MANAN(TM) SUPER-CORE BIOPSY NEEDLES

K974814 · Medical Device Technologies, Inc. · KNW · Jan 9, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974814
• Device Name: MANAN(TM) SUPER-CORE BIOPSY NEEDLES
• Applicant: Medical Device Technologies, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.

Device Story

Manan™ Super-Core Biopsy Needle is a spring-loaded, manual surgical instrument designed for soft tissue biopsy collection. Device features an echogenic needle integrated into a plastic handle, enabling single-handed operation. Clinicians use the device to obtain tissue samples from organs including liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung. Needle placement is guided by x-ray or ultrasonography. The spring-loaded mechanism facilitates specimen collection. Device is intended for prescription use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Spring-loaded biopsy needle; echogenic needle design; plastic handle; manual operation; visualization via x-ray or ultrasound.

Indications for Use

Indicated for obtaining soft tissue biopsies from liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.

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

• Super-Core Biopsy Needle (K950732)

Submission Summary (Full Text)

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Gainesville, Florida 320 TEL: [phone] FAX: [phone]

97 4814

## 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™ Super-Core Biopsy Needle |
| COMMON NAME: | Spring loaded biopsy needle |
| CLASSIFICATION NAME: | §878.4800 - Needle, biopsy (Manual surgical instrument for<br>general use) |

## SUBSTANTIAL EQUIVALENCE:

| Company Name | Product Name | 510(k) No. |
|------------------------|--------------------------|------------|
| Manan Medical Products | Super-Core Biopsy Needle | K950732 |

## DESCRIPTION OF DEVICE:

The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung. It is composed of a echogenic spring loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection. The placement position of the needle may be visualized by either x-ray or ultrasonography.

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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 caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN - 8 1998

Re: K974814

> Trade Name: Manan™ Super-Core Biopsy Needle Regulatory Class: II Product Code: KNW Dated: December 18, 1997 Received: December 23, 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 compirance with the current Good Manufacturing Practice requirements , 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 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

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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 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,

Celta M. Witten, Ph.D., M.D. Director Division of General and Restorative 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 a logo with the letters "AMD" in bold, white font against a black background. Below the letters, there are several lines of smaller text, also in white. The text appears to be a company name or slogan associated with the AMD brand. The overall design is simple and modern, with a focus on the company's initials.

145-310 S.W. 35th Gainesville, Florida 3260 TEL: [phone] FAX: [phone]

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Manan™ Super-Core Biopsy Needle.

Indications for Use:

The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from 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 of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Rach
510(k) Number K974814

Prescription Use
(Per 21 CFR 801(109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96.)