← Product Code [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW) · K961407

# SPEED-CUT (K961407)

_Gallini Intl., Inc. · KNW · Nov 21, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K961407

## Device Facts

- **Applicant:** Gallini Intl., Inc.
- **Product Code:** [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW.md)
- **Decision Date:** Nov 21, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1075
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Indications for Use

An automatic biopsy system designed to take core samples from a variety of soft tissues, including (but not limited to) liver, prostate, kidney.

## Device Story

Speed-Cut® is an automatic, spring-loaded, depth-programmable, disposable biopsy instrument. Used by surgeons to obtain soft tissue core samples (liver, prostate, kidney). Operates via spring-loaded mechanism to capture tissue. Small form factor and extended needle lengths allow use in laparoscopic procedures, guided by fiber optics or ultrasound. Output is a tissue core sample for diagnostic evaluation. Benefits include precise, automated tissue acquisition with safety margin established by firing-to-failure testing.

## Clinical Evidence

Bench testing only. Testing included firing tests (mean 50 fires before failure), intracutaneous reactivity, acute systemic activity, pyrogen testing, and cytotoxicity. All tests passed.

## Technological Characteristics

Automatic spring-loaded biopsy instrument; disposable; depth-programmable; various sizes available for laparoscopic use; compatible with fiber optic or ultrasound guidance.

## Regulatory Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

## Predicate Devices

- ACECUT Automatic Biopsy System (Meadox Medical, Inc.)

## Submission Summary (Full Text)

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NOV 21 1996
K961407
P192

# 510K SUMMARY

**Owner:** Gallini s.r.l.
88/90 Via S. Faustino
41037-Mirandola-Italy

**Contact:** Paul L. Hawthorne
U.S. Representative
C/O Coeurage Enterprises
3106 Bretton Court
Glen Allen, VA 23060

**Submission Date:** April, 1996

**Device Name:** Speed-Cut® - Automatic Biopsy System

**Predicate Device:** ACECUT Automatic Biopsy System
Meadox Medical, Inc.

**Description of Device Function**
The Speed-Cut® is an automatic spring loaded, depth programmable, disposable biopsy instrument.

**Intended Use:** An automatic biopsy system designed to take core samples from a variety of soft tissues, including (but not limited to) liver, prostate, kidney.

# TECHNOLOGICAL CHARACTERISTICS

The SPEED-CUT® Automatic Biopsy System is equivalent to the predicate device in terms of technological characteristics.

Due to the variety of sizes available for this device, it may be used in laparoscopic procedures. The small size and longer needles facilitate placement through one of the incisions while the surgeon “views” the tissue to be biopsied using fiber optics or ultra-sound.

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K961407
P292

# 510K SUMMARY

The following tests were performed to verify the safety and efficacy of the instrument.

|  TEST | RESULTS  |
| --- | --- |
|  Firing Test* | Passed  |
|  Intracutaneous Reactivity | Passed  |
|  Acute Systemic Activity | Passed  |
|  Pyrogen Test | Passed  |
|  Cytotoxicity | Passed  |

* - Gallini exhaustive test procedures (firing until failure) indicate the Speed-Cut® biopsy instruments may be fired on average fifty (50) times before failing. The manufacturer feels a ten to one (fire to fail/max.pt. use) ratio provides adequate safety margin.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K961407](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K961407)

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