(59 days)
Not Found
Not Found
No
The summary describes a mechanical device with a proprietary design for enhanced flow and clog prevention. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No
The device is used as a venous drainage cannula during extracorporeal bypass, which is a supportive function during a medical procedure, not a treatment for a specific disease or condition. Its purpose is to facilitate the bypass, not to provide a therapeutic effect itself.
No
Explanation: The device is a cannula used for venous drainage during extracorporeal bypass, designed to facilitate fluid flow and material removal. Its intended use and description do not involve diagnosing a condition, but rather aiding in a therapeutic procedure.
No
The device description clearly describes a physical, wire-reinforced cannula with a balloon-activated tip, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "venous drainage cannula during extracorporeal bypass." This is a device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details a physical device designed to be inserted into the vascular system for fluid drainage. It describes its physical characteristics, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to diagnose diseases or conditions, monitor treatments, or screen for health issues by examining samples in vitro.
This device is a surgical/interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vortex Cannula is intended for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours.
Product codes
DWF
Device Description
The Vortex Cannula is a wire reinforced, ranging from 22 to 26 French, device that is of appropriate stiffness and flexibility so that it can be manipulated throughout the vascular svstem. The cannula is rigid enough to resist kinking, collapse and deformation that may compromise the lumen and inhibit flow through the cannula. The cannula has a proprietary distal end with a balloon activated, expandable, funnel-shaped tip that willenhance flow when the balloon is activated and will prevent clogging of the cannula with commonly encountered undesirable intravascular material that occurs with the predicate devices and facilitate en-bloc removal of such material from the vascular system. The cannula has a proximal end that can attach to a standard off the shelf extracorporeal circuit. The cannula will be shipped to the user in a sterile package and ready for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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)
Bench top testing was conducted and comparisons were made to the predicated device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Vortex Cannula is substantially equivalent to the Estech Remote Access Perfusion Femoral Venous Cannula
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 870.4210 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
K091304 Pg 10F 2
510(k) SUMMARY
JUL - 2 2009
PENDING 510(k) NUMBER:
Mike Glennon 510(k) OWNER: Vortex Medical Inc.50 Loring Drive Norwell, MA 02061
CONTACT PERSON: Chervl Blake 949-285-3517 949-448-7016 (fax) e-mail cheryl.blake@interfaceusa.com
January 28, 2009 DATE OF PREPARATION:
NAME OF DEVICE: Vortex Cannula
- Not Determined TRADE NAME:
COMMON OR USUAL NAME:
CLASSIFICATION NAME: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass
INDICATIONS FOR USE: Indications for Use: The Vortex Cannula is intended for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours.
SUMMARY STATEMENT:
Identification of the legally marketed: The Vortex Cannula is substantially equivalent to the Estech Remote Access Perfusion Femoral Venous Cannula
Description:
The Vortex Cannula is a wire reinforced, ranging from 22 to 26 French, device that is of appropriate stiffness and flexibility so that it can be manipulated throughout the vascular svstem. The cannula is rigid enough to resist kinking, collapse and deformation that may compromise the lumen and inhibit flow through the cannula. The cannula has a proprietary distal end with a balloon activated, expandable, funnel-shaped tip that willenhance flow when the balloon is activated and will prevent clogging of the cannula with commonly encountered undesirable intravascular material that occurs with the predicate devices and facilitate en-bloc removal of such material from the vascular system. The cannula has a proximal end that can attach to a standard off the shelf extracorporeal circuit. The cannula will be shipped to the user in a sterile package and ready for use.
1
Non-clinical Testing: Bench top testing was conducted and comparisons were made to the predicated device.
Summary of Technological Characteristics: The Technological characteristics are the same as or equivalent to the predicated device and introduce no new safety and effectiveness issues when used as instructed.
Design Control / Risk Analysis/Design Verification: Design control, risk analysis and design verification activities for the subject of this Special 510(k) have been conducted in accordance with all applicable internal Design Procedures. The design control process employed is inclusive of the elements stipulated by 21 CFR § 820.30. The risk analysis preformed identified the risks relative to the performance requirements, as specified by ISO 14971and QSR and internal procedures for risk analysis. The Design Risk Assessment Profile was conducted in accordance to ISO 14971 and QSR internal Stand Operating Procedures, EN 1441 standards, ISO 9001/ISO 13485, AAMI/ISO TIR 14971, and 21 CFR § 820.30, validation and verification activities addressed the profile. Based on the risk analysis, validation and verification activities are formally controlled and addressed the activities included the methods, tests used, and acceptance criteria applied.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2009
Vortex Medical Inc. c/o Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 455 Saginaw Drive Redwood City, Ca 94063
Re: K091304
Vortex Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DWF Dated: June 17, 2009 Received: June 19, 2009
Dear Mr. Christensen:
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.
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Page 2 - Mr. Morten Simon Christensen
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
Ashley B. Boa
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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:_ VortexCannula
Indications for Use: The Vortex Cannula is intended for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arluley Boan for BD2
lovascular Devices
Page I of
510(k) Number K071384