MANAN TECHNA-CUT ASPIRATION NEEDLE

K974766 · Medical Device Technologies, Inc. · KNW · Jan 8, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974766
• Device Name: MANAN TECHNA-CUT ASPIRATION NEEDLE
• Applicant: Medical Device Technologies, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jan 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Manan Techna-Cut biopsy needle is intended for use in obtaining biopsy material from tissues such as the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.

Device Story

Manan Techna-Cut biopsy needle; manual surgical instrument; utilizes Menghini cutting tip geometry to excise tissue samples. Includes locking syringe for aspiration. Used by clinicians in clinical settings to obtain biopsy material from various organs (liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung). Provides tissue specimens for diagnostic evaluation; aids in disease state assessment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual biopsy needle; Menghini cutting tip geometry; includes locking syringe. Disposable device.

Indications for Use

Indicated for obtaining biopsy tissue samples from liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung. For 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.

Predicate Devices

• Techna-Cut Biopsy Needle (K943651)

Submission Summary (Full Text)

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

MD

K974766

4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

JAN - 8 1998

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™ Techna-Cut Biopsy Needle | |
| COMMON NAME: | Biopsy needle | |
| CLASSIFICATION NAME: | §878.4800-Manual surgical instrument for general<br>use; disposable aspiration and injection needle. | |
| SUBSTANTIAL EQUIVALENCE: | | |
| Company Name | Product Name | 510(k) No. |
| Manan Medical Products | Techna-Cut Biopsy Needle | K943651 |

DESCRIPTION OF DEVICE:

The Manan Techna-Cut biopsy needle is a cutting biopsy needle based upon the Menghini cutting tip geometry. A syringe is included with the syringe used is a locking syringe. The Manan Techna-Cut biopey needle is intended for use in obtaining biopsy material from tissues such as the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, with flowing lines suggesting movement or energy. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 8 1998

Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Incorporated 4445-310 SW 35th Terrace Gainsville, Florida 32608

Re: K974766 Trade Name: Manan™ Techna-Cut Biopsy Needle Regulatory Class: II Product Code: KNW Dated: December 18, 1997 Received: December 22, 1997

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 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 requirements , as set forth in the Onality 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 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

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

Page 2 - Mr. Swartz

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 vour 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

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

MD

4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

Page 1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Manan™M

Indications for Use:

The Manan Techna-Cut biopsy needle is intended for use in obtaining biopsy material from tissues such as the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.

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

| Concurrence of CDRH, Office | Device Evaluation (ODE) |
|-----------------------------------------|-------------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | IL974766 |

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

(Optional Format 1 -- -