The BD Prevue™ II Peripheral Vascular Access System is intended for diagnosiic ultrasound imaging of the human body performed by appropriately trained healthcare professionals in a medical setting. Specific clinical applications include:

Pediatric
· Peripheral Vessel and Vascular Access

Typical examinations performed using the BD Prevue™ II Peripheral Vascular Access System include:

ImagingApplications	Exam Type (Adult and Pediatric)
Vascular	Assessment of vessels in the extremities and neck leading to or coming from theheart, superficial veins in the arms and legs, and vessel mapping. Assessment ofsuperficial thoracic vessels.
VascularAccess	Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial lineplacement, accessto fistula and grafts, and general vein and artery access.

The Cue™ Needle Tracking System is intended to provide visual needle tracking to assist with ultrasound guided vascular access.

Device Description

The subject device, the BD Prevue™ II Peripheral Vascular Access System ("Prevue II System") is a portable device that features real-time 2D ultrasound imaging, customized vascular access applications, procedure documentation, vessel measurement tools and electronic connectivity (if enabled).

The subject Prevue II System is intended to aid in the placement of peripheral vascular access devices and ultimately increase first stick success. The system is intended to be a relatively low cost, easy to use and adaptable system, targeted specifically for use in the Intensive Care Unit (ICU) and Emergency Department (ED).

The subject Prevue II System can be viewed as the next generation Prevue ultrasound system (i.e., K120882 and K150529) and is essentially a pareddown version of its predicate device, the Site® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (K182281).

The subject Prevue II System includes the optional Cue™ Needle Tracking System, which is the same identical needle quidance technology already cleared with the predicate device, the Site~Rite® 8 Ultrasound System, under K182281.

The Cue™ Needle Tracking System technology is designed to track and display the location and traiectory of a needle under ultrasound quidance. The technology consists of software installed on the Prevue II System and a sensor incorporated into the ultrasound probes. The ultrasound probe sensor detects a passive magnetic field emitted from a needle that has been previously magnetized using the Cue™ Needle Tracking System Magnetizer, which is a system also included in the predicate device. The probe interprets the data received from the sensor and creates a virtual imaqe of the needle on the ultrasound display, providing clinicians with a visual representation of the needle during the insertion process. The tracked needle's current position, trajectory and intersection window are displayed over the ultrasound image. The Cue™ Needle Tracking System is currently included with the predicate device and is not a subject of this 510(k) submission.

The subject Prevue II System differs from its predicate device, the Site® 8 Ultrasound System (K182281), in that it provides a more portable and simpler to use device that can be operated by less experienced ultrasound users, primarily in an ICU and/or ED medical setting. Aside from this simplification of features, most of the other previously cleared features of the predicate device are being brought forward.

The subject Prevue II System includes the following main components:

Ultrasound System Console .
Ultrasound Beamformer ●
System Software (including Cue™ Needle Tracking System Software) ●
Ultrasound Probes (Cue™ compatible) ●
Cue™ Needle Tracking System Hardware (i.e., Magnetizer and RFID . Reader)

Additionally, the subject Prevue II System is compatible with the following accessories:

Site~Rite® Probe Cover Kits ●
Cue™ Magnetizer ●
Cue™ Compatible Needles
Probe Holder Accessory ●
Cable Wrap Accessory
. Prevue II Magnetizer Cover
Prevue II Roll Stand ●
. USB Storage Device (off-the-shelf flash-drive used to save files or perform software updates)

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the BD Prevue™ II Peripheral Vascular Access System, based on the provided document:

This document describes a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically means that clinical performance studies proving efficacy (like a comparative effectiveness study with human readers) are often not required if substantial equivalence can be shown through non-clinical testing and comparison of intended use, indications, and technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with reported performance for each criterion in the way a clinical trial might. Instead, it states that "Acceptance criteria have been established to ensure that the subject device performs in a manner that is substantially equivalent to the cited predicate device." The "reported device performance" is described as the device successfully passing a series of non-clinical tests.

Summary of Acceptance - Non-Clinical Tests Passed:

Test Category	Description of Acceptance (Implicit)	Reported Device Performance
Acoustic Safety Testing	Compliance with relevant acoustic safety standards.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
System Electrical Safety Testing	Compliance with relevant electrical safety standards (e.g., IEC 60601-1).	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Electromagnetic Compatibility Testing	Compliance with relevant EMC standards (e.g., IEC 60601-1-2).	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
FCC Compliance Testing	Compliance with FCC regulations (Parts 18, 15 B, 15 C).	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Biocompatibility Testing	Compliance with biological safety standards for patient-contacting materials (e.g., ISO 10993-1).	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
System Mechanical Testing	Verification of mechanical integrity and function.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Fluid Ingress Testing	Verification of protection against fluid penetration.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Operating Temperature and Humidity Testing	Verification of performance under specified environmental conditions.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Electrical Reliability Testing	Verification of electrical component reliability.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Software Verification Testing	Verification that software functions as intended (e.g., IEC 62304).	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Cybersecurity Assessment	Assessment of cybersecurity risks and controls.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Human Factors and Validation	Assessment of usability and user interface (e.g., IEC 62366-1, FDA Guidance on Human Factors).	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Ultrasound Image Testing	Verification of image quality and diagnostic capabilities.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Ultrasound Response Time Testing	Verification of timely response of ultrasound imaging.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Cue Needle Tracking Accuracy Testing	Verification of the accuracy of the Cue™ Needle Tracking System.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Cue Tools Accuracy Testing	Verification of the accuracy of other Cue™-related tools.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Cleaning/Reprocessing Testing	Verification of cleaning and reprocessing compatibility.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Ship Testing	Verification of device integrity after shipping conditions.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.
Roll Stand Testing	Verification of the stability and functionality of the roll stand accessory.	The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing.

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

Sample Size for Test Set: Not specified in terms of number of cases, images, or patients. The non-clinical tests relate to device performance characteristics rather than diagnostic accuracy on a patient dataset.
Data Provenance: Not applicable as the studies were non-clinical, bench testing, and engineering verification and validation. There's no mention of country of origin for patient data or retrospective/prospective collection.

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

Experts for Ground Truth: Not applicable. The "ground truth" here is compliance with engineering specifications and regulatory standards, which are demonstrated through validated test methods and measurements, not expert consensus on medical images for diagnostic accuracy.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. As this is non-clinical performance data, the testing involves objective measurements against established criteria and standards rather than subjective expert adjudication of medical performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. The document explicitly states: "No clinical testing was conducted in support of the BD Prevue™ II Peripheral Vascular Access System, as the intended use, indications and technology are equivalent to those of the predicate device." Therefore, there is no information on the effect size of human readers improving with AI vs. without AI assistance. The device is primarily an ultrasound imaging system with needle tracking, not an AI-assisted diagnostic interpretation tool in the traditional sense of comparing human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: The "Cue™ Needle Tracking System" is an integrated component of the device. Its accuracy (a form of standalone performance for the tracking algorithm) was tested as part of the "Cue Needle Tracking Accuracy Testing" and "Cue Tools Accuracy Testing." However, the specific results or metrics for this standalone performance (e.g., tracking error in mm) are not provided; only that it passed the testing. This is distinct from a standalone diagnostic algorithm for image interpretation.

7. Type of Ground Truth Used

Ground Truth Type: For the non-clinical tests, the "ground truth" used is defined by engineering specifications, validated test methods, and compliance with national and international voluntary standards (e.g., IEC and ISO standards for safety, EMC, software, usability, etc., and FDA guidance documents). For accuracy tests of the Cue™ Needle Tracking System, the ground truth would be precise physical measurements of needle position and trajectory.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This document describes a 510(k) submission for a medical device (ultrasound system with needle tracking), not a machine learning or AI algorithm in the context of being trained on a large dataset of patient images. While the device contains software, the phrase "training set" in an ML context is not used or relevant here. The software development process would follow standards like IEC 62304.

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

Ground Truth for Training Set: Not applicable, as no training set (in the machine learning sense) is mentioned or implied for this device's regulatory review.

Summary

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June 25, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA name on the right. The seal features an eagle with its wings spread, surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA". To the right of the seal is the text "FDA U.S. FOOD & DRUG ADMINISTRATION", with "FDA" in a blue square and the rest of the text in blue.

Bard Access Systems, Inc, (C.R. Bard, Inc.) % Fabio De Pasquale Regulatory Affairs 605 North 5600 West SALT LAKE CITY UT 84116

Re: K211193

Trade/Device Name: BD Prevue™ II Peripheral Vascular Access System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX, LLZ Dated: April 21, 2021 Received: April 21, 2021

Dear Fabio De Pasquale:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K211193

Device Name

BD Prevue™ II Peripheral Vascular Access System

Indications for Use (Describe)

Pediatric
· Peripheral Vessel and Vascular Access

Typical examinations performed using the BD Prevue™ II Peripheral Vascular Access System include:

ImagingApplications	Exam Type (Adult and Pediatric)
Vascular	Assessment of vessels in the extremities and neck leading to or coming from theheart, superficial veins in the arms and legs, and vessel mapping. Assessment ofsuperficial thoracic vessels.
VascularAccess	Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial lineplacement, accessto fistula and grafts, and general vein and artery access.

The Cue™ Needle Tracking System is intended to provide visual needle tracking to assist with ultrasound guided vascular access.

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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Section 8 - 510(k) Summary

(in accordance with 21 CFR 807.92)

510(k) Number: K21193

l. Applicant Information

Applicant:	Bard Access Systems, Inc. (C.R. Bard, Inc.)(Bard has now joined Becton Dickinson)605 North 5600 WestSalt Lake City, UT 84116USA
Contact Person:	Fabio De PasqualeRegulatory AffairsTel: 1-250-920-6501e-mail: fabio.de.pasquale@bd.com
Application Correspondent:

Date Prepared:

April 21, 2021

Same as Applicant.

II. Subject Device Identification

Proprietary Name:	BD Prevue™ II Peripheral Vascular AccessSystem
Common/Usual Name:	Ultrasound System with Needle Tracking
Regulation Name:	Ultrasonic Pulsed Echo Imaging System
Regulation Number:	21 CFR 892.1560
Product Code:	IYO
Regulation Name:	Diagnostic Ultrasonic Transducer
Regulation Number:	21 CFR 892.1570
Product Code:	ITX
Regulation Name:	Medical Image Management and ProcessingSystem
Regulation Number:	21 CFR 892.2050
Product Code:	LLZ
Regulatory Class:	Class II
Classification Panel:	Radiology

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lll. Predicate Device

The subject device, the BD Prevue™ II Peripheral Vascular Access System, is substantially equivalent to the following cleared predicate device. The subject and predicate devices have the same fundamental scientific technology and intended use:

510(k) Number:	K182281
Proprietary Name:	Site-Rite® 8 Ultrasound System with Cue™Needle Tracking System and Pinpoint™ GTNeedle Technology
Common/Usual Name:	Ultrasound System with Needle Tracking
Regulation Name:	Ultrasonic Pulsed Echo Imaging System
Regulation Number:	21 CFR 892.1560
Product Code:	IYO
Regulation Name:	Diagnostic Ultrasonic Transducer
Regulation Number:	21 CFR 892.1570
Product Code:	ITX
Regulation Name:	Picture Archiving and Communication System
Regulation Number:	21 CFR 892.2050
Product Code:	LLZ
Regulatory Class:	Class II
Classification Panel:	Radiology

IV. Subject Device Description

The subject Prevue II System includes the optional Cue™ Needle Tracking System, which is the same identical needle quidance technology already

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cleared with the predicate device, the Site~Rite® 8 Ultrasound System, under K182281.

The subject Prevue II System includes the following main components:

Ultrasound System Console .
Ultrasound Beamformer ●
System Software (including Cue™ Needle Tracking System Software) ●
Ultrasound Probes (Cue™ compatible) ●
Cue™ Needle Tracking System Hardware (i.e., Magnetizer and RFID . Reader)

Additionally, the subject Prevue II System is compatible with the following accessories:

Site~Rite® Probe Cover Kits ●
Cue™ Magnetizer ●
Cue™ Compatible Needles
Probe Holder Accessory ●
Cable Wrap Accessory
. Prevue II Magnetizer Cover
Prevue II Roll Stand ●
. USB Storage Device (off-the-shelf flash-drive used to save files or perform software updates)

As discussed in the following sections, the intended use, technological characteristics, principles of operation and materials of the subject device are substantially equivalent to the respective ones of the predicate device.

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V. Indications for Use

The BD Prevue™ II Peripheral Vascular Access System is intended for diagnostic ultrasound imaging of the human body performed by appropriately trained healthcare professionals in a medical setting. Specific clinical applications include:

Pediatric ●
Peripheral Vessel and Vascular Access ●

Typical examinations performed using the BD Prevue™ II Peripheral Vascular Access System include:

lmagingApplications	Exam Type (Adult and Pediatric)
Vascular	Assessment of vessels in the extremities and neck leading to or comingfrom the heart, superficial veins in the arms and legs, and vesselmapping. Assessment of superficial thoracic vessels
VascularAccess	Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterialline placement, access to fistula and grafts, and general vein and arteryaccess.

The Cue™ Needle Tracking System is intended to provide visual needle tracking to assist with ultrasound guided vascular access.

VI. Substantial Equivalence

Intended Use

The BD Prevue™ II Peripheral Vascular Access System and its predicate device have the same intended use: diagnostic ultrasound imaging of the human body.

Indications for Use

The BD Prevue™ II Peripheral Vascular Access System adopts the same Indications for Use of its predicate device, with some minor differences that do not change the intended use of the BD Prevue™ II Peripheral Vascular Access System when compared with the intended use of its predicate device.

The Indications for use for the subject BD Prevue™ II Peripheral Vascular Access System include a reduced number of clinical applications with respect to those of the predicate device, the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (K182281).

More specifically, the following imaging applications, which are included with the predicate Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology, are not included with the subject BD Prevue™ II Peripheral Vascular Access System:

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1. Small organs (i.e., breast, thyroid, parathyroid, testicles);
1. Musculo-skeletal (i.e., conventional and superficial);
1. Cardiac (i.e., adult and pediatric);
1. Interventional (i.e., quidance for biopsy and drainage); or
1. Superficial (i.e., assessment of breast, thyroid, parathyroid, testicle, lymph nodes, musculoskeletal procedures, soft tissue structures and surrounding anatomical structures).

For a more detailed comparison of the clinical applications of use between the subject and predicate device, please see the Substantial Equivalence Table below.

Technological Characteristics

The subject BD Prevue™ II Peripheral Vascular Access System employs the same identical fundamental scientific technology as the predicate device, the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (K182281), 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 subject device is technologically identical to the predicate device and incorporates the same needle guidance technology as the predicate device (i.e., the Cue™ Needle Tracking System). Both subject and predicate devices share substantially equivalent patient contacting materials.

Additionally, all the features presented by the BD Prevue™ II Peripheral Vascular Access System are included and are similar and substantially equivalent to the corresponding features of the predicate device.

The following table summarizes the substantial equivalence comparison between the subject and the predicate device.

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Substantial Equivalence Comparison Table

	Subject Device:	Predicate Device:(K182281)
Device Name	BD Prevue™ II Peripheral Vascular AccessSystem	Site~Rite® 8 Ultrasound System with Cue™Needle Tracking System and Pinpoint™ GTNeedle Technology
Product Codes	IYO - ITX - LLZ	IYO - ITX - LLZ
Regulation #s	892.1560 - 892.1570 - 892.2050	892.1560, 892.1570, 892.2050
Device Class	II	II
Intended Use /Indications forUse	The BD Prevue™ II Peripheral Vascular AccessSystem is intended for diagnostic ultrasoundimaging of the human body performed byappropriately trained healthcare professionals in amedical setting.	The Site~Rite® 8 Ultrasound System with Cue™Needle Tracking System and Pinpoint™ GTNeedle Technology is intended for diagnosticultrasound imaging of the human body.
	Specific clinical applications include:	Specific clinical applications include:
	• Pediatric• Peripheral Vessel and Vascular Access	• Pediatric• Peripheral Vessel and Vascular Access• Small Organ (breast, thyroid, parathyroid,testicles)• Musculo-skeletal (conventional andsuperficial)• Cardiac (adult and pediatric)
	Typical examinations performed using the BDPrevue™ II System include:	Typical examinations performed using theSite~Rite® 8 Ultrasound System include:
ImagingApplications	Exam Type (Adult andPediatric)	ImagingApplications	Exam Type (Adult andPediatric)
Vascular	Assessment of vessels in theextremities and neck leadingto or coming from the heart,superficial veins in the armsand legs, and vesselmapping. Assessment ofsuperficial thoracic vessels.	Vascular	Assessment of vessels in theextremities and neck leadingto or coming from the heart,superficial veins in the armsand legs, and vesselmapping. Assessment ofsuperficial thoracic vessels.
Vascular Access	Guidance for PICC, CVC,dialysis catheter, port, PIV,midline, arterial lineplacement, access to fistulaand grafts, and general veinand artery access	Vascular Access	Guidance for PICC, CVC,dialysis catheter, port, PIV,midline, arterial lineplacement, access to fistulaand grafts, and general veinand artery access
		Interventional	Guidance for biopsy anddrainage
		Superficial	Assessment of breast,thyroid, parathyroid, testicle,lymph nodes, hernias,musculoskeletal procedures(e.g., joints, ligaments,tendons), soft tissuestructures, and surroundinganatomical structures
The Cue™ Needle Tracking System is intended toprovide visual needle tracking to assist withultrasound guided vascular access.		Cue™ Needle Tracking System and Pinpoint™GT Needle Technology are each intended toprovide visual needle tracking to assist withultrasound guided vascular access.
Environment ofUse	Hospital/clinic medical setting.		Hospital/clinic medical setting.

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VII. Non-Clinical Performance Data

C.R. Bard, Inc. has conducted extensive verification and validation testing of the BD Prevue™ II Peripheral Vascular Access System, as an ultrasonic pulsed echo imaging system capable of providing diagnostic ultrasound imaging of the human body. The subject device was tested to ensure that it can provide all the capabilities necessary to operate safely and effectively.

Acceptance criteria have been established to ensure that the subject device performs in a manner that is substantially equivalent to the cited predicate device. Testing was conducted to verify the safety and performance requirements of the subject device and the test results support substantial equivalence to the predicate device. The following table lists the nonclinical tests performed on the subject BD Prevue™ II Peripheral Vascular Access System for a determination of substantial equivalence.

Prevue™ II System - Nonclinical Tests Performed
Acoustic Safety Testing
System Electrical Safety Testing
Electromagnetic Compatibility Testing
FCC Compliance Testing
Biocompatibility Testing
System Mechanical Testing
Fluid Ingress Testing
Operating Temperature and Humidity Testing
Electrical Reliability Testing
Software Verification Testing
Cybersecurity Assessment
Human Factors and Validation
Ultrasound Image Testing
Ultrasound Response Time Testing
Cue Needle Tracking Accuracy Testing
Cue Tools Accuracy Testing
Cleaning/Reprocessing Testing
Ship Testing
Roll Stand Testing

The BD Prevue™ II Peripheral Vascular Access System, complies with all the applicable voluntary standards related to its Regulations and Product Codes and successfully passed all respective testing.

The following guidance documents and standards were followed to determine appropriate methods for evaluating the performance of the subject device.

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Standards and Guidance Documents Applicable to Prevue™ II System
Standard/Guidance	Title
FDA Guidance	Marketing Clearance of Diagnostic Ultrasound Systems andTransducers
FDA Guidance	Applying Human Factors and Usability Engineering to MedicalDevices
FDA Guidance	Format for Traditional and Abbreviated 510(k)s
FDA Guidance	Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices
FDA Guidance	Content of Premarket Submissions for Management ofCybersecurity in Medical Devices
FDA Guidance	Post Market Management of Cybersecurity in Medical Devices
FDA Guidance	Use of International Standard ISO 10993-1, "Biological evaluationof medical devices - Part 1: Evaluation and testing within a riskmanagement process"
FDA Guidance	Recommended Content and Format of Non-Clinical BenchPerformance Testing Information in Premarket Submissions
FDA Guidance	The 510(k) Program: Evaluating Substantial Equivalence inPremarket Notifications [510(k)]
FDA Guidance	Appropriate Use of Voluntary Consensus Standards in PremarketSubmissions for Medical Devices
FDA Guidance	Refuse to Accept Policy for 510(k)s
FDA Guidance	eCopy Program for Medical Device Submissions
IEC 60601-1:2012	Medical Electrical Equipment - Medical Electrical Equipment - Part1: General Requirements for Basic Safety and EssentialPerformance
IEC 60601-1-2:2014	Medical Electrical Equipment - Part 1-2: General Requirements forBasic Safety and Essential Performance - Collateral Standard:Electromagnetic Disturbances - Requirements and Tests
IEC 60601-1-6:2013	Medical Electrical Equipment-Part 1-6: General Requirements forBasic Safety and Essential Performance - Collateral Standard:Usability
IEC 60601-2-37:2015	Medical Electrical Equipment - Part 2-37: Particular Requirementsfor the Basic Safety and Essential Performance of UltrasonicMedical Diagnostic and Monitoring Equipment
IEC 62359:2017	Ultrasonics - Field Characterization - Test Methods For TheDetermination Of Thermal And Mechanical Indices Related ToMedical Diagnostic Ultrasonic Fields
IEC 62304:2015	Medical device software - Software Life Cycle Processes
IEC 62366-1:2015	Medical Devices - Part 1: Application of Usability Engineering toMedical Devices
ISO 10993-1:2018	Biological Evaluation of Medical Devices - Part 1: Evaluation andTesting within a Risk Management Process
ISO 15223-1:2016	Medical Devices - Symbols To Be Used With Medical DeviceLabels, Labelling, And Information To Be Supplied - Part 1:General Requirements
ISO 14971:2007	Medical Devices - Application of Risk Management To MedicalDevices

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Standards and Guidance Documents Applicable to Prevue™ II System
Standard/Guidance	Title
FCC Title 47 CFR part 18	Telecommunication, Part 18 - Industrial, Scientific and MedicalEquipment
FCC Title 47 CFT Part 15 B	Telecommunication, Part 15 – Radiofrequency devices, Part B(Clan A) – Unintentional Radiators
FCC Title 47 CFR part 15 C	Telecommunication, Part 15 – Radio Frequency Devices; Part C –Intentional Radiators

VIII. Clinical Performance Data

No clinical testing was conducted in support of the BD Prevue™ II Peripheral Vascular Access System, as the intended use, indications and technology are equivalent to those of the predicate device. The non-clinical testing summarized in this submission supports the substantial equivalence of this device to the predicate with respect to safety and effectiveness.

IX. Statement of Substantial Equivalence

Based on substantially equivalent intended use, technological characteristics and safety and performance testing as the predicate device, the BD Prevue™ II Peripheral Vascular Access System is deemed to be substantially equivalent to its predicate, the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology cleared under K182281.

The BD Prevue™ II Peripheral Vascular Access System, as designed and manufactured, does not raise new questions regarding safety and effectiveness as compared to its predicate device and is concluded to be substantially equivalent to its predicate device.

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.

Track 1 orTrack 3	Track 1	Track 1
Power Source	AC Adapter with Internal Lithium-Ion BatteryPack.Power Consumption: 65 W	AC Adapter with Internal Lithium-Ion BatteryPack.Power Consumption: 60 W
SystemComponents	The BD Prevue™ II Ultrasound System includesthe following components:Prevue II Console Ultrasound Beamformer Software Ultrasound Probes Cue™ Needle Tracking System Hardware	The Site-Rite® 8 Ultrasound System includes thefollowing components:Site-Rite 8 Console Beamformer Software Ultrasound Probes Cue™ Needle Tracking System Hardware
System Console	The BD Prevue™ II Ultrasound System includes:7" Touch Screen Monitor Portable Weight 3.5 lbsGraphic User Interface (GUI):Touchscreen user interface with icons to access allavailable functionality, including the Cue™ NeedleTracking System.	The Site-Rite® 8 Ultrasound System includes:10" Touch Screen Monitor Portable Weight 5 lbsGraphic User Interface (GUI):Touchscreen user interface with icons to accessall available functionality, including the Cue™Needle Tracking System.
UltrasoundBeamformer	The BD Prevue™ II Ultrasound System uses Bmode for all compatible probes.	The Site-Rite® 8 Ultrasound System uses Bmode for all compatible probes.
UltrasoundFeatures	The BD Prevue™ II Ultrasound System includesthe following features:Intuitive controls allowing for rapid andeasy operation; Choice of battery or line voltage power:	The Site-Rite® 8 Ultrasound System includes thefollowing features:Intuitive controls allowing for rapid andeasy operation; Choice of battery or line voltage power:
	Portable system; Operating parameters of scanner determined by image depth; Image freeze frame; Simplified, touch screen user interface; Image saving; Vessel assessment tools; Clinician preference presets; Patient information and file management; and On-screen keyboard.	Portable system; Operating parameters of scanner determined by image depth; Image freeze frame; Simplified, touch screen user interface; Image saving; Vessel assessment tools; Clinician preference presets; Patient information and file management; and On-screen keyboard.
Software	Operating System (OS): MS Windows 10 Embedded Needle Guidance Technology: Passive magnetic tracking using the CueTM Needle Tracking System	Operating System (OS): MS Windows 7 Embedded Needle Guidance Technology: Passive magnetic tracking using the CueTM Needle Tracking System Passive magnetic tracking using the Pinpoint GT Needle Technology
	Needle Measurement Depths: 1.5 cm 2.5 cm	Needle Measurement Depths: 1 cm 1.5 cm 3 cm 4.5 cm 6 cm
	Ultrasound Settings: Gain/Brightness	Ultrasound Settings: Gain/Brightness
		Image filter Contrast (low/high)
Magnetic FieldDetectionTechnology	Cue™ Needle Tracking SystemRequires the use of:Prevue™ II Ultrasound System Console. Detachable Cue™ compatible Probe. Cue™ RFID Reader (embedded into theconsole handle) and a Cue™ Magnetizer(mounted to the side of the console). Qualified disposable needle that is presentin the system's needle library and packagedin Cue™ compatible packaging.	Cue™ Needle Tracking SystemRequires the use of:Site~Rite® 8 Ultrasound System Console. Detachable Cue™ compatible Probe. Cue™ RFID-Reader/Magnetizer unit (i.e.,the "Activator", a component of theCue™ Needle Tracking System)externally connected to the console viaUSB cable. Qualified disposable needle that is presentin the system's needle library andpackaged in Cue™ compatible packaging.
	The Cue™ Needle Tracking System softwaremodule is included with the Prevue™ II UltrasoundSystem.	The Cue™ Needle Tracking System softwaremodule is included with the Site~Rite® 8Ultrasound System.
	The Cue™ compatible needle is magnetized("activated") using the Cue™ Needle TrackingSystem Magnetizer.	The Cue™ compatible needle is magnetized("activated") using the Cue™ Needle TrackingSystem Activator.
	The Cue™ Needle Tracking System softwaremodule receives the information transmitted by theCue™ compatible Probe sensor board. Thesoftware receives information from the sensorboard regarding the relative position and movement	The Cue™ Needle Tracking System softwaremodule receives the information transmitted bythe Cue™ compatible Probe sensor board. Thesoftware receives information from the sensorboard regarding the relative position and
	of a passive magnet with a known magneticsignature (associated with a specific Cue™compatible needle). This information is convertedby the software into an overlay that is projectedover the ultrasound image representing the relativeposition, projected needle path, and movement of aneedle on the ultrasound image.	movement of a passive magnet with a knownmagnetic signature (associated with a specificCue™ compatible needle). This information isconverted by the software into an overlay that isprojected over the ultrasound image representingthe relative position, projected needle path, andmovement of a needle on the ultrasound image.
VisualizationFeatures	The BD Prevue™ II Ultrasound System Consoleincludes the following visualization features:Visualization of a vessel and surrounding anatomy. Visualization and measure of catheter size relative to a vessel. Visualization of a needle trajectory. Visualization of virtual catheter location during vascular access placement. Measure of remaining catheter length based on vessel depth and assumed insertion angle. Visualization of the insertion angle while using the Cue™ Needle Tracking System, allowing the user to set a “maximum angle rule" for system notification. Visualization of the remaining catheter length while using the Cue™ Needle Tracking System, allowing the user to set a “minimum remaining catheter length" rule for system notification.	The Site~Rite® 8 Ultrasound System Consoleincludes the following visualization features:Visualization of a vessel and surrounding anatomy. Visualization and measure of catheter size relative to a vessel. Visualization of a needle trajectory. Visualization of virtual catheter location during vascular access placement. Measure of remaining catheter length based on vessel depth and assumed insertion angle. Visualization of the insertion angle while using the Cue™ Needle Tracking System, allowing the user to set a “maximum angle rule" for system notification. Visualization of the remaining catheter length while using the Cue™ Needle Tracking System, allowing the user to set a “minimum remaining catheter length” rule for system notification.
UltrasoundProbes	The BD Prevue™ II Ultrasound System includesthe following 2 probes:Prevue II Traditional Probe	The Site~Rite® 8 Ultrasound System includes thefollowing 3 probes:Detachable Cue™ 20mm Linear Probe
	Prevue II Vascular Access Probe Prevue II Probes Characteristics: Cue™ compatible → Yes Buttons → No Acoustics → B-mode imaging	Detachable 20mm Pinpoint™ GT Linear probe Detachable 32mm Linear Probe Site~Rite 8 Probes Characteristics: Cue™ compatible → Yes Buttons → Yes Acoustics → B-mode imaging
Accessories	The BD Prevue™ II Ultrasound System is compatible with the following accessories: Site~Rite® Probe Cover Kits Probe Holder Accessory Prevue II Roll Stand Cue™ Compatible Needles Cue™ Magnetizer Cover Cable Wrap Accessory USB storage device() () Users are able to save files or perform software updates using a standard off-the-shelf USB storage device.	The Site~~Rite® 8 Ultrasound System is compatible with the following accessories: Site~~Rite® Probe Cover Kits Probe Holder Accessory MER Roll Stand Cue™ Compatible Needles Cue™ Activator Mounting Arm Site~~Rite® Needle Guide Kits Pinpoint™ GT Needle Guide Kits Keyboard Kickstand Mounting Accessory Site~~Rite® 8 Ultrasound System Roller Bag Optional printers (with mounting hardware)() Silex® Wireless Bridge() USB storage device() () The optional printer(s) and the Silex® Wireless Bridge are standard off-the-shelf (non-medical) accessories qualified to be used with the Site~Rite® 8 Ultrasound System. Users are also
			able to save files or perform software updatesusing a standard off-the-shelf USB storage device.
CompatibleNeedles andCatheters	All needles available in the market are compatiblewith the Prevue II system.	All needles available in the market are compatiblewith the Site~Rite 8 system.
	Additionally, the system is also compatible with allCueTM catheters currently cleared for sale.	Additionally, the system is also compatible withall CueTM catheters currently cleared for sale.