AUTOMATED CORE BIOPSY DEVICE

K994272 · Promex, Inc. · KNW · Jan 7, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K994272
• Device Name: AUTOMATED CORE BIOPSY DEVICE
• Applicant: Promex, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jan 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

To obtain percutaneous core biopsy samples from soft tissue to obtain percutaneous core biopsy samples, kidney, prostate, and tumors of such organs as when used for breast biopsy, the product is for diagnosis only.

Device Story

Automated core biopsy device designed to obtain percutaneous tissue samples from soft organs including kidney, prostate, and breast tumors. Device is used by clinicians for diagnostic purposes. Operation involves mechanical tissue sampling. Device provides physical tissue cores for pathological examination. Intended for clinical use.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Automated mechanical core biopsy instrument for soft tissue sampling. Device is a manual/mechanical tool; no electronic, software, or energy-based components described.

Indications for Use

Indicated for obtaining percutaneous core biopsy samples from soft tissue, including kidney, prostate, and tumors (e.g., breast) for diagnostic purposes.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2000

Mr. Joseph L. Mark Vice President Promex. Inc. 3049 Hudson Street Franklin, Indiana 46131

Re: K994272 Trade Name: Automated Core Biopsy Device Regulatory Class: II Product Code: KNW Dated: December 10, 1999 Received: December 20, 1999

Dear Mr. Mark:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 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. Joseph L. Mark

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,

ames E. Dillard III Acting 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):_____________________________________________________________________________________________________________________________________________________

Device Name: Automated Core Biopsy Device

Indications For Use:

To obtain percutaneous core biopsy samples from soft tissue 10 obtain perculations core bropsy surves, kidney, prostate, and culturs of sach organs as awnen used for breast blopsy, the product is for diagnosis only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General Restorative Devices K994272 510(k) Number.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

..

(Optional Formal 1-2-96)