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.

Device Description

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.

AI/ML Overview

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.

Summary

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PK® Button Electrode Gyrus ACMI, Inc. 136 Turnpike Rd Southborough, MA 01772

JUN 2 0 2012

Traditional 510(k) Notification June 4, 2012

510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. PK® Button Electrode

General Information

Manufacturer:

Establishment Registration Number:

510(k) Submitter:

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Description

Classification Name:

Project Name:

Trade Name(s):

Generic/Common Name:

Gyrus Medical Ltd Fortran Road, St Mellons Cardiff, CF3 0LT, UK

9617070

Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104

3003790304

Neil Kelly Regulatory Affairs Specialist 508.804.2690 neil.kelly@olympus-OSTA.com

June 4, 2012 -

Electrode, Electrosurgical, Active, Urological Class 2 21 CFR 876.4300 Gastroenterology/Urology Panel

Gyrus ACMI PK® Button Electrode

Bipolar Vaporization and Coagulation Electrode

Electrosurgical vaporization and coagulation device

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Traditional 510(k) Notification June 4, 2012

Predicate Devices

Gyrus ACMI PK Button Electrode (K093181) - Existing design Olympus HF-Resection Electrodes (K102781) - Existing design / desired indications Gyrus ACMI SuperPulse System (K100816) - Common generator

Intended Use

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 turnors. The PK® Button is not to be used to resect tissue.

Product Description

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PK® Button Electrode Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

watertight seal. The distal tip and the return tubes assembly are known to have direct contact with patient during use.

The proposed device is identical to the existing PK Button K093181. and of the same fundamental scientific technology as the predicate HF Resection/Vaporization electrode K102781. The distal tip of the electrodes are identical (304 SS), the connector arms are identical (Pt-Ir 70%-30%), and the Electrode sleeve is also identical (PTFE). The predicate K10281 device has no additional design features/functions that make it safer and/or more effective than the proposed device for transurethral vaporization of bladder turnors. The devices are of the same design, and same fundamental scientific technology. 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.

Technological Characteristics and Substantial Equivalence

The proposed PK® Button utilizes features incorporated into the following legally marketed predicate devices:

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 in the single use connector cable and will . be recognized by the generator to set default optimal power output parameters for the subject instrument
The PK® Button uses the same patient-contacting materials that are utilized in the . predicate devices.

The PK® Button will have 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, and has the same intended use, design, and scientific technology as the proposed device.

The bioolar 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. Althouugh the predicate PK Button lacks the transurethral vaporization of bladder tumors indication it was selected to demonstrate the device is currently on the market, and cleared for use by the FDA via K093181. The proposed device is also of the same design and scientific technology as the predicate Olympus HF-Resection Electrodes (K102781), which carries a transurethral vaporization of bladder tumors, the proposed devices desired indication. In addition, the PK® SuperPulse® Generator is the same generator that provides bipolar energy to the currently marketed predicate PK® Button Electrode (K093181) and the currently marketed Olympus HF-Resection Electrodes (K102781). Bench and animal

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testing in predicate submissions demonstrated that the performance requirements were met. In addition 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.

In summary, the PK @ Button electrode is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy. Please see Sections 8, 9, and 10 for a more details.

In addition, the following standards are applicable: IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic

safety and essential performance

IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic

safety and essential performance - collateral standard: Electromagnetic Compatibility -

Requirements and Tests

IEC 60601-2-2 - Medical electrical equipment - Part 2-2: Particular Requirements for the safety of High Frequency Surgical Equipment.

IEC 60601-2-18 -- Medical electrical equipment -- Part 2-18 Particular requirements for the basic safety and essential performance of endoscopic equipment.

AAMI/ANSI/ISO 11135-1: Medical Devices -- Validation and Routine Control of Ethylene Oxide Sterilization

AAMI/ANSI/ISO 11607-1- Packaging for Terminally Sterilized Medical Devices

AAMI/ANSI/ISO 10993-1 - Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 0 2012

Mr. Neil Kelly Regulatory Affairs Specialist Gyrus ACMI, Inc. 136 Turnpike Road SOUTHBOROUGH MA 01772

Re: K120567

Trade/Device Name: Gyrus ACMI PK® Button Electrode Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS, GEI Dated: June 4, 2012 Received: June 8, 2012

Dear Mr. Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

and an Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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KI20567

Indications for Use

510(k) Number: K120567

Device Name: Gyrus ACMI PK® Button Electrode

Indications for Use:

Prescription Use: X

OR Over-the-Counter Use:

(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tony M. Why

Gastro-Renal, and

Regulation Number and Section

§ 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).