(30 days)
The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.
The Veloxion System consists of the following components:
- Veloxion Controller (with Integrated Fluid Control and video)
- Footswitch
- Veloxion Resectoscope
- Veloxion Fluid Control Set
- Veloxion Roll Stand
The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes:
- Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
- Tissue Catch: For collection of gross resected tissue pieces for pathology.
The Veloxion System provides bipolar resection and coagulation of prostate adenomas, it distends the cavity by filling with saline and it provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.
The provided text describes a 510(k) premarket notification for the Veloxion System, a medical device used for prostate adenoma resection. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria based on a clinical study of its diagnostic or therapeutic efficacy.
Therefore, many of the requested details regarding acceptance criteria for device performance (e.g., sensitivity, specificity, or effect size of human reader improvement with AI) and a study proving the device meets these criteria are not present in this regulatory submission document. This document is instead a technical comparison and non-clinical testing summary to assert device safety and effectiveness.
However, I can extract information related to the technical specifications and performance testing conducted to demonstrate substantial equivalence, which serves as the "acceptance criteria" for this type of regulatory submission.
Here's the closest interpretation of your request based on the provided text:
Acceptance Criteria and Device Performance (Based on Technical Specifications and Non-Clinical Testing for Substantial Equivalence)
| Acceptance Criteria (Technical/Functional) | Reported Device Performance and Comparison to Predicate |
|---|---|
| Indications for Use | The device has the Same indications for use as the predicate: "The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device." |
| Energy Type (Bipolar RF) | Same as predicate. |
| Optics (Integrated, Sterile, 10-degree Endoscope) | Same as predicate. |
| Ability to set cavity pressure on device | Same as predicate (Yes). |
| Continuous Flow | Same as predicate (Yes). |
| Irrigation Fluid | Same as predicate (Saline). |
| Pump Type | Same as predicate (Dual Pump for Irrigation/Aspiration). |
| Ability to monitor saline remaining | Same as predicate (Yes). |
| Programmed Flow Rate (Steady State, Coag, Aspirate) | Same as predicate: Steady State = 50ml/min, Coag = 50ml/min, ASPIRATE = 400ml/min. |
| Programmed Flow Rate (Cut Mode) | Difference: Subject device: 200ml/min; Predicate: 380ml/min. Justification: "Flow rate for CUT mode was reduced to shorten initial plasma ignition while not affecting the ability to evacuate tissue chip." |
| Passive Flow Rate (User adjustable via Roller Clamp) | Same as predicate. Nominal flow rate (clamp fully open): 360ml/min (at 20mmHg), 500ml/min (at 60mmHg). |
| Set Pressure Range | Same as predicate (20 to 60mmHg). |
| Positive action to increase pressure above 40 mmHg | Same as predicate (Yes). |
| Pressure Sensor (Dual, independent, direct sensing) | Same as predicate. |
| Over-pressure condition detection | Same as predicate (Yes). |
| Maximum allowable actual cavity pressure | Same as predicate (75mmHg). |
| Ultimate mitigation for risk of over-pressurization of cavity | Same as predicate: Non-defeatable, continuous notification tone and message: "Remove device from cavity. Check for Clog." |
| Max. Shaft OD (Sheath) | Same as predicate: 25Fr (8.3mm). |
| Working Length (Sheath) | Same as predicate: 220mm. |
| Materials (Electrode/Insulation) | Same as predicate: Electrode: Tungsten (99.95% purity), Insulation: FEP. |
| How Supplied (Sterility) | Same as predicate: Sterile, Single Use (Veloxion Resectoscope). |
| Software Verification and Validation | Performed per IEC 62304 and FDA guidance. |
| Functional Testing (Cut, Coag, Aspiration, Irrigation, Pressure Control) | Performed per approved test protocols. Conclusion: "Functional Testing for all components of the system" was performed. "Simulated Use: Tissue resection and spot coagulation of cavity pressure, imaging" was performed. Comparative testing to predicate for electrode durability, pressure control and fluid control was performed and supports substantial equivalence. |
| Integrity (System withstands operating pressures) | Performed per approved test protocols. |
| Dimensional Inspection and Testing | Performed per approved test protocols. |
| Maximum LED Tip Temperature | Performed per approved test protocols. |
| Comparative Visualization Testing (Simulated Model) | Performed per approved test protocols. |
| Durability Testing (Electrode) | Performed per approved test protocols for tissue resection and coagulation. Comparative testing to predicate for electrode durability. |
| Thermal Effects Evaluation | Performed. |
| Biocompatibility | Performed in accordance with ISO 10993-1. |
| Sterility | Performed in accordance with ISO 11135:2014, ISO 11137-1:2006, ISO 11137-2:2013. |
| Packaging | Performed in accordance with ASTM D4169:14 and ISO 11607-1:2006. |
| Shelf-life | Performed in accordance with ASTM F1980:2007. |
| Electrical Safety & EMC | Performed in accordance with IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18:2009 and IEC 60601-2-2:2009. |
| Usability Testing | Use related risk evaluation performed. |
Study Proving the Device Meets the Acceptance Criteria:
The document describes non-clinical testing rather than a traditional clinical study with patient outcomes or reader performance data. The "study" here refers to a battery of engineering and bench tests designed to demonstrate that the small changes in the new Veloxion System (subject device) do not alter its safety or effectiveness compared to the previously cleared Veloxion System (predicate device).
Here's a breakdown of details relevant to your questions, adapted to the context of this 510(k) submission:
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Sample sizes used for the test set and the data provenance:
- The document does not specify sample sizes for individual non-clinical tests (e.g., number of units tested for durability, or number of simulated uses). This information is typically detailed in the full test reports, not summarized in the 510(k) summary letter.
- Data Provenance: The data is generated from non-clinical performance testing conducted by the manufacturer, Corinth MedTech, Inc. The location of the testing is not specified, but it would typically be conducted at the manufacturer's facilities or a qualified testing lab. The nature is retrospective in the sense that these tests were completed before the 510(k) submission, and reported as final results. There is no mention of data from human subjects or real-world clinical use.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for this device's regulatory pathway is established through engineering specifications, validated test methods, and comparison to a predicate device's known performance. There were no human readers or expert consensus required to establish a "ground truth" for diagnostic or analytical performance, as this is not a diagnostic AI device. The tests, like functional testing, biocompatibility, electrical safety, etc., have well-defined pass/fail criteria based on standards and engineering principles.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging or AI devices, where human expert disagreement needs a resolution mechanism for ground truth. In non-clinical performance testing, the results are typically quantitative measurements against predefined specifications, or qualitative observations per a test protocol, which do not usually require a human "adjudication" process like a clinical reading study.
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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:
- This is not applicable. The Veloxion System is an electrosurgical device for tissue resection, not an AI-assisted diagnostic tool. No MRMC study or AI assistance evaluation was conducted or is relevant for this type of device.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. This device is a surgical instrument system, not an AI algorithm. Its function relies on mechanical, electrical, and fluidic principles controlled by the user, not a standalone AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" for meeting regulatory requirements is primarily based on:
- Engineering specifications and standards: e.g., electrical safety standards (IEC 60601 series), biocompatibility standards (ISO 10993), sterility standards (ISO 11135), etc.
- Defined functional performance criteria: for aspects like flow rates, pressure control, temperature limits, tissue cutting/coagulation performance (demonstrated in simulated use), and durability.
- Comparison to Predicate Device: The ultimate "ground truth" for a 510(k) relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of safety and effectiveness, based on similar technological characteristics and comparable performance. Any differences (like the cut mode flow rate) must be shown not to raise new questions of safety or effectiveness, which was addressed via performance testing.
- For this device, the "ground truth" for meeting regulatory requirements is primarily based on:
-
The sample size for the training set:
- This is not applicable. There is no "training set" in the context of this device, as it is not an AI/machine learning product.
-
How the ground truth for the training set was established:
- This is not applicable for the same reason as above. There is no training set mentioned in this context.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.