CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM

K101235 · Neos Surgery S.L · GXR · Oct 25, 2010 · Neurology

Device Facts

• Record ID: K101235
• Device Name: CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
• Applicant: Neos Surgery S.L
• Product Code: GXR · Neurology
• Decision Date: Oct 25, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cranial Loop Cranial Bone Fixation System is a long-term implantable device indicated for post-craniotomy bone flap fixation.

Device Story

Cranial LOOP is a biocompatible, long-term implantable system for fixing bone flaps to the skull following craniotomy. Device functions as a mechanical fixation mechanism; requires no specific surgical instruments for handling or implantation. Provided sterile for single use. Used by neurosurgeons in clinical/OR settings to secure bone flaps; facilitates stable bone healing. Benefits include simplified surgical workflow and secure cranial reconstruction.

Clinical Evidence

Bench testing only. Mechanical and performance testing confirmed the device performs as intended and is substantially equivalent to predicate devices.

Technological Characteristics

Biocompatible, long-term implantable cranial bone fixation system. Provided sterile for single use. Mechanical fixation principle. No specific surgical instruments required for implantation.

Indications for Use

Indicated for post-craniotomy bone flap fixation in patients requiring long-term cranial bone stabilization.

Regulatory Classification

Identification

A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

Predicate Devices

• INVISx (K010361)
• CranioFix (K040080)
• CranioFix Titanium (K972332)

Submission Summary (Full Text)

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## Section 5: 510(k) Summary

OCT 2 5 2010

The following information is provided as required by 21 CFR § 807.87 for the Cranial LOOP Cranial Bone Fixation System (Cranial LOOP) 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

Sponsor: Neos Surgery S.L. Parc Tecnològic del Vallès C/Ceramistes, 2 (08290) Cerdanyola del Vallès Barcelona, Spain

Contact: Marcos Velez-Duran M Squared Associates, Inc. 901 King Street, Suite 200 Alexandria, VA 22314 Ph: 703-562-9800 Ext 206 Fax: [phone] Email: [e-mail]

Date of Submission: April 30, 2010

| Proprietary Name: | Cranial LOOP Cranial Bone Fixation System |
|-------------------|----------------------------------------------------------------------------------|
| Common Name: | cranial fixation device |
| Regulatory Class: | 882.5250 Burr hole cover, 882.5330 Preformed. nonalterable<br>cranioplasty plate |
| Product Codes: | GXR, GXN |

Predicate Device(s): INVISx-K010361, CranioFix- K040080, CranioFix Titanium-K972332

Device Description: The Cranial LOOP Cranial Bone Fixation System is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull, without any specific surgical instrument for its handling or implantation. It is provided sterile, for single use.

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Intended Use: The Cranial Loop Cranial Bone Fixation System is a long-term implantable device indicated for post-craniotomy bone flap fixation.

Discussion of performance testing: Mechanical and various performance testing confirms the Cranial LOOP Cranial Bone Fixation System performs as intended and is substantially equivalent to the predicate devices.

Technological comparison: The claim of substantial equivalence of the Cranial Loop to the predicate devices is based on the comparison of the intended use, product technical characteristics, performance characteristics and product handling.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Neos Surgery, S.L. % Mr. Marcos Velez-Duran President M Squared Associates, Incorporated 901 King Street, Suite 200 Alexandria, VA 22314

· OCT 2 5 2010

Re: K101235

Trade/Device Name: Cranial LOOP Cranial Bone Fixation System . Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: September 29, 2010 Received: October 1, 2010

Dear Mr. Velez-Duran:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Velez-Duran

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Keora Alexander

Image /page/3/Picture/7 description: The image shows the word "for" written in cursive. The word is written in black ink on a white background. The letter "f" is tall and slender, and the letters "o" and "r" are smaller and rounder. The word is slightly tilted to the right.

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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OCT 2 5 2010

## Section 4: Indications for Use Statement

510(k) Number: . To be assigned K / 0 / 2 35

Cranial LOOP Cranial Bone Fixation System Device Name:

Indications for Use: The Cranial LOOP Cranial Bone Fixation System is a long-

term implantable device indicated for post-craniotomy bone flap fixation.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ruanal

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K101235

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