |
| Director RA/QA |
2 Device
| Proprietary Name | Gish Tubing and Connectors with HA Coating |
|---|---|
| Common Name | Cardiopulmonary Bypass Tubing and Connectors |
| Classification Name | Catheter, Cannula or Tubing, Vascular |
| Cardiopulmonary Bypass | |
| Adaptor, Stopcock, Manifold, or Fitting, | |
| Cardiopulmonary Bypass |
3 Predicate Devices
Gısh Tubıng and Connectors Both manufactured by Gısh Bıomedical, Inc
র্ব Classifications Names & Citations
21 CFR 870 4210, Catheter, Cannula or Tubıng, Vascular Cardiopulmonary Bypass, Class II, DWF, Cardiovascular
21 CFR 870 4290, Adaptor, Stopcock, Manifold, or Fitting, Cardiopulmonary Bypass, Class II, DTL, Cardiovascular
5 Description
1
The Gish Tubing and Connectors with HA Coating are used in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass cırcuit - Specifically they are used in connecting oxygenators, reservoirs, filters, heat exchangers and other devices used in surgical procedures The tubing is polyvinyl chloride (PVC) The connectors are polycarbonate of various configurations such as straight, "Y", Luer and reducer types
1
The components of this system which have contact with the fluid path are sterle and nonpyroqenic
All materials of the Gish Tubing and Connectors are biocompatible and coated with a proprietary coating
The Gish Tubing and Connectors with HA Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit
6 Indications for use
The Gish Tubing and Connectors with HA Coating are indicated for use in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass cırcuit it is designed to operate at flow rates of one (1 0) to six (6) liters per minute for periods up to six (6) hours
7 Contra-Indications '
For HA coated tubing and connectors, no contra-indications have been noted
8 Comparıson
The Gish Tubing and Connectors with HA Coating have the same device characteristics as the predicate devices
9 Test Data
The Gish Tubing and Connectors with HA Coating has been subjected to extensive safety, performance, and validations prior to release Final testing for the systems ıncludes vanous 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 Tubing and Connectors with HA Coating
11 Conclusions
The conclusion drawn from these tests is that Gish Tubing and Connectors with HA Coating is equivalent in safety and efficacy to its predicated devices
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2009
Gish Biomedical, Inc c/o Ms Janet Peets Regulatory & Clinical Affairs Specialist 22942 Arroyo Vista Rancho Santa Margarita, CA 92688
Re K081881
Gish Tubing and Connectors with HA Coating Regulation Number 21 CFR 870 4210 Regulation Name Cardiopulmonary Bypass Cannula or Tubing Regulatory Class Class II Product Code DWF 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 prior 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 regure 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 etther 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 requirements, 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 (OS) 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.
onna 2. Volmer
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_08) 88 |
Device Name Gish Tubing and Connectors with HA Coating
Indications for use.
The Gish Tubing and Connectors with HA Coating are indicated for use in Surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit It is designed to operate at flow rates of one (1 0) to six (6) liters per minute for periods up to six (6) 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)
uma R. Jones
(Driver Sig. OR)
(Division Simn-Off) Division of Cardiovascular Devices
510(k) Number_k08)&&
Indications forUse_K081881 doo Gish Blomadles Rancho Santa Marganta CA 92688