BD Prevue II Peripheral Vascular Vascular Access System

K211193 · Bard Access Systems, Inc. (C.R. Bard, Inc.) · IYO · Jun 25, 2021 · Radiology

Device Facts

• Record ID: K211193
• Device Name: BD Prevue II Peripheral Vascular Vascular Access System
• Applicant: Bard Access Systems, Inc. (C.R. Bard, Inc.)
• Product Code: IYO · Radiology
• Decision Date: Jun 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended 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: Imaging Applications Exam Type (Adult and Pediatric) Vascular 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. VascularAccess Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, 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 Story

Portable ultrasound system for vascular access guidance in ICU/ED settings. Inputs: ultrasound signals from piezoelectric transducers; passive magnetic field data from magnetized needles via probe-integrated sensors. Processing: beamforming and software-based magnetic tracking; calculates needle position, trajectory, and intersection relative to anatomy. Outputs: real-time 2D ultrasound images with overlaid needle tracking graphics on a 7-inch touchscreen. Operated by trained healthcare professionals. Benefits: aids needle placement, potentially increasing first-stick success. Clinicians use visual feedback to guide needle insertion and verify catheter location.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including acoustic safety, electrical safety, electromagnetic compatibility, biocompatibility, mechanical testing, software verification, cybersecurity assessment, and needle tracking accuracy testing.

Technological Characteristics

Portable ultrasound system; 7-inch touchscreen; piezoelectric transducer; B-mode imaging. Includes Cue™ Needle Tracking System (passive magnetic tracking). Connectivity: USB storage for file management/updates. Power: AC adapter/internal Li-ion battery. Software: Windows 10 Embedded. Sterilization: compatible with probe covers. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and IEC 62359.

Indications for Use

Indicated for pediatric and adult patients requiring diagnostic ultrasound imaging of the human body, specifically for peripheral vessel and vascular access, including PICC, CVC, dialysis catheter, port, PIV, midline, and arterial line placement, and assessment of extremity, neck, and superficial thoracic vessels.

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® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (K182281)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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:

| Imaging<br>Applications | Exam Type (Adult and Pediatric) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vascular | Assessment of vessels in the extremities and neck leading to or coming from the<br>heart, superficial veins in the arms and legs, and vessel mapping. Assessment of<br>superficial thoracic vessels. |
| VascularAccess | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line<br>placement, 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 ( <i>Select one or both, as applicable</i> ) |
|-------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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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.)<br>(Bard has now joined Becton Dickinson)<br>605 North 5600 West<br>Salt Lake City, UT 84116<br>USA |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fabio De Pasquale<br>Regulatory Affairs<br>Tel: [phone]<br>e-mail: [e-mail] |
| Application Correspondent: | |

Date Prepared:

April 21, 2021

Same as Applicant.

#### II. Subject Device Identification

| Proprietary Name: | BD Prevue™ II Peripheral Vascular Access<br>System |
|-----------------------|----------------------------------------------------|
| 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 Processing<br>System |
| 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™<br>Needle Tracking System and Pinpoint™ GT<br>Needle 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 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

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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)

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:

| lmaging<br>Applications | Exam Type (Adult and Pediatric) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vascular | Assessment of vessels in the extremities and neck leading to or coming<br>from the heart, superficial veins in the arms and legs, and vessel<br>mapping. Assessment of superficial thoracic vessels |
| Vascular<br>Access | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial<br>line placement, access to fistula and grafts, and general vein and artery<br>access. |

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);
- 2. Musculo-skeletal (i.e., conventional and superficial);
- 3. Cardiac (i.e., adult and pediatric);
- 4. Interventional (i.e., quidance for biopsy and drainage); or
- 5. 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:<br>(K182281) | |
|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | BD Prevue™ II Peripheral Vascular Access<br>System | Site~Rite® 8 Ultrasound System with Cue™<br>Needle Tracking System and Pinpoint™ GT<br>Needle 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 /<br>Indications for<br>Use | The BD Prevue™ II Peripheral Vascular Access<br>System is intended for diagnostic ultrasound<br>imaging of the human body performed by<br>appropriately trained healthcare professionals in a<br>medical setting. | The Site~Rite® 8 Ultrasound System with Cue™<br>Needle Tracking System and Pinpoint™ GT<br>Needle Technology is intended for diagnostic<br>ultrasound imaging of the human body. | |
| | Specific clinical applications include: | Specific clinical applications include: | |
| | • Pediatric<br>• Peripheral Vessel and Vascular Access | • Pediatric<br>• Peripheral Vessel and Vascular Access<br>• Small Organ (breast, thyroid, parathyroid,<br>testicles)<br>• Musculo-skeletal (conventional and<br>superficial)<br>• Cardiac (adult and pediatric) | |
| | Typical examinations performed using the BD<br>Prevue™ II System include: | Typical examinations performed using the<br>Site~Rite® 8 Ultrasound System include: | |
| Imaging<br>Applications | Exam Type (Adult and<br>Pediatric) | Imaging<br>Applications | Exam Type (Adult and<br>Pediatric) |
| Vascular | Assessment of vessels in the<br>extremities and neck leading<br>to or coming from the heart,<br>superficial veins in the arms<br>and legs, and vessel<br>mapping. Assessment of<br>superficial thoracic vessels. | Vascular | Assessment of vessels in the<br>extremities and neck leading<br>to or coming from the heart,<br>superficial veins in the arms<br>and legs, and vessel<br>mapping. Assessment of<br>superficial thoracic vessels. |
| Vascular Access | Guidance for PICC, CVC,<br>dialysis catheter, port, PIV,<br>midline, arterial line<br>placement, access to fistula<br>and grafts, and general vein<br>and artery access | Vascular Access | Guidance for PICC, CVC,<br>dialysis catheter, port, PIV,<br>midline, arterial line<br>placement, access to fistula<br>and grafts, and general vein<br>and artery access |
| | | Interventional | Guidance for biopsy and<br>drainage |
| | | Superficial | Assessment of breast,<br>thyroid, parathyroid, testicle,<br>lymph nodes, hernias,<br>musculoskeletal procedures<br>(e.g., joints, ligaments,<br>tendons), soft tissue<br>structures, and surrounding<br>anatomical structures |
| The Cue™ Needle Tracking System is intended to<br>provide visual needle tracking to assist with<br>ultrasound guided vascular access. | | Cue™ Needle Tracking System and Pinpoint™<br>GT Needle Technology are each intended to<br>provide visual needle tracking to assist with<br>ultrasound guided vascular access. | |
| Environment of<br>Use | Hospital/clinic medical setting. | | Hospital/clinic medical setting. |

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| Track 1 or<br>Track 3 | Track 1 | Track 1 | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Power Source | AC Adapter with Internal Lithium-Ion Battery<br>Pack.<br><br>Power Consumption: 65 W | AC Adapter with Internal Lithium-Ion Battery<br>Pack.<br><br>Power Consumption: 60 W | |
| System<br>Components | The BD Prevue™ II Ultrasound System includes<br>the following components:<br>Prevue II Console Ultrasound Beamformer Software Ultrasound Probes Cue™ Needle Tracking System Hardware | The Site-Rite® 8 Ultrasound System includes the<br>following components:<br>Site-Rite 8 Console Beamformer Software Ultrasound Probes Cue™ Needle Tracking System Hardware | |
| System Console | The BD Prevue™ II Ultrasound System includes:<br>7" Touch Screen Monitor Portable Weight 3.5 lbs<br>Graphic User Interface (GUI):<br>Touchscreen user interface with icons to access all<br>available functionality, including the Cue™ Needle<br>Tracking System. | The Site-Rite® 8 Ultrasound System includes:<br>10" Touch Screen Monitor Portable Weight 5 lbs<br>Graphic User Interface (GUI):<br>Touchscreen user interface with icons to access<br>all available functionality, including the Cue™<br>Needle Tracking System. | |
| Ultrasound<br>Beamformer | The BD Prevue™ II Ultrasound System uses B<br>mode for all compatible probes. | The Site-Rite® 8 Ultrasound System uses B<br>mode for all compatible probes. | |
| Ultrasound<br>Features | The BD Prevue™ II Ultrasound System includes<br>the following features:<br>Intuitive controls allowing for rapid and<br>easy operation; Choice of battery or line voltage power: | The Site-Rite® 8 Ultrasound System includes the<br>following features:<br>Intuitive controls allowing for rapid and<br>easy 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 Field<br>Detection<br>Technology | Cue™ Needle Tracking System<br>Requires the use of:<br>Prevue™ II Ultrasound System Console. Detachable Cue™ compatible Probe. Cue™ RFID Reader (embedded into the<br>console handle) and a Cue™ Magnetizer<br>(mounted to the side of the console). Qualified disposable needle that is present<br>in the system's needle library and packaged<br>in Cue™ compatible packaging. | Cue™ Needle Tracking System<br>Requires the use of:<br>Site~Rite® 8 Ultrasound System Console. Detachable Cue™ compatible Probe. Cue™ RFID-Reader/Magnetizer unit (i.e.,<br>the "Activator", a component of the<br>Cue™ Needle Tracking System)<br>externally connected to the console via<br>USB cable. Qualified disposable needle that is present<br>in the system's needle library and<br>packaged in Cue™ compatible packaging. | |
| | The Cue™ Needle Tracking System software<br>module is included with the Prevue™ II Ultrasound<br>System. | The Cue™ Needle Tracking System software<br>module is included with the Site~Rite® 8<br>Ultrasound System. | |
| | The Cue™ compatible needle is magnetized<br>("activated") using the Cue™ Needle Tracking<br>System Magnetizer. | The Cue™ compatible needle is magnetized<br>("activated") using the Cue™ Needle Tracking<br>System Activator. | |
| | The Cue™ Needle Tracking System software<br>module receives the information transmitted by the<br>Cue™ compatible Probe sensor board. The<br>software receives information from the sensor<br>board regarding the relative position and movement | The Cue™ Needle Tracking System software<br>module receives the information transmitted by<br>the Cue™ compatible Probe sensor board. The<br>software receives information from the sensor<br>board regarding the relative position and | |
| | of a passive magnet with a known magnetic<br>signature (associated with a specific Cue™<br>compatible needle). This information is converted<br>by the software into an overlay that is projected<br>over the ultrasound image representing the relative<br>position, projected needle path, and movement of a<br>needle on the ultrasound image. | movement of a passive magnet with a known<br>magnetic signature (associated with a specific<br>Cue™ compatible needle). This information is<br>converted by the software into an overlay that is<br>projected over the ultrasound image representing<br>the relative position, projected needle path, and<br>movement of a needle on the ultrasound image. | |
| Visualization<br>Features | The BD Prevue™ II Ultrasound System Console<br>includes the following visualization features:<br>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 Console<br>includes the following visualization features:<br>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. | |
| Ultrasound<br>Probes | The BD Prevue™ II Ultrasound System includes<br>the following 2 probes:<br>Prevue II Traditional Probe | The Site~Rite® 8 Ultrasound System includes the<br>following 3 probes:<br>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 updates<br>using a standard off-the-shelf USB storage device. |
| Compatible<br>Needles and<br>Catheters | All needles available in the market are compatible<br>with the Prevue II system. | All needles available in the market are compatible<br>with the Site~Rite 8 system. | |
| | Additionally, the system is also compatible with all<br>CueTM catheters currently cleared for sale. | Additionally, the system is also compatible with<br>all CueTM catheters currently cleared for sale. | |

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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 and<br>Transducers | | | |
| FDA Guidance | Applying Human Factors and Usability Engineering to Medical<br>Devices | | | |
| FDA Guidance | Format for Traditional and Abbreviated 510(k)s | | | |
| FDA Guidance | Guidance for the Content of Premarket Submissions for Software<br>Contained in Medical Devices | | | |
| FDA Guidance | Content of Premarket Submissions for Management of<br>Cybersecurity in Medical Devices | | | |
| FDA Guidance | Post Market Management of Cybersecurity in Medical Devices | | | |
| FDA Guidance | Use of International Standard ISO 10993-1, "Biological evaluation<br>of medical devices - Part 1: Evaluation and testing within a risk<br>management process" | | | |
| FDA Guidance | Recommended Content and Format of Non-Clinical Bench<br>Performance Testing Information in Premarket Submissions | | | |
| FDA Guidance | The 510(k) Program: Evaluating Substantial Equivalence in<br>Premarket Notifications [510(k)] | | | |
| FDA Guidance | Appropriate Use of Voluntary Consensus Standards in Premarket<br>Submissions for Medical Devices…