AIM

K121479 · Inneroptic Technology, Inc. · IYO · Sep 13, 2012 · Radiology

Device Facts

• Record ID: K121479
• Device Name: AIM
• Applicant: Inneroptic Technology, Inc.
• Product Code: IYO · Radiology
• Decision Date: Sep 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

AM 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

AIM is an ultrasound accessory for needle guidance. Inputs: electromagnetic tracking data from sensors mounted on ultrasound transducer and needle; B-scan ultrasound images. Operation: system overlays needle image and predicted path onto ultrasound display in real-time; stereoscopic monitor provides 3D visualization. Used in clinical settings by physicians. Output: visual guidance on stereoscopic monitor. Benefit: improved accuracy and success rate for needle placement during interventional procedures.

Clinical Evidence

Bench testing only. Study conducted using novice users performing needle placement in tumor mimics within agar phantom gels. Comparison: guidance with AIM vs. without AIM at 0-degree and 90-degree approach angles. Results: 92% success rate with AIM guidance vs. 8% without. Data demonstrates safety and effectiveness equivalent to predicate.

Technological Characteristics

System includes electromagnetic position tracking, tracking sensors/mounts, custom guidance software, and stereoscopic monitor with passive glasses. Operates as an accessory to ultrasound imaging systems. Connectivity: integrates with ultrasound B-scan displays. Software-based guidance.

Indications for Use

Indicated for patients undergoing ultrasound-guided interventional procedures requiring needle or needle-like rigid device placement (e.g., biopsy, aspiration, ablation).

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

• InVision System (K083728)

Submission Summary (Full Text)

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510k Premarket Application

1 3 2012

# Section 5: 510(k) Summary

Submitted by:

InnerOptic Technology, Inc

Contact:

Caroline K. Green Ouality and Regulatory Manager 106-A N. Churton St. Chapel Hill, NC 27278 Ph. 919-732-2090 Email: [e-mail]

Date Summary Prepared: 005/17/2012

| Proprietary Name: | AIM |
|-------------------|-----------------------------------------------|
| Common Name: | Ultrasonic pulsed echo imaging system |
| Regulatory Class: | Class II per 21 CFR 892.1560 |
| Product Codes: | IYO: system, imaging, pulsed echo, ultrasonic |
| | OEW: tracking, soft tissue, intraoperative |

Device Description: AM is an accessory to ultrasound systems that provides guidance for the placement of needles or 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).

AIM consists of four (4) principal components:

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

Intended Use: AM is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an

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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.

Technological characteristics, comparison to predicate device: The technological characteristics and indications for use of AIM are the same or similar to those found in the predicate device. AM is substantially equivalent to InnerOptic's InVision System cleared in K083728.

The AIM 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: Testing was conducted to evaluate the performance characteristics of AIM. A novice user made placement attempts in tumor mimics within agar phantom gels, both with and without AlM's guidance, at two different angles of approach - 0 degrees ("in plane"), and 90 degrees ("out of plane"). The novice's success rate with AIM's guidance was 92%, and without it was 8%. The results of these studies demonstrate that AM is capable of safely and accurately performing the stated intended use. The results also show similar effectiveness to AIM's predicate device, the InVision System (K083728).

Conclusion: AnM is equivalent to the predicate device in safety and effectiveness.

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## 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

SEP 13 2012

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

Re: K121479

Trade/Device Name: AIM Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and OEW Dated: August 15, 2012 Received: August 20, 2012

Dear Ms. Green:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your Section 9 ro(x) premise is substantially equivalent (for the indications relerenced above and nave decembined we as a comments marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce proc to May 26, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been reclassified in above approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require apple of the general controls provisions of the Act. The You may, uleretore, market me device, sanyon to use no use ments for annual registration, listing of general controls provisionis of the fiel 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 If your device is classified (sec above) into exase ff (St your device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Oode of Poucharies concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a succemines with other requirements of the Act
that FDA has made a determination that your device complies with other requirements o that FDA has made a decemmanon that your correct by other Federal agencies. You must or any Federal statutes and regulations adminities to: registration and listing (21)
comply with all the Act's requirements, including, but not any any a many of comply with an the Act 3 requirements, incruding, or 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 with anow you to begal mading 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 11 you don't 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 I va may 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

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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## Section 4: Indications for Use Statement

510(k) Number: AIM Device Name:

#### Indications for Use:

AM 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 (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)

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(**Division Sign-Off**)
Division of Radiological Devices

. I Ok

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