(139 days)
No
The summary describes a surgical electrode and generator system for tissue ablation and coagulation, with no mention of AI or ML capabilities.
Yes
The device is described as a bipolar instrument intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required, specifically for transurethral electrovaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy. These functions are therapeutic interventions.
No
The device is described as a bipolar instrument intended for use in urological surgical procedures involving the ablation or removal of soft tissue and hemostasis, specifically for transurethral electrovaporization of the prostate. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a bipolar, sterile/disposable, vaporizing/coagulating electrode, which is a physical hardware component used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (transurethral electrovaporization of the prostate) involving the ablation or removal of soft tissue and hemostasis. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a surgical instrument (electrode) used in conjunction with a generator and resectoscope. It is designed for physical interaction with tissue during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.
Therefore, the Gyrus ACMI PK® Button Electrode is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
FAS
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
urological surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench and animal testing demonstrated that the performance requirements were met, and that the PK® Button exhibited comparable performance characteristics to both predicates.
Summary of Performance Studies
Bench and animal testing demonstrated that the performance requirements were met, and that the PK® Button exhibited comparable performance characteristics to both predicates.
Key Metrics
Not Found
Predicate Device(s)
K031085, K990628, K973820, K903323
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 | ||
| 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