(30 days)
BD Prevue™ II Peripheral Vascular Access System is indicated for Vascular Access Imaging Applications performed by appropriately trained healthcare professionals in a medical setting. Typical examinations performed using the BD Prevue™ II Peripheral Vascular Access System include:
Imaging Applications:
Vascular [Exam Type (Adult and Pediatric)]: Assessment of vessels in the extremities and neck leading to or coming from the heart, superficial veins in the arms and legs, and vessel mapping. Assessment of superficial thoracic vessels. Vascular Access [Exam Type (Adult and Pediatric)]: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and general vein and artery access in adult and pediatric patients, including those patients with difficult intravascular access who may have small, fragile, and/or non-palpable vessels.
The BD Prevue™ II Peripheral Vascular Access System is a portable device that features real-time 2D ultrasound imaging, customized vascular access applications, procedure documentation, vessel measurement tools, and electronic connectivity (if enabled).
The BD Prevue™ II Peripheral Vascular Access System is equipped with Cue™ Needle Tracking System which is designed to track and display the location and trajectory of a needle under ultrasound guidance. The technology consists of software installed on an ultrasound system and sensors incorporated into the ultrasound probes. The sensors detect a passive magnetic field emitted from the needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle during the insertion process.
The Cue™ Needle Tracking System requires the use of either the Cue™ Traditional Probe or Cue™ Vascular Access Probe, the Cue™ Magnetizer and a Cue™ enabled needle. The Cue™ Traditional Probe and Vascular Access Probe contain sensors for tracking Cue™ compatible needles (following magnetization by the Cue™ Magnetizer). The tracked needle's current position, trajectory, and intersection window are displayed over the ultrasound image.
The information provided pertains to the BD Prevue™ II Peripheral Vascular Access System. The device has undergone an administrative change to its 510(k) to include the specification of difficult intravascular access (DIVA) patients in its indications for use.
Based on the provided text, a new study was not conducted to specifically prove the device meets new acceptance criteria for the updated indication. Instead, the manufacturer, Bard Access Systems, Inc. (now BD), states that no new verification or validation activities were required because the modifications to the Indications for Use and the Instructions for Use do not involve changes to the device's design, materials, performance, or risk profile. The performance testing conducted for the predicate device clearance (K211193) is deemed to cover the proposed specified difficult intravascular access patient population.
Therefore, the acceptance criteria and performance data referenced are those from the original submission (K211193) for the predicate device, which is the same device, the BD Prevue™ II Peripheral Vascular Access System, but with a narrower previous indication.
Due to the administrative nature of this submission (K240146) and the reliance on previous predicate device testing, the provided text does NOT contain the specific details required for sections 1-9 as no new study was performed for this 510(k).
However, I can extract the available information regarding the device and the rationale for not requiring a new study for K240146:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria for K240146: Not explicitly stated as new criteria in this document. The submission relies on the existing performance data and acceptance criteria established for the predicate device (K211193), which is deemed to cover the expanded indication.
- Reported Device Performance for K240146: Not explicitly stated as no new performance data was generated for this administrative change. The statement is that the original performance testing for K211193 is sufficient.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable for K240146, as no new test set was used. The submission relies on the performance testing from the predicate device (K211193).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable for K240146, as no new ground truth establishment was reported. The submission relies on the performance testing from the predicate device (K211193).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable for K240146, as no new test set was used. The submission relies on the performance testing from the predicate device (K211193).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This device is an Ultrasound System with Needle Tracking, not an AI-assisted diagnostic tool for interpretation of medical images by human readers. Therefore, an MRMC comparative effectiveness study of this nature is not applicable in the context of this device's function.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- The BD Prevue™ II Peripheral Vascular Access System is a medical imaging device with needle tracking capability, which is inherently used with human-in-the-loop (healthcare professional). Therefore, a standalone algorithm-only performance study is not applicable for this type of device. The "Cue™ Needle Tracking System" is described as software and sensors that create a virtual image for the clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for K240146, as no new ground truth establishment was reported. The submission relies on the performance testing from the predicate device (K211193). For an ultrasound imaging and needle tracking system, ground truth in previous studies would likely involve phantom studies for accuracy, clinical observations for usability and performance in procedures, or comparison to established imaging modalities.
8. The sample size for the training set
- Not applicable for K240146, as no mention of a training set for a new study is made. The device performs real-time 2D ultrasound imaging and needle tracking; while it uses software, the context does not indicate an AI model requiring a "training set" in the common sense for diagnostic interpretations. If machine learning is involved in the needle tracking, details about its training set would reside in the K211193 submission.
9. How the ground truth for the training set was established
- Not applicable for K240146 for the same reasons as #8.
§ 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.