SEVRAIN CRANIAL CLAMP

• K Number: K971252
• Device Name: SEVRAIN CRANIAL CLAMP
• Manufacturer: IKONOS CORP.
• Date Cleared: 1998-07-06 ( 459 days)
• Product Code: GXN
• Regulation Number: 882.5330
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: K013050 , K020088 , K031034 , K991029

Intended Use

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

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text only contains an FDA 510(k) clearance letter for the "SCC-100" device without any details about acceptance criteria or a study proving its performance. The letter simply states that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Summary

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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 Requlatory 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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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 requlation (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,

f
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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K971252
Indication For Use

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

Beeler

Sign-Off) 12971252

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
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.(b)
Classification. Class II (performance standards).