(30 days)
Not Found
No
The description focuses on mechanical and electrical functions for cutting and sealing tissue under endoscopic visualization, with no mention of AI or ML terms or capabilities.
No.
The device is used for surgery (cutting tissue and controlling bleeding, blunt dissection) to harvest vessels, which is a surgical procedure, not a therapeutic treatment.
No
The device is an endoscopic vessel harvesting system used for cutting tissue and controlling bleeding, not for diagnosis. Its purpose is to perform surgical procedures, not to identify or determine the nature of a disease or condition.
No
The device description clearly outlines a physical medical device with hardware components such as a harvesting cannula, lumens, C-Ring, harvesting tool with jaws, heating elements, and an activation toggle. It is used in conjunction with an endoscope, which is also a hardware device.
Based on the provided information, the VasoView® HemoPro™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used during surgery on a patient's body (in vivo). It's used for accessing, cutting, dissecting, and controlling bleeding of tissues and vessels within the patient.
- Device Description: The description details a surgical instrument with lumens, a harvesting tool with jaws, and a mechanism for cutting and sealing branches using direct current. This is consistent with a surgical device, not a device used to examine samples outside the body.
- Anatomical Site: The specified anatomical sites are within the human body (extremity and thoracic space, veins, arteries, chest wall).
- Input Imaging Modality: Endoscopic visualization is a method of viewing structures inside the body.
- Intended User / Care Setting: Minimally invasive surgery and endoscopic surgery are procedures performed on patients.
IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. The VasoView® HemoPro™ System does not perform this function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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
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)
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. 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
Guidant Corporation
Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System Special 510(k)
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) 845-2077 |
| Contact Person | M. Laurie Wong |
| Date Prepared | August 19, 2005 |
| Device Trade | |
| Name | Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System |
| 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® HemoPro™ Endoscopic Vessel Harvesting System are | |
| substantially equivalent with regard to those features in the predicate devices: | |
| the VV4 (K030512, May 14, 2003), and the VV6 (K041981, August 20, 2004). | |
| Device | |
| description | 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 | |
| Indications for | |
| Use | 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. | |
| Technological | |
| characteristics | The Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System |
| incorporates the same fundamental scientific technology as the predicate devices. | |
| Performance | |
| data | 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. | |
| 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.
3
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
4
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
Page 1 of 1
510(k) Number K052274