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510(k) Data Aggregation
(136 days)
The Ultravision2™ System is indicated for use in surgery including laparoscopic surgery.
· The Ultravision2™ Generator is interface directly with the electrosurgical generator and serve as a passthrough for HF energy to HF electrosurgical instruments, to manage surgical smoke produced by energy-based instruments, and is indicated for use in surgery including laparoscopic surgery.
· The Ionwand™ Pack is intended to be used to manage surgical smoke and is indicated for use in surgery including laparoscopic surgery.
· The Ultravision™ 5mm Trocar is intended to be used to establish a path of entry for instruments and includes an Ionwand to manage surgical smoke, and is indicated for laparoscopic surgery.
· The Integrated Monopolar L-Hook (H/S)™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during laparoscopic surgical procedures, and is indicated for use in laparoscopic surgery.
· The IonPencil™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during general surgical procedures, and is indicated for use in surgery.
The Ultravision2™ System is a multifunctional system that synchronizes visual field clearing with the activation of smoke-producing electrosurgical devices. The system interfaces with commercially available electrosurgical instruments. The Ultravision2™ Generator connects directly to a commercially available electrosurgical generator (ESU) and passes the RF energy through to the desired electrosurgical instrument connected to the Utravision2™ Generator. The Ultravison2™ System is able to automate the activation of the Ionwand for visual field clearing to the electrosurgical device to synchronize visual field clearing with the generation of smoke.
The components of the overall system will be:
- Ultravision2TM system comprising: .
- . Ultravision2TM generator
- Link cables (x4)
- . Power cable
- Equipotential cable .
- . IonPencil™ accessory
- . Integrated Monopolar L-Hook(H/S)TM accessory
- Ionwand™ accessory
- . Ultravision™ 5mm Trocar accessory
The IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It's addition to the Ultravision 2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory.
The IonPencil™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The IonPencil™ provides two smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of smoke management (visual field clearing) is electrostation as per the predicate Ultravision system. When the tissue cutting or coagulation is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision2™ generator user interface.
Activation of the HF function of the IonPencil™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision2™ system. The IonPencil™ itself is incompatible with the connectors of third-party electrosurgical generators. The IonPencil™ is provided with a 69mm long PTFE coated blade.
The following cleared accessories have not changed:
• The Integrated Monopolar L-Hook(H/S)™ is a bifunctional laparoscopic device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device.
· The Ionwand™ pack comprises a dedicated percutaneous 3mm trocar/catheter which accommodates the Ionwand™ cable that delivers low energy from the generator to the patient for smoke management.
- · The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable.
The provided text describes the acceptance criteria and the results of non-clinical testing for the Ultravision2™ IonPencil. The study aims to demonstrate that the device is as safe, effective, and performs as well as or better than legally marketed predicate devices.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical safety and electromagnetic compatibility (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2) | Device must meet the requirements of the applicable clauses in the standards. | Pass |
| Shelf Life (ASTM F1980-16, ASTM 2096, ASTM F88/F88M -15) | Product and package must demonstrate stability for the claimed shelf life of six months. | Pass |
| Mechanical robustness of device | Device must meet mechanical specification per internal standards. | Pass |
| General, visual, dimensional and electrical verification of instrument | Device must meet dimensional, electrical, and physical specifications per internal standards. | Pass |
| Visual field clearing (surgical smoke removal) | Device must meet performance specifications per the internal standards. | Pass |
| Electrical bench tests | Device must meet electrical performance and safety specifications per the internal standards. | Pass |
| Assessment of thermal depth of margin | The thermal margin must be substantially equivalent to the predicate device in terms of its potential for tissue damage. | Pass |
| Design validation under simulated use conditions | Device must achieve its intended use when used by end users and that performance is at least equivalent to the predicate device. | Pass |
| Biocompatibility Testing | ||
| Cytotoxicity (ISO 10993-5: 2009) | Under the condition of the test, the test article must be non-cytotoxic. | Pass |
| Skin Irritation Study in Rabbits (ISO10993-23: 2021) | Under the condition of the test, the test article must be non-irritating. | Pass |
| Systemic Toxicity in Mice (ISO 10993-11: 2017) | Under the condition of the test, the test article must not elicit evidence of systemic toxicity. | Pass |
| Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2021) | Under the condition of the test, the test article must be non-sensitizing. | Pass |
| Hemolysis (ISO 10993-4: 2017) | Under the condition of the test, the test article must be non-hemolytic. | Pass |
| Material Mediated Pyrogens (USP General Chapter ) | Under the condition of the test, the test article must be non-pyrogenic. | Pass |
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain the detailed methodology and results of a clinical study that would be used to prove novel device performance. The information outlines non-clinical testing and design validation under simulated use conditions.
Regarding the remaining questions, the provided text does not contain the requested information:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text mentions "non-clinical testing" and "design validation under simulated use conditions" but does not specify sample sizes for these tests or the provenance of any data. These are likely bench tests and not human subject studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as the tests described are non-clinical, primarily focused on device specifications and performance rather than diagnostic accuracy involving human interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical testing.
- 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: Not applicable. This document describes a surgical smoke precipitator, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is typically defined by engineering specifications, standard test methods, and comparison to predicate device performance. For biocompatibility, it's defined by the specific criteria of the ISO standards.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.
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