Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System

K150529 · C.R. Bard, Inc. · IYO · Mar 30, 2015 · Radiology

Device Facts

• Record ID: K150529
• Device Name: Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
• Applicant: C.R. Bard, Inc.
• Product Code: IYO · Radiology
• Decision Date: Mar 30, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Site-Rite Prevue Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include: Adult Cephalic Neonatal Cephalic Pediatric Peripheral Vessel The Site-Rite Prevue+ Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include: Adult Cephalic Neonatal Cephalic Pediatric Peripheral Vessel The gel cap is intended for use as an ultrasound coupling medium for use with the Site-Rite Prevue® Ultrasound System. The device is intended for use with pediatrics and adults. The needle guides are intended to provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure. This device is intended for use with pediatrics and adults.

Device Story

Portable 2D ultrasound imaging system; utilizes piezoelectric transducer to transmit/receive sound waves; converts reflections to electrical signals for display. Includes beamformer board set and software for ultrasound generation. Used by clinicians for real-time imaging and needle guidance. Features compact design, simple user interface, and USB storage support. Accessories include upright stand, A/C adapter, needle guides, and gel caps. Assists medical practitioners in visualizing structures and guiding needle placement; improves accuracy of needle tip positioning in specific structures; benefits patients by facilitating image-guided procedures.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed performance against predetermined specifications and standards, including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, and NEMA UD 2-2004.

Technological Characteristics

Portable 2D ultrasound system; piezoelectric transducer; new beamformer board set; software-controlled ultrasound generation. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound performance), ISO 10993-1 (biocompatibility), NEMA UD 2 (acoustic output). Connectivity: USB support for storage.

Indications for Use

Indicated for ultrasound imaging of adult and pediatric patients for cephalic and peripheral vessel applications; needle guides assist practitioners in needle placement.

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 Prevue Ultrasound System (K120882)

Submission Summary (Full Text)

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

March 30, 2015

C.R. Bard, Inc. % Mr. Reily Inman Regulatory Affairs Associate 605 North 5600 West SALT LAKE CITY UT 84116

Re: K150529

Trade/Device Name: Site-Rite Prevue and Prevue+ Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: February 27, 2015 Received: March 2, 2015

Dear Mr. Inman:

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Robert A Ocks

Robert Ochs. Ph.D. Acting 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) K150529

#### Device Name

Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System

#### Indications for Use (Describe)

The Site-Rite Prevue Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:

- · Adult Cephalic
- Neonatal Cephalic
- Pediatric
- · Peripheral Vessel

The Site-Rite Prevue+ Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:

- · Adult Cephalic
- · Neonatal Cephalic
- Pediatric
- · Peripheral Vessel

The gel cap is intended for use as an ultrasound coupling medium for use with the Site-Rite Prevue® Ultrasound System. The device is intended for use with pediatrics and adults.

The needle guides are intended to provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure. This device is intended for use with pediatrics and adults.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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Site~Rite Prevue® Ultrasound System and Site~Rite Preve+® Ultrasound System (includes nondetachable, linear, 52 element probe with no unique operating controls)

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|--------------------------------------------------------------------------------------|-------------------|---|-----|---------|--------------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CW<br>D | Color<br>Doppler<br>(CD) | Combined<br>(Specify) | Other†<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (abdominal,<br>thoracic, and vascular) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | | | | | |
| | Small Organ (breast, thyroid,<br>parathyroid, testicles,<br>prostate, uterus, ovary) | | | | | | | |
| Fetal Imaging & Other | Neonatal Cephalic | P | | | | | | |
| | Adult Cephalic | P | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-Esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | P | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

+Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Prescription Use (Per 21 CFR 801.109)

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510(k) Summary

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# 510(k) Summary 21 CFR 807.92

# The Site~Rite Prevue® Ultrasound System and the Site~Rite Prevue+® Ultrasound System

| General<br>Provisions | Submitter Name:<br>Submitter Address: | Bard Access Systems, Inc.<br>605 North 5600 West<br>Salt Lake City, UT 84116 |
|-----------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Reily Inman<br>Regulatory Affairs Associate<br>Bard Access Systems, Inc.<br>[e-mail]<br>801.522.5937<br>801.522.5425 |
| | Date of Preparation: | February 27, 2015 |

## Subject Devices for Which Clearance is Requested:

| Subject Device(s) | Trade Names: | Site~Rite Prevue® Ultrasound System<br>Site~Rite Prevue+® Ultrasound System |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| | Classification Name: IYO 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System<br>ITX 21 CFR 892.1570 Diagnostic Ultrasonic Transducers<br>Class II, Radiology | |
| | Common Name: IYO 21 CFR 892.1560 System, Imaging, Pulsed Echo, Ultrasonic<br>ITX 21 CFR 892.1570 Transducer, Ultrasonic, Diagnostic | |
| Predicate Device | Trade Name: | Site~Rite Prevue® Ultrasound System |
| | Classification Name: | IYO 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System<br>ITX 21 CFR 892.1570 Diagnostic Ultrasonic Transducers<br>Class II, Radiology |
| | Common Name: | IYO 21 CFR 892.1560 System, Imaging, Pulsed Echo, Ultrasonic<br>ITX 21 CFR 892.1570 Transducer, Ultrasonic, Diagnostic |
| | | Premarket Notification: K120882, concurrence date 30 May, 2012 |

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### Subject Device Descriptions:

| Device<br>Description -<br>Site~Rite<br>Prevue®<br>Ultrasound<br>System | The Site~Rite Prevue® Ultrasound System is a portable device<br>that features real-time 2D ultrasound imaging. Additional features<br>include compact size, simple user interface, and various<br>calculations. The system may incorporate various accessories,<br>including an upright stand, A/C adapter, needle guide/gel cap kits,<br>etc. The system includes USB support for storage devices with no<br>external power connections (eg., USB flash drive). |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description -<br>Site~Rite<br>Prevue®<br>Ultrasound<br>System | The Site~Rite Prevue® Ultrasound System is a portable device<br>that features real-time 2D ultrasound imaging. Additional features<br>include compact size, and simple user interface. The system may<br>incorporate various accessories, including an upright stand, A/C<br>adapter, needle guide, etc. The system includes USB support for<br>storage devices with no external power connections (e.g., USB<br>flash drive). |
| Device<br>Description -<br>Site~Rite<br>Prevue+®<br>Ultrasound<br>System | The Site~Rite Prevue+® Ultrasound System is a portable<br>device that features real-time 2D ultrasound imaging. Additional<br>features include compact size and a simple user interface. The<br>system may incorporate various accessories, including an upright<br>stand, A/C adapter, needle guide, etc. The system includes USB<br>support for storage devices with no external power connections<br>(eq., USB flash drive). |

# Subject Device Indications for Use/Intended Use:

| Indications for<br>Use/Intended<br>Use - Site~Rite<br>Prevue®<br>Ultrasound<br>System | The Site~Rite Prevue® Ultrasound System is intended to<br>provide ultrasound imaging of the human body. Specific clinical<br>applications include:<br>• Adult Cephalic<br>• Neonatal Cephalic<br>• Pediatric<br>• Peripheral Vessel |
|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use/Intended<br>Use - Site~Rite<br>Prevue+®<br>Ultrasound<br>System | The Site~Rite Prevue+® Ultrasound System is intended to<br>provide ultrasound imaging of the human body. Specific clinical<br>applications include:<br>• Adult Cephalic<br>• Neonatal Cephalic<br>• Pediatric<br>• Peripheral Vessel |

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| Indications for<br>Use/Intended<br>Use - Pinpoint®<br>Gel Cap and<br>Pinpoint®<br>Needle Guide | The gel cap is intended for use as an ultrasound coupling medium<br>for use with the Site~Rite Prevue® Ultrasound System. The<br>device is intended for use with pediatrics and adults.<br><br>The needle guides are intended to provide guidance for a needle<br>to intersect an ultrasound beam at a fixed distance below the skin<br>to assist the medical practitioner in placing the tip of a needle in a<br>specific structure. This device is intended for use with pediatrics<br>and adults. |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

# Subject Devices Technological Characteristics:

With respect to the fundamental scientific technology, the subject devices and the predicate device are the same. The subject devices operate identically to the predicate device 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 Technoloqical that are processed and displayed as 2D images. However, the Characteristics subject devices will utilize a new beamformer board set (ultrasound generator) and accompanying software, which affects ultrasound generation for the subject devices. Design verification has been conducted and test results show that the subject devices are safe and effective for their intended use/indications for use and the difference in technological characteristics did not raise any new questions regarding safety and effectiveness.

| Safety &<br>Performance<br>Tests | Verification and validation activities were designed and performed<br>to demonstrate that the subject Site~Rite Prevue® Ultrasound<br>System and the Site~Rite Prevue+® Ultrasound System met<br>predetermined performance specifications. The following<br>standards in conjunction with in-house protocols were used to<br>determine appropriate methods for evaluating the performance of<br>the device: |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IEC 60601-1:2005 |
| CORR. 1(2006), | For Basic Safety and Essential Performance - Edition 3 |
| CORR. 2(2007) | |
| IEC 60601-1-2:2007 | Medical Electrical Equipment – Part 1.2: General Requirements |
| For Basic Safety and Essential Performance – Edition 3.1 | |

IEC 60601-2-37:2007 Medical Electrical Equipment - Part 2-37: Particular Requirements For the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitory Equipment

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| ISO 10993-1:2009 | Biological Evaluation of Medical Devices – Part 1: Evaluation and<br>Testing within a Risk Management Process |
|---------------------------|---------------------------------------------------------------------------------------------------------------|
| NEMA UD 2-2004<br>(R2009) | Acoustic Output Measurement Standard for Diagnostic<br>Ultrasound Equipment Revision 3 |

The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device.

| Safety &<br>Performance<br>Tests | Based on the intended use/indications for use, technological<br>characteristics, and safety and performance testing, the subject<br>Site~Rite Prevue® Ultrasound System and the Site~Rite<br>Prevue+® Ultrasound System meet the minimum requirements<br>that are considered adequate for their intended use and are<br>substantially equivalent in design, principles of operation, and<br>intended use/indications for use to the predicate device, the<br>Site~Rite Prevue® Ultrasound System (K120882). Based on the<br>performance testing, the subject devices, the Site~Rite Prevue®<br>Ultrasound System and the Site~Rite Prevue+® Ultrasound<br>System are as safe, as effective, and perform as well as the<br>predicate device, the Site~Rite Prevue® Ultrasound System<br>(K120882). |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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