C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ

K964173 · Richard Wolf Medical Instruments Corp. · FET · Dec 13, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K964173
• Device Name: C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Dec 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The C-Mount objective lenses serve to connect endoscope to video cameras. The lenses with clamping mechanism are used for video-controlled diagnostics and therapy and allow quick adaptation and fixation of the standard telescopes with eyepiece. The focus ring serves to focus an endoscopic image on the monitor.

Device Story

C-Mount objective lenses facilitate coupling of endoscopes to video cameras; feature rotatable focus ring for image adjustment on monitor; include clamping mechanism for fixation to standard telescopes. Used in clinical settings by physicians for video-controlled diagnostics and therapy. Device redesigned to support steam sterilization; maintains original production method and function.

Clinical Evidence

No clinical tests performed. Bench testing confirmed no leakage or reduction in optical quality following steam sterilization.

Technological Characteristics

C-Mount objective lenses with integrated clamping mechanism and rotatable focus ring. Redesigned for steam sterilization compatibility. Mechanical optical coupling device; no electronic or software components.

Indications for Use

Indicated for use in video-controlled endoscopic diagnostics and therapy to connect standard telescopes with eyepieces to video cameras.

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

• RIWO lenses f = 15 mm, 30 mm, 60 mm (pre-enact.)
• C-mount lenses f = 25 mm, 38 mm (Karl Storz)
• Coupler 28 mm, 35 mm (Snowden Pencer)

Submission Summary (Full Text)

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DEC 13 1996 K94173 p172

# 510(k) Summary of Safety and Effectiveness

| Submitter: | | | Date of Preparation: October 17, 1996 | |
| --- | --- | --- | --- | --- |
| Company / Institution name: RICHARD WOLF MEDICAL INSTRUMENTS CORP. | | | FDA establishment registration number: 14 184 79 | |
| Division name (if applicable): N.A. | | | Phone number (include area code): [phone] | |
| Street address: 353 Corporate Woods Parkway | | | FAX number (include area code): [phone] | |
| City: Vernon Hills | State/Province: Illinois | Country: USA | | ZIP / Postal Code: 60061 |
| Contact name: Mr. Robert L. Casarsa | | | | |
| Contact title: Quality Assurance Manager | | | | |
| Product Information: | | | | |
| Trade name: C-Mount objective lenses, steam-sterilizable | | Model number: 85 261.172 85 261.212
85 261.242 85 261.272 85 261.322
85 261.382 85 261.452 | | |
| Common name: C-Mount objective lenses | | Classification name: Endoscope and/or accessories | | |
| Information on devices to which substantial equivalence is claimed: | | | | |
| 510(k) Number | Trade or proprietary or model name | | Manufacturer | |
| 1 pre-enact. | 1 RIWO lenses f = 15 mm, 30 mm, 60 mm, Model no. 5400/15, 5400/30, 5400/60 | | 1 Richard Wolf M.I.C. | |
| 2 | 2 C-mount lenses f = 25 mm, 38 mm, Model no. 20230041, 20230043 | | 2 Karl Storz | |
| 3 | 3 Coupler 28 mm, 35 mm, , Model no. 88-9714, 88-9715 | | 3 Snowden Pencer | |
| 4 | 4 | | 4 | |
| 5 | 5 | | 5 | |
| 6 | 6 | | 6 | |

## 1.0 Description

The C-Mount objective lenses allows a telescope to be coupled to a video camera.

The focus ring on the objective lenses is rotatable to allow the camera to focus on the telescope to obtain the proper picture.

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K964173
P292

## 2.0 Intended Use

The C-Mount objective lenses serve to connect endoscope to video cameras.

The lenses with clamping mechanism are used for video-controlled diagnostics and therapy and allow quick adaptation and fixation of the standard telescopes with eyepiece.

The focus ring serves to focus an endoscopic image on the monitor.

## 3.0 Technological Characteristics

The C-Mount objective lenses are redesigned for steam sterilization.

The production method and function of the device mainly stayed the same.

## 4.0 Substantial Equivalence

These Devices are substantially equivalent to pre-enactment devices sold by Richard Wolf and to actual 510(k) devices sold by Karl Storz and Snowden Pencer. The differences do not affect safety or effectiveness of the device.

## 5.0 Performance Data

The devices have been tested to assure that there is no leakage or reduced optical quality when subjected to steam sterilization.

## 6.0 Clinical Tests

No clinical tests performed.

## 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual.

By: Robert L. Casarsa
Quality Assurance Manager
Date: Oct 16, 1996

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