DAUM NEUROGATE TROCAR

K990782 · Daum GmbH · KNW · Apr 28, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990782
• Device Name: DAUM NEUROGATE TROCAR
• Applicant: Daum GmbH
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Apr 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Daum NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be inserted into the skull. The insertion is done with the aid of an insertion tool. This trocar function is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (11G, 14G, 16G) allowing a combination with all Daum neuro needles. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Device Story

Daum NeuroGate Trocar is a reusable titanium surgical instrument; designed for insertion into the skull via an insertion tool. Device provides a channel for the insertion and fixation of neurosurgical needles and instruments. Available in multiple channel diameters (11G, 14G, 16G) to accommodate various Daum neuro needles. Used in clinical/surgical settings by physicians to stabilize instruments during neurosurgical procedures. Benefits include precise needle/instrument guidance and fixation within the skull.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable surgical instrument; material: titanium; form factor: trocar with multiple channel diameters (11G, 14G, 16G); intended for manual insertion into the skull using an insertion tool; non-powered; mechanical device.

Indications for Use

Indicated for use as a surgical instrument for insertion into the skull to facilitate the insertion and fixation of needles and instruments during neurosurgical procedures. Restricted to prescription use by physicians.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 1999

Daum GmbH c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114

K990782 Re: Trade Name: Daum NeuroGate Trocar Regulatory Class: II Product Code: KNW Dated: March 9, 1999 Received: March 9, 1999

Dear Mr. Smith:

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 requirement, 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 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 - Mr. E.J.Smith

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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FROM : SMITH ASSOCIATES

Page 1 of 1

510(k) Number (if known):

Device Name: Daum NeuroGate Trocar

Classification Panel:

Indications for Use:

The Daum NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be I he Daum Nedroodie Trocal is a routes skull. The insertion is done with the aid of an insertion tool. This trocar function is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (I IG, 14G, 16G) allowing a combination with all Daum neuro needles.

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**

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Or

Over the Counter Use

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eneral Restorative Device