GYRUS ACMI PK BUTTON ELECTRODE

K093181 · Gyrus Acmi, Inc. · FAS · Feb 24, 2010 · Gastroenterology, Urology

Device Facts

Record IDK093181
Device NameGYRUS ACMI PK BUTTON ELECTRODE
ApplicantGyrus Acmi, Inc.
Product CodeFAS · Gastroenterology, Urology
Decision DateFeb 24, 2010
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 876.4300
Device ClassClass 2
AttributesTherapeutic

Intended Use

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 Story

Bipolar, sterile, disposable electrosurgical electrode; front-loaded into reusable resectoscope. Connects to Gyrus ACMI PlasmaKinetic (PK) SuperPulse generator. Uses identification capacitor in connector cable to set default power parameters. Operates via bipolar vaporization and coagulation of soft tissue; used in urological procedures. Physician-operated in clinical/OR setting. Output is thermal energy for tissue ablation/hemostasis. Benefits patient by enabling minimally invasive treatment of benign prostatic hypertrophy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench and animal testing comparing vaporization and coagulation performance against predicate devices (Plasma V and TURis Button).

Technological Characteristics

Bipolar electrosurgical electrode; sterile/disposable. Features identification capacitor for generator parameter setting. Distal tip button design. Materials identical to predicate Gyrus ACMI devices. Compatible with Elite USA 1 and 2 resectoscopes. Energy source: PlasmaKinetic (PK) SuperPulse generator.

Indications for Use

Indicated for transurethral electrovaporization of the prostate (TUVP/TVP) in patients with benign prostatic hypertrophy. Not for tissue resection.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ # 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 {1}------------------------------------------------ ## Predicate Devices | SuperSect® & SuperLoop® Electrodes, | | | |-------------------------------------------------------------------------------------------------|--|---------| | Gyrus PlasmaKinetic™ SuperPulse® System | | K031085 | | The Gyrus (ACMI) Endourology System | | K990628 | | The Circon ACMI USA Elite System ™ Vaporization Electrode<br>and VaporTome™ Resection Electrode | | K973820 | | Olympus TURis Button (Resectoscope loops) | | K903323 | #### Intended Use 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. #### Product 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). 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). {2}------------------------------------------------ ## 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ Page 2 - 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 {5}------------------------------------------------ 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: 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. 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
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%