(28 days)
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.
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.
The Guidant VasoView® 6 Harvesting Cannula is designed for use in conjunction with a 7 mm Endoscope for minimally invasive vessel harvesting.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The provided document summarizes that the Guidant VasoView® 6 Harvesting Cannula "meet the established acceptance criteria and performs in a manner equivalent to the predicate devices." However, the specific quantitative acceptance criteria are not explicitly detailed in the provided text. The document refers to "the established acceptance criteria" but does not define them. Similarly, the "reported device performance" is not quantitatively presented, but rather asserted to be equivalent to predicate devices.
Therefore, for the request, a table of acceptance criteria and reported device performance cannot be fully populated with specific metrics directly from the input. Instead, what can be stated is the general claim of equivalence.
| Acceptance Criteria (Not explicitly detailed, inferred from claims) | Reported Device Performance (Summary statement) |
|---|---|
| Functional equivalence to predicate devices (VV4, VV5, VV6) | The Guidant VasoView® 6 Harvesting Cannula meets established acceptance criteria and performs in a manner equivalent to the predicate devices. |
| Safety equivalence to predicate devices | No new safety or effectiveness issues were raised during the testing program. |
| Effectiveness equivalence to predicate devices | Performs in a manner equivalent to predicate devices for indications such as cutting tissue, controlling bleeding through coagulation, and blunt dissection of tissue. |
Study Details:
-
Sample Size used for the Test Set and Data Provenance:
- The document does not specify the sample size used for the test set (number of devices tested, number of procedures simulated, or number of patients if applicable).
- The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. The testing appears to be verification testing, likely conducted in a lab environment rather than a clinical trial.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not mention using experts to establish ground truth for a test set. The performance data refers to "verification testing," which typically involves engineering or lab-based assessments against specifications, rather than clinical ground truth established by expert review.
-
Adjudication Method for the Test Set:
- Not applicable/Not mentioned. Since no expert review or clinical assessment for ground truth is indicated, there is no mention of an adjudication method.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No such study was done or mentioned. The device is a surgical instrument, not a diagnostic imaging device that would typically involve human readers.
-
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable/Not mentioned. This device is a surgical tool, not an algorithm. Its performance is intrinsically tied to human operation.
-
Type of Ground Truth Used:
- Not explicitly stated in terms of clinical ground truth. The "Performance data" section refers to "verification testing," suggesting the ground truth was based on engineering specifications, design requirements, and performance characteristics compared to predicate devices, rather than clinical outcomes, pathology, or expert consensus on clinical findings.
-
Sample Size for the Training Set:
- Not applicable/Not mentioned. The device is a physical surgical instrument, not an AI/ML algorithm that requires a training set.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable/Not mentioned. As it's not an AI/ML algorithm, there is no training set or associated ground truth.
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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). |
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| Devicedescription | The Guidant VasoView® 6 Harvesting Cannula is designed for use inconjunction with the 7 mm Endoscope. The Harvesting Cannula has fourlumens which house the Endoscope, C-Ring wire, endoscope washer tube andBipolar Bisector for ligation and division of vessel branches. TheC-Ring/endoscope washer is independently controlled by a C-Ring Slider onthe handle of the device for retraction of the vessel as well as washing of thedistal tip of the Endoscope. The Bipolar Bisector can beextended/retracted/rotated with the Bisector Carriage, and mechanical cuttingis achieved with the toggle located on the Bisector Carriage. Bipolarcoagulation is achieved using electrosurgical energy. Positioning of thedevice, coagulation, and mechanical cutting are performed under endoscopicvisualization. This device is intended for use with the bipolar outputs ofcompatible generators. |
|---|---|
| Indications forUse | The VasoView® 6 System is indicated for use in minimally invasive surgeryallowing access for vessel harvesting, and is primarily indicated for patientsundergoing endoscopic surgery for arterial bypass. It is indicated for cuttingtissue and controlling bleeding through coagulation, and for patients requiringblunt dissection of tissue including dissection of blood vessels, dissection ofblood vessels of the extremities, dissection of ducts and other structures in theextraperitoneal or subcutaneous extremity and thoracic space. Extremityprocedures include tissue dissection/vessel harvesting along the saphenousvein for use in coronary artery bypass grafting and peripheral artery bypass orradial artery for use in coronary artery bypass grafting. Thoracoscopicprocedures include exposure and dissection of structures external to theparietal pleura, including nerves, blood vessels and other tissues of the chestwall. |
| Technologicalcharacteristics | Guidant VasoView 6 Harvesting Cannula incorporates the same fundamentalscientific technology as the predicate devices. |
| Performancedata | The results of the verification testing demonstrate that the Guidant VasoView6 Harvesting Cannula meet the established acceptance criteria and performsin a manner equivalent to the predicate devices. No new safety oreffectiveness issues were raised during the testing program. |
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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.
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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
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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
§ 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.