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 Description

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.

AI/ML Overview

This is a 510(k) submission for a physical medical device, not an AI/ML powered device. As such, many of the requested categories (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable.

Here's the available information presented according to your request:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Device functions as intended to clamp and hold the patient's head in a particular position for procedures requiring MRI of the brain structure and targets.	The device passed performance testing (bench testing) with positive outcomes. It is stated to have the "same method of construction and use as the predicates," implying equivalent performance in head fixation and MRI compatibility.
Compliance with applicable standards.	Testing to applicable Standards has been completed with positive outcomes.
Equivalent in scope of practical application to predicate devices.	The Head Fixation Arc and Table Base is equivalent to the predicate devices in the scope of practical application.
Equivalent in effectiveness at this application to predicate devices.	The Head Fixation Arc and Table Base is equivalent to the predicate devices in effectiveness at this application.
Ensuring the safety of its subject.	The Head Fixation Arc and Table Base is equivalent to the predicate devices in ensuring the safety of its subject.
No new safety or effectiveness issues.	The Head Fixation Arc and Table Base do not raise any new safety or effectiveness issues.

Study Details

Sample size used for the test set and the data provenance: Not applicable. This device is a physical head fixation system, not an AI/ML device that processes data. Testing was likely bench-top performance testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance is not relevant here. Device performance was likely assessed against engineering specifications and industry standards during bench testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The nature of the testing described (bench testing for a physical device) does not typically involve human adjudication in the way AI/ML studies do.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical device, not an AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, "ground truth" would likely refer to objective engineering measurements and the ability to maintain specified physical parameters (e.g., stability, secure fixation, MRI compatibility) under controlled conditions, as determined by bench testing against established performance standards. The submission implies compliance with these standards and equivalence to predicate devices.
The sample size for the training set: Not applicable. This is a physical device, not an AI/ML powered device, so there is no training set in the AI/ML sense.
How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.

Summary

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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 MusickIrvine, CA 92618
Telephone:	949-900-6833
Fax:	949-900-6834
Contact:	Edward Waddell
E-mail:	Ewaddell@surgivision.com
Correspondent:	J. Harvey Knauss
Address:	11984 South Evelyn CircleHouston, Texas 77071-3404
Telephone:	713-723-4080
Fax:	713-723-0786
E-mail:	harvey.knauss@gmail.com

2. Device Name:

Common Name:	Neurological headholder
Proprietary Name:	Head Fixation Arc andTable 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:

5. Description of Device:

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

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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 (800) 638-2041 or (240) 276-3150 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

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

Regulation Number and Section

§ 882.4460 Neurosurgical head holder (skull clamp).

(a)
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.(b)
Classification. Class II (performance standards).