MANAN GENERAL PURPOSE INTRODUCER NEEDLE

K980004 · Medical Device Technologies, Inc. · KNW · Jan 9, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980004
• Device Name: MANAN GENERAL PURPOSE INTRODUCER NEEDLE
• 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™ Co-Axial Introducer Needle is intended for a range of biopsy applications of soft tissue.

Device Story

Manan™ Co-Axial Introducer Needle is a manual surgical instrument for soft tissue biopsy. Device consists of 304 stainless steel cannula (lengths 2-8 inches, gauges 8-22) and stainless steel stylet; molded medical-grade plastic hub. Assembly terminates in trocar-type needle point. Used by clinicians in clinical settings to introduce biopsy needles into soft tissue. Device facilitates access to target tissue for diagnostic sampling.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual surgical instrument. Materials: 304 stainless steel (cannula/stylet), medical grade plastic (hub). Dimensions: 2-8 inch length, 8-22 gauge. Trocar-type needle point. Non-powered, manual operation.

Indications for Use

Indicated for soft tissue biopsy applications. Intended for prescription use.

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

• Co-Axial Introducer Needles (K940024)
• Hawkins-Akins Blunt Needle (K881957)

Submission Summary (Full Text)

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MD

980004

JAN - 9 1998

4445-310 S.W. 35th Terra Gainesville, Florida 32608 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™ Co-Axial Introducer Needles |
| COMMON NAME: | General introducer needle, biopsy needle |
| CLASSIFICATION NAME: | §878.4800-Manual Surgical Instrument for General Use; Disposable<br>Aspiration and Injection Needle |

## SUBSTANTIAL EQUIVALENCE:

| Company Name | Product Name | 510(k) No. |
|-----------------------------------|-----------------------------|------------|
| Manan Medical Products | Co-Axial Introducer Needles | K940024 |
| Medical Device Technologies, Inc. | Hawkins-Akins Blunt Needle | K881957 |

## DESCRIPTION OF DEVICE:

The Manan Co-Axial Introducer Needle is a general purpose introducer-type needle assembly intended for a range of biopsy applications of soft tissue. The device is composed of a cannula, available in various lengths in the range of 2 ins. to 8 in. and gauges of between 8 and 22, constructed of 304 stainless steel into which a stainless steel stylet fits. The molded hub holding the cannula is comprised of medical grade plastic. The combination of the stylet and needle terminates in a trocar-type needle point.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 1998

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

Re: K980004

Trade Name: Manan™ Co-Axial Introducer Needles Regulatory Class: II Product Code: KNW Dated: December 31, 1997 Received: January 2, 1998

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 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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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,

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

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145-310 S.W. 35th Gainesville, Florida 326 TEL: [phone] FAX: [phone]

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K9/0004

510(k) Number (if known):

Device Name: Manan™ Co-Axial Introducer Needles

Indications for Use:

The Manan™ Co-Axial Introducer Needle is intended for a range of biopsy applications of soft tissue.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)