(302 days)
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.
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.
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.
§ 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.