SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)

K971408 · Ikonos Corp. · GXN · May 12, 1998 · Neurology

Device Facts

• Record ID: K971408
• Device Name: SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
• Applicant: Ikonos Corp.
• Product Code: GXN · Neurology
• Decision Date: May 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SCC 200 is indicated for use as a means to cover the burr hole and reattach the bone flap after a craniotomy procedure. The SCC 200 is not intended for use where only a single burr hole is made.

Device Story

Sevrain Cranial Clamp 200 Series (SCC 200) is a cranial fixation device used to secure bone flaps following craniotomy. Device covers burr holes and reattaches bone flaps to the cranium. Used in surgical settings by neurosurgeons. Provides mechanical stabilization of the skull post-procedure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed of polyethylene. Mechanical cranial fixation device. Dimensions and form factor designed for burr hole coverage and bone flap reattachment.

Indications for Use

Indicated for patients undergoing craniotomy procedures requiring bone flap reattachment and burr hole coverage. Contraindicated for procedures involving only a single burr hole.

Regulatory Classification

Identification

A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a profile view.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 1998

Mr. Christophe J-P. Sevrain Chairman and CEO Ikonos Corporation 320 Southwest Sixth Avenue, Second Floor Portland, Oregon 97204-1749

K971408 Re : Sevrain Cranial Clamp 200 Series Trade Name: (Polyethylene) Regulatory Class: II Product Codes: GXN and GXR Dated: February 4, 1998 February 11, 1998 Received:

Dear Ms. Sevrain:

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with --the current Good Manufacturing Practice requirement, 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 Adminietration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations. Bor __________________________________________________________________________________________________________________________________________________________________________

{1}------------------------------------------------

## Page 2 - Mr. Christophe J-P. Sevrain

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sistem privalence of your device to a legally marketed predicate device results in a classification for your marketed production overmits 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 che promotion and clance 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

Division of General and Restorative Devices Office of Device Evaluation · Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## 2971408 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Sevrain Cranial Clamp 200 Series

Indications For Use:

ﻟﻴﺮﺍ

The SCC 200 is indicated for use as a means to cover the burr hole and reattach the bone flap after a craniotomy procedure. The SCC 200 is not intended for use where only a single burr hole is made.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K971408

Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)