MANAN SOFT TISSUE BIOPSY NEEDLES

K980122 · Medical Device Technologies, Inc. · KNW · Jan 30, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980122
• Device Name: MANAN SOFT TISSUE BIOPSY NEEDLES
• Applicant: Medical Device Technologies, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Mananths Soft Tissue Biopsy Needles are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.

Device Story

Manan™ Soft Tissue Biopsy Needles are manual instruments designed for percutaneous tissue sampling. The device consists of a needle with a collection orifice; it is inserted into soft tissue under imaging guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy). The physician manually manipulates the needle to capture a tissue specimen within the orifice. The device is used in clinical settings by qualified physicians to obtain diagnostic tissue samples, aiding in the assessment of disease states in the pleura and abdominal cavities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual biopsy needle; percutaneous insertion; collection orifice mechanism; used under external imaging guidance (CT, Ultrasound, Fluoroscopy).

Indications for Use

Indicated for percutaneous soft tissue biopsies (pleural cavity, abdominal cavity, and associated organs) in patients requiring tissue sampling, performed by a qualified physician under imaging guidance.

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

• Manual Biopsy Needles (K944837)
• Franseen Needle (K851831)
• Greene Needle (K851835)
• Westcott Needle (K851837)
• Chiba Needle (K851838)
• Trocar Needle (K852426)
• Spinal Needle (K852427)
• Turner Needle (K873208)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo for MD Tech Power Drive Technologies Inc. The logo is in black and white, with the text "MD TECH" in large, bold letters at the top. Below the text is the phrase "POWER DRIVE TECHNOLOGIES INC." in smaller letters. The logo has a rectangular shape with rounded corners.

JAN 30 1998

K980122

ainesville, Florida 3 TEL: [phone] FAX: [phone]

## 510(k) SUMMARY

| APPLICANT: | Medical Device Technologies, Inc.<br>4445-310 SW 35th Terrace<br>Gainesville, FL 32608 |
|------------------|----------------------------------------------------------------------------------------|
| CONTACT: | Karl Swartz<br>Quality Assurance Manager |
| TELEPHONE: | [phone]<br>fax [phone] |
| TRADE NAMES: | Manan™ Soft Tissue Biopsy Needles |
| COMMON NAME: | Manual biopsy needles for soft tissue biopsies |
| SIFICATION NAME: | Needle, Biopsy, Cardiovascular, No. 79DWO |

## SUBSTANTIAL EQUIVALENCE:

CLASS

| Company Name | Product Name | 510(k) No |
|-----------------------------------|-----------------------|-----------|
| Medical Device Technologies, Inc. | Manual Biopsy Needles | K944837 |
| Manan Medical Products | Franseen Needle | K851831 |
| Manan Medical Products | Greene Needle | K851835 |
| Manan Medical Products | Westcott Needle | K851837 |
| Manan Medical Products | Chiba Needle | K851838 |
| Manan Medical Products | Trocar Needle | K852426 |
| Manan Medical Products | Spinal Needle | K852427 |
| Manan Medical Products | Turner Needle | K873208 |

## DESCRIPTION OF DEVICE:

These devices are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 30 1998

Mr. Karl Swartz Ouality Assurance Manager Medical Device Technologies, Incorporated 4445-310 S.W. 35th Terrace Gainesville, Florida 32608

Re: K980122

> Trade Name: Manan™ Soft Tissue Biopsy Needles Regulatory Class: II Product Code: KNW Dated: December 31, 1997 Received: January 14, 1998

Dear Mr. Swartz:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , as set forth in the Ouality 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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.

{2}------------------------------------------------

Page 2 - Mr. Swartz

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

to sollyz

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

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a logo for RADTECH MEDICAL DEVICE TECHNOLOGIES, INC. The logo is in white text on a black background. The text is in a sans-serif font and is arranged in two lines. The first line is the word "RADTECH", and the second line is the phrase "MEDICAL DEVICE TECHNOLOGIES, INC."

445-310 S.W. 35th Te Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

Page 1 of 1

510(k) Number (if known): __ K980122

Device Name: Manan™ Soft Tissue Biopsy Needles

Indications for Use:

The Mananths Soft Tissue Biopsy Needles are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.

## (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 | K980122 |

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

(Optional Format 1-2-96)

Image /page/3/Picture/10 description: The image shows a logo and some text. The logo is a stylized design with vertical lines. Below the logo, the text "A member of The Marmon Group of companies" is present. The text indicates an affiliation or membership with The Marmon Group.