(113 days)
Not Found
No
The description focuses on the mechanical function of the cannula and extracorporeal circuit, with no mention of AI or ML capabilities.
Yes.
The device is indicated for the removal of fresh, soft thrombi or emboli, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is described as a venous drainage cannula and for the removal of fresh, soft thrombi or emboli, which are interventional and therapeutic functions, not diagnostic.
No
The device description clearly details a physical cannula with a balloon-actuated tip, designed for insertion into the venous system and connection to an extracorporeal circuit. This is a hardware device, not software.
Based on the provided information, the AngioVac Cannula is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. They perform tests outside the body.
- AngioVac Cannula Function: The AngioVac Cannula is a surgical device used within the body (in vivo) to remove thrombi or emboli from the venous system during extracorporeal bypass. It is a mechanical device that physically removes material, not a device that analyzes biological samples.
The description clearly indicates its use in a surgical setting for a physical intervention, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The AngioVac Cannula is indicated for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours. The cannula is also indicated for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.
Product codes
DWF
Device Description
The AngioVac device is a 22 Fr cannula with a balloon-actuated, expandable, funnel shaped distal tip that can be advanced through a 26 Fr sheath over a guidewire into the venous system percutaneously or via a surgical cut-down. During use, the cannula is connected to an extracorporeal circuit and a commercially available pump head and bubble trap. A commercially available reinfusion camula is placed for venous return (typically within internal jugular or one of the common femoral veins) and connected to the extracorporeal circuit. When the bypass pump is started, suction is created, removing blood and debris from around the tip of the Angio Vac cannula, circulating the blood through the filter, and returns the blood to the patient via the venous return cannula. A benefit of the AngioVac Cannula is that it allows for removal of clot material, while minimizing blood loss via recirculation of blood through a standard extracorporeal (venovenous) bypass circuit. The device may be used in target vessels for thrombus/embolus extraction include, but are not limited to, the illiofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Atrium (RA).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
illiofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Atrium (RA)
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
Bench and animal testing was performed to support substantial equivalence of the AngioVac Cannula when used for the removal of soft fresh thrombi or emboli. The AngioVac Cannula met all specified design and performance requirements. Additionally, the AngioVac Cannula has fulfilled the biocompatibility testing requirements identified in ISO 10993: Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process.
Key Metrics
Not Found
Predicate Device(s)
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
K133445
MAR - 5 2014
510(k) SUMMARY
Device Name: AngioVac Cannula
Date Prepared: March 3, 2014
A. Sponsor
Vortex Medical Inc. 26 Forest Street Marlborough, MA 01752
B. Contact
Lorraine M. Hanley Vice President of Global Regulatory Affairs F: 508-658-7976 E: lorraine.hanley@navilyst.com
C. Device Name
| Trade Name: | AngioVac Cannula |
|---|---|
| Common/Usual names: | Cardiopulmonary Bypass Venous Cannula |
| Extraction Catheter | |
| Classification Names: | Catheter, cannula and tubing, vascular, |
| cardiopulmonary bypass | |
| 21 CFR§870.4210, ProCode DWF | |
| Classification: | Class II |
D. Predicate Device
| .
100
.
. 506-51
S . ARE
イータックペータを良いのの部をなってきたくなりますからなくアマンターのならないです | | FIFT T . FEST . LEAD . LEAST . LE . LE . LE . LE
11 -- 1491-52 252-623-157 15 2 - 691 1281 1281 11 8 11
1499/18 = = ( = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = |
|---------------------------------------------------------------------------------------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 3012/1 | 100 4 4 |
E. Device Description
The AngioVac device is a 22 Fr cannula with a balloon-actuated, expandable, funnel shaped distal tip that can be advanced through a 26 Fr sheath over a guidewire into the venous system percutaneously or via a surgical cut-down. During use, the cannula is connected to an extracorporeal circuit and a commercially available pump head and bubble trap. A commercially available reinfusion camula is placed for venous return (typically within internal jugular or one of the common femoral veins) and connected to the extracorporeal circuit. When the bypass pump is started, suction is created, removing blood and debris from around the tip of the Angio Vac cannula, circulating the blood through the filter, and returns the blood to the patient via the venous return cannula. A benefit of the AngioVac Cannula is that it allows for removal of clot material, while minimizing blood loss via recirculation of blood through a standard extracorporeal (venovenous) bypass circuit. The device may be used in target vessels for thrombus/embolus extraction include, but are not limited to, the illiofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Atrium (RA).
1
510(k) SUMMARY (Cont'd)
Device Name: AngioVac Cannula
Date Prepared: March 3, 2014
F. Intended Use
The Angio Vac Cannula is indicated for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours. The cannula is also indicated for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.
G. Technology Characteristics
The proposed device has similar materials, design and components and technological characteristics as the predicate currently marketed AngioVac Cannula (K091304). The AngioVac Cannula is also similar to other devices used for removal of soft fresh thrombi or emboli such as the Pronto .035" Extraction Catheter (K070403 - Vascular Solutions) and the F.A.S.T. Funnel Catheter (K040010 -Genesis Medical, Inc.).
H. Performance Data
Bench and animal testing was performed to support substantial equivalence of the AngioVac Cannula when used for the removal of soft fresh thrombi or emboli. The AngioVac Cannula met all specified design and performance requirements. Additionally, the AngioVac Cannula has fulfilled the biocompatibility testing requirements identified in ISO 10993: Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process.
I. Clinical Testing
Not applicable
J. Conclusion
Based on results of in vitro and in vivo testing and responses to questions posed in the FDA's Decision Making Tree, the proposed device is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2014
Vortex Medical Inc. Lorraine M. Hanley Vice President of Global Regulatory Affairs 26 Forest Street Marlborough, MA 01752
Re: K133445
Trade/Device Name: AngioVac Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, cannula and tubing, vascular, cardiopulmonary bypass Regulatory Class: Class II Product Code: DWF Dated: December 4, 2013 Received: December 5, 2013
Dear Ms. Lorraine Hanley:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Lorraine M. Hanley
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
M. A. Hillman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K133445
Device Name: AngioVac Cannula
Indication For Use:
The AngioVac Cannula is indicated for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours. The cannula is also indicated for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. Atillman