INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 8781

K964258 · Richard Wolf Medical Instruments Corp. · GCJ · Jan 16, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964258
• Device Name: INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 8781
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The “ESDP” instrument set is used for minimally invasive visualization and diagnostic and therapeutic procedures of superficial veins in the lower extremities, e.g. the saphenous vein. The intervention takes place under sterile conditions.

Device Story

ESDP instrument set comprises operating telescope, endoscopic operating tube, laser guide, and hook knife. Used by physicians in sterile clinical settings for minimally invasive visualization and treatment of lower extremity superficial veins (e.g., saphenous vein). Device facilitates endoscopic access and visualization; enables surgical intervention on veins. Benefits include minimally invasive approach compared to traditional open surgery.

Clinical Evidence

No clinical data or performance testing generated.

Technological Characteristics

System includes operating telescope, endoscopic operating tube, laser guide, and hook knife. Mechanical endoscopic accessory set. No specific materials, energy sources, or software characteristics described.

Indications for Use

Indicated for patients requiring minimally invasive visualization, diagnostic, or therapeutic procedures on superficial veins of the lower extremities, such as the saphenous vein.

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

• Richard Wolf Model 8981.01
• Richard Wolf Model 8449.20
• Richard Wolf Model 8960.01
• Richard Wolf Model 8960.02
• Richard Wolf Model 8960.03
• Richard Wolf Model 4937D
• Richard Wolf Model 8383.753
• Richard Wolf Model 8267.10

Submission Summary (Full Text)

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JAN-10-1997 14:14 RICHARD WOLF GA DEPT. 1 847 913 0924 P.04

# 510(k) Summary of Safety and Effectiveness

**K964258** JAN 16 1997

| **Submitter:** | | | **Date of Preparation:** October 21, 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:
Instruments for Endoscopic Subfascial
Discision of Perforating Veins (ESDP) | | Model number:
8781 | | |
| Common name:
Operating Tubes
Operating Telescope
Laser Guide
Knife | | Classification name:
Endoscopic Accessories | | |
| **Information on devices to which substantial equivalence is claimed:** | | | | |
| 510(k) Number | Trade or proprietary or model name | | Manufacturer | |
| 1 | 1 see Contents of submission | | 1 | |
| 2 | 2 | | 2 | |
| 3 | 3 | | 3 | |
| 4 | 4 | | 4 | |
| 5 | 5 | | 5 | |
| 6 | 6 | | 6 | |

## 1.0 Description

The device consists of an operating telescope, endoscopic operating tube, a laser guide, and a hook knife.

## 2.0 Intended Use

The “ESDP” instrument set is used for minimally invasive visualization and diagnostic and therapeutic procedures of superficial veins in the lower extremities, e.g. the saphenous vein. The intervention takes place under sterile conditions.

## 3.0 Technological Characteristics

There are no significant technological characteristics of the new device compared to the existing device.

7 - 2

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## 4.0 Substantial Equivalence

The ESDP systems substantially equivalent to devices sold or previously sold by Richard Wolf Medical Instruments. Specifically models 8981.01, 8449.20, 8960.01/.02/.03, 4937D, 8383.753, and 8267.10.

## 5.0 Performance Data

No data generated.

## 6.0 Clinical Tests

No clinical tests performed.

## 7.0 Data Conclusions

No data available.

By: Robert L. Casarsa
Quality Assurance Manager
Date: Oct 21, 96