GALLINI ATRA-CUT NEEDLE

K990645 · Gallini U.S., LLC · KNW · May 19, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990645
• Device Name: GALLINI ATRA-CUT NEEDLE
• Applicant: Gallini U.S., LLC
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: May 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Gallini Atra-Cut Needle is used for fine bone biopsy and aspiration procedures.

Device Story

The Gallini Atra-Cut Needle is a manual surgical instrument designed for bone biopsy and aspiration. It functions as a mechanical tool for tissue sampling. The device is intended for use by clinicians in a clinical or hospital setting. It provides a physical means to access and extract bone marrow or bone tissue samples for diagnostic purposes, aiding in the clinical assessment of bone-related pathologies.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual surgical needle for bone biopsy and aspiration. Mechanical design; no energy source, software, or electronic components.

Indications for Use

Indicated for patients requiring fine bone biopsy and aspiration 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.

Submission Summary (Full Text)

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Public I lealth Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 1099

Mr. Paul L. Hawthornc U.S. Representative Gallini U.S. LLC 3991 Glenside Drive, Suite F Richmond, Virginia 23229

K990645 Re: Trade Name: Gallini Atra-Cut® Needle Regulatory Class: II Product Code: KNW Dated: February 26, 1999 Received: February 26, 1999

Dear Mr. Hawthorne:

We have reviewed your Section 510(k) notification of intent to market the device eefenered con we nave reviewed your Bection 210(x) notistantially equivalent (for the indications for above and we have decements devices marketed in interstate commerce prior to use stated in the cheristics to do roos he Medical Device Amendments, or to devices that May 26, 1970, the enacified in accordance with the provisions of the Federal Food, I rug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls, Cosment Act (ACT). " Tourmay, merciore, manor and the Act include requirements for provisions or alle Act. - ing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (soc abone) n.to such additional controls. Existing major (Premarket Approval), it may be subject to satil additions and regulations, Title 21, regulations areeting your device can be reads to mination assumes compliance with the Faris 800 to 695. A substantian J equirement, as set forth in the Quality System current Oooo Manufacturing Praetice requirement regulation (21 CFR Part 820) and that, Regulation (QS) for Modical 727.000. Food and Drug Administration (FDA) will verify through perfoune (Q5) mispectons, the GMP regulation may result in regulations in such assumptions. Thanne to compty with the Orie organing your device in the Federal Register. Please note: this response to your premarket notification submission docs Federal Rogister. Trease note: this response or sections 531 through 542 of the Act for not allect ally obtigation you might have care as a control provisions, or other Federal laws or regulations.

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Page 2 – Mr. Paul I .. Hawthorne

This letter will allow you to begin marketing your device as described in your 510(k) i his letter will anow you to begin mancemig your antial equivalence of your device to a premarket notification. The FT/A midling of substantial of a more of the may of the and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 If you desire Specific advice in your devices), please contact the Office of and additionally 809.10 for in Vitto diagnous for questions on the promotion and Compliance at [phone]. Auditionally, 161 Compliance at [phone].
advertising of your dcvice, please contact the Office of Compliance at anymorshal Also, please note the regulation entitled, "Misbranding by reference to premarket. Also, please note the regulation onlines, "Mrs.org.network on your responsibilities under the notification" (21 C.F. 807.97). Other general Missimaliantiacturers Assistance at its toll-free Act may be ontained 41 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known) | K99 0645 |
|--------------------------|----------------------------------------------------------------------------------------|
| Device Name: | Atra-Cut® Needle |
| Indications for Use: | The Gallini Atra-Cut Needle is used for fine bone biopsy and<br>aspiration procedures. |

(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use _

picote

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices K970645
510(k) Number

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