(211 days)
Not Found
No
The device description and intended use focus on mechanical filtration and storage of blood during cardiopulmonary bypass, with no mention of AI or ML technologies.
No
Explanation: The device is a blood reservoir used during cardiopulmonary bypass surgery, primarily for collecting, storing, filtering, and defoaming blood, rather than directly treating a medical condition itself.
No
Explanation: The device is described as a storage reservoir and filter for blood during cardiopulmonary bypass surgery, and for blood collection and autotransfusion. Its function is to manage blood flow and prepare it for return to the patient's circulatory system, not to diagnose a condition.
No
The device description clearly details a physical, disposable hardware device made of polycarbonate with internal filters and sponges, used for collecting and filtering blood during surgery.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for use during cardiopulmonary bypass surgery to store, filter, and defoam blood. It also mentions the collection and autotransfusion of postoperative shed blood. These are procedures performed on the patient's body or with blood collected directly from the patient for reinfusion, not for testing or analysis outside the body to diagnose a condition.
- Device Description: The description details a physical device designed for handling blood flow and filtration within an extracorporeal circuit. It doesn't mention any components or functions related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (markers, substances)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Mentioning any kind of assay, test, or analytical procedure.
This device is a medical device used in a surgical procedure to manage blood flow and quality within an extracorporeal circuit. It is not designed to provide diagnostic information.
N/A
Intended Use / Indications for Use
The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patient's postoperative shed blood with the addition of the Postoperative Conversion Pack with water seal/manometer.
Product codes
DTN
Device Description
The Gish CAPVRF44 Hardshell Venous Reservoirs with hyaluronan based coating (HA Coating) are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The Gish CAPVRF44 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the ½" venous inlet where it is directed to the bottom of the device and passes through a 160 micron screen filter. Intrathoracic suctioned blood enters the top section of the defoamer/filter cartridge and passes through a defonor sponge and 20 micron depth filter. The maximum venous flow rate is 8 lom. The maximum cardiotomy flow rate is 4 lpm.
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
The Gish CAPVRF44 Hardshell Venous Reservoir 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. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
FEB - 4 2009
510(k) (Traditional) Submission Section 5, 510(k) Summary
Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
- 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 | |
| martins@gishbiomedical.com | |
| Contact: | Martin Sellers |
| Sr. Director of Operations and RA |
2. Device:
| Proprietary Name: | Gish CAPVRF44 Hardshell Venous Reservoir with
HA Coating |
|----------------------|---------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary Blood Reservoir |
| Classification Name: | Extracorporeal circuit blood defoamer
Cardiopulmonary bypass blood reservoir |
3. Predicate Devices:
Gish CAPVRF45 Hardshell Venous Reservoir, K964973 and Gish CAPVRF44 Hardshell Venous Reservoir with GBS™ Coating, K030726. Both manufactured by Gish Biomedical, Inc.
4. Classifications Names & Citations:
21 CFR 870.4230, 21 CFR 870.4400, Extracorporeal circuit blood defoamer, Cardiopulmonary bypass blood reservoir, Cardiopulmonary Bypass, Class II, DTN, Cardiovascular.
5. Description:
The Gish CAPVRF44 Hardshell Venous Reservoirs with hyaluronan based coating (HA Coating) are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The Gish CAPVRF44 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the ½" venous inlet where it is directed to the bottom of the device and passes through a 160 micron screen filter. Intrathoracic suctioned blood enters the top section of the defoamer/filter cartridge and passes through a defonor
1
sponge and 20 micron depth filter. The maximum venous flow rate is 8 lom. The maximum cardiotomy flow rate is 4 lpm.
6. Indications for use:
The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patient's postoperative shed blood with the addition of the Postoperative Conversion Pack with water seal/manometer.
7. Contra-indications:
For HA coated reservoirs, no contra-indications have been noted.
8. Comparison:
The Gish CAPVRF44 Hardshell Venous Reservoirs with HA Coating has the same device characteristics as the predicate devices.
9. Test Data:
The Gish CAPVRF44 Hardshell Venous Reservoir 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. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards.
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 CAPVRF44 Hardshell Venous Reservoirs with HA Coating.
11. Conclusions:
Based upon the testing and comparison to the predict device the Gish Biomedical, Inc., CAPVRF44 Hardshell Venous Reservoir with HA Coating has the same intended use, with similar technological characteristics. Gish Biomedical, Inc., therefore posits that its device is equivalent to predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB ~ 4 2009
Gish Biomedical, Inc. c/o Ms. Janet Peets Regulatory & Clinical Affairs Specialist 22942 Arroyo Vista Rancho Santa Margarita, CA 92688
Re: K081947
Gish CAPVRF44 Hardshell Venous Reservoirs with HA Coating Regulation Number: 21 CFR 870,4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN 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 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 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 (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,
Duna R. Vochner
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 (1947
Device Name: Gish CAPVRF44 Hardshell Venous Reservoirs with HA Coating
Indications for use:
The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopyimonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patients are also including and allood with the addition of the Postoperative Conversion Pack with water seal/manometer.
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)
Munna D. Vachme
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K081947
OS Indications for Use do Delphi Consulting Group Houston, TX 7707