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The Hybrid Plasma Scalpel provides cutting and gas coagulation during open surgical procedure where monopolar electrosurgery (cutting and coagulation) is normally used. The Hybrid Plasma Scalpel is a monopolar handpiece used with compatible electrosurgical units.

The Canady Vieira Hybrid Plasma™ Scalpel is an accessory multi-functional electrosurgical handpiece used for open surgical procedures where monopolar radio frequency electrosurgical handpieces (cutting, coagulation) is normally used. The handpiece uses radio frequency (RF) monopolar electrosurgical current to cut or coagulate biological tissue. The handpiece can also combine argon gas with radio frequency monopolar cut or coagulation currents to produce a hybrid plasma cut, or argon plasma coagulation. The handpiece consists of three major components: Handle, Telescoping Nozzle, and Electrode. The insulated handle encases the radio frequency (RF) current and gas tubing for controlling the flow of argon gas and activation of RF current for the device. RF current is activated by two push buttons yellow (standard CUT mode) and blue (standard COAG mode) which are top of the handle. Argon gas is delivered via the handle by activating a third push button (purple) which is also on top of the handle. The electrode tip has 4 modes of operation and as shown in the below table, this words appear depending on the mode of operation that is necessary. Depending on the RF current mode (CUT or COAG), the handpiece can function in the following argon modes: HYBRID PLASMA CUT – Argon gas is delivered through the handpiece while the attached electrosurgical generator is set in the CUT mode. Hybrid Argon Plasma Cut mode will cut and coagulate the tissue at the same time. ARGON PLASMA COAGULATION – Argon gas is delivered through the handpiece while the attached electrosurgical generator is set in the COAG mode. Argon Plasma Coagulation will coagulate the tissue. The Canady Vieira Hybrid Plasma™ Scalpel is an accessory that is used with the Argon 2 (CPC2) and Argon 4 (CPC4) generators, previously cleared by FDA. These generators provide a controlled flow of argon to the electrosurgical handpiece during Hybrid Plasma Cutting or Argon Plasma Coagulation modes. The Physician manually sets the flow rate on the Plasma coagulator. The telescoping nozzle can be extended or shortened over the electrode as desired when the surgeon is performing argon procedures.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Canady Vieira Hybrid Plasma™ Scalpel:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • Clinical Studies: "No Clinical studies were performed for the submission of this 510(k)." Therefore, there is no test set in the context of clinical human data.
   • Biocompatibility Testing: The sample size for biocompatibility testing is not specified. Data provenance is not specified beyond meeting ISO 10993-1 and USP requirements.
   • Bench Studies: The sample sizes for bench testing (IEC 60601-1-2, IEC 60601-2-2, compatibility, cutting/coagulation, shelf life, sterility) are not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical studies were performed. For bench and biocompatibility testing, ground truth is established through adherence to standards and test protocols, not expert consensus in the human data sense.

3. Adjudication method for the test set: Not applicable. No clinical studies were performed requiring adjudication of human data.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. No clinical studies, and therefore no MRMC studies, were performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrosurgical handpiece, not an AI algorithm. Its performance is assessed through its physical and electrical characteristics and ability to perform cutting and coagulation, not through an algorithm's standalone performance.

6. The type of ground truth used:

   • Biocompatibility: Adherence to established standards (ISO 10993-1, USP requirements).
   • Performance Testing (Bench Studies): Adherence to established electrical safety standards (IEC 60601-1-2, IEC 60601-2-2), functional performance (cutting, coagulation), and physical characteristics (shelf life, sterility, compatibility with generators). The "ground truth" here is the successful demonstration of compliance with these standards and functionalities.

7. The sample size for the training set: Not applicable. This is a medical device, not an AI algorithm that requires a training set.

8. How the ground truth for the training set was established: Not applicable. No training set was used.

Summary of the Study provided:

The submission for the Canady Vieira Hybrid Plasma™ Scalpel is based on a substantial equivalence pathway, primarily relying on comparisons to predicate devices and extensive bench testing and biocompatibility testing.

• Bench Studies: These studies confirmed the device meets electrical safety standards (IEC 60601-1-2 and IEC 60601-2-2), is compatible with specified electrosurgical generators, and can successfully perform cutting and coagulation, as well as demonstrating shelf life and sterility.
• Biocompatibility Testing: Conducted in accordance with ISO 10993-1 and USP requirements to validate patient-contacting materials.
• Clinical Studies: No clinical studies were performed. The safety and effectiveness claim is based on substantial equivalence to predicate devices, supported by the non-clinical testing. The argument is that the device does not raise new issues of safety and effectiveness compared to the already cleared predicate devices.

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