Site-Rite 6 Ultrasound System with Pinpoint GT Technology

K142443 · C.R. Bard, Inc. · IYO · Oct 30, 2014 · Radiology

Device Facts

• Record ID: K142443
• Device Name: Site-Rite 6 Ultrasound System with Pinpoint GT Technology
• Applicant: C.R. Bard, Inc.
• Product Code: IYO · Radiology
• Decision Date: Oct 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed. Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

Device Story

Portable ultrasound system for bedside vascular access; used in ICU, ER, OR, and catheterization labs. System utilizes piezoelectric transducer to transmit/receive sound waves for 2D imaging. Pinpoint™ GT Technology adds passive magnetic tracking: sensors in probe detect magnetic field from needle; software processes sensor data to overlay virtual needle trajectory onto ultrasound display. Clinicians view real-time needle position relative to anatomy to guide insertion. Benefits include improved accuracy and safety during needle/catheter placement.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed performance against predetermined requirements. Standards applied include IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound performance), IEC 62304 (software lifecycle), and ISO 10993-1 (biocompatibility).

Technological Characteristics

Portable ultrasound system; piezoelectric transducer (64 element linear probe). Passive magnetic tracking technology. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-6, IEC 62304, IEC 62366, ISO 10993-1. Software-based image processing and needle tracking.

Indications for Use

Indicated for ultrasound-guided needle and catheter placement in vascular structures (intraoperative or percutaneous) and diagnostic ultrasound imaging of vascular structures, organs, and body structures in patients requiring such 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

• Site~Rite® 6 Ultrasound System (K071204)

Reference Devices

• Site~Rite Vision® II Ultrasound System (K132942)
• GE LOGIQ E9 (K092271)
• Electromagnetic Tracking System (VirtuTRAX) (K092619)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines above them.

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

October 30, 2014

C.R. Bard, Inc. Bard Access Systems. Inc. % Ms. Kerrie Hamblin Regulatory Affairs Project Manager 605 North 5600 West SALT LAKE CITY UT 84116

Re: K142443

Trade/Device Name: Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: August 29, 2014 Received: September 2, 2014

Dear Ms. Hamblin:

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.

This determination of substantial equivalence applies to the following transducers intended for use with the Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology, as described in your premarket notification:

# Transducer Model Number

# Pinpoint™ GT 20 mm 64 Element Linear Probe

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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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/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 yours,

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for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K142443

Device Name

Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology

Indications for Use (Describe)

The Site® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.

Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

| | | Type of Use (Select one or both, as applicable) | |
|--|--|-------------------------------------------------|--|
| | | | |

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Diagnostic Ultrasound Indication for Use

#### Ultrasound System: Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology (Ultrasound without transducer)

| Clinical<br>Applications | A | B | M | PWD | CWD | Mode of Operation | | | Combined<br>(specify) | Other<br>(specify) |
|-------------------------------------------------------------------------|---|---|---|-----|-----|-------------------|----------------------|---------------------------|-----------------------|--------------------|
| | | | | | | Color<br>Doppler | Amplitude<br>Doppler | Color Velocity<br>Imaging | | |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | | | | | |
| Intraoperative<br>(epiaortic scanning) | | P | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(breast, testes, thyroid, etc.) | | P | | | | | | | | |
| Neonatal<br>Cephalic | | P | | | | | | | | N [1] |
| Adult Cephalic | | P | | | | | | | | N [1] |
| Cardiac | | P | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transeurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>Vascular | | P | | | | | | | | N [1] |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | P | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | | |
| Notes: [1] Needle Guidance Imaging | | | | | | | | | | |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

(Please do not write below this line – Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K142443

Prescription Use (per 21 CFR 801.109

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# Diagnostic Ultrasound Indication for Use

#### Ultrasound System: Site~Rite 6 Ultrasound System with Pinpoint™ GT Technology Transducer: Pinpoint™ GT 20 mm 64 Element Linear Probe

| Clinical Applications | A | B | M | PWD | CWD | Mode of Operation | | | | Other<br>(specify) |
|-------------------------------------------------------------------------|---|---|---|-----|-----|-------------------|-------------------|------------------------|-----------------------|--------------------|
| | | | | | | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined<br>(specify) | |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | | | | | |
| Intraoperative<br>(epiaortic<br>scanning) | | P | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(breast, testes,<br>thyroid, etc.) | | P | | | | | | | | |
| Neonatal<br>Cephalic | | P | | | | | | | | N [1] |
| Adult Cephalic | | P | | | | | | | | N [1] |
| Cardiac | | P | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transeurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>Vascular | | P | | | | | | | | N [1] |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | P | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | | |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Notes: [1] Needle Guidance Imaging (Please do not write below this line – Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K142443

Prescription Use (per 21 CFR 801.109

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# 510(k) Summary
21 CFR 807.92

| General Provisions: | Submitter Name: | Bard Access Systems, Inc. |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| | Contact Person: | Kerrie Hamblin<br>Regulatory Affairs Project Manager<br>Bard Access Systems, Inc.<br>[e-mail]<br>801-522-5000 ext. 4909<br>801-522-5425 fax |
| | Date of Preparation: | 29 August 2014 |
| Subject Devices: | Trade Names: | Site-Rite® 6 Ultrasound System with Pinpoint™ GT<br>Technology |
| | Classification<br>Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging<br>System<br>ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer |
| | Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,<br>Ultrasonic<br>ITX, 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic |
| Primary<br>Predicate<br>Device: | Trade Name: | Site-Rite® 6 Ultrasound System |
| | Classification<br>Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging<br>System<br>ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer |
| | Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,<br>Ultrasonic<br>ITX, 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic |
| | Premarket<br>Notification: | K071204, concurrence, 18 May 2007 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Reference<br>Devices: | Trade Name: | Site-Rite Vision® II Ultrasound System |
| | Classification<br>Name: | IYN, CFR 892.1550, Ultrasonic Pulsed Doppler Imaging<br>System<br>IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging<br>System |
| | LLZ, 21 CFR 892.2050, Picture Archiving and<br>Communications System | |
| Common Name: | IYN, CFR 892.1550, System, Imaging, Pulsed Doppler,<br>Ultrasonic<br>IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,<br>Ultrasonic<br>ITX, 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic<br>LLZ, 21 CFR 892.2050, System, Image Processing,<br>Radiological | |
| Premarket<br>Notification: | K132942, concurrence, 17 October 2013 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Trade Name: | GE LOGIQ E9 | |
| Classification<br>Name: | IYN, CFR 892.1550, Ultrasonic Pulsed Doppler Imaging<br>System<br>IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging<br>System<br>ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | |
| Common Name: | IYN, CFR 892.1550, System, Imaging, Pulsed Doppler,<br>Ultrasonic<br>IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,<br>Ultrasonic<br>ITX, 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic | |
| Premarket<br>Notification: | K092271, concurrence, 17 November 2009 | |
| Manufacturer: | GE Healthcare | |
| Trade Name: | Electromagnetic Tracking System (VirtuTRAX) | |
| Classification<br>Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging<br>System<br>JAK, 21 CFR 892.1750, Computed Tomography X-Ray<br>System | |
| Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,<br>Ultrasonic<br>JAK, 21 CFR 892.1750, System, X-Ray, Tomography,<br>Computed | |
| Premarket<br>Notification: | K092619, concurrence, 13 November 2009 | |
| Manufacturer: | CIVCO Medical | |
| Descriptions: | mode ultrasonic pulsed echo imaging system designed primarily to assist physicians in gaining vascular access to major veins and arteries. The Site~Rite® 6 Ultrasound System is portable and therefore easy to use at the bedside and in a variety of clinical scenarios, including intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. In addition, the Site~Rite® 6 Ultrasound System is designed with simple operating controls to facilitate easy operation.<br><br>The Pinpoint™ GT Technology is designed to track and display the location and trajectory of a needle under ultrasound guidance. The technology consists of software installed on an ultrasound system and sensors incorporated into the ultrasound probe. The sensors detect a passive magnetic field emitted from a needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process. | |
| Intended<br>Use/Indications for<br>Use: | The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.<br><br>Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data. | |
| Technological<br>Characteristics: | The Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology employs the same fundamental scientific technology as the primary predicate device, Site~Rite® 6 Ultrasound System (K071204), in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D images. The Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology has also been evaluated with consideration to multiple reference devices where differences in technology between the subject and primary predicate device are present. The subject device is technologically similar to the reference devices, Site~Rite Vision® II Ultrasound System (K132942), GE LOGIQ E9 (K092271), and Electromagnetic Tracking System – VirtuTRAX (K092619). | |
| Safety and<br>Performance Tests: | Verification and validation activities were designed and performed to demonstrate that the subject Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology met predetermined performance requirements. The following standards in conjunction with internal protocols were used to determine appropriate methods for evaluating the performance of the subject device:<br><br>IEC 60601-1:2005,<br>CORR. 1(2006),<br>CORR 2(2007) Medical Electrical Equipment - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance - Edition 3.1<br><br>IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests | |
| | IEC 60601-2-<br>37:2007 | Medical Electrical Equipment - Part 2-37: Particular<br>Requirements for the Basic Safety and Essential<br>Performance of Ultrasonic Medical Diagnostic and<br>Monitoring Equipment |
| | IEC 60601-1-6:2010 | Medical Electrical Equipment-Part 1-6: General<br>Requirements for Basic Safety and Essential Performance<br>– Collateral Standard: Usability |
| | IEC 62304:2006 | Medical Device Software - Software Life Cycle Processes<br>– Edition 1.0 |
| | IEC 62366:2007 | Medical Devices - Application of Usability Engineering to<br>Medical Devices – Edition 1.0 |
| | ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing Within a Risk Management<br>Process |
| | The subject device met all pre-determined acceptance criteria and demonstrated<br>substantial equivalence as compared to the primary predicate device. Where<br>differences between the subject and primary predicate device exist with respect<br>to technological characteristics, consideration to the reference devices was given<br>to support those technological characteristics. | |
| Summary of<br>Substantial<br>Equivalence | The subject device, Site~Rite® 6 Ultrasound System with Pinpoint™ GT<br>Technology, has the same intended use as the primary predicate device,<br>Site~Rite® 6 Ultrasound System (K071204). The subject device has similar<br>indications for use, technological characteristics, and safety and performance<br>testing as the primary predicate device. Where there are differences in<br>indications for use and technological characteristics between the subject device<br>and the primary predicate device, consideration to the reference devices,<br>Site~Rite Vision® II Ultrasound System (K132942), GE LOGIQ E9 Ultrasound<br>System (K092271), and Electromagnetic Tracking System – VirtuTRAX<br>(K092619) was given. The Site~Rite® 6 Ultrasound System with Pinpoint™ GT<br>Technology met the predetermined performance requirements for its intended<br>use and is as safe, as effective, and performs as well as or better than the<br>primary predicate device, Site~Rite® 6 Ultrasound System (K071204). Based on<br>this assessment, the subject Site~Rite® 6 Ultrasound System with Pinpoint™ GT<br>Technology is determined to be substantially equivalent to the primary predicate<br>device, Site~Rite® 6 Ultrasound System. | |

# Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology

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