(114 days)
The Gyrus ACMI PK® Button Electrode is a bipolar instrument intended for use in urological electrosurgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indication for the PK® Button device is Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy, and for Transurethral Vaporization of bladder tumors. The PK® Button is not to be used to resect tissue.
The PK® (PlasmaKinetic) electrodes works by exploiting the electrically conductive properties of saline irrigating fluid and wet tissue at the operative site to form a conductive field. Energy is delivered from the Generator, through the proposed electrode, and to the operative site when the footswitch is activated. The proposed electrode is used through a resectoscope to reach the operative site. Irrigating fluid (saline) exits the resectoscope via the attached continous flow sheath and wets the tissue at the operative site prior to the use of the proposed electrode. RF energy is conducted through the irrigating field to the tissue to vaporize and/or coagulate the tissue.
The PK® Button Electrode has a button shaped distal tip with connecting arms, with an electrode shaft, and connector cable at the proximal end. The single use Gyrus ACMI PK® Button Electrode will be provided sterile and packaged with a single use electrical connector cable. The distal end of the connector cable is secured to the working element of the Gyrus ACMI Elite Resectoscope (K.021166). A three pin plug on the proximal end of the cable connector is secured to the generator. An ID capacitor molded into the connector cable allows the generator to use its instrument recognition feature to automatically configure the system for optimal safe performance with the Gyrus ACMI PK® Button Electrode. This is the identical technology used in the predicate devices, including (K093181 and K102781).
Like the predicate K093181, and K102781 the distal tip of the electrode is a Stainless Steel 304 button measuring 3.16mm in diameter. Two Pt-Ir 70%-30% wires are welded, formed and drawn into the return arms to connect to the active wire. At the distal tip, the Pt-Ir 70%-30% arms are insulated with PVDF heat shrink and then clad with PTFE sleeve. The PVDF insulated Pt-Ir 70%-30% wires are threaded through the ceramic tubes and then through the return loop arm assembly. The gap between the ceramic-return tube and ceramic-PVDF insulation are sealed with Epo-Tek (an epoxy-resin) to form a watertight seal. The distal tip and the return tubes assembly are known to have direct contact with patient during use.
This 510(k) premarket notification for the Gyrus ACMI PK® Button Electrode does not contain the specific details of a study with acceptance criteria and reported device performance in the format requested. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with quantitative acceptance criteria.
The key points from the provided text regarding device performance are:
- Technological Characteristics and Substantial Equivalence: The document states, "The bipolar vaporization and coagulation performance of the PK® Button is identical to the known tissue vaporization and coagulation performance characteristics of the predicate PK® Button electrode, as it is the exact same device." It also mentions, "Bench and animal testing in predicate submissions demonstrated that the performance requirements were met."
- No new risks: "the current risk analysis was reviewed and there were no new risks identified by expanding the indication that were not already covered in the original risk analysis."
Given these statements, the "study" proving the device meets acceptance criteria is primarily an argument of its identity and equivalence to previously cleared devices which have already demonstrated safe and effective performance.
Therefore, the following information is based on the provided text, and where specific data is absent (e.g., sample size, expert qualifications), it's noted as "Not specified in the document."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly stated or Inferred from document) | Reported Device Performance (from document) |
|---|---|
| Intended Use: Bipolar instrument for urological electrosurgical procedures involving ablation/removal of soft tissue and hemostasis. Specific indications: Transurethral Vaporization of prostate (TUVP/TVP) for benign prostatic hypertrophy, and Transurethral Vaporization of bladder tumors. Not to be used to resect tissue. | The device has the "same intended use and similar indications as the predicate PK Button Electrode (K093181) with the addition of 'and Transurethral Vaporization of bladder tumors'." The predicate Olympus HF Resection Electrodes (K102781) already has this additional indication. |
| Performance (Vaporization and Coagulation): Safe and effective tissue vaporization and coagulation. | "The bipolar vaporization and coagulation performance of the PK® Button is identical to the known tissue vaporization and coagulation performance characteristics of the predicate PK® Button electrode, as it is the exact same device." |
| Materials: Use of patient-contacting materials similar to predicate devices. | "The PK® Button uses the same patient-contacting materials that are utilized in the predicate devices." (Stainless Steel 304, Pt-Ir 70%-30%, PTFE, PVDF, Epo-Tek) |
| Compatibility: Connects to specific electrosurgical generators and is recognized by the generator for optimal settings. | "The proposed PK® Button Electrode connects to the same electrosurgical generator as the predicate PK® Button Electrode, and predicate Olympus HF Resection/Vaporization Electrode." "An identification capacitor is imbedded... and will be recognized by the generator to set default optimal power output parameters." |
| Safety: No new risks created or identified compared to predicate devices. | "There are no new risks created or identified by expanding the indications for use on the proposed device to match that of the predicate devices." "the current risk analysis was reviewed and there were no new risks identified by expanding the indication that were not already covered in the original risk analysis." |
| Sterility: Provided sterile. | "The single use Gyrus ACMI PK® Button Electrode will be provided sterile." (Compliance with AAMI/ANSI/ISO 11135-1 implies sterilization validation). |
| Biocompatibility: Biologically safe for patient contact. | (Implied by compliance with AAMI/ANSI/ISO 10993-1, though specific results not given). |
2. Sample size used for the test set and the data provenance
The document does not describe a new "test set" in the context of a prospective clinical study with specific sample sizes. Instead, it relies on the history and performance of its predicate devices (K093181 and K102781) and their associated testing.
- Sample size: Not specified as a new test set was not conducted for this 510(k). The evaluation relies on the equivalence to existing, legally marketed devices.
- Data provenance: Not explicitly stated for specific a test set, but general implication is from "Bench and animal testing in predicate submissions" (likely preclinical testing) and widespread clinical use of the predicate devices. Country of origin for the predicate device manufacturing is the UK (Gyrus Medical Ltd).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a clinical study where ground truth would be established by experts for a new test set. The substantial equivalence argument relies on the established safety and efficacy of predicate devices within the medical community.
4. Adjudication method for the test set
Not applicable. No new clinical test set with an adjudication method is described.
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 instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an electrosurgical instrument, not an algorithm. Its performance is determined by its physical and electrical characteristics when used by a surgeon.
7. The type of ground truth used
For the purpose of this 510(k), the "ground truth" for the device's acceptable performance is established through:
- Prior regulatory clearances: The safety and efficacy of the predicate devices (K093181 and K102781) have already been accepted by the FDA.
- Bench and animal testing: Mentioned as having been conducted for predicate submissions, demonstrating performance requirements were met.
- Clinical experience (implied): The widespread use of the predicate devices in clinical practice provides a basis for their established performance.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm that requires a training set.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).