SEVRAIN CRANIAL CLAMP

K971252 · Ikonos Corp. · GXN · Jul 6, 1998 · Neurology

Device Facts

• Record ID: K971252
• Device Name: SEVRAIN CRANIAL CLAMP
• Applicant: Ikonos Corp.
• Product Code: GXN · Neurology
• Decision Date: Jul 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SCC-100 is indicated for the re-attachment of the bone flap after a craniotomy.

Device Story

The SCC-100 is a surgical fixation device used for re-attaching bone flaps following craniotomy procedures. It is intended for use by neurosurgeons in an operating room setting. The device functions as a mechanical fixation system to secure the bone flap to the cranium, facilitating proper healing and structural integrity post-surgery. It is a purely mechanical device.

Technological Characteristics

Mechanical bone fixation device for craniotomy procedures.

Indications for Use

Indicated for patients undergoing craniotomy requiring re-attachment of the bone flap.

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}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUL 6 1998

Mr. Christophe Sevrain
Chief Executive Officer
Ikonos Corporation
320 SW 6th Ave., 2nd Floor
Portland, Oregon 97204

Re: K971252
Trade Name: SCC-100
Regulatory Class: II
Product Code: GXN
Dated: April 6, 1998
Received: April 8, 1998

Dear Mr. 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 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 (QS) 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

{1}

Page 2 - Mr. Christophe Sevrain

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 at [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

{2}

06-26-98 08:17 IKONOS CORPORATION ID=5032244428 P.02

K971252
Indication For Use

The SCC-100 is indicated for the re-attachment of the bone flap after a craniotomy.

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971252

Prescription Use ☐
(Per 21 CFR 801.109)