NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX

K031885 · Image-Guided Neurologics, Inc. · HBL · Aug 21, 2003 · Neurology

Device Facts

• Record ID: K031885
• Device Name: NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
• Applicant: Image-Guided Neurologics, Inc.
• Product Code: HBL · Neurology
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4460
• Device Class: Class 2

Intended Use

The Navigus Passive Head Restraint System is intended to be used for the stabilization of a patient's head during neurosurgical procedures.

Device Story

The Navigus Passive Head Restraint System is a neurosurgical head holder (skull clamp) used to stabilize a patient's head during neurosurgical procedures. It functions as a mechanical support device to maintain patient positioning throughout surgery. It is intended for use in a clinical/surgical setting by neurosurgeons or trained surgical staff. The device provides rigid or semi-rigid fixation to prevent movement, thereby facilitating surgical access and precision. It does not involve electronic inputs, software, or automated processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical neurosurgical head holder (skull clamp). Classified under 21 CFR 882.4460, Product Code HBL. Device is a passive restraint system; no energy source, software, or connectivity.

Indications for Use

Indicated for stabilization of the patient's head during neurosurgical procedures.

Regulatory Classification

Identification

A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three overlapping profiles, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 21 2003

Mr. David Lee Director of Regulatory Affairs Image-Guided Neurologics, Inc. 2290 West Eau Gallie Boulevard Melbourne. Florida 32935

Re: K031885

Trade/Device Name: Navigus Passive Head Restraint System Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: June 13, 2003 Received: June 24, 2003

Dear Mr. Lee:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Page 2 - Mr. David Lee

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N Milken

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

{2}------------------------------------------------

1 of Page

510(K) NUMBER (IF KNOWN): KO 31885

DEVICE NAME:

INDICATIONS FOR USE:

Intended Use: The Navigus Passive Head Restraint System is intended tinentied Use. The Nating ---------------------------------------------------------------------------------------------------------------------------------------------------neurosurgical procedures.

Mark A Milkeres

Division sign-Off eral. Restorative Di ision of Ge and Neurologi 1887

5 !0(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

× Prescription Use (Per 21 CFR 801.109)

OR

Over - The - Counter - Use (Optional Format: 1-7