CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE

K012886 · Cbyon, Inc. · HAW · Oct 9, 2001 · Neurology

Device Facts

• Record ID: K012886
• Device Name: CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE
• Applicant: Cbyon, Inc.
• Product Code: HAW · Neurology
• Decision Date: Oct 9, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The CBYON System with Image Enhanced Fluoroscopy Module intended use is as a computer-aided, image-guided system intended for planning and intraoperative navigation for cranial, spinal, and cranial biopsy procedures.

Device Story

CBYON System with Image Enhanced Fluoroscopy Module is a computer-aided, image-guided surgical navigation system. It utilizes preoperative and intraoperative imaging data to assist surgeons in planning and navigating cranial, spinal, and cranial biopsy procedures. The system provides real-time visualization and guidance to the surgeon in the operating room, facilitating precise instrument positioning relative to patient anatomy. By integrating fluoroscopic images with navigation data, the device aids in surgical decision-making and improves procedural accuracy, potentially reducing surgical trauma and improving patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Computer-aided image-guided navigation system; integrates fluoroscopic imaging with surgical navigation software; intended for cranial and spinal procedures. Technical specifications and materials not detailed in provided text.

Indications for Use

Indicated for planning and intraoperative navigation during cranial, spinal, and cranial biopsy procedures.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• CBYON System (K0001714)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2001

Ms. Krishna Sudhakaran Regulatory Compliance Manager Cbyon, Inc. 2275 E. Bayshore Road, Suite 101 Palo Alto, California 94303

Re: K012886

Trade/Device Name: Cbyon System with Image Enhanced Fluoroscopy Module Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: September 8, 2001 Received: September 10, 2001

Dear Ms. Sudhakaran:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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); 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.

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## Page 2 - Ms. Krishna Sudhakaran

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, MD

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Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT 2

## Indications for Use Statement

## 510(k) # 0001714

Device Name: CBYON System with Image Enhanced Fluoroscopy Module

Indications for Use: The CBYON System with Image Enhanced Fluoroscopy Module intended use is as a computer-aided, image-guided system intended for planning and intraoperative navigation for cranial, spinal, and cranial biopsy procedures.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

Signature Sign Off

(Division Sign-Off) Division of General, Restorative and Neurological Devices

4 Number is for the predicate device, the CBYON System

A

510(k) Number K012886