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The AccuCath Ace™ Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used for adult and pediatric patients, including those patients with difficult intravascular access who may have small, fragile, and/or non-palpable vessels, with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath Ace™ IV Catheter is suitable for use with power injectors.

The AccuCath Ace™ Intravascular Catheter system consists of a radiopaque catheter with a valve mechanism delivered over a guidewire with an atraumatic tip design; a flashback chamber to enhance flashback visualization, and a safety container that prevents sharp injuries. The AccuCath Ace IV Catheter is designed to reduce blood exposure during insertion, for use with ultrasound, and for use with the Cue Needle Tracking System.

The information provided indicates that the AccuCath Ace™ Intravascular Catheter did not undergo a new study to prove it meets acceptance criteria for its current submission. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (AccuCath™ Intravascular Catheter, K162894) based on a modification to its Indications for Use, which now explicitly includes patients with difficult intravascular access (DIVA).

The document states that a risk analysis determined that no verification or validation activities were required because the modifications to the Indications for Use and labeling "do not include any changes to the design, materials, performance, or risk profile of the cited predicate device."

Therefore, the "acceptance criteria" and "device performance" described below are in reference to the previous clearance of the predicate device and the modifications that had been made to it, for which "Verification, sterilization, biocompatibility, and packaging testing was carried out as necessary for each of these changes at the time of the change." The current submission does not detail these specific tests, their criteria, or results, but rather asserts that the changes "were found to be as safe and as effective and introduced no new or modified risks."

The table below summarizes the information provided regarding the comparison between the subject device (AccuCath Ace™ Intravascular Catheter) and its predicate device (AccuCath™ Intravascular Catheter, K162894), highlighting what is considered "met" based on the substantial equivalence argument rather than new primary testing.

1. Table of Acceptance Criteria and Reported Device Performance

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The SiteRite™ 9 Ultrasound 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
• · Small Organ (breast, thyroid, parathyroid, testicles)
• · Musculo-skeletal (conventional and superficial)
• · Cardiac (adult and pediatric)

The SiteRite™ 9 Ultrasound System is indicated for Vascular, Vascular Access, Interventional, and Superficial Imaging Applications. Typical examinations performed using the SiteRite™ 9 Ultrasound 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.
Interventional: Guidance for biopsy and drainage.
Superficial: Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, musculoskeletal procedures, soft tissue structures, and surrounding anatomical structures.

The subject device, the SiteRite™ 9 Ultrasound System ("SiteRite 9 System") is a portable device that features real-time 2D ultrasound imaging for vascular access device placement, which includes vessel measurement tools, vascular access device selection, procedure documentation and electronic connectivity.

The subject SiteRite 9 System is intended to aid in the placement of peripheral and central line vascular access devices and ultimately increase first stick success. The system is the replacement platform for the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (i.e., the predicate device) and includes more up-to-date and reliable components aimed at providing improved image quality, while maintaining ease of operation.

The subject SiteRite 9 System can be viewed as the next generation SiteRite™ ultrasound system and is equivalent from a functionality standpoint to its predicate device, to the SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (K182281). The SiteRite 9 System is essentially replacing its predicate device, the SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology ("Site~Rite 8 System"), due to the end-oflife obsolescence of its components.

The subject SiteRite 9 System differs from its predicate device, the Site~Rite 8 System (K182281). in that it includes newer, more "state of the art" hardware components resulting in a more efficient and reliable use of the device. Aside from these technical upgrades, most of the previously cleared features of the predicate device are being brought forward.

The subject SiteRite 9 System includes the following main components:

• Ultrasound System Console
• Ultrasound Beamformer
• System Software
• 9 Ultrasound Probe

Additionally, the subject SiteRite 9 System is compatible with the following accessories:

• SiteRite™ Probe Cover Kits
• Site~Rite® Needle Guide Kits
• Pinpoint TM GT Needle Guide Kits
• MER Roll Stand with Mounting Accessory (optional accessory)
• Kickstand with Mounting Accessory (optional accessory)
• Sony Printer UP-X898MD (off-the-shelf, optional accessory)
• USB Storage Device (off-the-shelf, optional accessory)

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the SiteRite™ 9 Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not include a specific table of quantitative acceptance criteria and corresponding device performance metrics for the SiteRite™ 9 Ultrasound System itself. Instead, it relies on a qualitative comparison to a predicate device and a statement that the device "successfully passed all respective testing" based on applicable standards and guidance documents.

However, based on the text, the overarching acceptance criterion is substantial equivalence to the predicate device (Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology, K182281), particularly in terms of:

• Intended Use: Diagnostic ultrasound imaging of the human body.
• Indications for Use: Pediatric, Peripheral Vessel and Vascular Access, Small Organ, Musculo-skeletal, Cardiac imaging applications, and guidance for procedures.
• Technological Characteristics: Same fundamental scientific technology (piezoelectric material, 2D ultrasound imaging), patient-contacting materials, and software features.
• Safety and Performance: Demonstrated through non-clinical testing to meet relevant safety and performance requirements.

Reported Device Performance:
The document primarily states that the device "passed all respective testing" and that its performance "support[s] substantial equivalence to the predicate device." It also highlights that the SiteRite™ 9 includes "newer, more 'state of the art' hardware components resulting in a more efficient and reliable use of the device" and aims for "improved image quality" compared to its predicate.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size for any specific individual non-clinical test set. The data provenance is internal to Bard Access Systems, Inc. (C.R. Bard, Inc.) through their conducted "extensive verification and validation testing." As this is a non-clinical submission, the data would be laboratory-based and not related to patient retrospective or prospective data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. Given that the testing is non-clinical (primarily bench testing) and relies on compliance with standards rather than expert review of images, the concept of "ground truth" established by experts in the clinical sense is not applicable here.

4. Adjudication method

This information is not provided and is not relevant for the type of non-clinical testing described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device described is an ultrasound system, not an AI-powered diagnostic tool, and the submission explicitly states: "No clinical testing was conducted in support of the SiteRite™ 9 Ultrasound System, as the intended use, indications and technology are equivalent to those of the predicate device."

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

No, a standalone performance study in the context of an algorithm's performance was not done. This device is a hardware-software integrated ultrasound system, not an independent algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be defined by engineering specifications, established physical properties, and compliance with recognized standards (e.g., acoustic output limits, electrical safety parameters, image quality metrics as defined by test phantoms or calibrated equipment). For example, "Acoustic Safety Testing" would have acceptance criteria based on standard limits for acoustic output, and the "ground truth" is that the device's output should not exceed those limits when measured.

8. The sample size for the training set

This information is not applicable and not provided. The SiteRite™ 9 Ultrasound System is not described as an AI/ML device that requires a training set for model development. It's a traditional medical imaging device.

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

This information is not applicable and not provided, as there is no training set mentioned for an AI/ML model.

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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

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:

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.

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