KSEA VAPORIZATION ELECTRODES

K961702 · Karl Storz Endoskop GmbH · FAS · Aug 29, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961702
• Device Name: KSEA VAPORIZATION ELECTRODES
• Applicant: Karl Storz Endoskop GmbH
• Product Code: FAS · Gastroenterology, Urology
• Decision Date: Aug 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA vaporization electrodes are intended to be used to cut prostate tissue, superficial bladder tumors, and to cauterize minor bleeding in the prostate and bladder (hemostasis).

Device Story

Manually operated, single-use endoscopic electrodes; accessory to resectoscopes; used for cutting prostate tissue, superficial bladder tumors, and cauterizing minor bleeding (hemostasis). Operated by surgeons in clinical/surgical settings. Device provides mechanical access to surgical site; electrical energy delivery for tissue vaporization/hemostasis. Benefits include precise tissue removal and bleeding control during urological procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manually operated, single-use endoscopic instruments; designed as resectoscope accessories; body contact materials with established medical history; provided sterile.

Indications for Use

Indicated for patients requiring resection of prostate tissue or superficial bladder tumors, and for hemostasis of minor bleeding in the prostate and bladder.

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.

Submission Summary (Full Text)

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STORZ
Karl Storz Endoscopy

Karl Storz
Endoscopy-America, Inc.
600 Corporate Pointe
Culver City, California 90230-7600
Phone [phone]
Toll Free 800 421 0837
Fax [phone]
K961702

AUG 29 1996

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this documents are accurate and complete to the best of KSEA’s knowledge.

**Applicant:**
Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe
Culver City, CA 90230
[phone]

**Contact:**
Betty M. Johnson
Manager, Regulatory Affairs

**Device Identification:**
Common Name
Endoscopic electrodes

**Indications:** The KSEA vaporization electrodes are intended to be used to cut prostate tissue, superficial bladder tumors, and to cauterize minor bleeding in the prostate and bladder (hemostasis).

**Device Description:** The KSEA vaporization electrodes are manually operated, single-use instruments which are provided sterile to the end-user. The instruments are long enough to gain access to the surgical area, and are designed to be used as accessories to resectoscopes. The body contact materials have a long history of use in medical devices, and do not pose any new issues of safety and effectiveness.

**Substantial Equivalence:** The KSEA vaporization electrodes are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and intended uses raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.

Signed:
Betty M. Johnson
Manager, Regulatory Affairs

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