SONIXGPS

K121812 · Ultrasonix Medical Corporation · BSP · Dec 2, 2013 · Anesthesiology

Device Facts

• Record ID: K121812
• Device Name: SONIXGPS
• Applicant: Ultrasonix Medical Corporation
• Product Code: BSP · Anesthesiology
• Decision Date: Dec 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SonixGPS Nerve Block Needle Kit is intended for use in regional anesthesia and pain therapy by a trained physician, to target peripheral nerves by visualization at the needle tip using an ultrasound imaging device. The needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures.

Device Story

The SonixGPS Nerve Block Needle Kit facilitates needle tip visualization during ultrasound-guided regional anesthesia. The system integrates a needle with an ultrasound imaging device to allow physicians to track the needle tip in real-time. By providing enhanced visualization of the needle tip relative to the targeted nerve bundle, the device assists the clinician in accurately placing local anesthesia or analgesics. Used in clinical settings by physicians, the device aims to improve the precision of nerve blocks, potentially reducing procedure time and complications associated with needle placement.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

The device consists of a needle kit designed for ultrasound-guided procedures. It utilizes electromagnetic or similar tracking technology to provide needle tip visualization on an ultrasound display. The system is designed for use with compatible ultrasound imaging equipment. Materials are standard medical-grade components for anesthesia needles. Sterilization is performed via standard methods.

Indications for Use

Indicated for use by trained physicians for regional anesthesia and pain therapy, specifically for targeting peripheral nerves to inject local anesthesia or analgesics for surgical procedures.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

• SonixGPS (K113566)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

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

December 2, 2013

Ultrasonix Medical Corporation C/O Mr. Raymond Kelly Licensale Incorporated 57 Lazy Brook Road Monroe, CT 06468

Re: K121812

Trade/Device Name: SonixGPS Nerve Block Needle Kit Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: November 21, 2013 Received: November 26, 2013

Dear Mr. Kelly:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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,

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Page 2 - Mr. Kelly

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportalProblem/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ErinFDXAith

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): K121812

SonixGPS Nerve Block Needle Kit Device Name:

Indications for Use:

The SonixGPS Nerve Block Needle Kit is intended for use in regional anesthesia and pain therapy by a trained physician, to target peripheral nerves by visualization at the needle tip using an ultrasound imaging device. The needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nayan Patel
2013.12.02 11:37:59 -05'00'