The SonixGPS™ Vascular Access Needle Kit includes: Vascular Access Needle: Disposable sterile vascular access needle Sensor Introducer: Disposable sterile sensor introducer into which the needle sensor (K111818) is inserted Cover: Disposable sterile cover provides a barrier to prevent transfer of microorganisms, body fluids and' particulate material to the reusable component.

AI/ML Overview

The SonixGPS™ Vascular Access Needle Kit underwent performance testing to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Applicable Standard	Test	Acceptance Criteria Met?
ISO 10993-5:2009	Cytotoxicity	Yes
ISO 10993-7:2008	Ethylene Oxide Sterilization Residuals	Yes
ISO 10993-10:2009	Sensitization	Yes
ISO 10993-10:2010	Irritation or intracutaneous reactivity	Yes
ISO 10993-11	Systemic toxicity (acute)	Yes
ASTM F756-08	Hemolysis	Yes
FDA guideline on	LAL Bacterial Endotoxins Testing	Yes
USP 33:2010 <85>	Bacterial Endotoxins Test	Yes
ISO 11607-1:2006 &	Sterile Packaging Validation	Yes
ISO 11607-2:2006
ISO 11135-1:2007	ETO Sterilization Validation	Yes
ISO 7864:1993	Sterile Hypodermic Needles for Single Use	Yes
ISO 9626:1991	Stainless Steel Needle Tubing for	Yes
ASTM F1140-07	Standard Test Methods for Internal	Yes
ASTM F1980-07	Standard Guide for Accelerated Aging of	Yes
ASTM F2096-04	Standard Test Method for Detecting Gross	Yes
ASTM F88-09/F88M-09	Standard Test Method for Seal Strength of	Yes
EN 556-1:2001+AC:2006	Sterilization of medical devices -	Yes
AAMI TIR 28:2009	Product adoption and process equivalency	Yes
ISO 14971:2007	Medical devices - Application of risk	Yes

2. Sample Size Used for the Test Set and Data Provenance

The document details performance testing for various aspects (biocompatibility, sterilization, packaging, mechanical) but does not specify the exact sample sizes for each test in the provided text. The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond "Animal performance testing was conducted."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the specific performance tests listed. These tests are primarily laboratory and standardized evaluations against pre-defined criteria.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method as it applies to human interpretation or decision-making on a test set. The performance tests are objective evaluations against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or mentioned in the provided text. The device is a physical medical kit (needle, sensor introducer, cover), not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study

The performance testing listed (biocompatibility, LAL, packaging, sterilization, mechanical) can be considered "standalone" in that they evaluate the device itself against established criteria, without requiring human interaction or interpretation beyond conducting the test and recording results. However, the animal performance testing was conducted to demonstrate the combined function of the SonixGPS™ Vascular Access Needle Kit with the Sonix Ultrasound Scanners and SonixGPS™ Needle Sensor. This implies an evaluation of the system as a whole, rather than the needle kit in strict isolation, in a functional setting.

7. Type of Ground Truth Used

For the various performance tests (biocompatibility, sterilization, packaging, mechanical), the ground truth is established by the specified international standards and guidelines (e.g., ISO, ASTM, USP, FDA guidelines). For the "Animal performance testing," the ground truth was the observable function of the device in assisting vessel cannulation without impairing the function or raising new safety/effectiveness concerns.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or machine learning. The device is a physical medical device kit and not an AI or software product that would typically undergo training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for this device.

Summary

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K120349
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APR - 9 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: 604-279-8550 Fax: 604-279-8552 Email: chas.yu@ultrasonix.com

Date Prepared: February 28, 2011

II. Device Name

SonixGPS™ Vascular Access Needle Kit Proprietary Name:

Classification Name: Vessel dilator for percutaneous catheterization

DRE Product Codes:

Classification Regulation: 21 CFR 870.1310

Classification Panel: Cardiovascular

lll. Predicate Device

The SonixGPS™ Vascular Access Needle Kit is substantially equivalent to K081940 - Avalon Elite Vascular Access Kit.

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Description of the Device IV.

The SonixGPS™ Vascular Access Needle Kit includes:

Vascular Access Needle: Disposable sterile vascular access needle

Sensor Introducer:

Disposable sterile sensor introducer into which the needle sensor (K111818) is inserted

Cover:

Disposable sterile cover provides a barrier to prevent transfer of microorganisms, body fluids and' particulate material to the reusable component.

V. Indications for Use of the Device

The device is intended for use by a trained physician in conjunction with the SonixGPS Needle Sensor to assist in vessel cannulation.

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VI. Technological Characteristics

The SonixGPS™ Vascular Access Needle Kit has a similar vascular access needle as the predicate needle in terms of the materials, construction, tip configuration and needle hub. It also provides the same capability to accommodate standard 0.038" size guide wires. The difference in gauge of the SonixGPS™ Vascular Access Needle Kit does not affect function, performance or Intended Use, as compared to predicate device.

The SonixGPS™ Vascular Access Needle is to be used in conjunction with the SonixGPS™ needle sensor (K111818) and theSonixGPS™ ultrasound systems (K093462 and K102997) to provide real-time needle guidance which limits complications and minimizes the number of vessel access attempts.

		SonixGPS Vascular Access Kit	Avalon Elite Kit
MainNeedle	Needle - Cannula Material	Stainless Steel 304 Cannula	same
	Needle - Cannual Diameter	Ga 17	Ga 18
	Needle - Hub	Plastic with Luer lock feature	same
	Needle - Tip	Bevel Tip	same
	Sensor Introducer	Included in Subject kit	Not included in predicate kit
	Cover	Included in Subject kit	Not included in predicate kit
Accessory - Dilator		Not Included in subject Kit	Included in Predicate kit
Accessory - 0.038" Guidewire		Not Included in subject Kit	Included in Predicate kit
Accessory - Scalpel		Not Included in subject Kit	Included in Predicate kit
Accessory - Syringe		Not Included in subject Kit	Included in Predicate kit

Table 1 – Technological Similarities and Differences

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VII. Performance Testing

SonixGPS™ Vascular Access Needle Kit Underwent the following validation testing:

. Biocompatibility
. LAL Bacterial Endotoxins
. Packaging integrity
Sterilization validation .
Mechanical .

Applicable Standard	Test	Result
ISO 10993-5:2009	Cytotoxicity	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria.
ISO 10993-7:2008	Ethylene Oxide Sterilization Residuals	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria.
ISO 10993-10:2009	Sensitization	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria.
ISO 10993-10:2010	Irritation orintracutaneous reactivity	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria.
ISO 10993-11	Systemic toxicity(acute)	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria.
ASTM F756-08	Hemolysis	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria.
FDA guideline onvalidation of thelimulus amebocytelysate test as anend-productendotoxin test forhuman and animalparenteral drugs,biological products,and medical devices(December 1987)	LAL Bacterial EndotoxinsTesting	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria.
Applicable Standard	Test	Result
USP 33:2010 <85>	Bacterial Endotoxins Test	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria.
ISO 11607-1:2006 &ISO 11607-2:2006	Sterile PackagingValidation	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria.
ISO 11135-1:2007	ETO SterilizationValidation	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria.
ISO 7864:1993	Sterile HydodermicNeedles for Single Use	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria of the applicable sections.
ISO 9626:1991	Stainless Steel NeedleTubing for Manufactureof Medical Devices	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria of the applicable sections.
ASTM F1140-07	Standard Test Methodsfor InternalPressurization FailureResistance ofUnrestrained Packages.	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria of the applicable sections.
ASTM F1980-07	Standard Guide forAccelerated Aging ofSterile Barrier Systemsfor Medical Devices.	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria of the applicable sections.
ASTM F2096-04	Standard Test Methodfor Detecting Gross Leaksin Medical Packaging byInternal Pressurization(Bubble Test)	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria of the applicable sections.
ASTM F88-09/F88M-09	Standard Test Methodfor Seal Strength ofFlexible Barrier Materials	The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria of the applicable sections.
EN 556-1:2001+AC:2006	Sterilization of medical devices - Requirementsfor medical devices to bedesignated ""STERILE"" -Part 1: Requirements forterminally sterilizedmedical devices	The SonixGPS™ VascularAccess Needle Kit met theacceptance criteria of theapplicable sections.
AAMI TIR 28:2009	Product adoption andprocess equivalency forethylene oxidesterilization	The SonixGPS™ VascularAccess Needle Kit met theacceptance criteria of theapplicable sections.
ISO 14971:2007	ISO 14971:2007, Medicaldevices - Application ofrisk management tomedical devices.	The SonixGPS™ VascularAccess Needle Kit met thestandard requirements.

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VIII. Performance Testing - Animal

Animal performance testing was conducted to demonstrate that SonixGPS™ Vascular Access Needle Kit, Sonix Ultrasound Scanners (K093462 and K102997) and the SonixGPS™ Needle Sensor (K111818) function together without impairing the vessel cannulation function or raising new concerns of safety/effectiveness.

IX. Conclusion

Ultrasonix Medical Corporation claims the SonixGPS™ Vascular Access Needle Kit to be substantially equivalent to the predicate device K081940 -Avalon Elite Vascular Access Kit, as the SonixGPS™ Vascular Access Needle Kit has equivalent intended uses, manufacturing materials, operating principles, physical, and operational specifications as compared to the predicate device.

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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 Room -WO66-G609 Silver Spring, MD 20993-0002

Ultrasonix Medical Corporation c/o Ms. Paula Wilkerson Responsible Third Party Official Intertek Testing Services 2307 E. Aurora Road, Unit B7 Twinsburg, OH 44087

APR - 9 2012

Re: K120349

Trade/Device Name: SonixGPSTM Vascular Access Needle Kit Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: Class II Product Code: DRE Dated: March 12, 2012 Received: March 14, 2012

Dear Ms. Wilkerson:

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.

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

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Page 2 - Ms. Paula Wilkerson

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 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M. A. Killehein

Bram D. Zuckerman, M.D. Director . Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Device Name: SonixGPS™ Vascular Access Needle Kit

Indications For Use:

The device is intended for use by a trained physician in conjunction with the SonixGPS Needle Sensor to assist in vessel cannulation.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Page 1 of

M.A. Hillehan

(Division Sign-Off) (Division Sign of Cardiovascular Devices

510(k) Number K120349

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).