SONIXGPS NEEDLE SENSOR

K111818 · Ultrasonix Medical Corporation · IYO · Jun 13, 2012 · Radiology

Device Facts

• Record ID: K111818
• Device Name: SONIXGPS NEEDLE SENSOR
• Applicant: Ultrasonix Medical Corporation
• Product Code: IYO · Radiology
• Decision Date: Jun 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The device is available in two models 0.55mm and 0.9mm in diameter.

Device Story

SonixGPS™ Needle Sensor is an electromagnetic tracking device used in hospital settings by physicians. It consists of a sensor head containing coils, a cable, and a connector. The device is placed inside a tracked instrument and operates within an electromagnetic field to detect the instrument's real-time position and orientation. This spatial data is integrated with ultrasound imaging to assist in navigating instruments through delicate anatomy to a target center. By monitoring the instrument's trajectory, the device enables precise placement during procedures. The output is visualized by the physician to guide clinical decision-making, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Accuracy performance was verified using the Sonix 3D Motion Tracking protocol, comparing the 0.9mm and 0.55mm sensors against the predicate device. Results demonstrated equivalent performance meeting all defined accuracy criteria. Biocompatibility was confirmed per ISO 10993-1:2009, and electrical safety/EMC testing met EN 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Electromagnetic sensor assembly comprising a sensor head (polyimide tubing with internal coils), medical-grade PVC cable, and metal shell connector. Dimensions: 0.55mm or 0.9mm diameter; 96.8mm or 110.0mm length. Operates via electromagnetic field tracking. Non-sterile, reusable device. Complies with EN 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for use by physicians to provide electromagnetic tracking of instruments relative to image data during clinical procedures. Available in 0.55mm and 0.9mm diameters.

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

• Electromagnetic Tracking System (K092619)

Submission Summary (Full Text)

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K111818

JUN 1 3 2012

510(k) Summary (per 21 CFR 807.92)

#### l, Applicant

Ultrasonix Medical Corporation 130 - 4311 Viking Way Richmond, B.C. Canada V6V 2K9

Contact Person: Chas Yu, Quality Assurance Manager Tel: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: February 28, 2011

#### ll. Device Name

SonixGPS™ Needie Sensor Proprietary Name:

Ultrasonic pulsed echo imaging system Classification Name:

IYO Product Codes:

Classification Regulation: 21 CFR 892.1560

Classification Panel: Radiology

#### (11. Predicate Device

The SonixGPS™ Needle Sensor is substantially equivalent to K092619 -Electromagnetic Tracking System.

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#### IV. Description of the Device -

The SonixGPS™ Needle Sensor is an electromagnetic sensor that is placed inside a tracked instrument and used within an electromagnetic field. The position and orientation can be detected and combined with the acquired imaging to assist with navigation of the tracked instrument. The needle sensor allows physicians the precise placement of instruments during each procedure by monitoring the real-time trajectory of the instrument as it advances through delicate anatomy to the center of a target.

The needle sensor consists of a sensor head, cable and a connector:

Connector is a positive latching, user-removable interconnect that conducts sensor data from the Cable to the electronics unit.

Cable is the wiring harness for the sensor that conducts sensor data from the Sensor Head to the Connector.

Sensor Head contains a set of coils that make up the measuring element of the sensor assembly.

#### V. Indications for Use of the Device

The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The device is available in two models 0.55mm and 0.9mm in diameter.

#### Technological Characteristics VI.

The SonixGPS "" Needle Sensor has similar construction, manufacturing materials, operating principals and specifications as the predicate device.

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Image /page/2/Picture/0 description: The image shows a logo with the word "ULTRASONIX" in bold, sans-serif font. The word is horizontally centered and flanked by a circular pattern of dots on either side. The dots are arranged in concentric circles, with the density of dots decreasing as the circles expand outward from the center.

| | Table 1 – Technological Similarities and Differences |
|--|------------------------------------------------------|

| Product Name | SonixGPS™ Needle Sensor | Electromagnetic Tracking System |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k).Number | - | K092619 |
| Product Code(s) | IYO | IYO |
| Regulation # | 21 CFR 892.1560 | 21 CFR 892.1560 |
| Class | II | II |
| Intended Use | The SonixGPS™ Needle Sensor is<br>intended to provide physicians<br>with tools for electromagnetic<br>tracking of instruments with<br>respect to image data. | The device is intended to provide<br>physicians with tools for<br>electromagnetic tracking of<br>instruments with respect to<br>image data. |
| Diameter(s) | 0.9 mm and 0.55mm | 0.9mm |
| Length | 96.8mm and 110.0mm | 177.8mm |
| Connector<br>(Between Needle<br>Sensor and<br>Accessory) | Luer Lock | Clip on |
| Cable | 3.8mm OD cable<br>medical grade PVC<br>metal shell connector | same |
| Connector<br>(Between Needle<br>Sensor and control<br>unit) | metal shell connector | same |
| Sensor Head | polyimide tubing | same |
| Intended User | Physician | same |
| Where Used | Hospital | same |
| Duration of Use | ≤24h | same |
| Number of Uses | Reusable | same |
| Sterility | Non-Sterile | same |

The additional smaller sensor diameter, difference in sensor length and connection type compared to the predicate device does not affect performance and functionality.

・

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Image /page/3/Picture/0 description: The image shows the word "ULTRASONIX" in a bold, sans-serif font. The word is surrounded by three concentric circles made of dots. The dots are evenly spaced and increase in size as they move outward from the center.

#### VII. Brief Description of Non-clinical Data

## Performance Testing

The following performance test used the same ultrasound system and setup to perform the accuracy test for SonixGPS™ 0.9mm Needle Sensor, SonixGPS™ 0.55mm Needle Sensor and the predicate device.

| Test Type | Test Plan | Result |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System<br>Accuracy | Based on needle sensor accuracy<br>performance protocol; Sonix 3D Motion<br>Tracking (SonixGPS'") Verification<br>Protocol and Report | The SonixGPS™<br>0.9mm Needle<br>Sensor and<br>The SonixGPS™<br>0.55mm Needle<br>Sensor demonstrated<br>equivalent<br>performance which<br>met the defined<br>criteria. |

The subject devices met the same defined accuracy criteria as the predicate device. The technological differences did not affect the performance of the subject in comparison to the predicate device.

## Standards Testing

| Applicable Standard or Test<br>Performed | Result |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| EN 60601-1 (2nd Edition, 1988)<br>Electrical Safety Testing | The SonixGPS™ Needle Sensor met<br>the acceptance criteria. |
| IEC 60601-1-2 (2.1 Edition;<br>2001+A1:2004) Electromagnetic<br>compatibility testing | The SonixGPS™ Needle Sensor met<br>the acceptance criteria. |
| ISO 10993-1:2009 Biological<br>evaluation of medical devices | The SonixGPS™ Needle Sensor met<br>the biocompatibility requirements. |

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Image /page/4/Figure/0 description: The image shows the word "ULTRASONIX" in a bold, sans-serif font. The word is surrounded by three concentric circles made of dots. The dots are evenly spaced and create a visual effect of radiating outward from the center.

#### VIII. Conclusion

Ultrasonix Medical Corporation claims the SonixGPS™ Needle Sensor to be substantially equivalent to the predicate device K092619 - Electromagnetic Tracking System, as the SonixGPS™ Needle Sensor has equivalent intended uses, manufacturing materials, operating principles, physical specifications and performance as compared to the predicate device.

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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. 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

JUN 1 3 2012

Ultrasonix Medical Corporation % Mr. William J. Sammons Senior Project Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087

Re: K111818

Trade/Device Name: SonixGPSTM Needle Sensor Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: June 7, 2012 Received: June 8, 2012

Dear Mr. Sammons:

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 r that FDA has made a determination that your device complies with other requirements of the Act that I Drinas intatutes and regulations administered by other Federal agencies. You must or any 1 vith 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 Form

510(k) Number (if known): _

Device Name: SonixGPS™ Needle Sensor

Indications for Use:

The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The device is available in two models 0.55mm and 0.9mm in diameter.

X Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111818

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