(68 days)
The Vasoview Hemopro 3 Power Supply is used in conjunction with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System, which 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 3 Power Supply is a reusable. AC-powered device intended to be used only with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System. The Vasoview Hemopro 3 Power Supply provides DC current to the Vasoview Hemopro 3 Harvesting Tool to enable cutting and coagulation of vessels and tissue during vessel harvesting procedures. The Vasoview Hemopro 3 Power Supply is positioned outside the sterile field, and can be placed on a flat, non-sterile surface or may be suspended from a nearby IV pole. The Vasoview Hemopro 3 Power Supply does not make contact with the patient, nor does it deliver energy directly to the patient; energy to the patient is delivered by the Vasoview Hemopro 3 Harvesting Tool. The Vasoview Hemopro 3 Power Supply is intended to be used by healthcare professionals in an operating room environment.
The Vasoview Hemopro 3 Power Supply underwent several nonclinical tests to demonstrate its substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance
The FDA summary does not provide a table of acceptance criteria and reported device performance with specific numerical values for each test. Instead, it offers a high-level summary that "The results of the verification testing demonstrate that the Vasoview Hemopro 3 Power Supply meets the established acceptance criteria and performs in a manner equivalent to the predicate device."
However, the types of tests conducted and the standards they comply with can be inferred as acceptance criteria:
| Acceptance Criteria Category | Specific Criteria/Standards (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with ANSI/AAMI ES60601-1:2005/A2:2021, ES60601-1:2005/AMD1 1:2012, ES60601-1:2005/AMD2:2021 | Complies with the listed electrical safety performance standards. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2: 2018 | Complies with the listed EMC performance standards. |
| Usability / Human Factors | Adequately designed, safe, and effective for intended users, uses, and use environments; no unacceptable risks from a usability perspective (per FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" and IEC 62366-1:2015/AMD 1:2020) | Summation human factors validation study demonstrated the device is adequately designed and found to be safe and effective. No unacceptable risks remain. |
| Electrical Life Cycle | Demonstrated performance over its electrical lifespan | Testing was conducted, and results indicated it met established acceptance criteria. |
| Mechanical Life Cycle | Demonstrated performance over its mechanical lifespan | Testing was conducted, and results indicated it met established acceptance criteria. |
| Connection Force and Activation Cycle | Demonstrated reliable connection and activation cycles | Testing was conducted, and results indicated it met established acceptance criteria. |
| Life Cycle Durability | Durability, including design-specific characterization | Testing was conducted, and results indicated it met established acceptance criteria. |
| Cleaning and Disinfection | Validated effectiveness of cleaning and disinfection procedures | Validation was conducted. |
| Wet Handling | Demonstrated safe and effective operation in wet conditions | Verification was conducted. |
| Packaging and Labeling | Verified appropriateness and integrity of packaging and labeling | Verification was conducted. |
| Labeling and Markings | Legibility, adherence, and durability of labels and markings | Testing was conducted. |
| Shipping/Transit Life Cycle | Demonstrated integrity and functionality after shipping/transit | Verification was conducted. |
| General Performance | Equivalence to predicate devices; no new safety or effectiveness issues | Performs as intended and claimed; equivalent to predicate device; no new safety or effectiveness issues raised. |
2. Sample Size for Test Set and Data Provenance
- Electrical Safety & EMC Testing: The report does not specify the sample size for devices tested, nor does it explicitly state the data provenance (e.g., country of origin, retrospective/prospective). This type of testing typically involves a small number of production units.
- Human Factors / Usability Study: The report does not specify the sample size of users (healthcare professionals) involved in the summative human factors validation study. It also does not explicitly state the data provenance. Such studies are typically conducted in a simulated clinical environment.
- Bench Testing (Electrical Life Cycle, Mechanical Life Cycle, etc.): The report does not specify the sample sizes for these tests. These generally involve a limited number of test units to assess durability and performance. Data provenance for bench testing is inherently laboratory-based.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided for any of the nonclinical tests described. For a human factors study, "users" are typically healthcare professionals, but their specific qualifications and number are not detailed. For the other bench tests, ground truth is established through engineering specifications and standards, not expert consensus.
4. Adjudication Method for Test Set
This information is not applicable to the nonclinical studies described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of images or data to establish a ground truth when there might be discrepancies. The listed tests establish compliance through direct measurement against pre-defined engineering standards or through usability observations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission explicitly states "No clinical testing was conducted in support of this submission." The device is a power supply for an existing system, and the evaluation focused on non-clinical performance and equivalence to predicate devices.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
This question is not directly applicable as the device (Vasoview Hemopro 3 Power Supply) is a hardware component that provides power to a surgical tool. It does not involve an algorithm or AI. Its performance is evaluated in conjunction with the harvesting tool, but its role is as a power source, not an intelligent system that operates independently from human control or interpretation.
7. Type of Ground Truth Used
- Electrical Safety & EMC: The ground truth used is established by recognized international and national consensus standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2). Compliance with these standards indicates the device meets safety and performance requirements.
- Human Factors / Usability: The ground truth for usability is typically established through observation of user interaction, identification of use errors, and ergonomic assessment against human factors principles and guidelines (FDA guidance, IEC 62366-1). The "success" of the study indicates that users can operate the device safely and effectively without unacceptable risks.
- Bench Testing: The ground truth for electrical, mechanical, durability, cleaning, packaging, and labeling tests is established by documented design specifications, engineering requirements, and relevant consensus standards (e.g., ISO, ASTM). The device's performance is measured against these predefined and objective criteria.
8. Sample Size for the Training Set
This question is not applicable as this device is a hardware power supply and does not involve AI/machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as this device does not involve AI/machine learning algorithms that require a training set and associated ground truth.
§ 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.