NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM

K013419 · Nicolet Biomedical · LLZ · Dec 20, 2001 · Radiology

Device Facts

• Record ID: K013419
• Device Name: NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM
• Applicant: Nicolet Biomedical
• Product Code: LLZ · Radiology
• Decision Date: Dec 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Indications for Use

The NEN provides intra-operative image guidance during neurosurgical operations. The NEN provides and operation and provides feedback and provides feedback concerning actions performed and parameters set. The device is to be used by or on order of a physician.

Device Story

Nicolet Biomedical Electromagnetic Navigation System (NEN) provides intra-operative image guidance for neurosurgical procedures. Device utilizes electromagnetic tracking technology to monitor surgical instruments relative to patient anatomy; provides real-time feedback on surgical actions and parameters. Operated by surgeons in clinical/OR settings. System assists in navigation; surgeon retains ultimate responsibility for surgical conduct. Benefits include enhanced spatial awareness and guidance during neurosurgical interventions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and regulatory review.

Technological Characteristics

Electromagnetic navigation system; utilizes electromagnetic tracking for intra-operative guidance. System provides feedback on surgical parameters and actions. Designed for neurosurgical application.

Indications for Use

Indicated for intra-operative image guidance during neurosurgical operations. Intended for use by or on order of a physician.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2001

Mr. David W. Wagner Director, Quality Assurance and Regulatory Affairs Nicolet Vascular, Inc. 6355 Joyce Drive GOLDEN CO 80403

Re: K013419

Trade/Device Name: Nicolet Biomedical Electromagnetic Navigation System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: October 5, 2001 Received: October 15, 2001

Dear Mr. Wagner:

We have reviewed your Section 510(k) premarket notification of intent to market the device weferenced 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 for association 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 I ou may , ater , worse , which , we , 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 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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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 predication. - The PDF interestion 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), please If you desire specific do Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Active of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding Other of Compilance at (201) Pation" (21 CFR Part 807.97). Other general information on of forchase to premained from the Act may be obtained from the Division of Small Manufacturers, your rooponshill.co 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,

Nancy C. Crozier

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4013419

## Application for 510(k)

Device Name: Nicolet Biomedical Electromagnetic Navigation System

Indications for Use:

The NEN provides intra-operative image guidance during neurosurgical operations. The NEN provides and operation and provides feedback and provides feedback concerning actions performed and parameters set.

actors performed and passic device. The ultimate responsibility for how and where the surgical operation is conducted is the responsibility of the surgeon.

The device is to be used by or on order of a physician.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Severson

Over-the-Counter Use

Prescription Use (per 21 CFR 801.109)