The Gyrus ACMI PK® Button Electrode is a bipolar instrument intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indication for the PK® Button is transurethral electrovaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy only. The PK® Button is not to be used to resect tissue.

Device Description

The proposed PK® Button is a bipolar, sterile/disposable, vaporizing/coagulating electrode) that uses the same Gyrus ACMI PlasmaKinetic™ (PK®) SuperPulse® Generator and footswitch, as the predicate bipolar Plasma V vaporizing/coagulating electrode. The PK® Button is a Frônt Loading Urological Instrument Device (FLUID) that will be front loaded into the reusable Elite USA 1 and 2 resectoscope (cleared under K021166).

AI/ML Overview

The provided text describes a 510(k) submission for the Gyrus ACMI PK® Button Electrode, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial to establish novel acceptance criteria and prove its meeting through a statistical study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or explicitly stated in the provided document, as a 510(k) typically relies on bench and animal testing for performance comparison, not large-scale clinical trials with defined acceptance criteria for a new clinical endpoint.

However, based on the information available, here's an attempt to answer as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

Formal, quantifiable acceptance criteria in the sense of a clinical trial's primary endpoint are not explicitly provided. Instead, the document states that the device's performance was evaluated against the "known tissue vaporization and coagulation performance characteristics of the predicate Plasma V and TURis Button electrodes." The "reported device performance" is that it met these requirements and exhibited comparable performance characteristics.

Acceptance Criteria (Implied)	Reported Device Performance
Comparable tissue vaporization performance to predicate devices (Plasma V and TURis Button electrodes)	Bench and animal testing demonstrated that the performance requirements were met, and the PK® Button exhibited comparable performance characteristics to both predicates.
Comparable tissue coagulation performance to predicate devices (Plasma V and TURis Button electrodes)	Bench and animal testing demonstrated that the performance requirements were met, and the PK® Button exhibited comparable performance characteristics to both predicates.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified. The document mentions "Bench and animal testing," but does not provide details on the number of samples, animals, or specific experimental runs.
Data Provenance: The testing was conducted in a lab setting (bench testing) and on animals (animal testing). The country of origin for this data is not specified, but the manufacturer is based in the UK and the submitter in the USA. The testing would be prospective within the context of these specific experimental designs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable/Not specified. For bench and animal testing comparing device characteristics, "ground truth" as established by experts in a clinical context (e.g., radiologists for imaging) is not relevant. Performance characteristics would be measured objectively (e.g., lesion size, coagulation depth) by qualified laboratory or animal study personnel, whose specific number and qualifications are not detailed here.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical endpoints. For bench and animal testing of device performance characteristics, the results are typically quantitative and directly measured.

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 electrode and does not involve AI or human "readers" interpreting data. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is geared towards AI/software devices. The PK® Button Electrode is a physical electrosurgical tool. Its primary performance is measured in a standalone fashion in bench and animal tests, meaning the device's inherent functional characteristics are evaluated directly, without human "interpretation" of its output in a diagnostic sense.

7. The Type of Ground Truth Used

The "ground truth" for the performance comparison was the "known tissue vaporization and coagulation performance characteristics" of the predicate devices (Plasma V and TURis Button electrodes). This would have been established through prior testing and understanding of those predicate devices. For the bench and animal tests of the PK® Button, the ground truth would be the measured physical effects on the tissue, such as depth of vaporization or coagulation, as determined by laboratory analysis (e.g., histology of treated tissue).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of developing this medical instrument.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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FEB 2 4 2010

PK® Button Electrode Gyrus ACMI, Inc. 136 Turapike Road Southborough, MA 01772 Traditional 510(k) Notification 510(k) Summary October 6, 2009

i09318/

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

General Information

Manufacturer:

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

Establishment Registration Number:

510(k) Submitter:

9617070

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

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Description

Classification Name:

3003790304

Graham A. L. Baillie Senior Regulatory Specialist

October 6 2009

Endoscopic Electrosurgical Unit and Accessories Class 2 21 CFR 876.4300 Gastroenterology-Urology Panel

Project Name:

Trade Name(s):

Generic/Common Name:

Gyrus ACMI PK® Button Electrode

Bipolar Vaporization and Coagulation Electrode

Electrosurgical vaporization and coagulation device

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Predicate Devices

SuperSect® & SuperLoop® Electrodes,
Gyrus PlasmaKinetic™ SuperPulse® System		K031085
The Gyrus (ACMI) Endourology System		K990628
The Circon ACMI USA Elite System ™ Vaporization Electrodeand VaporTome™ Resection Electrode		K973820
Olympus TURis Button (Resectoscope loops)		K903323

Intended Use

Product Description

The purpose of this submission is to demonstrate equivalence to predicate vaporizing/coagulating electrodes and clear the PK® Button electrode for a TUVP indication.

Technological Characteristics and Substantial Equivalence

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

o The bipolar PK® Button Electrode connects to the same electrosurgical generator as the predicate Plasma V vaporizing electrode (K990628) and the SuperSect® and SuperLoop® bipolar FLUID electrodes (K031085). Similar to the predicate Plasma V electrode and SuperSect® and SuperLoop, an identification capacitor imbedded in the single use connector cable will be recognized by the generator to set default optimal power output parameters for the subject instrument.
. The distal tip of the proposed PK® Button electrode has the same button design and uses the same materials as the predicate Olympus TURis Button electrode, (K903323).

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Continued ... Technological Characteristics and Substantial Equivalence

� The PK® Button uses the same patient-contacting materials that are utilized in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI.
The PK® Button will have the same intended use and similar indications as � the predicate Gyrus ACMI USA Elite System™ Vapor Trode™ Vaporization Electrode that includes: " ... coagulation and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia ... "

The bipolar vaporization and coagulation performance of the PK® Button were compared against the known tissue vaporization and coagulation performance characteristics of the predicate Plasma V and TURis Button electrodes. Bench and animal testing demonstrated that the performance requirements were met, and that the PK® Button exhibited comparable performance characteristics to both predicates.

In summary, the PK® Button electrode is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6( Silver Spring, MD 20993-0002

Mr. Graham A.L. Baillie Senior Regulatory Specialist Gyrus ACMI, Inc. 136 Turnpike Road SOUTHBOROUGH MA 01772

FEB 2 4 2010

Re: K093181

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 Dated: February 2, 2010 Received: February 3, 2010

Dear Mr. Baillie:

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 of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Janine M. Morris

Acting Director, Division of Reproductive. Abdominal, and Radiological Devices office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PK® Button Electrode Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772 Traditional 510(k) Notification Statement of Intended Use October 6, 2009

Indications for Use

510(k) Number:

K693/81

Device Name: Gyrus ACMI PK® Button Electrode

Indications for Use:

Preseription Use:

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)

vision Sign-Off) lvision of Reproductive, Abdominal 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).