TR NEEDLE

K970871 · Gallini Intl., Inc. · KNW · May 21, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970871
• Device Name: TR NEEDLE
• Applicant: Gallini Intl., Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: May 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The needle is designed to be used for soft tissue histological biopsy.

Device Story

TR Guillotine Needle is a manual surgical instrument used for soft tissue histological biopsy. Device functions as a mechanical cutting tool to obtain tissue samples. Used by clinicians in clinical settings. Provides tissue specimens for diagnostic evaluation; aids in clinical decision-making regarding patient pathology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual needle for soft tissue biopsy. Mechanical operation. No electronic components, software, or energy sources.

Indications for Use

Indicated for soft tissue histological biopsy. Prescription use only.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 21 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Paul L. Hawthorne
U.S. Representative
Gallini International, Inc.
4405 Cox Road, Suite 110
Glen Allen, Virginia 23060

Re: K970871
Trade Name: TR™ Guillotine Needle
Regulatory Class: II
Product Code: KNW
Dated: March 1997
Received: March 10, 1997

Dear Mr. Hawthorne

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Paul L. Hawthorne

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] 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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Page 1 of 1

K970871

510(k) Number (if known): K not known

Device Name: TR® Guillotine Needle

Indications for Use: The needle is designed to be used for soft tissue histological biopsy.

(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 ☐

(Optional Format 1-2-96)