PK SUPERPULSE SYSEM GENERATOR MODEL 744000

K100816 · Gyrus Acmi, Inc. · GEI · Jul 1, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100816
• Device Name: PK SUPERPULSE SYSEM GENERATOR MODEL 744000
• Applicant: Gyrus Acmi, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gyrus ACMI PK® Superpulse® System Generator is intended for use with Gyrus ACMI PK® Bipolar Instruments, Olympus TURis Bipolar Electrodes, PK® Endourology Electrodes with PK @ resectoscope or urological endoscope with 5 Fr or larger working channels and PK® Electrodes used in open, laparoscopic, and endourology procedures for cutting, coagulation, removal or ablation of soft tissue and where associated hemostasis is required in urological electrosurgical procedures. The Gyrus ACMI PK® Superpulse® System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Device Story

The PK® SuperPulse® System is an electrosurgical generator used in open, laparoscopic, and endourological procedures. It delivers bipolar energy to compatible electrodes (Gyrus ACMI PK® and Olympus TURis) for soft tissue cutting, coagulation, removal, or ablation. The system includes a saline monitoring feature that senses impedance to ensure saline is present before activation, preventing use in non-approved irrigants like glycine. The generator is operated by trained medical personnel in clinical settings. The system provides feedback via warning messages if impedance exceeds a fixed threshold. The device benefits patients by enabling precise tissue management and hemostasis in saline environments.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electrosurgical generator with bipolar output. Features a saline detection circuit that monitors impedance to ensure saline environment before activation. Includes a specific instrument ID band for Olympus TURis cable connectivity. Software-controlled saline monitoring prevents activation in non-saline irrigants. Operates at low power levels for impedance sensing, consistent with predicate UES-40 technology.

Indications for Use

Indicated for ablation, removal, resection, and coagulation of soft tissue and associated hemostasis in open, endoscopic, and laparoscopic surgical procedures, including urological electrosurgical procedures. Intended for use by qualified medical personnel trained in electrosurgical equipment.

Regulatory Classification

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.

Predicate Devices

• Gyrus PlasmaKinetic™ SuperPulse® System (K031085)
• Olympus XUES-41 Electrosurgical Unit and accessories (K030194)
• Gyrus ACMI PK® SuperPulse® System (K082054)

Submission Summary (Full Text)

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K100816

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

# JUL - I 2010

Traditional 510(k) Notification Executive Summary March 19, 2010

### 510(k) Summary of Safety and Effectiveness

## Gyrus ACMI, Inc. Gyrus ACMI PK® SuperPulse® System

9617070

Gyrus ACMI, Inc. 136 Turnpike Rd.

Graham A. L. Baillie

March 19, 2010

Senior Regulatory Specialist

3003790304

## General Information

Manufacturer:

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

Southborough, MA 01772-2104

Establishment Registration Number:

510(k) Submitter:

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Description

Classification:

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

Electrosurgical Cutting and Coagulation Device and Accessories Class 2, 21 CFR 878.4400 General and Plastic Surgery Panel

Product Code(s):

Project Name:

Trade Name(s):

Generic/Common Name:

GEI and KNS

PK® SuperPulse® System Generator® with TURis Electrodes

Gyrus ACMI PK® Superpulse® System (Generator, accessories)

Electrosurgical Generator and Accessories

9

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PK® SuperPulse® Gyrus ACMI. Inc. 136 Turnpike Road Southborough, MA 01772 Traditional 510(k) Notification Executive Summary March 19, 2010

### Predicate Devices

| Gyrus PlasmaKinetic™ SuperPulse® System | K031085 |
|------------------------------------------------------|---------|
| Olympus XUES-41 Electrosurgical Unit and accessories | K030194 |
| Gyrus ACMI PK® SuperPulse® System | K082054 |

#### Intended Use

The Gyrus ACMI PK® Superpulse® System Generator is intended for use with Gyrus ACMI PK® Bipolar Instruments, Olympus TURis Bipolar Electrodes, PK® Endourology Electrodes with PK @ resectoscope or urological endoscope with 5 Fr or larger working channels and PK® Electrodes used in open, laparoscopic, and endourology procedures for cutting, coagulation, removal or ablation of soft tissue and where associated hemostasis is required in urological electrosurgical procedures.

### Product Description

The proposed PK ® SuperPulse® System Generator and its software will be modified to allow the use of the Olympus TURis resectoscope and associated instruments. This functionality would be in addition to the existing released support for the Gyrus ACMI resectoscopes and compatible electrodes.

Modifications include:

- Modification to the Superpulse® software to add an additional instrument .
band to allow the connection of a TURis specific connector cable.Addition

of a saline monitoring facility to ensure that energisation is only applied to

the TURis connector cable when a saline environment is

sensed.Modification to User Manual to cover the above changes

The target applications and intended use for the PK® Superpulse® System Generator with the new software are unchanged from the previously marketed PK® Superpulse® System.

## Technological Characteristics and Substantial Equivalence

A new ID band has been assigned for a new instrument connection cable that will support the range of Olympus TURis instruments (The name TURis is derived from transurethral resection in saline).

Default settings and adjustments will be available to all Olympus TURis instruments connected to this TURis cable. The default settings and range of adjustment for these instruments have been provided by OWI (Olympus Winter und Ibe) located in Hamburg, Germany.

A new saline detection feature will be incorporated in the SuperPulse® software to ensure that saline is present before activation will be allowed to occur with Olympus TURis electrodes.

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PK® SuperPulse® Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772 Traditional 510(k) Notification Executive Summary March 19, 2010

## Continued...Technological Characteristics and Substantial Equivalence

The technical risk for the software release is low. This is because the project is replicating a feature already available on the Olympus UES-40 generator; information about the implementation of this feature is readily available. The performance of the saline detection feature should be such that it operates in a similar manner to that of the existing Olympus UES-40 generator used for TURis accessories. The power level used to sense the impedance is to be kept similar to the same low level as the UES-40 as this has been clinically accepted in the marketplace.

The purpose of the saline detection feature is to prevent activation in non-approved irrigants other than saline (e.g. glycine) that are typically used in monopolar based urology procedures. The saline detection facility will result in a warning message if the impedance of the tissue / saline is sensed above a fixed threshold. The new feature will be specific to the Olympus TURis band and existing alternative non-TURis product performance will be unchanged.

The proposed Gyrus ACMI PK® SuperPulse® System will have the same indications for use as the existing/predicate and its intended use will differ only in that it will be intended to support the additional Olympus TURis cable and electrodes. In summary, the PK® SuperPulse® System Generator is substantially equivalent to the predicate device and presents no new questions of safety or efficacy.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

# 1JUL - 1 2010

Gyrus Acmi, Inc. % Mr. Graham A.L. Baillie 136 Turnpike Road Southborough, Massachusetts 01772

Re: K100816

Trade/Device Name: Gyrus ACMI PK® SuperPulse® System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, KNS Dated: June 24, 2010 Received: June 25, 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 (reporting of medical 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.

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Page 2 - Mr. Graham Baillie

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark McMullen

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Traditional 510{k} Notification Intended Use Statement March 19, 2010

#### Indications for Use

510(k) Number:

Device Name: Gyrus ACMI PK® SuperPulse® System

Indications for Use:

The Gyrus ACMI PK® Superpulse® System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.

The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Prescription Use: ___ X __ (Per 21 CFR 801.109)

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)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100816