The VASOVIEW 6 PRO 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 VASOSHIELD Pressure Controlling Syringe is indicated for controlling pressure during the preparation and irrigation of blood vessels prior to use as a bypass graft.
The VASOVIEW 6 PRO Endoscopic Vessel Harvesting System consists of the VASOVIEW 6 PRO Harvesting Cannula which is designed for use in conjunction with the 7mm 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 branched. The system includes the following accessories- (1) The 7mm Extended Length Endoscope and Dissection Tip for blunt dissection of tissue and isolation of structures in the cavity. (2) Shortport Blunt Tip Trocar (BTT) to provide a port for insertion of endoscoic instruments into an incision site. (3) VASOSHIELD Pressure Controlling Syringe is a fully assembled 60 mL syringe with a pressure relief valve that is controlled by a pressure setting ring.
The Maquet Cardiovascular LLC VasoView 6 Pro Endoscopic Vessel Harvesting System is a medical device that received 510(k) clearance (K091733) on August 28, 2009. The submission indicates that the device's performance meets established acceptance criteria and is substantially equivalent to predicate devices. However, the provided document is a 510(k) summary and does not contain detailed information about specific acceptance criteria or a dedicated study report comparing the device's performance against these criteria.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary states generally that: "The results of the verification testing demonstrate that the VASOVIEW 6 PRO Performance meet the established acceptance criteria and performs in a manner equivalent to the predicate device." And similarly for the VASOSHIELD Pressure Controlling Syringe: "The results of the verification testing for the VASOSHIELD Pressure Controlling Syringe also demonstrate that the syringe meets established acceptance criteria and performs in a manner equivalent to its predicate device."
However, specific acceptance criteria (e.g., in terms of precision, accuracy, failure rates, etc.) and quantified performance results are not provided in this 510(k) summary. The summary only makes a general statement of compliance.
2. Sample size used for the test set and the data provenance:
- The 510(k) summary does not specify the sample size used for any test set.
- The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned. The verification testing generally implies that these tests were conducted by the manufacturer as part of their design control process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. The context suggests general engineering and product performance testing rather than clinical studies requiring expert ground truth for image or diagnostic interpretation.
4. Adjudication method for the test set:
- This information is not provided in the 510(k) summary. Given the nature of the device (endoscopic vessel harvesting system) and the general statements about verification testing, it's unlikely that "adjudication" in the sense of expert review for diagnostic accuracy would be applicable to the primary performance testing for this device.
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 information is not applicable and not provided. The VasoView 6 PRO is an endoscopic surgical device, not an AI or diagnostic imaging device that would typically undergo an MRMC study with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable and not provided. The device is an endoscopic harvesting system used by surgeons, not a standalone algorithm.
7. The type of ground truth used:
- The document describes "verification testing," which typically involves engineering and functional performance testing against predefined specifications (e.g., device dimensions, material properties, sterilization efficacy, electrical safety, mechanical strength, fluid flow rates, coagulation effectiveness). The "ground truth" would be established by measuring these physical or functional parameters. No pathology, outcomes data, or expert consensus in a diagnostic sense is mentioned.
8. The sample size for the training set:
- This information is not applicable and not provided. The VasoView 6 PRO Endoscopic Vessel Harvesting System is a mechanical and electrical surgical device, not a machine learning or AI-driven system that would require a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable and not provided as there is no mention of a training set for this type of device.
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Maquet Cardiovascular LLC
VasoView 6 Pro Endoscopic Vessel Harvesting System
System
Special 510(k)
AUG 2 8 2009
APPENDIX A: 510(K) SUMMARY
| Submitter | MAQUET Cardiovascular LLC |
|---|---|
| Submitter'sAddress | 40 Barbour Pond DriveWayne, NJ 07470 |
| Telephone | (408) 635-3987 |
| Fax | (408) 635-3907 |
| Contact Person | Artie Kaushik |
| Date Prepared | June 10, 2009 |
| Device TradeName | VASOVIEW 6 PRO 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 theVASOVIEW 6 PRO Endoscopic Vessel Harvesting System are substantiallyequivalent with regard to those features in the predicate device: the VV6(K041981, August 20, 2004) and VASOSHIELD Pressure Controlling Syringe(K082725, December 17, 2008) |
| Devicedescription | The VASOVIEW 6 PRO Endoscopic Vessel Harvesting System consists of theVASOVIEW 6 PRO Harvesting Cannula which is designed for use inconjunction with the 7mm Endoscope. The Harvesting Cannula has four lumenswhich house the Endoscope, C-Ring wire, endoscope washer tube and BipolarBiSector for ligation and division of vessel branched. The system includes thefollowing accessories- (1) The 7mm Extended Length Endoscope and DissectionTip for blunt dissection of tissue and isolation of structures in the cavity. (2)Shortport Blunt Tip Trocar (BTT) to provide a port for insertion of endoscoicinstruments into an incision site. (3) VASOSHIELD Pressure ControllingSyringe is a fully assembled 60 mL syringe with a pressure relief valve that iscontrolled by a pressure setting ring. |
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The VASOVIEW 6 PRO System is indicated for use in minimally invasive Indications for surgery allowing access for vessel harvesting, and is primarily indicated for Use 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 VASOSHIELD Pressure Controlling Syringe is indicated for controlling pressure during the preparation and irrigation of blood vessels prior to use as a bypass graft. The VASOVIEW 6 PRO Endoscopic Vessel Harvesting System incorporates the Technological same fundamental scientific technology as the predicate devices. characteristics The results of the verification testing demonstrate that the VASOVIEW 6 PRO Performance meet the established acceptance criteria and performs in a manner equivalent to data the predicate device. No new safety or effectiveness issues were raised during the testing program. The results of the verification testing for the VASOSHIELD Pressure Controlling Syringe also demonstrate that the syringe meets established acceptance criteria and performs in a manner equivalent to its predicate device.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with healthcare, with three overlapping lines forming the staff and a serpent winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Maquet Cardiovascular, LLC % Ms. Artie Kaushik Associate, Regulatory Affairs 170 Baytech Drive San Jose, California 95134
AUG 2 8 2009
Re: K091733
Trade/Device Name: VASOVIEW 6 PRO Endoscopic Vessel Harvesting System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, GBX Dated: July 31, 2009 Received: August 4, 2009
Dear Ms. Kaushik:
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 Cosmetic 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. Isting 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 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); medical device reporting (reporting of medical
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Page 2 - Ms. Artie Kaushik
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX B: INDICATIONS FOR USE STATEMENT
510(k) number (if known) The 510(k) number has not been issued yet.
Device name
VASOVIEW 6 PRO Endoscopic Vessel Harvesting System
Indications for Use
The VASOVIEW 6 PRO 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 VASOSHIELD Pressure Controlling Syringe is indicated for controlling pressure during the preparation and irrigation of blood vessels prior to use as a bypass graft.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use ﮐﮯ OR Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Page 1 of 1
§ 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.