(35 days)
Not Found
No
The description focuses on mechanical and endoscopic functions for tissue cutting and coagulation, with no mention of AI/ML terms or capabilities.
No
The device is described as a surgical tool used for cutting tissue and controlling bleeding through coagulation, which makes it an operative device, not a therapeutic one. It facilitates surgical procedures rather than providing a direct therapeutic effect on a disease or condition.
No
The device is described as a surgical tool for cutting tissue and controlling bleeding, specifically for vessel harvesting and tissue dissection. Its function is interventional, not diagnostic.
No
The device description clearly describes a physical, disposable surgical instrument with a cannula, handle, and scissors blades, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Description and Intended Use: The VasoView 5 Harvesting Cannula is a surgical instrument used during a surgical procedure on a patient's body. It is used for cutting tissue and controlling bleeding, not for analyzing samples in a lab.
The description clearly indicates it's a tool for performing surgery, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The VasoView 5 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 arafting.
The VasoView 5 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The VasoView 5 Harvesting Cannula is a disposable device designed to perform endoscopic 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. Opening, closing, extension and retraction of the scissors blades is actuated via controls on the handle.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary testing was performed on the VasoView 5 Harvesting Cannula to ensure that the product is substantially equivalent to the predicate devices and to ensure that the modified dimensions do not have a significant effect on safety and effectiveness.
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.
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
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
FEB 2 0 2002 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.
A. Name, Address, Phone and Fax number of the Applicant
Guidant Corporation Cardiac Surgery 3200 Lakeside Drive Santa Clara, CA 95054
Telephone: (408) 845-1842 Fax: (408) 845-1800
B. Contact Person
Anne Schlagenhaft Regulatory Affairs Associate
C. Date Prepared
December 18, 2001
Device Name D.
Trade Name: VasoView™ 5 Harvesting Cannula Classification Name: Electrosurgical cutting and coagulation device and accessories
E. Device Description
The VasoView 5 Harvesting Cannula is a disposable device designed to perform endoscopic 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. Opening, closing, extension and retraction of the scissors blades is actuated via controls on the handle.
1
K020143 2/2
510(k) Notification VasoView 5 Harvesting Cannula
Intended Use u
The VasoView 5 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 arafting.
Substantial Equivalence G.
The VasoView 5 Harvesting Cannula is substantially equivalent to the VasoView™ Uniport Plus, determined Class I exempt on February 18, 1998, the Everest Bipolar Scissors, cleared by the Food and Drug Administration under K945975 on December 21, 1994, and the CTS MIDCAB/SVH Bipolar Scissors cleared under K963930 on January 16, 1997. The design of the Harvesting Cannula is identical to the current Uniport Plus with the incorporation of the distal shaft, blades and electrodes of the Everest Bipolar Scissors. The Harvesting Cannula increases ease of use by combining the cutting and coaqulation function of the bipolar scissors into the endoscopic access function of the Uniport Plus to create a single device. The VasoView 5 Harvesting Cannula is substantially equivalent to the predicate devices in intended use, technological characteristics, materials, manufacturing processes, and components.
H. Device Testing Results and Conclusion
All necessary testing was performed on the VasoView 5 Harvesting Cannula to ensure that the product is substantially equivalent to the predicate devices and to ensure that the modified dimensions do not have a significant effect on safety and effectiveness.
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 stripes forming its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2002
Ms. Michelle Weidman KEMA Quality B.V. KEMA Medical 4377 County Line Road Chalfont, Pennsylvania 18914
Re: K020143
Trade/Device Name: VasoView 5 Harvesting Cannula Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 8, 2002 Received: February 11, 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 Cosmatic 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.
3
Page 2 - Ms. Michelle Weidman
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and w your to ough finding of substantial equivalence of your device to a legally premated notification " 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 11 you active specific arris09.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF F F ar 3659. Additionally, for questions on the promotion and advertising of Comphance at (301) 59 + 1697 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entires, "Thisocial on your responsibilities under the Act may be obtained from the Other general miorination turers, 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,
Miriam C. Provost
for 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
4
510(k) Number (if known): K020143
VasoView 5 Harvesting Cannula Device Name:
Indications For Use:
The VasoView 5 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.
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020143
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use /
OR (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)