Who is the manufacturer of SPEED-CUT?

Gallini Intl., Inc. submitted the Traditional clearance for SPEED-CUT (K961407).

What is the FDA product code for SPEED-CUT?

KNW. It is classified under 21 CFR 876.1075 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for SPEED-CUT?

510(k) clearance (submission type: Traditional).

SPEED-CUT

Q: What are the predicate devices for SPEED-CUT?

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

K961407 · Gallini Intl., Inc. · KNW · Nov 21, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K961407
Device Name	SPEED-CUT
Applicant	Gallini Intl., Inc.
Product Code	KNW · Gastroenterology, Urology
Decision Date	Nov 21, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 2

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.

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.

Indications for Use

Indicated for patients requiring soft tissue core biopsies, including liver, prostate, and kidney; suitable for use in laparoscopic procedures.

Regulatory Classification

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.)

Related Devices

K013069 — BIOSPEED · H.S. Hospital Services S.P.A. · Dec 12, 2001
K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES · Allegiance Healthcare Corp. · Jan 15, 2003
K981301 — SPEED-CUT AUTOMATIC BIOPSY SYSTEM · Gallini U.S., LLC · Jul 8, 1998
K962905 — TX BIOPSY NEEDLE · Gallini S.R.L. · Oct 11, 1996
K203141 — Uramix CuraWay Biopsy Needle · Uramix, Inc. · Sep 17, 2021

Submission Summary (Full Text)

{0} 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. {1} 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.