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Victan is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.

The Single Use Surgical Electrocoagulator is a sterile, single-patient-use electrosurgical accessory, and deliver electrical current from high-frequency generator to the surgical site. At the same time, the product can also provides suction or irrigation by connecting to a negative pressure drainage device. The proposed product consists of Electrode, External tube, Irrigation and suction tube, External tube control button, Rotator, Irrigation switch, Suction switch, Handle, Suction connecting tube, Suction connector, Irrigation connector, Cable, Irrigation connecting tube, Outer tube.

The provided text describes the 510(k) summary for the Victan Single Use Surgical Electrocoagulator (K230593). This document outlines the device performance data provided to support its substantial equivalence to a predicate device.

It's important to note that this 510(k) summary does NOT involve an AI/ML powered device, and therefore, many of the requested elements pertaining to AI model performance (like sample size for test/training sets, expert ground truth establishment, MRMC studies, and standalone performance) are not applicable. The device is a traditional electrosurgical accessory.

However, I can extract the relevant acceptance criteria and the study that proves the device meets those criteria, based on the information provided.

Device: Victan Single Use Surgical Electrocoagulator (K230593)
Device Type: Electrosurgical Accessory (not an AI/ML device)

1. Table of acceptance criteria and the reported device performance:

Since this is a physical medical device and not an AI/ML algorithm, the "acceptance criteria" are typically defined by compliance with recognized standards and successful performance in bench testing. The "reported device performance" refers to the results demonstrating this compliance.

• Cytotoxicity
• Sensitization
• Intracutaneous Reactivity
• Acute Systemic Toxicity
• Material-Mediated Pyrogenicity |
  | Electrical Safety: Device operates safely with regard to electrical hazards. | Study: Electrical safety testing.
  Results: Complies with relevant clauses of IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment) and IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment). |
  | Electromagnetic Compatibility (EMC): Device does not interfere with or is not interfered by other electronic devices. | Study: EMC testing.
  Results: Complies with IEC 60601-1-2 (Collateral Standard: Electromagnetic disturbances - Requirements and tests). |
  | Sterilization: Device is effectively sterilized and maintains sterility. | Study: Sterilization validation.
  Results: Sterilized by Ethylene Oxide (EO) to the same sterility assurance level as the predicate device. Valid period of sterilization confirmed as 3 years. |
  | Shelf-life: Device maintains performance and sterility over time. | Study: Accelerated Aging testing.
  Results: Confirmed an expiration date of 3 years from the manufacturing date. |
  | Bench Performance: Device meets design specifications for physical properties and essential functions. | Study: Bench testing.
  Results: Device applicable to specifications and demonstrated to be safe and effective for:
• Appearance
• Dimension
• Leakage
• Pressure Resistance
• Continuity
• Irrigation and Suction Flow
• Tensile Strength |

Regarding the other requested information (primarily for AI/ML devices):

2. Sample sized used for the test set and the data provenance: Not applicable. For a physical device, testing involves functional and safety evaluations on device units, not a "test set" of data in the AI/ML sense. Data provenance regarding country of origin or retrospective/prospective is not relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and medical device standards, and direct measurement/testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to human review of AI outputs.

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 MRMC study was done, as this is not an AI-assisted device. The "comparison" is to a legally marketed predicate device, demonstrating substantial equivalence based on technical characteristics, indications for use, and performance data, not an improvement in human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this physical device is established by:
* Compliance with recognized industry standards (e.g., ISO, IEC).
* Direct physical and electrical measurements (e.g., dimension, electrical safety tests).
* Functional tests (e.g., leakage, flow rates).
* Material properties assessment (e.g., biocompatibility testing).

8. The sample size for the training set: Not applicable. There is no training set as it's not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. There is no training set. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and medical device regulations.

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