TRU-CORE I REUSABLE BIOPSY INSTRUMENT

K990839 · Medical Device Technologies, Inc. · KNW · May 20, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990839
• Device Name: TRU-CORE I REUSABLE BIOPSY INSTRUMENT
• Applicant: Medical Device Technologies, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: May 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Tru-Core™ I Reusable Biopsy Instrument is intended for use in obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

Device Story

Tru-Core™ I is a spring-powered, reusable biopsy handle used with disposable soft tissue biopsy needles. Operated by clinicians under external guidance (e.g., ultrasound, mammography). Procedure: needle set loaded into handle; device cocked; fired into site. Firing sequence: stylet penetrates site, tissue fills stylet slot; cutting cannula advances to slice and enclose tissue. Specimen retrieved for laboratory evaluation. Enables multiple core samples from soft tissue lesions; aids in diagnosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Spring-powered reusable handle; disposable needle set. Mechanical firing mechanism. Manual operation. No software or electronic components.

Indications for Use

Indicated for obtaining multiple core samples from soft tissue (liver, kidney, prostate, breast, and various soft tissue lesions) in patients requiring biopsy. Not intended for bone.

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

• Tru-Core Reusable (K962969)
• Tru-Core Automatic Disposable (K982960)

Submission Summary (Full Text)

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## MAY 20 1933

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Image /page/0/Picture/3 description: The image shows a logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is black and white and features the letters "MDTECH" in a stylized font. The letters are stacked on top of each other, with the "MD" on top and the "TECH" on the bottom. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller font. The logo is surrounded by a black border.

3600 SW 47th Avenue Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

## 510(k) SUMMARY

| APPLICANT: | Medical Device Technologies, Inc.<br>3600 SW 47th Avenue<br>Gainesville, FL 32608 |
|--------------------------|-----------------------------------------------------------------------------------|
| CONTACT: | Karl Swartz<br>Quality Assurance Manager |
| TELEPHONE: | [phone]<br>fax [phone] |
| TRADE NAMES: | Medical Device Technologies, Inc. Tru-Core™ I<br>Reusable Biopsy Instrument |
| COMMON NAME: | Reusable handle gun for use with disposable biopsy<br>needles. |
| CLASSIFICATION NAME: | Instrument, Biopsy, No. 78KNW |
| SUBSTANTIAL EQUIVALENCE: | |

| Company Name | Product Name | 510(k) No |
|-----------------------------|-------------------------------|-----------|
| Medical Device Technologies | Tru-Core Reusable | K962969 |
| Medical Device Technologies | Tru-Core Automatic Disposable | K982960 |

## DESCRIPTION OF DEVICE:

Our company is presently authorized by the Food and Drug Administration to manufacture a reusable handle gun K962969 that utilizes the same disposable soft tissue biopsy needles as the disposable version of this gun, K982960. This new device has the same operation and firing cycle as the disposable gun, but is intended to be reusable, as in the gun submitted under K962969. This new device will also utilize the same disposable soft tissue biopsy needles.

The biopsy needle is guided into position utilizing external guidance (Ultrasound, Mammography, etc.). The device consists of a spring powered, reusable handle, and a disposable needle set. To operate, the needle set is loaded into the reusable handle, the device is "cocked", then "fired" into the appropriate site, and tissue (specimen) is retrieved from the needle set for laboratory evaluation and diagnosis. Specifically, when "fired", the inner part of the needle set (stylet) moves forward first, penetrating the biopsy site. Tissue fills a "slot" at the tip of the stylet.

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K990839

20FZ

Image /page/1/Picture/1 description: The image shows the logo for MD Tech Medical Device Technologies Inc. The logo is in black and white and features the letters "MD TECH" in a bold, sans-serif font. The words "MEDICAL DEVICE TECHNOLOGIES INC" are printed in a smaller font below the letters "MD TECH".

3600 SW 47th Avenue Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

## 510(k) SUMMARY(Cont.)

Then the outer part of the needle set (cutting cannula) advances forward slicing off the tissue in the slot and enclosing it during removal from the patient. The tissue specimen is removed from the stylet slot after placing the device in the sample retrieval position. The procedure is repeated for additional biopsies, if dictated by the physician

Indications for Use:

The Tru-Core™ I Reusable Biopsy Instrument is intended for use in obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1999

Mr. Karl Swartz Quality Manager Medical Device Technologies, Inc. 3600 SW 47th Avenue Gainesville, Florida 32608

Re: K990839

MD Tech Tru-Core™ I Reusable Biopsy Instrument Dated: March 5, 1999 Received: March 15, 1999 Regulatory Class: II 21 CFR §876.1075/Product Code: 78 KNW

Dear Mr. Swartz:

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 legally marketed predicate 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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.

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 requlation (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/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for MDTech Medical Device Technologies Inc. The logo is black and white and features the letters "MDTECH" in a bold, sans-serif font. The words "MEDICAL DEVICE TECHNOLOGIES INC" are printed in a smaller font below the letters. The logo is simple and modern.

3600 SW 47th Avenue Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MD Tech Tru-Core™ I Reusable Biopsy Instrument

Indications for Use:

The Tru-Core™ I Reusable Biopsy Instrument is intended for use in obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

(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)

1

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David A. Segeen

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dey 510(k) Number