(57 days)
The subject Cables (VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance and Active Return Cord) are accessories to the VASOVIEW Endoscopic Vessel Harvesting System. They are supplied non-sterile and must be sterilized prior to each.
The VASOVIEW HEMOPRO Extension Cable (P/N VH-3030), is a reusable cable designed for use with the VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System and the VASOVIEW HEMOPRO Power Supply. The Extension Cable is supplied non-sterile and must be sterilized prior to each use.
The VASOVIEW HEMOPRO 2 Extension Cable (P/N VH-4030), is a reusable cable designed for use with the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System and the VASOVIEW HEMOPRO Power Supply and the HEMOPRO 2 Adapter Cable. The Extension Cable is supplied non-sterile and shall be sterilized prior to each use. The Extension Cable connects to the VASOVIEW HEMOPRO Power Supply via the Adapter Cable.
The Active/Return extension cord with banana plugs (P/N 1838), is a reusable cord designed for use with the VASOVIEW Endoscopic Vessel Harvesting System VV6 Pro/VV7. Each cord is supplied non-sterile and must be sterilized prior to each use.
The Bipolar Extension Cable, Fixed Distance (P/N 2838) is a reusable cable designed for use with the VASOVIEW Endoscopic Vessel Harvesting System VV6 Pro /VV7. Each cable is supplied non-sterile and must be sterilized prior to each use.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:
Device: VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, and Active Return Cord (accessories to the VASOVIEW Endoscopic Vessel Harvesting System)
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner as one might expect for a clinical study on diagnostic accuracy or efficacy. Instead, it describes a series of performance qualifications and verifications undertaken to demonstrate substantial equivalence to predicate devices, particularly regarding reprocessing methods.
The "acceptance criteria" here are implied to be the successful completion and passing of these performance qualifications, demonstrating that the proposed cables perform equivalently or better in terms of safety and functionality under the specified reprocessing conditions.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliant with expanded cleaning methods: | All listed cleaning methods were successfully qualified. |
| - Manual Cleaning Process Performance Qualification | Performance Qualification successful. |
| - Manual with Ultrasonic Cleaning Process Performance Qualification | Performance Qualification successful. |
| - Automated Washer With Alkaline Detergent Cleaning Process Performance Qualification | Performance Qualification successful. |
| - Automated Washer with Enzyme Detergent Cleaning Process Performance Qualification | Performance Qualification successful. |
| Compliant with expanded reprocessing (sterilization) methods: | All listed sterilization methods were successfully qualified. |
| - Thermal Disinfection Performance Qualification | Performance Qualification successful. |
| - Complex Product Family Sterizone VP4 Sterilization Process Performance Qualification | Performance Qualification successful. |
| - Complex Product Family Steris® V-Pro™ 1 Plus Hydrogen Peroxide Sterilization Process Performance Qualification | Performance Qualification successful. |
| - Complex Product Family Ethylene Oxide Sterilization Process Performance Qualification | Performance Qualification successful. |
| - Complex Product Family Steam Sterilization Process Performance Qualification | Performance Qualification successful. |
| Demonstrate biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity) for residuals from new cleaning methods. | MEM Elution Cytotoxicity Testing for Enzymatic Detergent Residuals Performance Qualification successful. MEM Elution Cytotoxicity Testing for Alkaline Detergent Residuals Performance Qualification successful. |
| Human Factors Usability Validation | Validation successful. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each "Performance Qualification" test. These are typical engineering and laboratory tests, not clinical trials. The "test set" would refer to the physical devices (cables) subjected to the various cleaning and sterilization cycles. It's common for such tests to use a statistically representative number of devices to demonstrate reproducibility and worst-case scenarios, but specific numbers are not provided.
The data provenance is from laboratory testing (likely internal to the manufacturer or conducted by contract labs), rather than clinical data from a specific country, retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of testing (performance qualification for cleaning, sterilization, and biocompatibility of medical device accessories) typically does not involve human experts establishing a "ground truth" in the way a clinical study with medical image interpretation would. Instead, highly trained laboratory personnel, quality engineers, and microbiologists follow standardized protocols (e.g., ISO, AAMI standards) to perform the tests and interpret the results against predefined acceptance criteria from those standards. The "ground truth" is defined by the objective pass/fail criteria of these validated testing methods. Therefore, no information on the number or qualifications of "experts" for ground truth establishment in this context is provided or expected.
4. Adjudication method for the test set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. For laboratory performance testing of device reprocessing, results are generally objective and determined by validated methodologies, not subjective interpretation requiring "adjudication."
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. This is not an AI-assisted diagnostic device, nor is it a device that requires human interpretation of medical cases. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is an accessory to an electrosurgical system, not an algorithm or an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance qualifications is based on objective measurements and pass/fail criteria derived from recognized industry standards (e.g., ISO 10993-1 for biocompatibility, and validated cleaning/sterilization protocols). For instance, a cleaning qualification's ground truth would be the measurable reduction of protein, hemoglobin, or other contaminants below a specified threshold, as determined by laboratory assays. Biocompatibility ground truth is determined by the absence of cytotoxic effects in cell cultures or adverse reactions in animal models, according to standard test methods.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no training set in that sense.
9. How the ground truth for the training set was established
Not applicable. No training set as described in the context of AI/ML.
§ 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.