GENERAL PURPOSE ATL NEEDLE GUIDE KIT

K973958 · Protek Medical Products, Inc. · ITX · Jan 22, 1998 · Radiology

Device Facts

• Record ID: K973958
• Device Name: GENERAL PURPOSE ATL NEEDLE GUIDE KIT
• Applicant: Protek Medical Products, Inc.
• Product Code: ITX · Radiology
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The General Purpose ATL Needle Guide Kit consists of accessories for the Model ATL C3 Scanhead which are used for guiding a needle or catheter during a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement. The subject device is to be used only for those indications which have been FDA-cleared for the Model ATL C3 Scanhead (consult transducer manual).

Device Story

General Purpose ATL Needle Guide Kit functions as an accessory for ATL C3 ultrasound scanheads; facilitates needle or catheter guidance during diagnostic ultrasound procedures; enables biopsy or precise needle placement. Used in clinical settings by healthcare professionals; provides mechanical alignment for interventional procedures. Benefits include improved accuracy and safety during needle-based diagnostic interventions. Device consists of kit components for ultrasound-guided procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical needle/catheter guide accessory for ATL C3 ultrasound scanhead. Kit components must comply with general controls and quality system regulations.

Indications for Use

Indicated for use as an accessory to the ATL C3 Scanhead to guide needles or catheters during diagnostic ultrasound procedures, including biopsies and precise needle placement, in patients requiring such procedures as cleared for the ATL C3 transducer.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 1998

Rick L. Pruter -PROTEK Medical Products, Inc. 221 E. Market Street, Suite 291 Iowa City, IA 52245-2166

Re: K973958 Trade Name: General Purpose ATL Needle Guide Kit Requlatory Class: II Product Code: 90 ITX Dated: December 11, 1997 Received: December 16, 1997

Dear Mr. Pruter:

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 You may, therefore, market the device, subject to the general controls (Act) . . provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If vou purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510 (k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.

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Page 2 - Rick L. Pruter

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. I E you desire specific advice for your device on the 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,

David A. Szymon
for Lillian Yin, PhD.

Director, Division of Reproductive, 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):

Device Name: General Purpose Needle Guide Kit for use with ATL Ultrasound Transducers

Indications For Use:

The General Purpose ATL Needle Guide Kit consists of accessories for the Model ATL C3 Scanhead which are used for guiding a needle or catheter during a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement. The subject device is to be used only for those indications which have been FDA-cleared for the Model ATL C3 Scanhead (consult transducer manual).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Edward A. Seegm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number

(Optional Format 1-2-96)