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 Description

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

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

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

AI/ML Overview

The provided text is a 510(k) Summary for the Site-Rite Prevue® Ultrasound System and the Site-Rite Prevue+® Ultrasound System. It details aspects of the device's design, indications for use, and a comparison to a predicate device.

However, the document does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets the acceptance criteria. This type of detailed study information, including specific performance metrics, sample sizes for test/training sets, expert information, and adjudication methods, is typically found in the full 510(k) submission, not in the summary document. The summary only broadly states that "Verification and validation activities were designed and performed to demonstrate that the subject Site~~Rite Prevue® Ultrasound System and the Site~~Rite Prevue+® Ultrasound System met predetermined performance specifications" and "The subject devices met all pre-determined acceptance criteria."

Therefore, I cannot provide the requested table and detailed study information based on the provided text. The document refers to compliance with various medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, NEMA UD 2-2004), which outline general requirements for safety and performance, but it does not specify device-specific acceptance criteria or the study results that demonstrate these criteria were met.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, ribbon-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler(CD)	Combined(Specify)	Other†(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (abdominal,thoracic, and vascular)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P
	Small Organ (breast, thyroid,parathyroid, testicles,prostate, uterus, ovary)
Fetal Imaging & Other	Neonatal Cephalic	P
	Adult Cephalic	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-Esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	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 SiteRite Prevue® Ultrasound System and the SiteRite Prevue+® Ultrasound System

GeneralProvisions	Submitter Name:Submitter Address:	Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116
	Contact Person:	Reily InmanRegulatory Affairs AssociateBard Access Systems, Inc.reily.inman@crbard.com801.522.5937801.522.5425
	Date of Preparation:	February 27, 2015

Subject Devices for Which Clearance is Requested:

Subject Device(s)	Trade Names:	Site~~Rite Prevue® Ultrasound SystemSite~~Rite Prevue+® Ultrasound System
	Classification Name: IYO 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging SystemITX 21 CFR 892.1570 Diagnostic Ultrasonic TransducersClass II, Radiology
	Common Name: IYO 21 CFR 892.1560 System, Imaging, Pulsed Echo, UltrasonicITX 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 SystemITX 21 CFR 892.1570 Diagnostic Ultrasonic TransducersClass II, Radiology
	Common Name:	IYO 21 CFR 892.1560 System, Imaging, Pulsed Echo, UltrasonicITX 21 CFR 892.1570 Transducer, Ultrasonic, Diagnostic
		Premarket Notification: K120882, concurrence date 30 May, 2012

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Subject Device Descriptions:

DeviceDescription -Site~RitePrevue®UltrasoundSystem	The Site~Rite Prevue® Ultrasound System is a portable devicethat features real-time 2D ultrasound imaging. Additional featuresinclude compact size, simple user interface, and variouscalculations. The system may incorporate various accessories,including an upright stand, A/C adapter, needle guide/gel cap kits,etc. The system includes USB support for storage devices with noexternal power connections (eg., USB flash drive).
DeviceDescription -Site~RitePrevue®UltrasoundSystem	The Site~Rite Prevue® Ultrasound System is a portable devicethat features real-time 2D ultrasound imaging. Additional featuresinclude compact size, and simple user interface. The system mayincorporate various accessories, including an upright stand, A/Cadapter, needle guide, etc. The system includes USB support forstorage devices with no external power connections (e.g., USBflash drive).
DeviceDescription -Site~RitePrevue+®UltrasoundSystem	The Site~Rite Prevue+® Ultrasound System is a portabledevice that features real-time 2D ultrasound imaging. Additionalfeatures include compact size and a simple user interface. Thesystem may incorporate various accessories, including an uprightstand, A/C adapter, needle guide, etc. The system includes USBsupport for storage devices with no external power connections(eq., USB flash drive).

DeviceDescription -Site~RitePrevue®UltrasoundSystem

The Site~Rite Prevue® Ultrasound System is a portable devicethat features real-time 2D ultrasound imaging. Additional featuresinclude compact size, simple user interface, and variouscalculations. The system may incorporate various accessories,including an upright stand, A/C adapter, needle guide/gel cap kits,etc. The system includes USB support for storage devices with noexternal power connections (eg., USB flash drive).

DeviceDescription -Site~RitePrevue®UltrasoundSystem

The Site~Rite Prevue® Ultrasound System is a portable devicethat features real-time 2D ultrasound imaging. Additional featuresinclude compact size, and simple user interface. The system mayincorporate various accessories, including an upright stand, A/Cadapter, needle guide, etc. The system includes USB support forstorage devices with no external power connections (e.g., USBflash drive).

DeviceDescription -Site~RitePrevue+®UltrasoundSystem

The Site~Rite Prevue+® Ultrasound System is a portabledevice that features real-time 2D ultrasound imaging. Additionalfeatures include compact size and a simple user interface. Thesystem may incorporate various accessories, including an uprightstand, A/C adapter, needle guide, etc. The system includes USBsupport for storage devices with no external power connections(eq., USB flash drive).

Subject Device Indications for Use/Intended Use:

Indications forUse/IntendedUse - Site~RitePrevue®UltrasoundSystem	The Site~Rite Prevue® Ultrasound System is intended toprovide ultrasound imaging of the human body. Specific clinicalapplications include:• Adult Cephalic• Neonatal Cephalic• Pediatric• Peripheral Vessel
Indications forUse/IntendedUse - Site~RitePrevue+®UltrasoundSystem	The Site~Rite Prevue+® Ultrasound System is intended toprovide ultrasound imaging of the human body. Specific clinicalapplications include:• Adult Cephalic• Neonatal Cephalic• Pediatric• Peripheral Vessel

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Indications forUse/IntendedUse - Pinpoint®Gel Cap andPinpoint®Needle Guide	The gel cap is intended for use as an ultrasound coupling mediumfor use with the Site~Rite Prevue® Ultrasound System. Thedevice is intended for use with pediatrics and adults.The needle guides are intended to provide guidance for a needleto intersect an ultrasound beam at a fixed distance below the skinto assist the medical practitioner in placing the tip of a needle in aspecific structure. This device is intended for use with pediatricsand adults.
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Indications forUse/IntendedUse - Pinpoint®Gel Cap andPinpoint®Needle Guide

The gel cap is intended for use as an ultrasound coupling mediumfor use with the Site~Rite Prevue® Ultrasound System. Thedevice is intended for use with pediatrics and adults.The needle guides are intended to provide guidance for a needleto intersect an ultrasound beam at a fixed distance below the skinto assist the medical practitioner in placing the tip of a needle in aspecific structure. This device is intended for use with pediatricsand adults.

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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 &PerformanceTests	Verification and validation activities were designed and performedto demonstrate that the subject Site~~Rite Prevue® UltrasoundSystem and the Site~~Rite Prevue+® Ultrasound System metpredetermined performance specifications. The followingstandards in conjunction with in-house protocols were used todetermine appropriate methods for evaluating the performance ofthe 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 andTesting within a Risk Management Process
NEMA UD 2-2004(R2009)	Acoustic Output Measurement Standard for DiagnosticUltrasound Equipment Revision 3

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

Safety &PerformanceTests	Based on the intended use/indications for use, technologicalcharacteristics, and safety and performance testing, the subjectSite~~Rite Prevue® Ultrasound System and the Site~~RitePrevue+® Ultrasound System meet the minimum requirementsthat are considered adequate for their intended use and aresubstantially equivalent in design, principles of operation, andintended use/indications for use to the predicate device, theSite~~Rite Prevue® Ultrasound System (K120882). Based on theperformance testing, the subject devices, the Site~~Rite Prevue®Ultrasound System and the Site~~Rite Prevue+® UltrasoundSystem are as safe, as effective, and perform as well as thepredicate device, the Site~~Rite Prevue® Ultrasound System(K120882).
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Safety &PerformanceTests

Based on the intended use/indications for use, technologicalcharacteristics, and safety and performance testing, the subjectSite~~Rite Prevue® Ultrasound System and the Site~~RitePrevue+® Ultrasound System meet the minimum requirementsthat are considered adequate for their intended use and aresubstantially equivalent in design, principles of operation, andintended use/indications for use to the predicate device, theSite~~Rite Prevue® Ultrasound System (K120882). Based on theperformance testing, the subject devices, the Site~~Rite Prevue®Ultrasound System and the Site~~Rite Prevue+® UltrasoundSystem are as safe, as effective, and perform as well as thepredicate device, the Site~~Rite Prevue® Ultrasound System(K120882).

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Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
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.(b)
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.