(30 days)
The VasoView® HemoPro™ 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® HemoPro™ Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VasoView® HemoPro™ Harvesting Tool for cutting and sealing of vessel branches. The C-Ring/distal lens washer is independently controlled by a C-Ring Slider on the handle of the device that retracts the vessel and washes the distal tip of the Endoscope. The Harvesting Tool can be extended/retracted from the main cannula by inserting it into the Tool Adapter Port, and rotated independently. The Harvesting Tool has two curved Jaws. One Jaw contains the heating elements for branch cutting and sealing; the second Jaw is longer and has a serrated inner edge. Cutting and sealing of vessel branches is achieved in two steps: (1) capture of the branch between the Jaws of the Harvesting Tool and then (2) simultaneous coagulation and ligation of the branch with the Jaws using direct current. Both steps are achieved by mechanical application of the Activation Toggle. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the
The Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System (K052274) is a Class II electrosurgical cutting and coagulation device. This device is intended for use in minimally invasive surgery for vessel harvesting, primarily in endoscopic surgery for arterial bypass. It is indicated for cutting tissue, controlling bleeding through coagulation, and blunt dissection of tissue, including blood vessels, ducts, and other structures in extraperitoneal or subcutaneous spaces, as well as thoracic space.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document states that "The results of the verification testing demonstrate that the Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System meet the established acceptance criteria and performs in a manner equivalent to the predicate devices." However, the specific quantitative acceptance criteria (e.g., specific thresholds for sealing strength, cutting time, or tissue damage) and the reported performance values that met these criteria are not explicitly detailed in the provided text. The document broadly states equivalence to predicate devices (VV4 - K030512 and VV6 - K041981) regarding design, materials, method of delivery, and intended use.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "verification testing" and "testing program" but does not specify any sample sizes for the test set. It also does not provide information on data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
The provided text does not mention the use of experts to establish ground truth for a test set, nor does it specify their number or qualifications. This type of information is typically relevant for studies involving qualitative assessments or image-based diagnostics, which does not appear to be the primary focus of the performance data for this device.
4. Adjudication Method for the Test Set:
Since the document does not mention the use of experts or qualitative assessments for a test set, there is no information provided on any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is an electrosurgical cutting and coagulation device and not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device, and no such study is mentioned or implied.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a surgical instrument and not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable to this device, and no such study is mentioned.
7. The Type of Ground Truth Used:
The document indicates that the performance data for the device involved "verification testing" to ensure it "meet the established acceptance criteria." Given the nature of a surgical device, the ground truth would likely be established through objective measurements and assessments of physical performance characteristics such as:
- Sealing efficacy (e.g., burst pressure, hemostasis)
- Cutting performance (e.g., clean cuts, time to cut)
- Tissue damage assessments (e.g., thermal spread, charring)
- Durability and mechanical integrity
- biocompatibility (though not explicitly mentioned in the performance data section, it would be a standard part of device testing).
This "ground truth" would be determined by engineering and biological testing rather than expert consensus on a diagnostic outcome or pathology.
8. The Sample Size for the Training Set:
The concept of a "training set" is typically associated with machine learning and AI development. As this is a medical device and not an AI algorithm, there is no mention or applicability of a training set in the provided information. The device's performance is likely validated through traditional engineering and biological testing.
9. How the Ground Truth for the Training Set was Established:
As there is no training set for this type of device, there is no information provided on how ground truth for a training set was established.
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Guidant Corporation
Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System Special 510(k)
APPENDIX A: 510(K) SUMMARY
| Submitter | Guidant Corporation, Cardiac Surgery |
|---|---|
| Submitter'sAddress | 3200 Lakeside DriveSanta Clara, CA 95054 |
| Telephone | (408) 845-2014 |
| Fax | (408) 845-2077 |
| Contact Person | M. Laurie Wong |
| Date Prepared | August 19, 2005 |
| Device TradeName | Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System |
| DeviceCommon Name | Electrosurgical cutting and coagulation device and accessories |
| DeviceClassificationName | Electrosurgical cutting and coagulation device and accessories |
| DeviceClassification | Class II |
| Summary ofsubstantialequivalence | The design, materials, method of delivery, and intended use features of theGuidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System aresubstantially equivalent with regard to those features in the predicate devices:the VV4 (K030512, May 14, 2003), and the VV6 (K041981, August 20, 2004). |
| Devicedescription | The Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System isdesigned for use in conjunction with the 7 mm Endoscope. The HarvestingCannula has four lumens which house the Endoscope, C-Ring, distal lens washertube and VasoView® HemoPro™ Harvesting Tool for cutting and sealing ofvessel branches. The C-Ring/distal lens washer is independently controlled by aC-Ring Slider on the handle of the device that retracts the vessel and washes thedistal tip of the Endoscope. The Harvesting Tool can be extended/retracted fromthe main cannula by inserting it into the Tool Adapter Port, and rotatedindependently. The Harvesting Tool has two curved Jaws. One Jaw contains theheating elements for branch cutting and sealing; the second Jaw is longer and hasa serrated inner edge. Cutting and sealing of vessel branches is achieved in twosteps: (1) capture of the branch between the Jaws of the Harvesting Tool andthen (2) simultaneous coagulation and ligation of the branch with the Jaws usingdirect current. Both steps are achieved by mechanical application of theActivation Toggle. Positioning of the device, cutting, and sealing are performedunder endoscopic visualization. This device is intended for specific use with the |
| Indications forUse | The VasoView® HemoPro™ System is indicated for use in minimally invasivesurgery allowing access for vessel harvesting, and is primarily indicated forpatients undergoing endoscopic surgery for arterial bypass. It is indicated forcutting tissue and controlling bleeding through coagulation, and for patientsrequiring blunt dissection of tissue including dissection of blood vessels,dissection of blood vessels of the extremities, dissection of ducts and otherstructures in the extraperitoneal or subcutaneous extremity and thoracic space.Extremity procedures include tissue dissection/vessel harvesting along thesaphenous vein for use in coronary artery bypass grafting and peripheral arterybypass or radial artery for use in coronary artery bypass grafting. Thoracoscopicprocedures include exposure and dissection of structures external to the parietalpleura, including nerves, blood vessels and other tissues of the chest wall. |
| Technologicalcharacteristics | The Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting Systemincorporates the same fundamental scientific technology as the predicate devices. |
| Performancedata | The results of the verification testing demonstrate that the Guidant VasoView®HemoPro™ Endoscopic Vessel Harvesting System meet the establishedacceptance criteria and performs in a manner equivalent to the predicate devices.No new safety or effectiveness issues were raised during the testing program. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or lines extending from the head.
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. M. Laurie Wong Principal Regulatory Affairs Associate Guidant Corporation Cardiac Surgery 3200 Lakeside Drive Santa Clara, California 95054
Re: K052274
K052274
Trade/Device Name: Guidant Vaso View® HemoPro™ Endoscopic Vessel Harvesting System Regulation Number: 21 CFR 878.4400 Regulation Name: 21 CFR 078. 1100
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 19, 2005 Received: August 22, 2005
Dear Ms. Wong:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > ro(t) prematics is substantially equivalent (for the indications referenced above and nave ucterimined the acted predicate devices marketed in interstate for use stated in the encrosule for regally manatise for the Medical Device American so to commerce prior to May 20, 1970, the enaounter with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of the Unit devices that have been reclassified in acceraanse was a proval approval application (PMA). and Cosment Act (Act) that do not require approvile controls provisions of the Act. The You may, merelore, market the devices, belyer to the see of the sensual registration, listing of general controls provisions of the free morely of the more of the manage of the branding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) the entires and regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may may be subject to such additional controller 21, Parts 800 to 898. In addition, FDA may be found in the Oode of I cases in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 issuation of a basesian and other requirements of the Act that I DA has made a dolorimiation administered by other Federal agencies. You must of any I edical statutes and regalations and limited to: registration and listing (21 Comply with an the Act 5 requirements, as a sood manufacturing practice requirements as set CITY art 6077, adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 5 10(k) I his letter will anow you to begin manxoning of substantial equivalence of your device to a legally premarket notification. The PDA maing of saostalian organ 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 ac not 10-75-0115. Also, please note the regulation entitled, contact the Office of Complance at (210) 275 - 17 877 Part 807.97). You may obtain "Misoranding by relective to premarker notificas in the Act from the Division of Small other general International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara BuecheD
for
Mark N. Melkerson Acting 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): ____K052274
Device Name:_VasoView® HemoPro™ Endoscopic Vessel Harvesting System
Indications For Use:
Indications For Use:
The VasoView® HemoPro™ System is indicated for use in minimally invasive surgery The VasoView" HemoPro " System is indicated for patients undergoing allowing access for vesser narvesting, and is primating tissue and controlling
endoscopic surgery for arterial bypass. It is indicated for cutting the sue endoscopic surgery for antenal bypass. It is manufact blunt dissues of tissues bleeding through coagulation, and for patients routing analysis of the extremities,
including dissection of blood vessels, dissection of blood vessels of the extremity including dissection of blood vessels, and other straperitoneal or subcultaneous
dissection of ducts and other structures in the extraperity of the elissection/vi dissection of ducts and other stucctures in the extrapentonealise in the endissection/vessel
extremity and thoracic space. Extremity procedures include thisses graffing and extremity and thoracle space. Extremity prosediate and artery bypass grafting and harvesting along the Saphellous vein to use in coronary artery bypass grafting.
peripheral artery bypass or radial artery for use in coronary arternal peripheral artery bypass of faulal and in one in other unformation of estimal to the
Thoracoscopic procedures include exposure and dissection of the chest wall Thoracoscopic procedures include exposure and other tissues of the chest wall.
parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
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)
Soubane buchud formen
Division of General, Restorative, and Neurological Devices
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510(k) Number K052274
§ 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.