IRRIGATION/SUCTION HANDLE AND SHEATH

K963757 · Richard Wolf Medical Instruments Corp. · EOB · Nov 26, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K963757
• Device Name: IRRIGATION/SUCTION HANDLE AND SHEATH
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Nov 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sinus Irrigation / Suction Handle and the accompanying sheath are used to provide a means for irrigation fluids to be introduced into the sinus cavity, a means of suction from the same cavity and a holder for a 4.0mm telescope to view the sinus cavity. The Sinus Irrigation / Suction Handle can be used in conjunction with laser procedures and may be used with warm (heated) irrigation solutions. One such procedure is the VideoHydrascopic technique developed by Daniel Schuman, MD.

Device Story

Device consists of irrigation/suction handle and sheath; facilitates introduction of irrigation fluids, suctioning of sinus cavity, and housing of 4.0mm telescope for visualization. Used by physicians during sinus procedures, including laser-assisted techniques like VideoHydrascopic surgery. Provides integrated access for fluid management and endoscopic viewing; enables simultaneous irrigation, suction, and visualization to assist clinical decision-making during sinus surgery.

Clinical Evidence

No clinical tests performed; no performance data obtained.

Technological Characteristics

Manual irrigation/suction handle and sheath; designed to accommodate 4.0mm telescope. No new technological characteristics; non-powered mechanical device.

Indications for Use

Indicated for use in sinus cavity procedures requiring irrigation, suction, and visualization via a 4.0mm telescope; compatible with laser procedures and heated irrigation solutions.

Regulatory Classification

Identification

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Suction / irrigation handle 8475.25 (pre-enactment)
• Suction / irrigation handle 8475.26 (pre-enactment)

Submission Summary (Full Text)

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NOV 26 1996
K963757

# 510(k) Summary of Safety and Effectiveness

| Submitted by: | | | Date of Preparation: September 13, 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: IL 60061 |
| Contact name: Mr. Robert L. Casarsa | | | | |
| Contact title: Quality Assurance Manager | | | | |
| Product Information: | | | | |
| Trade name: Irrigation/Suction Handle with sheath | | Model number: Handle - 8475.221, Sheath - 8475.032 | | |
| Common name: Sinus irrigator / suction device | | Classification name: irrigator, sinus | | |
| Information on devices to which substantial equivalence is claimed: | | | | |
| 510(k) Number | Trade or proprietary or model name | | Manufacturer | |
| 1 pre enact. | 1 Suction / irrigation handle 8475.25 | | 1 Richard Wolf M.I.C. | |
| 2 | 2 Suction / irrigation handle 8475.26 | | 2 Richard Wolf M.I.C. | |
| 3 | | | | |
| 4 | | | | |
| 5 | | | | |
| 6 | | | | |

## 1.0 Description

The irrigation / suction handle with sheath allows the insertion of a 4.0mm telescope and provides the physician the ability to view, apply irrigation fluids, and suction the cavity.

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## 2.0 Intended Use

The Sinus Irrigation / Suction Handle and the accompanying sheath are used to provide a means for irrigation fluids to be introduced into the sinus cavity, a means of suction from the same cavity and a holder for a 4.0mm telescope to view the sinus cavity.

The Sinus Irrigation / Suction Handle can be used in conjunction with laser procedures and may be used with warm (heated) irrigation solutions. One such procedure is the VideoHydrascopic technique developed by Daniel Schuman, MD.

## 3.0 Technological Characteristics

There are no new technological characteristics for the irrigation / suction handle.

## 4.0 Substantial Equivalence

The irrigation / suction handle is substantially equivalent to prior suction / irrigation handle sold by Richard Wolf Medical Instruments Corporation. The predicate devices are listed in the information box above.

## 5.0 Performance Data

No performance data was obtained.

## 6.0 Clinical Tests

No clinical tests were performed.

## 7.0 Conclusions Drawn

The irrigation / suction handle is substantially equivalent to products currently marketed, particularly devices sold by Richard Wolf.

By:
Robert L. Casarsa
Quality Assurance Manager
Date: Sept 13, 96

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