SONIXGPS VASCULAR ACCESS NEEDLE KIT

K120349 · Ultrasonix Medical Corpation · DRE · Apr 9, 2012 · Cardiovascular

Device Facts

• Record ID: K120349
• Device Name: SONIXGPS VASCULAR ACCESS NEEDLE KIT
• Applicant: Ultrasonix Medical Corpation
• Product Code: DRE · Cardiovascular
• Decision Date: Apr 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

The SonixGPS Vascular Access Needle Kit is a sterile, disposable kit used by physicians to facilitate vessel cannulation. The kit includes a stainless steel 304 vascular access needle, a sensor introducer, and a sterile cover. The device is designed to be used in conjunction with the SonixGPS Needle Sensor (K111818) and SonixGPS ultrasound systems (K093462, K102997). The needle sensor integrates with the ultrasound system to provide real-time needle guidance, allowing the physician to visualize the needle tip during the procedure. This guidance helps minimize the number of access attempts and reduces potential complications during vessel cannulation. The sterile cover acts as a barrier to prevent the transfer of microorganisms and fluids to the reusable sensor components. The system is intended for clinical use by trained medical professionals.

Clinical Evidence

No clinical data provided. Performance was validated through bench testing, including biocompatibility (ISO 10993), sterilization validation (ISO 11135), and mechanical testing (ISO 7864, ISO 9626, ASTM standards for packaging). Animal performance testing was conducted to confirm that the needle kit, needle sensor, and ultrasound scanners function together as an integrated system without impairing vessel cannulation or introducing new safety risks.

Technological Characteristics

Needle: Stainless steel 304 cannula, 17 Ga, bevel tip, plastic hub with luer lock. Kit includes sensor introducer and sterile cover. Compatible with 0.038" guidewires. Sterilization: Ethylene Oxide (ETO). Standards: ISO 10993 (biocompatibility), ISO 11135 (sterilization), ISO 7864/9626 (needles/tubing), ASTM F88/F1140/F1980/F2096 (packaging).

Indications for Use

Indicated for use by trained physicians to assist in vessel cannulation in patients requiring vascular access.

Regulatory Classification

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.

Predicate Devices

• Avalon Elite Vascular Access Kit (K081940)

Reference Devices

• SonixGPS Needle Sensor (K111818)
• SonixGPS ultrasound systems (K093462)
• SonixGPS ultrasound systems (K102997)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Email: [e-mail]

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 |
|------------------------------|---------------------------|--------------------------------|-------------------------------|
| Main<br>Needle | 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 or<br>intracutaneous reactivity | The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria. |
| ISO 10993-11 | Systemic toxicity<br>(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 on<br>validation of the<br>limulus amebocyte<br>lysate test as an<br>end-product<br>endotoxin test for<br>human and animal<br>parenteral drugs,<br>biological products,<br>and medical devices<br>(December 1987) | LAL Bacterial Endotoxins<br>Testing | 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 &<br>ISO 11607-2:2006 | Sterile Packaging<br>Validation | The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria. |
| ISO 11135-1:2007 | ETO Sterilization<br>Validation | The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria. |
| ISO 7864:1993 | Sterile Hydodermic<br>Needles for Single Use | The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria of the applicable sections. |
| ISO 9626:1991 | Stainless Steel Needle<br>Tubing for Manufacture<br>of Medical Devices | The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria of the applicable sections. |
| ASTM F1140-07 | Standard Test Methods<br>for Internal<br>Pressurization Failure<br>Resistance of<br>Unrestrained Packages. | The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria of the applicable sections. |
| ASTM F1980-07 | Standard Guide for<br>Accelerated Aging of<br>Sterile Barrier Systems<br>for Medical Devices. | The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria of the applicable sections. |
| ASTM F2096-04 | Standard Test Method<br>for Detecting Gross Leaks<br>in Medical Packaging by<br>Internal Pressurization<br>(Bubble Test) | The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria of the applicable sections. |
| ASTM F88-09/F88M-09 | Standard Test Method<br>for Seal Strength of<br>Flexible Barrier Materials | The SonixGPS™ Vascular Access Needle Kit met the acceptance criteria of the applicable sections. |
| EN 556-<br>1:2001+AC:2006 | Sterilization of medical devices - Requirements<br>for medical devices to be<br>designated ""STERILE"" -<br>Part 1: Requirements for<br>terminally sterilized<br>medical devices | The SonixGPS™ Vascular<br>Access Needle Kit met the<br>acceptance criteria of the<br>applicable sections. |
| AAMI TIR 28:2009 | Product adoption and<br>process equivalency for<br>ethylene oxide<br>sterilization | The SonixGPS™ Vascular<br>Access Needle Kit met the<br>acceptance criteria of the<br>applicable sections. |
| ISO 14971:2007 | ISO 14971:2007, Medical<br>devices - Application of<br>risk management to<br>medical devices. | The SonixGPS™ Vascular<br>Access Needle Kit met the<br>standard 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

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

### 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 [phone] or [phone] 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