(13 days)
The VasoView® 6 Harvesting Cannula is intended for cutting and coagulation of tissue and providing access in minimally invasive vessel harvesting procedures for patients undergoing coronary artery bypass grafting.
The VasoView® 6 Harvesting Cannula has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery for vessel harvesting. It is indicated for cutting tissue and controlling bleeding through coagulation in general and cardiothoracic surgery including minimally invasive direct coronary artery bypass (MIDCAB), lower extremity and thoracoscopic procedures. Lower extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
The VasoView 6 Harvesting Cannula is a disposable device designed to perform endoscopic cutting and coagulation, including vessel isolation and division of vessel branches. The device has a tubular cannula for introduction of instrumentation into the surgical site with a proximal handle to hold and control the device during procedures. A lumen of the cannula allows insertion of an endoscope for illumination and visualization of the procedure. Extension, retraction and actuation of the transector cutting and coagulation tool is achieved with controls located on the handle.
The provided text describes a 510(k) premarket notification for the VasoView®6 Harvesting Cannula. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on establishing substantial equivalence to a predicate device (VasoView 5 Harvesting Cannula) based on:
- Intended Use: Identical.
- Technological Characteristics: Similar, with minor modifications (blades, electrode configuration, bipolar tool rotation, insufflation capability).
- Materials, Manufacturing Processes, and Components: Identical.
Therefore, I cannot fulfill your request for the tables and study details as they are not present in the provided text. The submission is a regulatory filing, not a clinical study report.
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AUG 2 8 2002
KO22718
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Name, Address, Phone and Fax number of the Applicant A.
Guidant Corporation Cardiac Surgery 3200 Lakeside Drive Santa Clara, CA 95054
Telephone: (408) 845-1842 (408) 845-1855 Fax:
B. Contact Person
Anne Schlagenhaft Regulatory Affairs Associate
- C. Date Prepared July 22, 2002
D. Device Name
Trade Name: VasoView®6 Harvesting Cannula Classification Name: Electrosurgical cutting and coagulation device and accessories
E. Device Description
The VasoView 6 Harvesting Cannula is a disposable device designed to perform endoscopic cutting and coagulation, including vessel isolation and division of vessel branches. The device has a tubular cannula for introduction of instrumentation into the surgical site with a proximal handle to hold and control the device during procedures. A lumen of the cannula allows insertion of an endoscope for illumination and visualization of the procedure. Extension, retraction and actuation of the transector cutting and coagulation tool is achieved with controls located on the handle.
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F. Intended Use
The VasoView 6 Harvesting Cannula is intended for cutting and coagulation of tissue and providing access in minimally invasive vessel harvesting procedures for patients undergoing coronary artery bypass grafting.
Substantial Equivalence G.
The VasoView 6 Harvesting Cannula is substantially equivalent to the VasoView 5 Harvesting Cannula, cleared by the Food and Drug Administration under K020143 on February 20, 2002. The design of the VasoView 6 Harvesting Cannula is identical to the current device with the exception of the modification of the blades and electrode configuration, addition of bipolar tool rotation, and insufflation capability through the cannula. The VasoView 6 Harvesting Cannula is substantially equivalent to the predicate devices in intended use, technological characteristics, materials, manufacturing processes, and components.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement above them.
AUG 2 8 2002 11 1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Guidant Corporation c/o Ms. Michelle Weidman Kema Medical 4377 County Line Road Chalfont, PA 18914
Re: K022718
Trade/Device Name: Vaso View® 6 Harvesting Cannula Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulating device and accessories Regulatory Class: II Product Code: GEI Dated: July 22, 2002 Received: August 15, 2002
Dear Ms. Weidman:
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.
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.
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Page 2 - Ms. Michelle Weidman
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
S. Stupt Rlurdu
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K_022418
VasoView® 6 Harvesting Cannula Device Name:
Indications For Use:
The VasoView® 6 Harvesting Cannula has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery for vessel harvesting. It is indicated for cutting tissue and controlling bleeding through coagulation in general and cardiothoracic surgery including minimally invasive direct coronary artery bypass (MIDCAB), lower extremity and thoracoscopic procedures. Lower extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of General, Restorativeer-The-Counter Use
and Neurological Devices
(Optional Format 1-2-96)
| 510(k) Number | K022718 |
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§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.