CT-GUIDE NEEDLE GUIDANCE SYSTEM

K110812 · Activiews, Ltd. · JAK · Jun 21, 2011 · Radiology

Device Facts

• Record ID: K110812
• Device Name: CT-GUIDE NEEDLE GUIDANCE SYSTEM
• Applicant: Activiews, Ltd.
• Product Code: JAK · Radiology
• Decision Date: Jun 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s). The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.

Device Story

System acts as stereotactic accessory for CT imaging; assists needle guidance during lung interventions. Components: ActiSensor (disposable video camera clipped to needle), ActiSticker (disposable radio-opaque/visual reference pad), workstation with dedicated computer, and software. Input: visual data from ActiSensor and CT-based organ models. Operation: system tracks interventional instrument relative to target organ; displays instrument position on monitor alongside CT model. Used in clinical settings; operated by clinicians. Output: real-time visual guidance on monitor. Benefit: improved accuracy and visualization for needle placement during lung procedures.

Clinical Evidence

Prospective, multi-center clinical study conducted. Results established system safety and effectiveness for intended use. Bench testing performed on custom phantom setup to verify performance and accuracy against specifications. Biocompatibility tested per ISO 10933-1; electrical safety and EMC tested per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

System includes disposable video camera (ActiSensor), disposable reference pad (ActiSticker), workstation, and software. Biocompatibility per ISO 10933-1. Electrical safety/EMC per IEC 60601-1 and IEC 60601-1-2. Stereotactic guidance principle using visual and radio-opaque markers.

Indications for Use

Indicated for use as a stereotactic accessory for CT systems to assist in clinical lung interventions where CT visualization is utilized.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Veran ig4 Image Guided System (K060903)
• UltraGuide MR Guide 3000 (K011418)

Submission Summary (Full Text)

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## 510(k) SUMMARY

K110812

#### ActiViews Ltd.'s CT-Guide Needle Guidance System

JUN 2 1 2011

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

ActiViews Ltd. 7 Nahum Haat Street Haifa 31905 Israel Phone: [phone] Facsimile: 97248551003

Contact Person: Yuval Zuk Date Prepared: March 22, 2011

#### Name of Device and Name/Address of Sponsor

CT-Guide Needle Guidance System

ActiViews Ltd. 7 Nahum Haat Street Haifa 31905 lsrael

## Common or Usual Name/Classification Name

Computed tomography x-ray system accessory

#### Predicate Devices

Veran ig4 Image Guided System (K060903) UltraGuide MR Guide 3000 (K011418)

#### Intended Use / Indications for Use

The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).

The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.

## Technological Characteristics

The CT-Guide System is comprised of four main components: (1) the ActiSensor, a disposable video camera that is mounted onto a holder, which is clipped to a needle; (2) the ActiSticker, a disposable pad, which provides visual and radio-opaque reference markers; (3) a workstation that contains a dedicated computer; and (4) accompanying computer software.

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## Performance Data

CT-Guide Needle Guidance System was tested for its performance and accuracy through several bench tests conducted on a custom phantom setup. All results were satisfactory and met the predefined specifications.

The CT-Guide software was validated and tested.

Skin contacting materials were tested for biocompatibility per ISO 10933-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

The CT-Guide system was tested for electromagnetic compatibility and electrical safety per IEC 60601-1 and IEC 60601-1-2

A prospective, multi-center clinical study was conducted with CT-Guide system. The results established that the system is safe and effective for its intended use.

In all instances, the CT-Guide functioned as intended and the testing results observed were as expected.

#### Substantial Equivalence

The CT-Guide is as safe and effective as the Veran ig4 Image Guided System and the UltraGuide MR Guide 3000. The CT-Guide has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the CT-Guide and its predicate devices raise no new issues of safety or effectiveness. Performance and clinical data demonstrate that the CT-Guide is as safe and effective as Veran ig4 Image Guided System and the UltraGuide MR Guide 3000. Thus, the CT-Guide is substantially equivalent.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

# 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

ActiViews, Ltd. % John J. Smith, M.D., L.D. Regulatory Counsel Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC 20004

JUN 2 1 2011

Re: K110812

Trade/Device Name: CT-Guide Needle Guidance System Regulation Number: 21 CFR 892.1750 1 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 23, 2011 Received: March 23, 2011

Dear Dr. Smith:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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,

Mary Patil

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

KI10812 510(k) Number (if known):

Device Name: CT-Guide Needle Guidance System

Indications for Use:

The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).

The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.

Prescription Use × (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 In Vitro Diagnostic Devices (OIVD)

Macy S. Padlo

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Office of In Vitro

K110812
510K