← Product Code [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) · K962799

# MINIATURE LAPAROSCOPE SET (MINI LAP) (K962799)

_Richard Wolf GmbH · GCJ · Oct 11, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K962799

## Device Facts

- **Applicant:** Richard Wolf GmbH
- **Product Code:** [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ.md)
- **Decision Date:** Oct 11, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic

## Indications for Use

The Miniature Laparoscope Set is used to apply and maintain pneumoperitoneum in the usual way, and to introduce telescopes and other auxiliary instruments, such as forceps and scissors for diagnostic and therapeutic purposes.

## Device Story

Miniature Laparoscope Set; includes spring-loaded Veress cannula, tubes, and telescopes. Used for establishing/maintaining pneumoperitoneum and introducing auxiliary instruments (forceps, scissors). Operated by physicians in clinical/surgical settings. Provides visualization for diagnostic and therapeutic laparoscopic procedures. Benefits include minimally invasive access via miniaturized diameter and length instruments.

## Clinical Evidence

No clinical data. Bench testing performed to verify spring-loaded cannula function and steam autoclave compatibility.

## Technological Characteristics

Materials: medical grade stainless steel, chrome-plated brass, glass lenses, glass fibers, plastic (eyepiece). Design: miniaturized diameter and length for minimally invasive access. Energy: mechanical (spring-loaded). Sterilization: steam autoclaving.

## Regulatory 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 pre-enactment devices
- Imagyn 510(k) devices
- Ethicon 510(k) devices
- Origin 510(k) devices

## Submission Summary (Full Text)

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OCT 11 1996
k962799

# 510(k) Summary of Safety and Effectiveness

1.0 **Classification Name:**
Set Laparoscopy

2.0 **Common/Usual Name:**
Veress Cannula Spring Loaded, Telescopes

3.0 **Trade Name:**
Mini Laparoscopes

4.0 **Equivalence:**
These devices are equivalent to existing pre-enactment devices sold by Richard Wolf and 510(k) devices sold by Imagyn, Ethicon, and Origin.

5.0 **Description:**
Cannula and tubes are made of medical grade stainless steel and chrome plated brass.

Telescopes are made of medical grade stainless steel (sleeve), glass-lenses, glass-fibers, brass chrome plated (housing) and plastic (eyepiece).

6.0 **Intended Use:**
The Miniature Laparoscope Set is used to apply and maintain pneumoperitoneum in the usual way, and to introduce telescopes and other auxiliary instruments, such as forceps and scissors for diagnostic and therapeutic purposes.

7.0 **Technological Characteristics:**
As the intended use describes, the set is miniaturized in diameter and length for minimal invasive laparoscopy. The veress cannula and the tubes are larger in diameter and longer in working length, the telescopes are shorter in length and smaller in diameter.

8.0 **Performance Data:**
Instruments have been tested to assure the function of the spring loaded cannula and the possibility of steam autoclaving.

9.0 **Clinical Tests:**
No clinical tests performed.

{1}

10.0 **Data Conclusion:**

The mentioned R. Wolf Mini Laparoscopy devices are substantially equivalent to existing devices on the market. They have been tested to allow safe usage, with no significant changes during the standard lifetime, when used according to our instructions.

By:
*Robert L. Casarsa*
Quality Assurance Manager
Date: *July 16, 96*

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K962799](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K962799)

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