(79 days)
Single-use electrosurgical accessory used to provide coagulation therapeutic energy to tissue and suction to aspirate blood, coagulum and small bits of tissue debris from the surgical site. The coagulation effect is achieved by the passage of high frequency current through the tissue of interest.
This suction coagulator has applications in general surgical procedures to provide a means of coagulation using electrosurgical current and also provide a means of suction using the vent on the handle. Suction and coagulation can be performed independently or simultaneously. The device consists of a cable for connection to the output of an electrosurgical generator unit, to carry high-frequency (HF) electrosurgical current to the distal end of the handpiece. gonerater and as either a hand-switching or foot-switching conduit in delivering the HF energy from the electrosurgical generator unit through the cannula tube to produce the therapeutic affect. Current is activated by the coagulation switching element buttons on the handpiece or by using the footswitch. The devices contain a non-stick (UltraClean™) coating on the cannula tip. The devices will be distributed sterile and non-sterile for single-use applications.
The provided text describes a 510(k) premarket notification for the CONMED UltraClean™ Suction Coagulator. This document focuses on demonstrating substantial equivalence to a predicate device and does not include detailed acceptance criteria or a dedicated study proving device performance against such criteria as would typically be found for a novel device or AI/software-as-a-medical-device (SaMD).
Instead, the submission primarily relies on:
- Technological Characteristics Comparison: Stating that the proposed device is "equivalent to the identified predicate device with respect to technological characteristics and function."
- Compliance with Standards: Designed to comply with applicable sections of ANSI/AAMI HF-18, IEC 60601-2-2, ISO 11137, ISO 14971, and ISO 10993.
- Biocompatibility Testing: Focusing on the new silicone coating (UltraClean™) added to the cannula tip, confirming it meets established biocompatibility requirements.
Therefore, many of the requested points regarding acceptance criteria, study design, and ground truth for performance evaluation are not applicable to this type of submission.
Here's a breakdown of what can be extracted and what is not present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for "device performance" in the context of diagnostic accuracy/AI (e.g., sensitivity, specificity). The acceptance criteria are implicitly met by:
- Demonstrating substantial equivalence to a legally marketed predicate device (K033003).
- Complying with relevant medical device standards (ANSI/AAMI HF-18, IEC 60601-2-2, ISO 11137, ISO 14971, ISO 10993).
- Passing biocompatibility tests for the new component.
- Reported Device Performance: No specific performance metrics (like sensitivity, specificity, or precision) are reported for the device in a clinical study context. The "performance" is considered equivalent to the predicate device and safe for its intended use.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K033003) | The device is found substantially equivalent. |
| Compliance with ANSI/AAMI HF-18 (Electrosurgical Devices) | The device has been designed to comply. |
| Compliance with IEC 60601-2-2 (Electrosurgical Devices) | The device has been designed to comply. |
| Compliance with ISO 11137 (Radiation Sterilization) | The device has been designed to comply. |
| Compliance with ISO 14971 (Medical Devices Risk Management) | The device has been designed to comply. |
| Compliance with ISO 10993 (Biocompatibility) for all materials | All original materials tested per ISO 10993. |
| Biocompatibility of new UltraClean™ coating (silicone) | Successfully completed Cytotoxicity, Hemolysis, Pyrogen, Intracutaneous Reactivity, Sensitization, and Acute Systemic Injection testing. |
| Functionality (coagulation and suction) | Stated to operate independently or simultaneously, equivalent to predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission does not involve a "test set" in the context of evaluating a diagnostic or AI algorithm. Biocompatibility testing typically involves in vitro and in vivo animal studies, but specific sample sizes and detailed provenance are not provided in this summary.
- Data Provenance: Not applicable for a clinical test set. Biocompatibility reports are referenced but their details (e.g., specific test animal origins, retrospective/prospective) are not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical "ground truth" establishment by experts is described as this is not a diagnostic device or AI algorithm requiring such validation. Biocompatibility testing follows standardized protocols, with interpretation by qualified toxicologists/biologists typically, though specific numbers/qualifications are not provided here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is described as there is no diagnostic test set requiring human review and consensus.
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
- Not applicable. This device is an electrosurgical accessory, not an AI or diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical electrosurgical accessory, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable for clinical performance. For biocompatibility, the "ground truth" is defined by established scientific principles and regulatory standards (e.g., ISO 10993) interpreted by lab results regarding cytotoxicity, hemolysis, etc. For functional performance, the "ground truth" is assumed to be equivalent to the predicate device's established safe and effective performance in surgical contexts.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set exists for this device.
§ 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.