QUICK-CUT AUTOMATIC BIOPSY SYSTEM

K980479 · Gallini U.S., LLC · KNW · May 6, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980479
• Device Name: QUICK-CUT AUTOMATIC BIOPSY SYSTEM
• Applicant: Gallini U.S., LLC
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: May 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

This device is to be used for soft tissue biopsy.

Device Story

Quick-Cut® Automatic Biopsy System is a mechanical device designed for soft tissue biopsy. It functions as an automatic biopsy instrument to obtain tissue samples. Used by clinicians in a clinical setting. The device facilitates the collection of tissue for diagnostic purposes, aiding in the assessment of disease states.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical automatic biopsy system. Class II device. Product code: KNW.

Indications for Use

Indicated for soft tissue biopsy in patients requiring tissue sampling.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 MAY

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

Re: K980479 Quick-Cut® Automatic Biopsy System Trade Name: Requlatory Class: II Product Code: KNW Dated: January 28, 1998 February 6, 1998 Received:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations.

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## Page 2 - Mr. 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,

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

Enclosure

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K98047x

:

Page_1_of __1

| 510(k) Number (if known) | Unknown |
|--------------------------|---------------------------------------------------|
| Device Name: | Quick-Cut® Automatic Biopsy System |
| Indications for Use: | This device is to be used for soft tissue biopsy. |

FDA/CDRH/ODE/DMC

6 FEB 98 14 40

RECEIVED

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| Prescription Use | X | OR | Over-the-Counter Use |
|----------------------|---|----|----------------------|
| (Per 21 CFR 801.109) | | | |

(Optional Format 1-2-96)

SK-35

K980479

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