HEAD FIXATION ARC AND TABLE BASE

K091439 · Surgivision, Inc. · HBL · Aug 25, 2009 · Neurology

Device Facts

• Record ID: K091439
• Device Name: HEAD FIXATION ARC AND TABLE BASE
• Applicant: Surgivision, Inc.
• Product Code: HBL · Neurology
• Decision Date: Aug 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4460
• Device Class: Class 2

Intended Use

The Head Fixation Arc and Table Base is intended for use as a device to clamp and hold the patients head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.

Device Story

Head Fixation Arc and Table Base immobilizes patient head during surgical procedures; provides mounting for headcoil and optional camera system. Patient head positioned inside headcoil and attached rigidly to arc; head does not contact coil. Used in clinical settings for MRI-guided procedures. Device ensures stable positioning for imaging brain structures and targets.

Clinical Evidence

Bench testing only.

Technological Characteristics

Neurosurgical head holder (skull clamp). Mechanical fixation device. Designed for MRI compatibility.

Indications for Use

Indicated for patients requiring head immobilization during MRI procedures of brain structures and targets.

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.

Predicate Devices

• Noras OR Head Holder (K071179)
• Malcolm-Rand Micro neurosurgical Cranio-XRay Frame (K874298)

Submission Summary (Full Text)

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# Summary

This summary of a Traditional 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the SurgiVision Head Fixation Arc and Table Base.

- AUG 2 § 2009 1. Company making the submission:

| Name of Owner: | SurgiVision, Inc. |
|----------------|--------------------------------------------------------|
| Address: | 5 Musick<br>Irvine, CA 92618 |
| Telephone: | 949-900-6833 |
| Fax: | 949-900-6834 |
| Contact: | Edward Waddell |
| E-mail: | [e-mail] |
| Correspondent: | J. Harvey Knauss |
| Address: | 11984 South Evelyn Circle<br>Houston, Texas 77071-3404 |
| Telephone: | 713-723-4080 |
| Fax: | 713-723-0786 |
| E-mail: | [e-mail] |

#### 2. Device Name:

| Common Name: | Neurological head<br>holder |
|--------------------|-------------------------------------|
| Proprietary Name: | Head Fixation Arc and<br>Table Base |
| Regulation Number: | 882.4460 |
| Product Code: | HBL |

#### Predicate Device: 3.

K071179, Noras OR Head Holder, Siemens Medical Solutions USA, Inc. Malvern PA 19355 and K874298, Malcolm-Rand Micro neurosurgical Cranio-XRay Frame. Engineered Orthopedic Technologies, Inc., San Clemente, CA.

Summary Head holder tracked dor Delphi Consulting Group

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(191439 P. 2 of 3

#### 4. Intended Use Statement:

The Head Fixation Arc and Table Base is intended for use as a device to clamp and hold the patients head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.

#### 5. Description of Device:

The Head Fixation Arc and Table Base is designed to immobilize the patients head during the surqical procedure. It has secondary design intent to provide mounting method for the headcoil and optional camera system. The patient's head is positioned inside the headcoil and attached rigidly to the Head Fixation Arc. The patients head never touches the head coil.

## 6. Summary of the technological characteristics of the device compared to the predicate device:

The candidate device, this submission, has the same method of construction and use as the predicates.

#### 7. Testing:

Testing to applicable Standards has been completed with positive outcomes.

Top level of testing performed:

Performance Testing - Bench

#### 8. Rx or OTC:

The Head Fixation Arc and Table Base is an Rx prescription device per 21 CFR Subpart D.

Summary Head holder tracked.doc
Delphi Consulting Group
Houston, TX 77071

14

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## 9. Conclusions:

KOG 1439 2.3 083

The Head Fixation Arc and Table Base is equivalent to the predicate devices in the scope of practical application, effectiveness at this application, and ensuring the safety of its subject.

The Head Fixation Arc and Table Base do not raise any new safely or effectiveness issues.

SurgiVision, Inc.

Eduard Waldelu

Edward Waddell Director of Regulatory Affairs

Date: July 22, 2009

Head holder tracked.

Section 5 510(k) Submission Page #

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Image /page/3/Picture/0 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

## AUG 2 5 2009

Surgi Vision, Inc. c/o Mr. J. Harvey Knauss Contract Consultant Dephi Consulting Group (DCG) 11874 South Evelyn Circle HOUSTON TX 77071

Re: K091439

Trade/Device Name: Head Fixation Arc and Table Base Regulation Number: 21 CFR §882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: July 22, 2009 Received: July 28, 2009

#### Dear Mr. Knauss:

We have reviewed vour 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. Iisting 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); medical device reporting (reporting of medical

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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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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 (2.1 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

#### 510(k) Number: K091439

Device Name: Head Fixation Arc and Table Base

The Head Fixation Arc and Table Base is intended for use as a device to clamp and hold the patients head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.

Prescription Use YES (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)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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Section 4 510(k) Submission Page #

Indcations for use form.doc Delphi Consulting Group Houston, TX 77071