WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE

K981889 · Worldwide Medical Technologies, LLC · FCG · Jul 31, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981889
• Device Name: WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
• Applicant: Worldwide Medical Technologies, LLC
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Jul 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The intended use for the Worldwide Medical Technologies Introducer Needle for Biopsy Needles is in the co-axial biopsy technique where the introducer needle is first percutaneously placed at the site of the lesion and the biopsy needle is placed through the introducer to take the sample. This allows for accurate multiple sampling of the same lesion. This technique is used in any of the soft tissue organs of the abdomen and thorax.

Device Story

The Worldwide Medical Technologies Introducer Needle is a manual surgical instrument designed for use in co-axial biopsy procedures. It functions as a guide for biopsy needles, allowing clinicians to maintain a stable access path to a lesion within soft tissue organs of the abdomen and thorax. By remaining in place after initial percutaneous insertion, the introducer enables the physician to perform multiple biopsy samples of the same lesion without repeated punctures. The device is intended for use by physicians in clinical settings. It provides a mechanical pathway for sampling instruments, thereby improving procedural efficiency and accuracy in tissue acquisition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual introducer needle for soft tissue biopsy. Designed for percutaneous insertion to facilitate co-axial needle placement. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring soft tissue biopsy of the abdomen and thorax. Used for percutaneous co-axial biopsy to facilitate multiple sampling of a single lesion.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 1998

Mr. Gary A. Lamoureux Worldwide Medical Technologies 125 Main Street North Woodbury, CT 06798-0505

Re: K981889

World wide Medical Technologies Introducer Needle Dated: May 21, 1998 Received: May 29, 1998 Regulatory Class: II 21 CFR 876.1075/Procode: 78 FCG

Dear Mr. Lamoureux:

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 (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 substantialion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 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 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/odrh/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): __ K 9 8 1 8 8 9

Device Name: Worldwide Medical Technologies Introducer Needle for Biopsy Needles

Indications For Use:

The intended use for the Worldwide Medical Technologies Introducer Needle for Biopsy Needles is in the co-axial biopsy technique where the introducer needle is first percutaneously placed at the site of the lesion and the biopsy needle is placed through the introducer to take the sample. This allows for accurate multiple sampling of the same lesion. This technique is used in any of the soft tissue organs of the abdomen and thorax.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproduction, Abdominal, ENT

Division of Reproductive, Abdominal, ENT. and Radiological Devices

510(k) Number K981889

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

EXHIBIT 1