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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

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The results of the risk analysis determined that no verification or validation activities were required because the subject device modifications to the Indications for use and resulting modifications to the instructions for use and labeling do not include any changes to the design, materials, performance, or risk profile of the cited predicate device. Therefore, it is not necessary to conduct additional performance tests including verification and validation."

This means there was no new test set specifically for this 510(k) submission to assess the AccuCath Ace™ in the context of the DIVA indication. The claim of equivalence is based on the previously cleared predicate device and earlier incremental changes.

However, the document mentions: "Verification testing was carried out on all changed aspects: the needle, packaging, ultrasound system/Cue compatibility, tracking accuracy, and magnetization. All acceptance criteria was met".

• Sample Size: Not specified.
• Data Provenance: Not specified, but these prior tests would likely have been internal validation tests conducted by the manufacturer.

The submission also cites "a body of literary evidence demonstrating that the AccuCath Ace Intravascular Catheter has equivalent or better outcomes in DIVA patients compared to catheters with no guidewire." This refers to clinical literature, not a new test set conducted by the manufacturer for this submission. The specifics of this literature (e.g., sample sizes, countries of origin, retrospective/prospective) are not provided within this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as a new test set requiring expert ground truth establishment was not conducted for this 510(k) submission. For the "body of literary evidence," the ground truth would be established by the clinicians and researchers involved in those studies, but their specific numbers and qualifications are not detailed here.

4. Adjudication Method for the Test Set

Not applicable, as a new test set was not conducted for this 510(k) submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done as part of this submission. The submission relies on existing clinical literature (not a new study conducted for this submission) that suggests improved outcomes for DIVA patients with the AccuCath Ace™ Intravascular Catheter compared to catheters without a guidewire. No "effect size of how much human readers improve with AI vs without AI assistance" is relevant or provided, as this is a medical device, not an AI-assisted diagnostic tool for human readers.

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

Not applicable, as this is a medical device (intravascular catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the previously conducted "verification testing" for incremental changes (e.g., Cue compatibility), the ground truth would have been established through objective measurement and engineering standards.

For the claim regarding DIVA patients, the submission refers to "a body of literary evidence demonstrating that the AccuCath Ace Intravascular Catheter has equivalent or better outcomes in DIVA patients compared to catheters with no guidewire. These outcomes include improved first attempt success, reduction of insertion complications, improved completion of therapy, increased dwell time of the catheter, and overall patient and clinician satisfaction." This implies that the ground truth for these claims comes from outcomes data reported in clinical literature.

8. The Sample Size for the Training Set

Not applicable, as this is a medical device, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is a medical device, not a machine learning model.

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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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