ENDOCARE ELECTROSURGICAL ELECTRODE

K965243 · Endocare, Inc. · GEI · Feb 25, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K965243
• Device Name: ENDOCARE ELECTROSURGICAL ELECTRODE
• Applicant: Endocare, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• 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. Surgeon-operated; used in OR/clinic. Device delivers electrosurgical energy to tissue for cutting, coagulation, resection, vaporization. Variety of tip configurations for specific surgical applications. Reusable; requires manual cleaning and autoclave sterilization. Output is physical tissue modification; aids surgeon in removing/treating obstructive tissue, tumors, fibroids, cysts, BPH. Benefit: precise tissue management during minimally invasive procedures.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO-10993 standards. No clinical data provided.

Technological Characteristics

Electrosurgical electrode accessories; various tip configurations. Materials, chemical composition, and manufacturing identical to predicate. Sterilization: Autoclave (pre-vacuum, 132°C, 8 min exposure, 42-44 PSIA, 5 min dry).

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 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

• ENDOcare Electrosurgical Electrodes (K954321)

Reference Devices

• Unimed Electrodes (K944540)
• Unimed Electrodes (K945191)

Submission Summary (Full Text)

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Section 2.0 - SMDA 1990 Requirements
P192 K965243
FEB 25 1997

## 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 Electrosurgical Electrodes (reference K954321) which were found to be substantially equivalent to the Unimed Electrodes (reference K944540 and K945191) on October 13, 1995.

### Sterilization Methodology

This electrode may be shipped as a non-sterile, reusable device. The following are the recommended cleaning and sterilization instructions:

#### (1) Cleaning

- Wipe all debris from the electrode with a moistened sponge or gauze pad.
- Rinse with cold tap water for approximately 30 seconds.
- Place the electrode in a warm bath of tap water and detergent and scrub with the appropriate brush, taking care to keep the electrode totally immersed at all times.

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K965243
p292

- Rinse with warm tap water for approximately 20 seconds to remove any debris or detergent. If necessary, place in an ultrasonic bath containing sonic detergent for 10 minutes at 60 hz. Remove and rinse with tap water for approximately 20 seconds.
- Rough dry.

### (2) Sterilization

- Check the electrode for particulate contamination. If necessary, wipe down the electrode with a clean gauze pad.
- Wrap the electrode in sterilization wrap using a standard hospital square wrap.
- Autoclave in a pre-vacuum cycle using the following parameters:

| Exposure Temperature | 132°C |
| --- | --- |
| Exposure Time | 8 minutes |
| Pressure | 42 to 44 PSIA |
| Dry Time | 5 minutes |

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