(65 days)
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.
The subject device, the BD Prevue™ II Peripheral Vascular Access System ("Prevue II System") is a portable device that features real-time 2D ultrasound imaging, customized vascular access applications, procedure documentation, vessel measurement tools and electronic connectivity (if enabled).
The subject Prevue II System is intended to aid in the placement of peripheral vascular access devices and ultimately increase first stick success. The system is intended to be a relatively low cost, easy to use and adaptable system, targeted specifically for use in the Intensive Care Unit (ICU) and Emergency Department (ED).
The subject Prevue II System can be viewed as the next generation Prevue ultrasound system (i.e., K120882 and K150529) and is essentially a pareddown version of its predicate device, the Site® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (K182281).
The subject Prevue II System includes the optional Cue™ Needle Tracking System, which is the same identical needle quidance technology already cleared with the predicate device, the Site~Rite® 8 Ultrasound System, under K182281.
The Cue™ Needle Tracking System technology is designed to track and display the location and traiectory of a needle under ultrasound quidance. The technology consists of software installed on the Prevue II System and a sensor incorporated into the ultrasound probes. The ultrasound probe sensor detects a passive magnetic field emitted from a needle that has been previously magnetized using the Cue™ Needle Tracking System Magnetizer, which is a system also included in the predicate device. The probe interprets the data received from the sensor and creates a virtual imaqe of the needle on the ultrasound display, providing clinicians with a visual representation of the needle during the insertion process. The tracked needle's current position, trajectory and intersection window are displayed over the ultrasound image. The Cue™ Needle Tracking System is currently included with the predicate device and is not a subject of this 510(k) submission.
The subject Prevue II System differs from its predicate device, the Site® 8 Ultrasound System (K182281), in that it provides a more portable and simpler to use device that can be operated by less experienced ultrasound users, primarily in an ICU and/or ED medical setting. Aside from this simplification of features, most of the other previously cleared features of the predicate device are being brought forward.
The subject Prevue II System includes the following main components:
- Ultrasound System Console .
- Ultrasound Beamformer ●
- System Software (including Cue™ Needle Tracking System Software) ●
- Ultrasound Probes (Cue™ compatible) ●
- Cue™ Needle Tracking System Hardware (i.e., Magnetizer and RFID . Reader)
Additionally, the subject Prevue II System is compatible with the following accessories:
- Site~Rite® Probe Cover Kits ●
- Cue™ Magnetizer ●
- Cue™ Compatible Needles
- Probe Holder Accessory ●
- Cable Wrap Accessory
- . Prevue II Magnetizer Cover
- Prevue II Roll Stand ●
- . USB Storage Device (off-the-shelf flash-drive used to save files or perform software updates)
Here's a breakdown of the acceptance criteria and the study information for the BD Prevue™ II Peripheral Vascular Access System, based on the provided document:
This document describes a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically means that clinical performance studies proving efficacy (like a comparative effectiveness study with human readers) are often not required if substantial equivalence can be shown through non-clinical testing and comparison of intended use, indications, and technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with reported performance for each criterion in the way a clinical trial might. Instead, it states that "Acceptance criteria have been established to ensure that the subject device performs in a manner that is substantially equivalent to the cited predicate device." The "reported device performance" is described as the device successfully passing a series of non-clinical tests.
Summary of Acceptance - Non-Clinical Tests Passed:
| Test Category | Description of Acceptance (Implicit) | Reported Device Performance |
|---|---|---|
| Acoustic Safety Testing | Compliance with relevant acoustic safety standards. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| System Electrical Safety Testing | Compliance with relevant electrical safety standards (e.g., IEC 60601-1). | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Electromagnetic Compatibility Testing | Compliance with relevant EMC standards (e.g., IEC 60601-1-2). | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| FCC Compliance Testing | Compliance with FCC regulations (Parts 18, 15 B, 15 C). | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Biocompatibility Testing | Compliance with biological safety standards for patient-contacting materials (e.g., ISO 10993-1). | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| System Mechanical Testing | Verification of mechanical integrity and function. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Fluid Ingress Testing | Verification of protection against fluid penetration. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Operating Temperature and Humidity Testing | Verification of performance under specified environmental conditions. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Electrical Reliability Testing | Verification of electrical component reliability. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Software Verification Testing | Verification that software functions as intended (e.g., IEC 62304). | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Cybersecurity Assessment | Assessment of cybersecurity risks and controls. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Human Factors and Validation | Assessment of usability and user interface (e.g., IEC 62366-1, FDA Guidance on Human Factors). | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Ultrasound Image Testing | Verification of image quality and diagnostic capabilities. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Ultrasound Response Time Testing | Verification of timely response of ultrasound imaging. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Cue Needle Tracking Accuracy Testing | Verification of the accuracy of the Cue™ Needle Tracking System. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Cue Tools Accuracy Testing | Verification of the accuracy of other Cue™-related tools. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Cleaning/Reprocessing Testing | Verification of cleaning and reprocessing compatibility. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Ship Testing | Verification of device integrity after shipping conditions. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
| Roll Stand Testing | Verification of the stability and functionality of the roll stand accessory. | The device complies with all applicable voluntary standards related to its regulations and product codes and successfully passed all respective testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of cases, images, or patients. The non-clinical tests relate to device performance characteristics rather than diagnostic accuracy on a patient dataset.
- Data Provenance: Not applicable as the studies were non-clinical, bench testing, and engineering verification and validation. There's no mention of country of origin for patient data or retrospective/prospective collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Experts for Ground Truth: Not applicable. The "ground truth" here is compliance with engineering specifications and regulatory standards, which are demonstrated through validated test methods and measurements, not expert consensus on medical images for diagnostic accuracy.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As this is non-clinical performance data, the testing involves objective measurements against established criteria and standards rather than subjective expert adjudication of medical performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. The document explicitly states: "No clinical testing was conducted in support of the BD Prevue™ II Peripheral Vascular Access System, as the intended use, indications and technology are equivalent to those of the predicate device." Therefore, there is no information on the effect size of human readers improving with AI vs. without AI assistance. The device is primarily an ultrasound imaging system with needle tracking, not an AI-assisted diagnostic interpretation tool in the traditional sense of comparing human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: The "Cue™ Needle Tracking System" is an integrated component of the device. Its accuracy (a form of standalone performance for the tracking algorithm) was tested as part of the "Cue Needle Tracking Accuracy Testing" and "Cue Tools Accuracy Testing." However, the specific results or metrics for this standalone performance (e.g., tracking error in mm) are not provided; only that it passed the testing. This is distinct from a standalone diagnostic algorithm for image interpretation.
7. Type of Ground Truth Used
- Ground Truth Type: For the non-clinical tests, the "ground truth" used is defined by engineering specifications, validated test methods, and compliance with national and international voluntary standards (e.g., IEC and ISO standards for safety, EMC, software, usability, etc., and FDA guidance documents). For accuracy tests of the Cue™ Needle Tracking System, the ground truth would be precise physical measurements of needle position and trajectory.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document describes a 510(k) submission for a medical device (ultrasound system with needle tracking), not a machine learning or AI algorithm in the context of being trained on a large dataset of patient images. While the device contains software, the phrase "training set" in an ML context is not used or relevant here. The software development process would follow standards like IEC 62304.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as no training set (in the machine learning sense) is mentioned or implied for this device's regulatory review.
§ 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.