OES UROLOGY

K950719 · Olympus America, Inc. · EZO · Dec 11, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K950719
• Device Name: OES UROLOGY
• Applicant: Olympus America, Inc.
• Product Code: EZO · Gastroenterology, Urology
• Decision Date: Dec 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4770
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Otis Urethrotome for Adult Use Olympus O0216 Otis Urethrotome and O2160 Replacement Blade are intended to be used for endoscopic and treatment within the urethra in adults. When compared with the intended use of predicate devices, the intended use of the subject devices has not been changed. Otis Urethrotome for Pediatric Use Olympus O2161 Otis Urethrotome and O2162 Replacement Blade are intended to be used for endoscopic treatment within the urethra in children. When compared with the predicate devices, the Olympus subject devices are intended for pediatric use, while the Olympus predicate devices were cleared for Infant Use in 510(k) # K904940.

Device Story

Rigid endoscopic system for urethral treatment; includes urethrotome and replacement blades. Used by urologists in clinical settings for endoscopic procedures. Device functions as mechanical surgical instrument; no electronic or software components. Provides visualization and access for urethral intervention; facilitates treatment of urethral strictures or obstructions. Benefits include minimally invasive access for urological therapy.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Rigid endoscopic urethrotome system; includes stainless steel or medical-grade metal components typical of urological instruments. Manual operation; no energy source or software. Sterilization via standard hospital protocols for rigid endoscopes.

Indications for Use

Indicated for endoscopic treatment within the urethra in adults and children.

Regulatory Classification

Identification

A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Olympus Urology System (K790071)
• Olympus Infant Resectoscope and Accessories (K904940)
• Olympus Flexible & Rigid Urethrotome System (K904339)

Reference Devices

• Karl Storz Endoscopes & Accessories for Urology

Submission Summary (Full Text)

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f172
K950719
DEC 11 1996

# 510 (k) SUMMARY FOR OLYMPUS OTIS URETHROTOME SYSTEM

| Device Name: | Olympus Otis Urethrotome System |
| --- | --- |
| Common/Usual Name: | Endoscopic Accessories for Urology |
| Classification Name: | Endoscope and Accessories |
| Predicate Devices: | Olympus Urology System (K790071)
Olympus Infant Resectoscope and Accessories (K904940)
Olympus Flexible & Rigid Urethrotome System (K904339) |
| | Karl Storz Endoscopes & Accessories for Urology (Unknown). |
| Submitted By:
(Contact Person) | Mr. Barry Sands
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
[phone] |
| Summary Preparation Date: | October 1, 1996 (Revised) |

## Statement of Intended Use:

Otis Urethrotome for Adult Use

Olympus O0216 Otis Urethrotome and O2160 Replacement Blade are intended to be used for endoscopic and treatment within the urethra in adults. When compared with the intended use of predicate devices, the intended use of the subject devices has not been changed.

Otis Urethrotome for Pediatric Use

Olympus O2161 Otis Urethrotome and O2162 Replacement Blade are intended to be used for endoscopic treatment within the urethra in children. When compared with the predicate devices, the Olympus subject devices are intended for pediatric use, while the Olympus predicate devices were cleared for Infant Use in 510(k) # K904940.

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K950719
p202

# Device Description

Olympus America Inc. has been marketing rigid endoscopes, hand instruments, associated accessories, and ancillary equipment for Urological Endoscopy since 1979. The Olympus Urethrotomy System includes the following products.

1. Otis Urethrotome for Adult Use
- O0216 Otis Urethrotome, 16 cm
- O2160 Replacement Blade for O0216 Urethrotome

2. Otis Urethrotome for Pediatric Use
- O2161 Otis Urethrotome, 10.5 cm
- O2162 Replacement Blade for O2162 Urethrotome

When these subject devices are compared with the predicate devices, which were cleared in 510(k)s # K790071 and K904940, no significant changes or modifications in intended use, design, material, function, method of operation, or reprocessing that could affect the safety and efficacy of the devices have occurred.

# General Safety

When compared with the predicate devices, Olympus Otis Urethrotome System does not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness of the subject device.