(28 days)
Not Found
No
The device description focuses on mechanical and electrosurgical functions for tissue dissection and vessel harvesting under endoscopic visualization. There is no mention of AI/ML terms, image processing for analysis, or data sets for training/testing.
No.
The device is described as a surgical tool used for vessel harvesting and tissue dissection, not for treating a disease or condition.
No
This device is designed for surgical procedures like vessel harvesting and tissue dissection, not for diagnosing medical conditions. It is an operative tool for intervention.
No
The device description clearly outlines a physical harvesting cannula with multiple lumens, a handle, sliders, and a toggle for mechanical cutting and bipolar coagulation. It is a hardware device used in conjunction with an endoscope and compatible generators.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgery for accessing, harvesting, cutting, and coagulating tissue and blood vessels. This is an in vivo (within a living organism) procedure, not an in vitro (in glass or outside the body) diagnostic test performed on samples like blood, urine, or tissue.
- Device Description: The description details a surgical instrument with lumens for an endoscope, wires, and a bipolar bisector for mechanical cutting and bipolar coagulation. These are all tools used directly on the patient during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the VasoView® 6 System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VasoView® 6 System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. 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 Guidant VasoView® 6 Harvesting Cannula is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring wire, endoscope washer tube and Bipolar Bisector for ligation and division of vessel branches. The C-Ring/endoscope washer is independently controlled by a C-Ring Slider on the handle of the device for retraction of the vessel as well as washing of the distal tip of the Endoscope. The Bipolar Bisector can be extended/retracted/rotated with the Bisector Carriage, and mechanical cutting is achieved with the toggle located on the Bisector Carriage. Bipolar coagulation is achieved using electrosurgical energy. Positioning of the device, coagulation, and mechanical cutting are performed under endoscopic visualization. This device is intended for use with the bipolar outputs of compatible generators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel harvesting, vessel branches, saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting, chest wall
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)
The results of the verification testing demonstrate that the Guidant VasoView 6 Harvesting Cannula meet the established acceptance criteria and performs in a manner equivalent to the predicate devices. No new safety or effectiveness issues were raised during the testing program.
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
§ 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.
0
AUG 2 0 2004
Appendix A – 510(k) Summary
| Submitter | Guidant Corporation, Cardiac Surgery |
|---|---|
| Submitter's Address | 3200 Lakeside Drive Santa Clara, CA 95054 |
| Telephone | (408) 845-2014 |
| Fax | (408) 845-1855 |
| Contact Person | M. Laurie Wong |
| Date Prepared | July 22, 2004 |
| Device Trade Name | Guidant VasoView ® 6 Harvesting Cannula |
| Device Common Name | Electrosurgical cutting and coagulation device and accessories |
| Device Classification Name | Electrosurgical cutting and coagulation device and accessories |
| Device Classification | Class II |
| Summary of substantial equivalence | The design, materials, method of delivery, and intended use features of the Guidant VasoView 6 Harvesting Cannula are substantially equivalent with regard to these features in the predicate devices: the VV4 (K030512, May 14, 2003), VV5 (K020143, February 20, 2002), and VV6 (K022718, August 28, 2002). |
1
| Device
description | The Guidant VasoView® 6 Harvesting Cannula is designed for use in
conjunction with the 7 mm Endoscope. The Harvesting Cannula has four
lumens which house the Endoscope, C-Ring wire, endoscope washer tube and
Bipolar Bisector for ligation and division of vessel branches. The
C-Ring/endoscope washer is independently controlled by a C-Ring Slider on
the handle of the device for retraction of the vessel as well as washing of the
distal tip of the Endoscope. The Bipolar Bisector can be
extended/retracted/rotated with the Bisector Carriage, and mechanical cutting
is achieved with the toggle located on the Bisector Carriage. Bipolar
coagulation is achieved using electrosurgical energy. Positioning of the
device, coagulation, and mechanical cutting are performed under endoscopic
visualization. This device is intended for use with the bipolar outputs of
compatible generators. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The VasoView® 6 System is indicated for use in minimally invasive surgery
allowing access for vessel harvesting, and is primarily indicated for patients
undergoing endoscopic surgery for arterial bypass. It is indicated for cutting
tissue and controlling bleeding through coagulation, and for patients requiring
blunt dissection of tissue including dissection of blood vessels, dissection of
blood vessels of the extremities, dissection of ducts and other structures in the
extraperitoneal or subcutaneous extremity and thoracic space. Extremity
procedures include tissue dissection/vessel harvesting along the saphenous
vein for use in coronary artery bypass grafting and peripheral artery bypass or
radial artery for use in coronary artery bypass grafting. Thoracoscopic
procedures include exposure and dissection of structures external to the
parietal pleura, including nerves, blood vessels and other tissues of the chest
wall. |
| Technological
characteristics | Guidant VasoView 6 Harvesting Cannula incorporates the same fundamental
scientific technology as the predicate devices. |
| Performance
data | The results of the verification testing demonstrate that the Guidant VasoView
6 Harvesting Cannula meet the established acceptance criteria and performs
in a manner equivalent to the predicate devices. No new safety or
effectiveness issues were raised during the testing program. |
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine and healthcare. The symbol features a central staff with three wavy lines extending from it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2004
Ms. M. Lautic Berg Sr. Regulatory Affairs Specialist Guidant Corporation Cardiac Surgery 3200 Lakeside Drive Santa Clara, California 95054
Rc: K041981
K041981
Trade/Device Name: Guidant VasoView® 6 Harvesting Cannula , Model VH-2000: Guidant
Trade/Device Name: Guidant Vasoview® -VasoView® 6 Regulation Number: 21 CFR 878.4400 Regulation Name: 21 CFR 878. 1100
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 22, 2004 Received: July 23, 2004
Dear Ms. Wong:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premained in substantially equivalent (for the indications for use stated in the enclosure) the assets of casted predicate devices marketed in interstate for use stated in the enclosure) to regally manced promotical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Drug commerce provide way 28, 1776, the enacertance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the hav devices that have been recuasince with association while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application o and Cosment Act (Act) that do not require approvide controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, economic for annual registration, listing of general controls provisions of the rist 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 If your device is classined (see above) mo entier on major regulations allecting your device can be may be subject to such additional controlls. Title 21. Parts 800 to 898. In addition. FDA may be found in the Code of Peacharding your device in the Federal Register.
Please be advised that FDA`s issuance of a substantial equivalence determination docs not mean Please be advised that FDA s issualled of a substantial explice with other requirements of the Act that FDA has made a deletimmation administered by other Federal agencies. You must
or any Federal statutes and regulations administered by other Federal agencies. You mis or any rederal statutes and regulations daminobers. but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set and CrK Part 607), natemig (21 CFR Part 820); government (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
Page 2 - Ms. M. Laurie Wong
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to tegil maketing your antial equivalence of your device to a legally premarket notheation: The PPA Tinang of the new cour 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 If you desire specific advice for your de rice of the Also, please note the regulation entitled, contact the Office of Compliance at (301) 377-777 Part 807.97). You may obtain Misbranding by reference to premance no itrease - expend the Act from the Division of Small other gelleral miormation on your responser 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,
Sincerely yours,
Mark A. Millhouser
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
Indications for Use
510(k) Number (if known):__K041981
510(in Number (in Known): 115-------------------------------------------------------------------------------------------------------------------------------------------------VasoView® 6
Indications For Use:
ll life in on 201 The VasoView" 6 System is indicated for use in minhinally invinces only of l ne vasurew - e open - and is primarily indicated for putting this and organization in and colling
endoscopic for retrenal bypass. It is indicated for cutting blunt dissue endoscopic surgery for and by ass. It is indicated for cating the surfacts of thissue
endoscopic surgery for anterial bypass. It is indicated on filissue
bleeding the site endoscopic surger), and for patients requiring blum of the extremities,
including through coasies, dissection of blood vessels of the extraperity bleeting through in the extrapertioner in thiod vossels of the many of the more of the more of the more of the more of the more of Including dissocion of the extrapentioned on substantoned on and other only of the studio of the studio and dissection of cases in the secures include tissue artery bypass grating and
extremity and the saphenous vin for use in coronary artery bypass grafting. externity and and the saphenous vein for use in coronary artery bypass grafting.
harvesting along the saphenous venture and dissection of structures external navesting along the st (
peripleral attery bypass or radial artery bruse in ortonaly and the many of the many of the comment of the chest wall. periprietal arough of the many of the many of structures with the chest wall.
parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
Mark D. Millham
ral, Restorative, Division of Neurological Devices
510(k) Number_
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
X04198
No