SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT

K113680 · Soma Access Systems, LLC · IYO · Dec 29, 2011 · Radiology

Device Facts

• Record ID: K113680
• Device Name: SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT
• Applicant: Soma Access Systems, LLC
• Product Code: IYO · Radiology
• Decision Date: Dec 29, 2011
• 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.

Device Story

The ExactTrack™ I Procedure Kit is a disposable, sterile accessory system for ultrasound-guided procedures. It includes an 18-gauge stainless steel needle with an integrated magnet in the hub, a cable sleeve, elastic bands, and a snap-on top/bottom shield assembly for OEM ultrasound transducers. The system enables electromagnetic tracking of the needle relative to ultrasound image data. The physician attaches the shield assembly to the ultrasound transducer and uses the needle guide/lock to maintain alignment. The magnet in the needle hub is detected by external OEM electromagnetic sensor equipment. This tracking allows the physician to visualize the needle position in real-time relative to the ultrasound image, facilitating accurate needle placement during clinical procedures. The device is intended for use by physicians in clinical settings.

Clinical Evidence

Bench testing only. Testing included comparative analysis, biocompatibility, sterilization, and design verification to validate system operations and ensure conformance to requirements.

Technological Characteristics

18-gauge stainless steel needle with integrated magnet; snap-on plastic shield assembly for OEM ultrasound transducers; cable sleeve; elastic bands. Electromagnetic sensing principle. Sterile, disposable components. No software or electronic circuitry contained within the kit itself; relies on external OEM electromagnetic tracking equipment.

Indications for Use

Indicated for physicians requiring electromagnetic tracking of instruments relative to image data 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

• eTRAX Needle System, eTRAX Variable Angle Needle Guidance System, Virtutrax Universal Tracker (K092619)

Submission Summary (Full Text)

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### 510(k) Summary

#### 510(k) Summary for the Soma Access Systems ExactTrack™ 7 I Procedure Kit

The 510(k) Summary is provided on the following pages.

Section 7

Soma Access Systems LLC Soma Accocss Bystonio 220
ExactTrack™ I Procedure Kit Confidential

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K113680

DEC 2 9 2011

## 510(k) Summary

# Soma Access Systems ExactTrack™ I Procedure Kit

| 510(k) Summary | This summary of 510(k) safety and effectiveness information is<br>being submitted in accordance with the requirements of 21<br>C.F.R & 807.92. |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Soma Access Systems LLC |
| Submitter | Soma Access Systems LLC.<br>109 Laurens Road, Suite 4C<br>Greenville, SC 29607<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person | Genoa Atwood, Director of Quality |
| Date Prepared | August 30, 2011 |
| Device Trade Name<br>Device Common Name | Soma Access Systems ExactTrackTM I Procedure Kit<br>Ultrasonic pulsed echo imaging system |
| Classification Name | EMT Device, Product Code IYO |
| Classification Panel | Radiology |
| Predicate Devices | eTRAX Needle System, eTRAX Variable Angle Needle<br>Guidance System, Virtutrax Universal Tracker (K092619). |
| Intended use | The device is intended to provide physicians with tools for<br>electromagnetic tracking of instruments with respect to image<br>data. |
| Device Description | The Soma Access Systems ExactTrack™ I Procedure Kit<br>consists of five disposable, sterile components: (1)<br>needle/hub/magnet and needle protective sheath assembly, (2)<br>cable sleeve, (3) elastic bands, (4) top shield assembly, and (5)<br>bottom shield assembly. The needle/hub/magnet assembly<br>consists of the needle, hub, magnet, and needle protective<br>sheath. The needle is 18 gauge stainless steel and accepts a<br>standard guidewire; the hub is an industry standard configuration<br>modified to retain the magnet which is detected by OEM<br>equipment electromagnetic sensors; the needle sheath protects<br>the needle/hub/magnet during packaging and transportation.<br>The cable sleeve is attached at one end to the assembled top and<br>bottom shield by an elastic band and extends over the ultrasound<br>transducer cable to prevent the transducer cable from coming in<br>direct contact with the sterile field. The top and bottom shields'<br>configuration has been designed to snap together while fitting |
| | tightly over OEM transducers. The top and bottom shields<br>utilize a needle guide and needle lock during ultrasound<br>procedures. |
| Performance data | Bench testing was performed to support a determination of<br>substantial equivalence and consisted of comparative,<br>biocompatibility, sterilization, and design verification. Results<br>from this testing provide assurance that the proposed device has<br>been designed and tested to assure conformance to the<br>requirements for its intended use. A risk analysis for the<br>proposed device was performed, and testing was conducted to<br>validate the systems overall operations. |
| Summary of Substantial<br>Equivalence | The Soma Access Systems ExactTrack™ I Procedure Kit utilizes<br>substantially equivalent performance attributes and safety<br>components as the predicate device. It shares the following<br>similarities to the predicate devices:<br>Needle Guide Sterile Sheath Covering of transducer/transducer cable Needle Handle Assembly Needle technology Packaging Principle of Operation |
| Conclusion | Based on the identical indications for use, technological<br>characteristics and performance testing, Soma Access Systems<br>LLC believes the Soma Access Systems ExactTrack™ I<br>Procedure Kit is substantially equivalent to the eTRAX Needle<br>System, eTRAX Variable Angle Needle Guidance System,<br>Virtutrax Universal Tracker (K092619). |

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

### 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

DEC 2 9 2011

SOMA Access Systems LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K113680

Trade/Device Name: Soma Access Systems ExactTrackTM I Procedure Kit Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO & ITX Dated: December 14, 2011 Received: December 15, 2011

Dear Mr. Job:

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 medical device related adverse o viality systems (QS) regulation (21 CFR Part 820). This letter requirences as be form inrketing your device as described in your Section 510(k) premarket with anow you to begally maing of your device of your device to a legally marketed nonlicate 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 optice of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. The 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 Tou inay 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 Pastel

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 Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ Soma Access Systems ExactTrack™ I Procedure Kit

Indications for Use:

The Soma Access Systems ExactTrack™ I Procedure Kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) ಸ್ತ್ರ

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

May S. Potter

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

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

510(k) 5113680

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