CT-GUIDE NEEDLE GUIDANCE SYSTEM

K120300 · Activiews, Ltd. · JAK · Apr 13, 2012 · Radiology

Device Facts

• Record ID: K120300
• Device Name: CT-GUIDE NEEDLE GUIDANCE SYSTEM
• Applicant: Activiews, Ltd.
• Product Code: JAK · Radiology
• Decision Date: Apr 13, 2012
• 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 and liver, where CT is currently used for visualizing such procedures.

Device Story

Stereotactic accessory for CT systems; assists needle placement during lung and liver interventions. System components: ActiSensor (disposable video camera clipped to needle), ActiSticker (disposable pad with visual/radio-opaque markers), workstation with computer, and software. Inputs: visual data from ActiSensor and CT-based organ models. Operation: tracks interventional instrument relative to target organ using visual/radio-opaque markers; displays instrument position on monitor alongside CT model. Used in clinical settings by physicians to guide needle placement. Benefits: provides real-time visualization of instrument trajectory relative to target anatomy, potentially improving accuracy of interventional procedures.

Clinical Evidence

Prospective, multi-center clinical study conducted to evaluate safety and effectiveness for lung and liver indications. Results confirmed system is safe and effective for intended use. Bench testing performed on custom phantom setup to verify accuracy and performance against predefined specifications.

Technological Characteristics

System includes ActiSensor (disposable camera), ActiSticker (disposable marker pad), workstation, and software. Biocompatibility per ISO 10993-1. Electrical safety/EMC per IEC 60601-1 and IEC 60601-1-2. Stereotactic guidance principle using visual/radio-opaque markers.

Indications for Use

Indicated for use as a stereotactic accessory for CT systems to display interventional instruments and CT-based organ models during clinical interventions in the lung and liver.

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

• CT-Guide Needle Guidance System (K110812)
• CT-Guide Needle Guidance System (K113063)

Submission Summary (Full Text)

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APR 1 3 2012 -

## 510(k) SUMMARY ActiViews Ltd.'s CT-Guide Needle Guidance System

## 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: January 31, 2012

## 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

CT-Guide Needle Guidance System (K110812) CT-Guide Needle Guidance System (K113063)

#### Intended Use / Indications for Use

The CT-Guide is a sterectactic 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 and liver, 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

The CT-Guide Needle Guidance System was tested for its performance and accuracy through 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 10993-1. The CT-Guide System was tested for electromagnetic compatibility and electrical safety per IEC 60601-1 and IEC 60601-1-2.

Lastly, a prospective, multi-center clinical study was conducted with the CT-Guide System. The results demonstrate 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 System is safe and effective for lung and liver indications. The CT-Guide has the same intended use, technological characteristics, and principles of operation as its predicate device. Clinical data shows that the use of the system in the new indication for use does not raise any new questions of safety or effectiveness. Performance and clinical data demonstrate that the CT-Guide for a liver indication is as safe and effective as it is for a lung indication. Thus, the CT-Guide system for a liver indication is substantially equivalent to the existing CT-Guide system cleared for use in the lung.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

# 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

APR 1 3 2012

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

Re: K120300

Trade/Device Name: CT-Guide Needle Guidance System Regulation Number: CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 31, 2012 Received: January 31, 2012

## 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,

Janine M. Morris

Acting 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

K120300 510(k) Number (if known):

CT-Guide Needle Guidance System Device Name:

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 and liver, where CT is currently used for visualizing such procedures.

Prescription Use _ X

AND/OR

Over-The-Counter Use

(Per 21 C.F.R. 807 Subpart C)

(Per 21 C.F.R. 801.109).

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) (Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K120308

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