(36 days)
The VASOVIEW HEMOPRO 2 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 the 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 VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VASOVIEW HEMOPRO 2 Harvesting Tool for the cutting and sealing of vessel branches. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting, sealing and spot cautery. An area near the tip of the convex side of the Jaw can be used for spot cautery. The Activation Toggle is used to control the Jaws to activate the heating elements. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the VASOVIEW HEMOPRO Power Supply, VASOVIEW HEMOPRO 2 Extension Cable, and an Adapter Cable.
This 510(k) summary describes a medical device, the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System. The document focuses on establishing substantial equivalence to a predicate device through functional characteristics and performance testing. However, it does not involve an AI/ML algorithm or a study with specific acceptance criteria in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC).
Instead, the "acceptance criteria" and "study" refer to the verification and validation testing performed to ensure the device functions as intended and safely, and is substantially equivalent to existing devices.
Here's an breakdown based on the provided text, noting limitations due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table with quantitative acceptance criteria (e.g., numerical thresholds for performance metrics) and corresponding reported performance values. Instead, it states:
| Performance Aspect | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Overall Function | Meets established acceptance criteria | "The results of verification and validation testing and Risk Analysis demonstrate that the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System data meets the established acceptance criteria and performs in a manner equivalent to the predicate devices." |
| Essential Functional Characteristics (Bench Testing) | Device functions as intended | "Bench testing was done to verify and validate essential functional characteristics of the device." |
| Thermal Spread | Acceptable extent of necrosis beyond jaws | "An example of this was thermal spread, i.e., the extent of necrosis beyond the length of the jaws." (Implied: met acceptable limits, though specific limits not provided). |
| User Needs (Non-Clinical Testing in Porcine Models) | Device meets user needs | "Non-clinical testing of the device in porcine models was done to validate that the device met user needs. In all cases the device met the acceptance criteria of the test." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "bench testing" and "non-clinical testing of the device in porcine models." The number of tests, specimens, or animals used is not provided.
- Data Provenance: The "study" (verification and validation testing) was performed internally by the manufacturer (MAQUET Cardiovascular). Data is "non-clinical" and involves "bench testing" and "porcine models." This indicates laboratory-based testing rather than human clinical data, and thus no specific country of origin is relevant in the same way as for clinical studies. It is prospective testing designed to evaluate the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not directly applicable to this type of device submission. For a physical medical device like an endoscopic vessel harvesting system, "ground truth" and "experts" are typically referred to as the engineering specifications, design requirements, and a qualified team performing the verification and validation (V&V) testing. The "ground truth" is that the device must function according to its design and safety specifications. There's no "ground truth" in the diagnostic or interpretative sense.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic device where human reader performance is compared with and without AI assistance. The device is a surgical tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. There is no AI algorithm in this device. Performance is evaluated on the physical function of the device itself.
7. Type of Ground Truth Used
The "ground truth" refers to the established technical specifications, design requirements, and safety standards for an endoscopic vessel harvesting system. For instance:
- Engineering specifications for jaw movement, heating element temperature, cutting force, sealing effectiveness.
- Biocompatibility and sterilization standards.
- Safety parameters like thermal spread in tissue.
- Functional design requirements (e.g., prevention of "false turn-on's," ergonomic handle).
8. Sample Size for the Training Set
Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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510(k) Premarket Notification VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System
510(k) SUMMARY
101274
IUN I I 2010
| Submitter | MAQUET CardiovascularJUN 11 2010 |
|---|---|
| Submitter's Address | 170 Baytech RoadSan Jose, CA 95134 |
| Telephone | (408) 635-0630 |
| Fax | (408) 635-3907 |
| Contact Person | Mark H. Smith |
| Date Prepared | March 19, 2010 |
| Device Trade Name | VASOVIEW HEMOPRO 2 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 VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System are substantially equivalent with regard to those features in the predicate VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System (K052274), and with regard to the spot cautery element in the VasoView 6 Harvesting Cannula (K041981). |
| Device description | The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VASOVIEW HEMOPRO 2 Harvesting Tool for the cutting and sealing of vessel branches. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting, sealing and spot cautery. An area near the tip of the convex side of the Jaw can be used for spot cautery.The Activation Toggle is used to control the Jaws to activate the heating elements. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the VASOVIEW HEMOPRO Power Supply, VASOVIEW HEMOPRO 2 Extension Cable, and an Adapter Cable. |
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The VASOVIEW HEMOPRO 2 System is indicated for use in minimally Indications for invasive surgery allowing access for vessel harvesting, and is primarily Use 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 the 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 The fundamental scientific technology of the VASOVIEW HEMOPRO 2 characteristics Endoscopic Vessel Harvesting System is the same as that of the predicate VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System (cleared under K052274). The HEMOPRO 2 Endoscopic Vessel Harvesting System is designed to be used with the existing HEMOPRO Power Supply (a supply that converts commonly available AC to a specified DC) and the 7 mm Extended Length Endoscope for visualization. An Extension Cable connects the HEMOPRO 2 to an Adaptor Cable, which in turn attaches to the HEMOPRO Power Supply. The Harvesting Cannula holds the BTT (both cleared as part of the predicate HEMOPRO device), the Endoscope, Dissection Tip, and the Harvesting Tool. The BTT seals the tunnel to maintain insufflation and can supply CO2 for insufflation. The Endoscope allows for visualization and dissection. The Dissection Tip attaches to the distal end of the Endoscope to dissect the target vessel away from the surrounding tissue. The Harvesting Tool has two jaws which contain heating elements which cut and coaqulate tissue like the predicate. A section of the iaws is constructed such that part of the heating element is revealed to create a spot cautery area. The heating elements (and thereby the spot cautery area) is activated by the actuation toggle on the handle of the tool. Technological changes from the HEMOPRO predicate include: redesigned circuitry in the handle that prevents false turn-on's, redesigned heating element to reduce cost and provide a spot cautery area, a new cable configuration and new connector type, more ergonomic handle, increased insulation of the jaws (preventing thermal spread), and improved cutting length.
Performance The results of verification and validation testing and Risk Analysis demonstrate that the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System data meets the established acceptance criteria and performs in a manner equivalent to the predicate devices. Bench testing and non-clinical validation testing were performed. Bench testing was done to verify and validate essential functional characteristics of the device. An example of this was thermal spread, i.e., the extent of necrosis beyond the length of the jaws. Non-clinical testing of the device in porcine models was done to validate that the device met user needs. In all cases the device met the acceptance criteria of the test.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a single snake winding around a staff.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Maquet Cardiovascular, LLC % Underwriters Laboratories, Inc. Mr. Casey Conry 1285 Walt Whitman Road Melville, NY 11747
JUN 1 1 2010
Re: K101274
Trade/Device Name: VASOVIEW HEMOPRO 2 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 Dated: May 5, 2010 Received: May 6, 2010
Dear Mr. Conry:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 - Mr. Casey Conry
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 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/ucm11.5809.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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark McMullen
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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510(k) Premarket Notification VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System
INDICATIONS FOR USE STATEMENT
510(k) number (if known) The 510(k) number has not been issued yet.
number
(if known)
Device name VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System
Indications for Use
The VASOVIEW HEMOPRO 2 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.
Prescription Use × (21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kision Sign-Off
sion Slan-Off Division of Surgical, Orthopedic, and Restorative Devices
March 19, 2010
510(k) Number K101274
Page 95
§ 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.