INVISION SYSTEM

K083728 · Inneroptic Technology, Inc. · IYO · Aug 12, 2009 · Radiology

Device Facts

• Record ID: K083728
• Device Name: INVISION SYSTEM
• Applicant: Inneroptic Technology, Inc.
• Product Code: IYO · Radiology
• Decision Date: Aug 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The InVision System is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.

Device Story

InVision System is an ultrasound accessory for needle guidance. Inputs: passive infrared tracking data from mounts on ultrasound transducer and needle. Processing: custom software calculates needle position and predicted path relative to ultrasound image. Output: real-time stereoscopic overlay of needle and path on B-scan ultrasound display via stereoscopic monitor and passive glasses. Used in clinical settings by physicians to improve needle placement accuracy during interventional procedures. Benefits: enhanced visualization of needle trajectory relative to anatomical targets, potentially increasing procedural precision.

Clinical Evidence

Bench testing only. Studies evaluated performance characteristics, confirming the system's ability to safely and accurately perform needle guidance and path prediction. Results demonstrated effectiveness similar to the Ultraguide 1000 predicate.

Technological Characteristics

Consists of passive infrared position tracking system, tracking mounts for transducer/needle, custom guidance software, and stereoscopic monitor with passive glasses. Provides real-time 3D overlay of needle path on standard ultrasound B-scan images.

Indications for Use

Indicated for enhancing ultrasonic visualization and path prediction of interventional needles (biopsy, aspiration, ablation) during ultrasound-guided procedures.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Ultraguide 1000 (K974432)
• IG4 Image Guided System (K060903)
• Linasys Image-Guided Liver Surgery System (K071063)
• Karl Storz 3D Video System (K001362)

Submission Summary (Full Text)

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K0837228

InVision System

510k Premarket Application

# AUG 1 2 2009

## Section 5: 510(k) Summary

Submitted by:

InnerOptic Technology, Inc

Contact:

Caroline K. Green Quality and Regulatory Manager 106-A N. Churton St. Chapel Hill, NC 27278 Ph. 919-722-2090 Fax. [phone] Email: [e-mail]

Date of Submission: December 15, 2008 Proprietary Name: InVision System Common Name: Ultrasonic pulsed echo imaging system Class II per 21 CFR 892.1560 Regulatory Class: IYO: system, imaging, pulsed echo, ultrasonic Product Codes: OEW: tracking, soft tissue, intraoperative

Device Description: The InVision System is an accessory to ultrasound systems that provides guidance for the placement of needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters).

The InVision System consists of four (4) principal components:

- a passive infrared position tracking system; (1)
- (2) tracking mounts for the ultrasound transducer and the needle;
- custom guidance software installed on a computer; and (3)
- (4) a stereoscopic monitor with passive glasses for viewing the monitor.

Intended Use: The InVision System is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a

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stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.

Technological characteristics, comparison to predicate device: The technological charactcristics and indications for use of the InVision System are the same or similar to those found in the predicate devices. The InVision System is substantially equivalent to the following FDA cleared guidance systems:

| System Name | Product<br>Code | 510(k) Approval Number |
|----------------------------------------------|--------------------------------------------------|------------------------|
| Ultraguide 1000 | IYO: system, imaging,<br>pulsed echo, ultrasonic | K974432 |
| IG4 Image Guided System | JAK: system, x-ray,<br>tomography, computed | K060903 |
| Linasys Image-Guided Liver Surgery<br>System | OEW: tracking, soft<br>tissue, intraoperative | K071063 |
| Karl Storz 3D Video System | GCI: laryngoscope,<br>endoscope | K001362 |

The device labeling contains instructions for use, including indications for use, cautions, contraindications, warnings and planning guidance. This information assures safe and effective use of this device.

Discussion of performance testing: Bench tests were conducted to evaluate the performance characteristics of the InVision System. The results of these studies demonstrate that the InVision System is capable of safely and accurately performing the stated intended use. The results also show similar effectiveness to the Ultraguide 1000 predicate device (K974432).

Conclusion: The InVision System is equivalent to the predicate devices in safety and effectiveness.

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

## AUG 1 2 2009

Ms. Caroline Green Quality & Regulatory Manager InnerOptic Technology, Inc. 106-A North Churton Street HILLSBOROUGH NC 27278

Re: K083728

Trade/Device Name: InVision System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: July 10, 2009 Received: July 16, 2009

#### Dear Ms. Green;

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. Ilsting 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/CDRHOffices/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 (21 CFR Part 803), please go to http://www.fda.gov/cdrh/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,

Lammy M. Morsel

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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### Section 4: Indications for Use Statement

510(k) Number: Device Name:

InVision System

### Indications for Use:

The InVision System is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for -predicting its future path on a stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.

Prescription Use __ X (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)

Page 1 of

InnerOptic Technology, Inc. December 15, 2008

Aopith thay

on Sign-Off on of Reproductive, Abdominal, and Radiological Devices

510(k) Number.