WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE

K981470 · Worldwide Medical Technologies, LLC · IZH · Jun 19, 1998 · Radiology

Device Facts

• Record ID: K981470
• Device Name: WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE
• Applicant: Worldwide Medical Technologies, LLC
• Product Code: IZH · Radiology
• Decision Date: Jun 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Intended Use

The intendended use of the Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device is to hold the needle in the stereotactic device for precise location of the needle tip in the needle biopsy of the breast. This device is intended to be used with the Lorad Stereotactic Device only.

Device Story

Needle guide accessory for Lorad Stereotactic Device; holds biopsy needle in fixed position during breast biopsy procedures. Used in clinical radiology settings by physicians. Facilitates precise needle tip placement for tissue sampling. Mechanical device; no electronic or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical needle guide; designed for compatibility with Lorad Stereotactic Device. No energy source, software, or complex materials specified.

Indications for Use

Indicated for use in breast needle biopsy procedures to hold the needle within a Lorad Stereotactic Device for precise needle tip positioning.

Regulatory Classification

Identification

A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 1998

Gary A. Lamoureux President Worldwide Medical Technologies 125 Main St. N. Woodbury, CT 06798

Re:

K981470

Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device Dated: April 17, 1998 Received: April 23, 1998 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH

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 (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 (OS) for Medical Devices: General regulation (2) 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 result in recult in reculatory 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 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 vitne 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/dsmaldsmam.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5 10(k) Number (if known):

Device Naune: ----------------------------------------------------------------------------------------------------------------------------------------------------------------Indications For Use:

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The intendended use of the Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device is to hold the needle in the stereotactic device for precise location of the needle tip in the needle biopsy of the breast. This device is intended to be used with the Lorad Stereotactic Device only.

(PLEASE DO NOT WRITE BELOW TIUS LINE - CONTINUE ON ANOTHER PAGE IF NEEDBO)

Concurrence of CDRH, Office of Dovice Evaluation (ODE)

David B. Skjerven

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(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

Prescription Usc (Pcr 21 CFR 801.109)

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Over-The-Counter Use

(Optional Formal 1-2-96)