SH-1 SURGICAL HOLDER FOR TELESCOPE

K960068 · Olympus America, Inc. · OCV · May 5, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K960068
• Device Name: SH-1 SURGICAL HOLDER FOR TELESCOPE
• Applicant: Olympus America, Inc.
• Product Code: OCV · Gastroenterology, Urology
• Decision Date: May 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Olympus SH-1 Surgical Holder for Telescope can be utilized for the manipulation and positioning of a telescope during laparoscopic procedures.

Device Story

Mechanical surgical holder; used for manipulation and positioning of telescope during laparoscopic procedures. Device provides stable support for endoscope; reduces manual holding requirements for surgical staff. Operated by surgical team in OR environment. Benefits include improved visualization stability and reduced fatigue for assistants.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical telescope holder; manual positioning and locking mechanism; designed for laparoscopic surgical environment.

Indications for Use

Indicated for use in laparoscopic surgical procedures to manipulate and position a telescope.

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

• Scope Holders manufactured by Aesculap
• Andronic
• Automated Medical Products
• Codman
• Computer Motion Inc.
• Leonard Medical
• Mediflex
• Thompson Medical Products

Submission Summary (Full Text)

{0}

K960068
MAY -5 1997

# 510(k) SUMMARY FOR OLYMPUS SH-1 Surgical Holder for Telescope

| Device Name: | Olympus SH-1 Surgical Holder for Telescope |
| --- | --- |
| Common/Usual Name: | Telescope Holder |
| Classification Name: | Endoscopes and Accessories
Laparoscope and Accessories |
| Predicate Devices: | Scope Holders manufactured by Aesculap, Andronic, Automated Medical Products, Codman, Computer Motion Inc., Leonard Medical, Mediflex, and Thompson Medical Products. |
| Submitted By:
(Contact Person) | Mr. Barry Sands
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, NY 11747
[phone] |
| Summary Preparation Date: | December 29, 1995 |

## Statement of Intended Use:

The Olympus SH-1 Surgical Holder for Telescope can be utilized for the manipulation and positioning of a telescope during laparoscopic procedures.

## Comparison to Predicate Devices:

The Olympus SH-1 Surgical Holder for Telescope is similar in design, function, and intended use to currently marketed devices for laparoscopic surgery manufactured by Aesculap, Andronic, Automated Medical Products, Codman, Computer Motion Inc., Leonard Medical, Mediflex, and Thompson Medical Products.

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