Who is the manufacturer of ENDOCARE MONOPOLAR ELECTRODE?

Endocare, Inc. submitted the Traditional clearance for ENDOCARE MONOPOLAR ELECTRODE (K965118).

What is the FDA product code for ENDOCARE MONOPOLAR ELECTRODE?

FAS. It is classified under 21 CFR 876.4300 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for ENDOCARE MONOPOLAR ELECTRODE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ENDOCARE MONOPOLAR ELECTRODE?

ENDOcare Monopolar Electrodes (K952587).

ENDOCARE MONOPOLAR ELECTRODE

K965118 · Endocare, Inc. · FAS · Feb 25, 1997 · Gastroenterology, Urology

Device Facts

Record ID	K965118
Device Name	ENDOCARE MONOPOLAR ELECTRODE
Applicant	Endocare, Inc.
Product Code	FAS · Gastroenterology, Urology
Decision Date	Feb 25, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The ENDOcare Electrosurgical Electrodes are designed for use in general surgery, urology, gynecology and orthopedics for cutting, coagulation, resection and vaporization of tissue including BPH (Benign Prostatic Hyperplasia), tumors, fibroids, cysts and obstructive tissue.

Device Story

ENDOcare Electrosurgical Electrodes; accessories for resectoscopes, cystoscopes, laparoscopes, hysteroscopes, pencil/pistol grips. Device provides various tissue interaction tips for surgeon-selected surgical applications. Used in OR/clinical settings by surgeons for cutting, coagulation, resection, and vaporization of tissue. Benefits include surgical versatility across multiple specialties. Device is passive electrosurgical accessory; no active electronic processing.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO-10993; sterilization validated per ANSI/AAMI/ISO 11135 (EtO) and ANSI/AAMI/ISO 11137 (Gamma). No clinical data presented.

Technological Characteristics

Electrosurgical electrode tips; compatible with standard endoscopic/surgical handles. Materials, chemical composition, and manufacturing identical to predicate. Sterilization: Ethylene Oxide (ANSI/AAMI/ISO 11135, SAL 10^-6) or Gamma Radiation (ANSI/AAMI/ISO 11137, SAL 10^-6). Packaging: disposable plastic film/coated paper pouch.

Indications for Use

Indicated for patients requiring surgical tissue cutting, coagulation, resection, or vaporization in general surgery, urology, gynecology, and orthopedics, including treatment of BPH, tumors, fibroids, cysts, and obstructive tissue.

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

ENDOcare Monopolar Electrodes (K952587)

Reference Devices

Unimed Electrodes (K944540)
Unimed Electrodes (K945191)

Related Devices

K965243 — ENDOCARE ELECTROSURGICAL ELECTRODE · Endocare, Inc. · Feb 25, 1997
K152092 — Resection Electrodes · Olympus Winter & Ibe GmbH · Oct 26, 2015
K974637 — ELECTRODES/PROBES/DEVICES · Ximed/Prosure/Injectx · Jan 7, 1998
K030831 — LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS · Modern Medical Equipment Mfg., Ltd. · Jun 15, 2004
K981256 — ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE · Ximed/Prosure/Injectx · May 12, 1998

Submission Summary (Full Text)

{0} FEB 25 1997 P192 K965118 # Section 2.0 - SMDA 1990 Requirements ## 2.1 510(k) Summary ### Device Description The ENDOcare Electrosurgical Electrodes are accessories that fit commercially available resectoscopes, cystoscopes, laproscopes and hysteroscopes, pencil grips and pistol grips. Each model has a different configuration which offers the surgeon a variety of tissue interaction tips depending on the specific surgical application. ### Biocompatibility The biocompatibility requirements were determined through use of the International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” The ENDOcare Electrosurgical Electrode has the same material, manufacturing process, chemical composition, body contact and sterilization method as the currently marketed electrode. Therefore, per the FDA matrix, the biocompatibility requirements were met and no additional testing was performed. ### Substantial Equivalence Support The ENDOcare Electrosurgical Electrodes are designed for use in general surgery, urology, gynecology and orthopedics for cutting, coagulation, resection and vaporization of tissue including BPH (Benign Prostatic Hyperplasia), tumors, fibroids, cysts and obstructive tissue. The ENDOcare Electrosurgical Electrodes are substantially equivalent to the ENDOcare Monopolar Electrodes (reference K952587) which were found to be substantially equivalent to the Unimed Electrodes (reference K944540 and K945191) on July 17, 1995. ### Sterilization Methodology Two methods of sterilization may be employed for this device: #### (1) Ethylene Oxide Sterilization validation will be conducted utilizing an overkill method based on the recommendations in the current American Association for the Advancement of Medical Instrumentation (ANSI/AAMI/ISO 11135 1994) Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. A minimum Sterility Assurance Level (SAL) of $10^{-6}$ will be achieved. Sterile barrier packaging will consist of standard disposable pouch containing a plastic film and a coated paper side. This is the same type of sterile barrier packaging that is used with the currently marketed device. Maximum levels of EtO residuals will not exceed: {1} K965118 P292 25 ppm for ethylene oxide 25 ppm for ethylene chlorohydrin 250 ppm for ethylene glycol ## (2) Gamma Radiation Sterilization will be based on the recommendations in the current American Association for the Advancement of Medical Instrumentation (ANSI/AAMI/ISO 11137-1994) Guideline for the Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization. A minimum Sterility Assurance Level (SAL) of $10^{-6}$ will be achieved. Sterile barrier packaging will consist of standard disposable pouch containing a plastic film and a coated paper side. This is the same type of sterile barrier packaging that is used with the currently marketed device.