(65 days)
Not Found
No
The document describes a real-time 2D ultrasound imaging system with a needle tracking system based on passive magnetic field detection. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an imaging system intended for diagnosis and guidance during vascular access procedures, not for direct therapeutic intervention. It aids in placing vascular access devices, but does not itself provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The BD Prevue™ II Peripheral Vascular Access System is intended for diagnostic ultrasound imaging of the human body..." and further confirms this in the "Summary of Performance Studies" by stating it is "capable of providing diagnostic ultrasound imaging of the human body."
No
The device description explicitly lists hardware components such as the Ultrasound System Console, Ultrasound Beamformer, Ultrasound Probes, and Cue™ Needle Tracking System Hardware (Magnetizer and RFID Reader). While it includes software, it is not solely software.
Based on the provided information, the BD Prevue™ II Peripheral Vascular Access System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "diagnostic ultrasound imaging of the human body" and "Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access." This describes an imaging and procedural guidance device used on the patient, not a device used to examine specimens from the patient.
- Device Description: The description focuses on real-time 2D ultrasound imaging, vascular access applications, and needle tracking. These are all functions related to imaging and guiding procedures within the body.
- Input Imaging Modality: The input is "Ultrasonic pulsed echo imaging system," which is a method of imaging the inside of the body.
- Anatomical Site: The anatomical sites listed are parts of the human body (extremities, neck, vessels).
- No mention of analyzing biological specimens: There is no indication that the device is used to analyze blood, urine, tissue, or any other biological sample.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The BD Prevue™ II Peripheral Vascular Access System is an imaging and guidance device used directly on the patient.
N/A
Initial Marketing Notification (510k)
Intended Use / Indications for Use
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: 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. Vascular Access Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to 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.
Product codes
IYO, ITX, LLZ
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 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 includes the optional Cue™ Needle Tracking System, which is the same identical needle guidance technology already cleared with the predicate device, the SiteRite® 8 Ultrasound System, under K182281. The Cue™ Needle Tracking System technology is designed to track and display the location and trajectory of a needle under ultrasound guidance. 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 image 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.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).
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human body, specifically vessels in the extremities and neck, superficial veins in the arms and legs, and superficial thoracic vessels.
Indicated Patient Age Range
Pediatric, Adult
Intended User / Care Setting
Appropriately trained healthcare professionals in a medical setting, primarily in an Intensive Care Unit (ICU) and/or Emergency Department (ED).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: C.R. Bard, Inc. has conducted extensive verification and validation testing of the BD Prevue™ II Peripheral Vascular Access System. 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. Nonclinical tests performed include: 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known)
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
| 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.
| 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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3
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 West
Salt Lake City, UT 84116
USA |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fabio De Pasquale
Regulatory Affairs
Tel: 1-250-920-6501
e-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 Access
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
System |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Regulatory Class: | Class II |
| Classification Panel: | Radiology |
4
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™ GT | |
| 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
5
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.
6
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
| 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 | |
| Vascular | |
| Access | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial |
| line placement, access to 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.
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:
7
-
- Small organs (i.e., breast, thyroid, parathyroid, testicles);
-
- Musculo-skeletal (i.e., conventional and superficial);
-
- Cardiac (i.e., adult and pediatric);
-
- Interventional (i.e., quidance for biopsy and drainage); or
-
- 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.
8
Substantial Equivalence Comparison Table
| | Subject Device: | Predicate Device:
(K182281) | |
|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | BD Prevue™ II Peripheral Vascular Access
System | SiteRite® 8 Ultrasound System with Cue™Rite® 8 Ultrasound System with Cue™
Needle Tracking System and Pinpoint™ GT
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 /
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. | The Site
Needle Tracking System and Pinpoint™ GT
Needle Technology is intended for diagnostic
ultrasound 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 and
superficial)
• Cardiac (adult and pediatric) | |
| | Typical examinations performed using the BD
Prevue™ II System include: | Typical examinations performed using the
Site~Rite® 8 Ultrasound System include: | |
| Imaging
Applications | Exam Type (Adult and
Pediatric) | 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. | 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. |
| Vascular Access | Guidance for PICC, CVC,
dialysis catheter, port, PIV,
midline, arterial line
placement, access to fistula
and grafts, and general vein
and artery access | Vascular Access | Guidance for PICC, CVC,
dialysis catheter, port, PIV,
midline, arterial line
placement, access to fistula
and grafts, and general vein
and artery access |
| | | Interventional | Guidance for biopsy and
drainage |
| | | Superficial | Assessment of breast,
thyroid, parathyroid, testicle,
lymph nodes, hernias,
musculoskeletal procedures
(e.g., joints, ligaments,
tendons), soft tissue
structures, and surrounding
anatomical structures |
| The Cue™ Needle Tracking System is intended to
provide visual needle tracking to assist with
ultrasound guided vascular access. | | Cue™ Needle Tracking System and Pinpoint™
GT Needle Technology are each intended to
provide visual needle tracking to assist with
ultrasound guided vascular access. | |
| Environment of
Use | Hospital/clinic medical setting. | | Hospital/clinic medical setting. |
9
10
| Track 1 or
| Track 3 | Track 1 | Track 1 | |
|---|---|---|---|
| Power Source | AC Adapter with Internal Lithium-Ion Battery | ||
| Pack. |
Power Consumption: 65 W | AC Adapter with Internal Lithium-Ion Battery
Pack.
Power Consumption: 60 W | |
| System
Components | The BD Prevue™ II Ultrasound System includes
the following components:
Prevue II Console Ultrasound Beamformer Software Ultrasound Probes Cue™ Needle Tracking System Hardware | The Site-Rite® 8 Ultrasound System includes the
following 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 lbs
Graphic User Interface (GUI):
Touchscreen user interface with icons to access all
available functionality, including the Cue™ Needle
Tracking System. | The Site-Rite® 8 Ultrasound System includes:
10" Touch Screen Monitor Portable Weight 5 lbs
Graphic User Interface (GUI):
Touchscreen user interface with icons to access
all available functionality, including the Cue™
Needle Tracking System. | |
| Ultrasound
Beamformer | The BD Prevue™ II Ultrasound System uses B
mode for all compatible probes. | The Site-Rite® 8 Ultrasound System uses B
mode for all compatible probes. | |
| Ultrasound
Features | The BD Prevue™ II Ultrasound System includes
the following features:
Intuitive controls allowing for rapid and
easy operation; Choice of battery or line voltage power: | The Site-Rite® 8 Ultrasound System includes the
following features:
Intuitive controls allowing for rapid and
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
Detection
Technology | Cue™ Needle Tracking System
Requires the use of:
Prevue™ II Ultrasound System Console. Detachable Cue™ compatible Probe. Cue™ RFID Reader (embedded into the
console handle) and a Cue™ Magnetizer
(mounted to the side of the console). Qualified disposable needle that is present
in the system's needle library and packaged
in Cue™ compatible packaging. | Cue™ Needle Tracking System
Requires the use of:
SiteRite® 8 Ultrasound System Console. Detachable Cue™ compatible Probe. Cue™ RFID-Reader/Magnetizer unit (i.e.,Rite® 8
the "Activator", a component of the
Cue™ Needle Tracking System)
externally connected to the console via
USB cable. Qualified disposable needle that is present
in the system's needle library and
packaged in Cue™ compatible packaging. | |
| | The Cue™ Needle Tracking System software
module is included with the Prevue™ II Ultrasound
System. | The Cue™ Needle Tracking System software
module is included with the Site
Ultrasound System. | |
| | The Cue™ compatible needle is magnetized
("activated") using the Cue™ Needle Tracking
System Magnetizer. | The Cue™ compatible needle is magnetized
("activated") using the Cue™ Needle Tracking
System Activator. | |
| | The Cue™ Needle Tracking System software
module receives the information transmitted by the
Cue™ compatible Probe sensor board. The
software receives information from the sensor
board regarding the relative position and movement | The Cue™ Needle Tracking System software
module receives the information transmitted by
the Cue™ compatible Probe sensor board. The
software receives information from the sensor
board regarding the relative position and | |
| | of a passive magnet with a known magnetic
signature (associated with a specific Cue™
compatible needle). This information is converted
by the software into an overlay that is projected
over the ultrasound image representing the relative
position, projected needle path, and movement of a
needle on the ultrasound image. | movement of a passive magnet with a known
magnetic signature (associated with a specific
Cue™ compatible needle). This information is
converted by the software into an overlay that is
projected over the ultrasound image representing
the relative position, projected needle path, and
movement of a needle on the ultrasound image. | |
| Visualization
Features | The BD Prevue™ II Ultrasound System Console
includes 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 SiteRite® 8 Ultrasound System ConsoleRite® 8 Ultrasound System includes the
includes 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. | |
| Ultrasound
Probes | The BD Prevue™ II Ultrasound System includes
the following 2 probes:
Prevue II Traditional Probe | The Site
following 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 SiteRite 8 Probes Characteristics: Cue™ compatible → Yes Buttons → Yes Acoustics → B-mode imaging | |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
| Accessories | The BD Prevue™ II Ultrasound System is compatible with the following accessories: SiteRite® 8 Ultrasound System is compatible with the following accessories: SiteRite® Probe Cover Kits Probe Holder Accessory MER Roll Stand Cue™ Compatible Needles Cue™ Activator Mounting Arm SiteRite® Needle Guide Kits Pinpoint™ GT Needle Guide Kits Keyboard Kickstand Mounting Accessory SiteRite® 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 SiteRite® 8 Ultrasound System. Users are also | |Rite 8 system. | |
| | | | able to save files or perform software updates
using a standard off-the-shelf USB storage device. |
| Compatible
Needles and
Catheters | All needles available in the market are compatible
with the Prevue II system. | All needles available in the market are compatible
with the Site
| | Additionally, the system is also compatible with all
CueTM catheters currently cleared for sale. | Additionally, the system is also compatible with
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 | |||
| Transducers | ||||
| FDA Guidance | Applying Human Factors and Usability Engineering to Medical | |||
| Devices | ||||
| FDA Guidance | Format for Traditional and Abbreviated 510(k)s | |||
| FDA Guidance | Guidance for the Content of Premarket Submissions for Software | |||
| Contained in Medical Devices | ||||
| FDA Guidance | Content of Premarket Submissions for Management of | |||
| 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 | |||
| of medical devices - Part 1: Evaluation and testing within a risk | ||||
| management process" | ||||
| FDA Guidance | Recommended Content and Format of Non-Clinical Bench | |||
| Performance Testing Information in Premarket Submissions | ||||
| FDA Guidance | The 510(k) Program: Evaluating Substantial Equivalence in | |||
| Premarket Notifications [510(k)] | ||||
| FDA Guidance | Appropriate Use of Voluntary Consensus Standards in Premarket | |||
| Submissions 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 - Part | |||
| 1: General Requirements for Basic Safety and Essential | ||||
| Performance | ||||
| IEC 60601-1-2:2014 | Medical Electrical Equipment - Part 1-2: General Requirements for | |||
| Basic Safety and Essential Performance - Collateral Standard: | ||||
| Electromagnetic Disturbances - Requirements and Tests | ||||
| IEC 60601-1-6:2013 | Medical Electrical Equipment-Part 1-6: General Requirements for | |||
| Basic Safety and Essential Performance - Collateral Standard: | ||||
| Usability | ||||
| IEC 60601-2-37:2015 | Medical Electrical Equipment - Part 2-37: Particular Requirements | |||
| for the Basic Safety and Essential Performance of Ultrasonic | ||||
| Medical Diagnostic and Monitoring Equipment | ||||
| IEC 62359:2017 | Ultrasonics - Field Characterization - Test Methods For The | |||
| Determination Of Thermal And Mechanical Indices Related To | ||||
| Medical 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 to | |||
| Medical Devices | ||||
| ISO 10993-1:2018 | Biological Evaluation of Medical Devices - Part 1: Evaluation and | |||
| Testing within a Risk Management Process | ||||
| ISO 15223-1:2016 | Medical Devices - Symbols To Be Used With Medical Device | |||
| Labels, Labelling, And Information To Be Supplied - Part 1: | ||||
| General Requirements | ||||
| ISO 14971:2007 | Medical Devices - Application of Risk Management To Medical | |||
| Devices |
18
| Standards and Guidance Documents Applicable to Prevue™ II System | |
|---|---|
| Standard/Guidance | Title |
| FCC Title 47 CFR part 18 | Telecommunication, Part 18 - Industrial, Scientific and Medical |
| Equipment | |
| 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.