FLEXIBLE MINI-FIBERSCOPES

K962172 · Richard Wolf Medical Instruments Corp. · FBN · Dec 2, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962172
• Device Name: FLEXIBLE MINI-FIBERSCOPES
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: FBN · Gastroenterology, Urology
• Decision Date: Dec 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The flexible mini-fiberscopes are intended to be used in various Gastroenterology/Urology Procedures. These uses are: 1) Cystoscope - Used to examine the urinary tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures. 2) Choledochoscope - Used to examine the bile ducts, and using, additional accessories, to perform various diagnostic and therapeutic procedures. 3) Ureteroscope - Used to examine the ureter, and using additional accessories, to perform various diagnostic and therapeutic procedure. 4) Nephroscope - Used to examine the kidney, and with additional accessories, to perform various diagnostic and therapeutic accessories. 5) Uretero-renoscope - Used to examine the ureter and kidney, and additional accessories, to perform various diagnostic and therapeutic procedures. Accessory Indications for use. 6) Flexible Biopsy Forceps - Used to obtain small biopsies from tissue. 7) Flexible Grasping Forceps - For grasping calculi, both renal and biliary. 8) Button Electrode - Used for unipolar coagulation. 9) Dormia Stone Extractor - Used for grasping and removal of calculi, both renal and biliary. 10) Three Pronged Grasper - Used for grasping and removal of calculi, both renal and biliary.

Device Story

Flexible mini-fiberscopes; physician-controlled tip position; working channel for accessory instruments. Used in gastroenterology/urology for visualization of urinary tract, bile ducts, ureter, and kidney. Accessories include biopsy forceps, grasping forceps, button electrodes, and stone extractors. Physician-operated in clinical settings. Provides direct visualization to assist in diagnostic and therapeutic procedures; enables tissue sampling and calculus removal. Benefits include minimally invasive access to internal structures.

Clinical Evidence

No clinical data. Bench testing only: 2,000 flex cycles, 10,000 insertion cycles, thermal hazard assessment, and high-frequency electrical hazard assessment.

Technological Characteristics

Flexible fiber-optic endoscope; smaller form factor than predicate devices. Biocompatible materials. Manual tip articulation. No electronic sensing or software.

Indications for Use

Indicated for patients requiring diagnostic or therapeutic examination of the urinary tract, bile ducts, ureter, or kidney. Includes use with accessories for biopsy, calculus removal, and unipolar coagulation.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Circon ACMI Models AUR-8, AUR-9, AUR-PN
• Karl Storz Model 11274AA
• Olympus Models PF-28, URF-P2

Submission Summary (Full Text)

{0}

K962172
p192

Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Telephone: [phone]
Fax: [phone]

Summary of Safety and Effectiveness
510(K) Summary of Safety and Effectiveness

1.0 Classification Name:
DEC - 2 1996
K962172

2.0 Common/Usual Name:
Flexible Endoscope

3.0 Trade Name
Flexible Mini-Fiberscopes

4.0 Equivalence:
The submitted devices are equivalent to the following devices already on the market:

Circon ACMI Models AUR-8, AUR-9, AUR-PN
Karl Storz Model 11274AA
Olympus Models PF-28, URF-P2

5.0 Description:
The flexible mini-fiberscopes are endoscopes with working channels that allow physician control of the tip position and accessory instruments.

6.0 Intended Use:
The flexible mini-fiberscopes are intended to be used in various Gastroenterology/Urology Procedures. These uses are:

1) Cystoscope - Used to examine the urinary tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
2) Choledochoscope - Used to examine the bile ducts, and using, additional accessories, to perform various diagnostic and therapeutic procedures.
3) Ureteroscope - Used to examine the ureter, and using additional accessories, to perform various diagnostic and therapeutic procedure.
4) Nephroscope - Used to examine the kidney, and with additional accessories, to perform various diagnostic and therapeutic accessories.

RICHARD WOLF

{1}

NOV-22-1996 13:48
RICHARD WOLF QA DEPT.
1 847 913 0924 P.03
K962172
p292

# Richard Wolf Medical Instruments Corporation

Summary of Safety and Effectiveness (cont.)

5) Uretero-renoscope - Used to examine the ureter and kidney, and additional accessories, to perform various diagnostic and therapeutic procedures.

Accessory Indications for use.

6) Flexible Biopsy Forceps - Used to obtain small biopsies from tissue.

7) Flexible Grasping Forceps - For grasping calculi, both renal and biliary.

8) Button Electrode - Used for unipolar coagulation.

9) Dormia Stone Extractor - Used for grasping and removal of calculi, both renal and biliary.

10) Three Pronged Grasper - Used for grasping and removal of calculi, both renal and biliary.

## 7.0 Technological Characteristics:

The only variation of the submitted devices, when compared to existing scopes on the market, is their smaller size.

## 8.0 Performance Data:

Tests were performed to assure: (a) continued flexibility after repeated (2000) flexs (b) ability to withstand repeated (10,000) insertions (c) that no thermal hazard exists, and (d) that the fiberscopes do not present a High Frequency Hazard.

## 9.0 Clinical Data:

No clinical data was obtained.

## 10.0 Data Conclusion:

The flexible mini-fiberscopes provide expected durability, uses biocompatably safe materials; and when cleaned, disinfected/sterilized as recommended will provide a patient ready instrument.

By: Robert L. Casarsa
Quality Assurance Manager
Date: Nov 22, 1996