BD Prevue™ II Peripheral Vascular Access System is indicated for Vascular Access Imaging Applications performed by appropriately trained healthcare professionals in a medical setting. Typical examinations performed using the BD Prevue™ II Peripheral Vascular Access System include:

Imaging Applications:

Vascular [Exam Type (Adult and Pediatric)]: Assessment of vessels in the extremities and neck leading to or coming from the heart, superficial veins in the arms and legs, and vessel mapping. Assessment of superficial thoracic vessels. Vascular Access [Exam Type (Adult and Pediatric)]: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and general vein and artery access in adult and pediatric patients, including those patients with difficult intravascular access who may have small, fragile, and/or non-palpable vessels.

Device Description

The BD Prevue™ II Peripheral Vascular Access 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 BD Prevue™ II Peripheral Vascular Access System is equipped with Cue™ Needle Tracking System which 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 probes. The sensors detect a passive magnetic field emitted from the 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 during the insertion process.

The Cue™ Needle Tracking System requires the use of either the Cue™ Traditional Probe or Cue™ Vascular Access Probe, the Cue™ Magnetizer and a Cue™ enabled needle. The Cue™ Traditional Probe and Vascular Access Probe contain sensors for tracking Cue™ compatible needles (following magnetization by the Cue™ Magnetizer). The tracked needle's current position, trajectory, and intersection window are displayed over the ultrasound image.

AI/ML Overview

The information provided pertains to the BD Prevue™ II Peripheral Vascular Access System. The device has undergone an administrative change to its 510(k) to include the specification of difficult intravascular access (DIVA) patients in its indications for use.

Based on the provided text, a new study was not conducted to specifically prove the device meets new acceptance criteria for the updated indication. Instead, the manufacturer, Bard Access Systems, Inc. (now BD), states that no new verification or validation activities were required because the modifications to the Indications for Use and the Instructions for Use do not involve changes to the device's design, materials, performance, or risk profile. The performance testing conducted for the predicate device clearance (K211193) is deemed to cover the proposed specified difficult intravascular access patient population.

Therefore, the acceptance criteria and performance data referenced are those from the original submission (K211193) for the predicate device, which is the same device, the BD Prevue™ II Peripheral Vascular Access System, but with a narrower previous indication.

Due to the administrative nature of this submission (K240146) and the reliance on previous predicate device testing, the provided text does NOT contain the specific details required for sections 1-9 as no new study was performed for this 510(k).

However, I can extract the available information regarding the device and the rationale for not requiring a new study for K240146:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria for K240146: Not explicitly stated as new criteria in this document. The submission relies on the existing performance data and acceptance criteria established for the predicate device (K211193), which is deemed to cover the expanded indication.
Reported Device Performance for K240146: Not explicitly stated as no new performance data was generated for this administrative change. The statement is that the original performance testing for K211193 is sufficient.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable for K240146, as no new test set was used. The submission relies on the performance testing from the predicate device (K211193).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable for K240146, as no new ground truth establishment was reported. The submission relies on the performance testing from the predicate device (K211193).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable for K240146, as no new test set was used. The submission relies on the performance testing from the predicate device (K211193).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This device is an Ultrasound System with Needle Tracking, not an AI-assisted diagnostic tool for interpretation of medical images by human readers. Therefore, an MRMC comparative effectiveness study of this nature is not applicable in the context of this device's function.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

The BD Prevue™ II Peripheral Vascular Access System is a medical imaging device with needle tracking capability, which is inherently used with human-in-the-loop (healthcare professional). Therefore, a standalone algorithm-only performance study is not applicable for this type of device. The "Cue™ Needle Tracking System" is described as software and sensors that create a virtual image for the clinician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for K240146, as no new ground truth establishment was reported. The submission relies on the performance testing from the predicate device (K211193). For an ultrasound imaging and needle tracking system, ground truth in previous studies would likely involve phantom studies for accuracy, clinical observations for usability and performance in procedures, or comparison to established imaging modalities.

8. The sample size for the training set

Not applicable for K240146, as no mention of a training set for a new study is made. The device performs real-time 2D ultrasound imaging and needle tracking; while it uses software, the context does not indicate an AI model requiring a "training set" in the common sense for diagnostic interpretations. If machine learning is involved in the needle tracking, details about its training set would reside in the K211193 submission.

9. How the ground truth for the training set was established

Not applicable for K240146 for the same reasons as #8.

Summary

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March 1, 2024

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

Bard Access Systems, Inc. % Samira Saeed Regulatory Affairs Specialist I 605 N 5600 W SALT LAKE CITY UT 84116

Re: K240146

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, IYX, LLZ

Dear Samira Saeed:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 18, 2014. Specifically, FDA is updating this SE Letter to include the correct IFU statement and 510(k) Summary, as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yanna Kang, OHT8: Office of Radiological Health, (301) 796-6704, Yanna.Kang@fda.hhs.gov.

Sincerely,

Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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February 18, 2024

Image /page/1/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters 'FDA' in white. Next to the blue square, the text 'U.S. FOOD & DRUG ADMINISTRATION' is written in blue.

Bard Access Systems, Inc. % Samira Saeed Regulatory Affairs Specialist I 605 N 5600 W SALT LAKE CITY UT 84116

Re: K240146

Dear Samira Saeed:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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).

Sincerelv.

Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammograph and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K240146

Device Name

BD Prevue™ II Peripheral Vascular Access System

Indications for Use (Describe)

[Table]

Imaging Applications:

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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Image /page/4/Picture/1 description: The image shows the logos of two companies, BD and Bard. The BD logo is in blue and consists of the letters "BD" next to an orange sun-like symbol. The Bard logo is in green and consists of the word "BARD" in a stylized font, with the text "has joined BD" underneath it in a smaller font.

BD Prevue™ II Peripheral Vascular Access System Special 510(k) Premarket Notification

510(k) Summary 21 CFR 807.92(a)

GeneralProvisions	Submitter Name:	Bard Access Systems, Inc. (Bard has joined BD)
	Submitter Address:	605 North 5600 WestSalt Lake City, Utah 84116
	Contact Person:	Samira SaeedRegulatory Affairs Specialist
	Telephone Number:	801.522.5000
	Date of Preparation:	January 16 2023
SubjectDevice:	Trade Name:	BD Prevue II Peripheral Vascular Access System
	Common Name:	Ultrasound System with Needle Tracking
	Regulation Name:	Ultrasonic Pulsed Echo Imaging SystemDiagnostic Ultrasonic TransducerPicture Archiving and Communication System
	Regulation Number:	21 CFR 892.156021 CFR 892.157021 CFR 892.2050
	Product Code:	IYOITXLLZ
	Regulatory Class:	Class II
	Classification Panel:	Radiology
PredicateDevice	Trade Name:	BD Prevue II Peripheral Vascular Access System
	Common Name:	Ultrasound System with Needle Tracking
	Regulation Name:	Ultrasonic Pulsed Echo Imaging SystemDiagnostic Ultrasonic TransducerPicture Archiving and Communication System
	Regulation Number:	21 CFR 892.156021 CFR 892.157021 CFR 892.2050
	Product Code:	IYOITXLLZ
	Regulatory Class:	Class II
	Classification Panel:	Radiology
	Premarket Notification Number:	K211193
DeviceDescription	BD Prevue™ II Peripheral Vascular Access System Device Description:
	The BD Prevue™ II Peripheral Vascular Access System is a portable device that features real-time 2D ultrasound imaging, customized vascular access applications, proceduredocumentation, vessel measurement tools, and electronic connectivity (if enabled).
	Cue™ Needle Tracking System Description:
	Imaging Applications	Exam Type (Adult and Pediatric)
Indications for Use	Vascular	Assessment of vessels in the extremities and neck leading to orcoming from the heart, superficial veins in the arms and legs, andvessel mapping. Assessment of superficial thoracic vessels.
	Vascular Access	Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterialline placement, access to fistula and grafts, and general vein andartery access in adult and pediatric patients, including thosepatients with difficult intravascular access who may have small,fragile, and/or non-palpable vessels.
TechnologicalCharacteristics	Technological characteristics of the subject BD Prevue™ II Peripheral Vascular Access Systemare substantially equivalent with respect to design and function to those of the cited predicatedevice. The key modification made to the subject device when compared to the predicatedevice is the specification of difficult intravascular access (DIVA) patients in the indications foruse. As a result, the indications for use in the product instructions for use was updated toreflect the modification. There are no other differences between the subject and predicatedevice.
PerformanceTests	As part of Bard Access Systems, Inc.'s design controls, risk analysis wasconducted to assess the impact of the proposed subject device indications for usemodifications. The results of the risk analysis determined that no verification or validationactivities were required because the subject device modifications to the Indications for use andresulting modifications to the instructions for use and labeling do not include any changes tothe design, materials, performance, or risk profile of the cited predicate device and theperformance testing conducted in the predicate device clearance (K211193) covers theproposed specified difficult intravascular access patient population. Therefore, it is notnecessary to conduct additional verification and validation testing.

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Image /page/5/Picture/1 description: The image shows two company logos. The first logo consists of an orange starburst-like symbol to the left of the letters "BD" in blue. The second logo shows the word "BAIRD" in green. Below the word "BAIRD" is the phrase "has joined BD" in a smaller font.

BD Prevue™ II Peripheral Vascular Access System Special 510(k) Premarket Notification

BD Prevue™ II Peripheral Vascular Access System is indicated for Vascular and Vascular Access Imaging Applications performed by appropriately trained healthcare professionals in a medical setting. Typical examinations performed using the BD Prevue™ II Peripheral Vascular Access System include:

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Image /page/6/Picture/1 description: The image shows the logos of two companies, BD and BARD. The BD logo is in blue, and the BARD logo is in green. Underneath the BARD logo, it says "has joined BD" in a smaller font. The BD logo is on the left, and the BARD logo is on the right.

BD Prevue™ II Peripheral Vascular Access System Special 510(k) Premarket Notification

Summary of	The modification to the indications for use and resulting modifications to the product
Substantial	instructions for use has no impact on the intended use, technological characteristics, or risk
Equivalence	predicate device. Therefore, the subject BD Prevue™ II Peripheral Vascular Access System issubstantially equivalent to the predicate BD Prevue™ II Peripheral Vascular Access System.

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.