The VirtuoSaph® Plus Endoscopic Vessel Harvesting 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 and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting.

Device Description

The VirtuoSaph® Plus Endoscopic Vessel Harvesting System is a device used in minimally invasive surgery for vessel harvesting. It utilizes bipolar radio frequency (RF) energy for tissue cauterization and cutting. The device is designed to be used with an endoscope and provides CO2 insufflation. It includes a full-length dissector for tunnel dissection.

AI/ML Overview

This is a 510(k) premarket notification for the Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System, specifically seeking to expand its indications to include Radial Artery Harvesting. The document primarily focuses on demonstrating substantial equivalence to a predicate device, the Guidant VasoView 6 Endoscopic Vessel Harvesting System.

Therefore, the "acceptance criteria" discussed are not specific performance metrics with numerical targets for a standalone device, but rather the demonstration of substantial equivalence to an existing predicate device for the expanded indication. The "study" proving this is a series of performance assessments designed to show this equivalence.

Here's an breakdown of relevant information:

1. Table of Acceptance Criteria (Demonstrated Equivalence) and Reported Device Performance:

Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be that the performance of the VirtuoSaph® Plus for radial artery harvesting is comparable to, and demonstrably safe and effective as, the predicate VasoView® 6 device in relevant aspects.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance (Summary from Document)
Intended Use/Indications for Use: Expanded indication for radial artery harvesting must be substantially equivalent to predicate.	VirtuoSaph® Plus Indications (Proposed): "...or radial artery for use in coronary artery bypass grafting." Predicate VasoView® 6 Indications: "...harvesting of the radial artery for use in coronary artery bypass grafting." The submission explicitly states the intent to expand the VirtuoSaph® Plus indications to match the predicate for radial artery harvesting. The conclusion states substantial equivalence.
Product Technology: Different cutting mechanisms should not impact safety/effectiveness; bipolar RF energy for cauterization must perform equivalently.	VirtuoSaph® Plus: Bipolar RF energy for tissue separation (cutting) and cauterization. Predicate VasoView® 6: Mechanical blade for cutting, bipolar RF energy for cauterization. The document acknowledges the difference in cutting mechanisms but states: "Terumo Cardiovascular Systems conducted performance assessments to demonstrate equivalence to the identified predicate device." Both use bipolar RF for cauterization, and for both, the RF current is transmitted across two electrodes for cauterization/sealing.
Design: Must be functionally similar and achieve equivalent clinical outcomes for tunnel dissection and vessel harvesting.	VirtuoSaph® Plus Dissector: Separate full-length dissector with integrated conical tip that "houses" the endoscope. Predicate VasoView® 6 Dissector: Dissector tip that can be affixed to endoscope for tunnel dissection. The document states: "There is no clinical relevance to this difference in tunnel dissection as either method safely and effectively accomplishes tunnel dissection." Both are designed for vessel harvesting with an endoscope, and both are packaged without endoscopes. Both utilize bipolar RF energy for coagulation and have necessary bipolar connectors.
Materials: Differences must not be clinically relevant or impact safety/effectiveness; biocompatibility requirements met.	"While there are differences among the materials of construction, these differences are not clinically relevant." Both devices' materials have been cleared by FDA for their respective uses. VirtuoSaph® Plus materials have satisfied all applicable biocompatibility requirements.
Insufflation: Must be effective for tunneling and harvesting without adverse clinical impact.	VirtuoSaph® Plus Insufflation: From distal position of system tools for dissection and harvesting. Predicate VasoView® 6 Insufflation: Proximal handle for dissection, distal position of harvester rod for harvesting. The document states: "This difference is clinically insignificant as insufflation is sufficiently accomplished with either device without adversely impacting clinical outcomes."
Overall Performance (specifically for Radial Artery Harvesting): Safety and effectiveness for the expanded indication must be demonstrated.	"Terumo Cardiovascular Systems conducted performance studies with the VirtuoSaph® Plus Endoscopic Vessel Harvesting System (with expanded radial harvest indication) - where a comparison was made to the predicate VasoView® 6 device. The studies were comparative in nature with the intent to demonstrate performance equivalence between the devices... There are no appreciable differences between the subject devices and the predicate devices with respect to product performance - including harvesting of the radial artery." Specific assessments included: Radial Artery Dissection and Harvesting, Insufflation, Cauterization, Radial Artery Encapsulation (V-Keeper), Burst Pressure, Spot Cauterization, Sealing/Bleeding.
Duration of Use: Must be equivalent.	Both devices "can each be used in procedures lasting up to 6 hours in duration."
Labeling: Must be comparable and satisfy regulatory requirements.	Labeling for the subject device (with radial artery harvest indication) is nearly identical to its prior version without the expanded indication, and "is comparable to the labeling associated with the predicate VasoView 6 device in that both labeling schemes satisfy the required with for medical device labeling - including adequate directions for use product including instructions, warnings/cautions, and contact information."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in terms of number of cases/animals/cadavers. The document mentions "animal studies, cadaver studies and bench evaluations" for performance assessments. No specific numbers are provided for these studies.
Data Provenance: Not specified regarding the country of origin. The studies are described as "performance assessments" conducted by Terumo Cardiovascular Systems. They are effectively prospective studies performed to demonstrate equivalence for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not mentioned. The "ground truth" for these performance assessments would likely be objective measurements (e.g., burst pressure, sealing effectiveness, visual observation of dissection quality) rather than expert consensus on interpretive tasks. The studies were performed to evaluate physical device performance characteristics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not mentioned. This type of adjudication is typically used for medical image interpretation or clinical outcomes where there's subjectivity and potential for disagreement among experts. The studies described are performance tests with objective endpoints.

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:

No, an MRMC study was not done. This device is an electrosurgical vessel harvesting system, not an AI diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the performance assessments were for the device itself. While the device is used by a human surgeon, the tests performed (e.g., burst pressure, cauterization effectiveness) are evaluations of the device's physical and functional capabilities, standing alone in its ability to perform its intended functions when operated correctly. These are not human-in-the-loop studies in the sense of AI-assisted decision-making.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for these performance assessments would have been objective measurements and observations from the animal, cadaver, and bench studies for parameters such as:
- Successful Radial Artery Dissection and Harvesting (visual assessment, integrity of harvested vessel).
- Effective Insufflation (measurement of pressure, visual assessment of tunnel creation).
- Successful Cauterization/Sealing (e.g., lack of leakage, burst pressure tests where relevant).
- Absence of significant tissue damage.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set. The "development" of the device would involve engineering, design, and internal verification testing, not data training in the modern AI sense.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set mentioned or implied for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 31, 2014

Terumo Cardiovascular Systems Corporation Mr. Garry Courtney, MBA, RAC Director, Regulatory Affairs 125 Blue Ball Road Elkton, Maryland 21921

Re: K140008

Trade/Device Name: VirtuoSaph® Plus Endoscopic Vessel Harvesting System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 29, 2014 Received: September 30, 2014

Dear Mr. Courtney:

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 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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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter "T" inside, followed by the word "TERUMO" in large, bold letters. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in smaller letters.

SECTION 4 - INDICATION FOR USE VirtuoSaph® Plus Endoscopic Vessel Harvesting System

510(k) Number (if known): Unknown at time of submission K140008

Device Name: VirtuoSaph® Plus Endoscopic Vessel Harvesting System

Indications for Use:

The VirtuoSaph® Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primearily indicated for priments undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring dissue and controlling dissection of blood vessels and dissection of blood vessels of the extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 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)

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Image /page/3/Picture/0 description: The image contains the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter "T" inside, followed by the word "TERUMO" in a bold, sans-serif font. Below the word "TERUMO" are the words "Cardiovascular Systems" in a smaller, sans-serif font. The logo is a teal color.

SECTION 5 – 510(K) SUMMARY VirtuoSaph® Plus Endoscopic Vessel Harvesting System

Date Prepared:	December 20, 2013
Sponsor Information:Owner/Applicant/Submitter:	Terumo Cardiovascular Systems Corporation125 Blue Ball RoadElkton, MD 21921Phone: 1-800-262-3304, Ext. 7486Fax: 410-398-6079Registration No. 1124841
Contact Person:	Garry A. Courtney, MBA, RACDirector, Regulatory AffairsPhone: 1-800-262-3304, Ext. 7486Fax: 410-398-6079Email: garry.courtney@terumomedical.com
Device Names/Classifications:Device Trade Name:	VirtuoSaph® Plus Endoscopic Vessel Harvesting System
Device Common Name:	Electrosurgical Cutting and Coagulation Device
Classification Name:	Electrosurgical Cutting and Coagulation Device
Regulation Number:	21 C.F.R. 878.4400
Classification:	Class II
Product Code:	GEI

Predicate Devices:

· Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System Cleared by FDA under K092789 on May 12, 2010.
· Guidant VasoView 6 Endoscopic Vessel Harvesting System Cleared by FDA under K041981 on August 20, 2004

Purpose of Submission:

Terumo Cardiovascular Systems Corporation is submitting this Premarket Notification because of its intent to expand the product's current usage indications. The expanded indication will allow for the device to be used in harvesting the radial artery for coronary artery bypass grafting procedures.

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Image /page/4/Picture/0 description: The image contains the logo for Terumo Cardiovascular Systems. The logo consists of a circle with a stylized "T" inside, followed by the word "TERUMO" in a bold, sans-serif font. Below "TERUMO" are the words "Cardiovascular Systems" in a smaller, lighter font. The logo is in a teal color.

Summary of Comparisons Between Subject and Predicate Devices:

This 510k Summary is intended to provide a brief presentation of the similarities and differences between the proposed VirtuoSaph® Plus device and the predicate VasoView 6 device. This summary will include a review of product indications, technology, design materials and product performance.

Intended Use/Indications for Use:

The subject VirtuoSaph® device shares common indications with the predicate VasoView® 6 device:

Proposed VirtuoSaph® Plus Indications:

The VirtuoSaph® Plus is currently 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 contralling bleeding through coagulation, and for patients requiring blunt dissection of itssue including dissection of blood vessels and dissection of blood vessels of the extentises, The extremity procedures include tissue dissection and/or vessel havesting anoming the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting.

Predicate VasoView 6 Indications:

The VasoView® 6 device is FDA-cleared for use in minimally invasive surgery allowing for access to vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is also indicated for putting times and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including the dissection of blood vessels and blood vessels of the externities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. These extremity procedures include tissue dissention end vein harvesting along the saphenous vein (for use in coronary and peripheral artery bypass procedures), as well as harvesting of the radial artery for use in coronary artery bypass grafting. Additionally, thoroscopic procedures include exposure and dissettin of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

A primary difference between these two product indications is that the predicate VasoView® 6 device is cleared for the harvesting of the radial artery for use in coronary artery bypass grifting. It is Terumo Cardiovascular System's intent to expand indications to include harvesting of the radial artery for use in coronary artery bypass grafting. No additional product indications are being pursued with this submission.

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Image /page/5/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter "T" inside, followed by the word "TERUMO" in a bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller font. The logo is likely used to represent the company and its focus on cardiovascular products and services.

The proposed product indications for the VirtuoSaph® Plus Endoscopic Vessel Harvesting System are:

The VirtuoSaph® Plus Endoscopic Vessel Harvesting 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 hylood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting.

Product Technology:

The primary functions of most vessel harvesting systems include tissue cauterization and tissue dissection functions. This is also true for the VirtuoSaph® Plus device and the predicate VasoView 6 device. The subject VirtuoSaph® Plus device and the predicate VasoView 6 device each rely upon bipolar radio frequency (RF) energy to cauterize vessels that are to be harvested. For each of these two devices, the RF current is transmitted a cross two electrodes in order to effect the necessary cauterization/sealing of the tissue is oppropriated is positioned between the two electrodes.

With respect to cutting of the tissue, the VirtuoSaph® Plus device relies upon bipolar RF energy to effect separation, whereas the cutting process with the predicate Vaso View® 6 is achieved by a mechanical blade which slices through the tissue to effect separation. While this difference is recognized, Terumo Cardiovascular Systems conducted performance assessments to deremonstrate equivalence to the identified predicate device.

Design:

The design of the VirtuoSaph® Plus device and the VasoView® 6 device are similar. Both devices are designed to harvest vessels from the human body that are deemed appropriate for subsequent use (i.e., bypass grafting). Both devices are designed to be used with pp epdoscope and both products are packaged without endoscope - as the endoscopes are commercially available separate from the vessel harvesting systems.

The VasoView® 6 device presents with a dissector tip that can be affixed to endoscope for tunnel dissection whereas the VirtuoSaph® Plus device presents a separate full-length dissector ror tonice (with integrated conical tip) which "houses" the endoscope during tunnel dissection. The difference being that the conical shaped tip is an attachment component with the VasonView 6 device verses a fully assembled device with the subject VirtuoSaph® Plus device. There is no clinical relevance to this difference in tunnel dissection as either method safely and effectively accomplishes tunnel dissection.

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Image /page/6/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter T inside, followed by the word "TERUMO" in a bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller, lighter font. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.

Both devices utilize upon bipolar RF energy to coagulate vessels/branches during the harvesting of the vessel. Additionally, both devices are presented with the necessary bipolar connector/cord that will interface with the bipolar outlets of compatible generators.

The VirtuoSaph® Plus device and the VasoView® 6 device each provide CO2 insufflation to assist in the tunneling and harvesting of target vessels. Insufflation with the VirtuoSaph® device is accomplished from the distal position of the system tools for both dissection and harvesting procedures, whereas the VasoView® 6 device provides insufflation from the proximal handle position for the dissection procedure – and from the distal position of the harvester rod during the harvesting procedure. This difference is clinically insugnificant as insufflig the sufficiently accomplished with either device without adversely impacting clinical ontounnal.

Materials:

The materials that are used in the construction of the VirtuoSaph® Plus device and the Vaso View 6 device vary from component to component. While there are differences annong the materials of construction, these differences are not clinically relevant. Both devices have already been cleared by FDA with their respective materials of construction, and because the devices are being used in the manner for which they were cleared, there would be no issues of the safety or effectiveness with respect to materials. Furthermore, the would be in issues on the construction of the VirtuoSaph® Plus have satisfied all applicable biocompatibility requirements. It is concluded that while difference in materials do exist, these differences are not clinically relevant.

Performance Evaluations:

Terumo Cardiovascular Systems conducted performance studies with the VirtuoSaph® Plus Endoscopic Vessel Harvesting System (with expanded radial harvest indication) - where a comparison was made to the predicate VasoView® 6 device. The studies were comparative in nature with the intent to demonstrate performance equivaleoce between the devices. The studies were also designed and conducted to ensure that the subject ViruoSaph® devices satisfies appropriate device performance specifications and to ensure that it satisfies customer needs. There are no appreciable differences between the subject devices and the predicate devices with respect to product performance - including harvesting of the radial artery.

Clinical studies involving patients are not necessary to demonstrate the safety and effectiveness of the subject devices. Performance assessments for safety and effectiveness were accomplished through animal studies, cadaver studies and bench evaluations. These studies assessed the following:

Radial Artery Dissection and Harvesting .
Insufflation .
Cauterization 0
o Radial Artery Encapsulation (V-Keeper)
Burst Pressure .
Spot Cauterization o
Sealing / Bleeding 0

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Image /page/7/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter "T" inside, followed by the word "TERUMO" in a bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller font. The logo is likely used to represent the company and its products or services related to cardiovascular health.

Additional Areas of Comparison:

The information presented in this section depicts other areas of focus for examining the similarities and differences between the VirtuoSaph® Plus Endoscopic Vessel Harvestinming System and the predicate device.

. Duration of Use:

The VirtuoSaph® Plus Endoscopic Vessel Harvesting System and the predicate VasoView® 6 can each be used in procedures lasting up to 6 hours in duration.

ರ್ಥ Comparison of Labeling:

The labeling that will be used for the VirtuoSaph® Plus Endoscopic Vessel Harvesting System (with radial artery harvest indication) is nearly identical to the labeling of the same device (VirtuoSaph® Plus) without the expanded product indication.

Additionally, the labeling for the subject device is comparable to the labeling associated with the predicate Vaso View 6 device in that both labeling schemes satisfy the required with for medical device labeling - including adequate directions for use product including instructions, warnings/cautions, and contact information.

Conclusion:

The information and data included in the 510(k) notice demonstrate the Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System is substantially equivalent to the prodicate Vaso View 6 Endoscopic Vessel Harvesting System with respect to harvesting of the prodial artery for use in bypass grafting.

Regulation Number and Section

§ 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.