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The SiteRite IV Ultrasound System with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously. The SiteRite IV Ultrasound System is not intended for ophthalmic applications.

The Site-Rite IV pulsed echo ultrasound system is a lightweight, lowoutput, portable, real-time, B-mode, ultrasound scanner designed primarily to assist clinicians in gaining vascular access to major veins, arteries and organs. It is a unique scanner that offers high resolution imaging to the depth of 18 cm. Site-Rite is portable and thus easy to use at the bedside and in a variety of clinical settings: intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. The Site-Rite IV ultrasound scanner can be operated on battery or AC power. It utilizes only proprietary probes manufactured and currently marketed by Dymax, with frequencies ranging from 3.5 MHz to 9.0 MHz. Image depth depends on the choice of probe and ranges from a minimum of 0.5 cm with the 9.0 MHz probe to a maximum of 18 cm with the 3.5 MHz probe. The disposable items, supplied in sterile packs, are currently marketed products.

The provided 510(k) summary for the Site~Rite IV Ultrasound Scanner (K032135) does not contain acceptance criteria or detailed study results directly proving the device meets specific performance acceptance criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (SiteRite 3 Ultrasound Scanner K993624 and Dymax SiteRite II Ultrasound System K862127). The core argument is that the Site~Rite IV has identical indications for use and similar technological characteristics, with updates primarily for manufacturability and reliability, and that these differences do not raise new questions of safety and effectiveness.

Here's an breakdown of the information available, and what is explicitly not included based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided within this document.

The document states: "Performance data are presented in the 510(k) and these data demonstrate equivalence." However, the summary itself does not contain a table of specific acceptance criteria (e.g., image resolution targets, penetration depth targets) or quantitative performance metrics for the Site~Rite IV or its predicates. The "performance data" mentioned would be in a separate, more detailed section of the 510(k) submission, not summarized here.

The document does mention the following capabilities:

• Imaging Depth: "high resolution imaging to the depth of 18 cm."
• Depth Range (by probe):
  • 9.0 MHz probe: minimum 0.5 cm
  • 3.5 MHz probe: maximum 18 cm

These are descriptive capabilities, not acceptance criteria with specific thresholds.

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

Not applicable/provided for a specific "test set" demonstrating acceptance criteria.

The submission relies on equivalence to predicate devices and general standards. It mentions: "Clinical studies carried out using the SiteRite 2 device, which uses the same transducers and image processing algorithms, has shown the usefulness of the SiteRite for needle placement in a number of different vascular and non-vascular applications. These studies are summarized and reports are included in the 510(k)."

• Sample Size: Not specified.
• Data Provenance: "Clinical studies carried out using the Site~Rite 2 device" - implying these were conducted prior to this submission and likely involved human subjects for clinical usefulness. The country of origin and whether they were retrospective or prospective are not mentioned in this summary.

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

Not applicable/provided.

Since there's no specific "test set" for the SiteRite IV's de novo performance assessment, there's no mention of experts establishing ground truth for such a test. The reliance is on the predicate device's established performance and the SiteRite IV's equivalent characteristics.

4. Adjudication Method for the Test Set

Not applicable/provided.

Again, without a specified "test set" for performance evaluation, adjudication methods are not discussed.

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

No, there is no mention of an MRMC comparative effectiveness study.

The submission does not discuss human readers, AI, or improvements with AI assistance. This device is an ultrasound scanner, not an AI-powered diagnostic tool in the sense of the examples typically related to MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/provided.

This device is an imaging system for clinical use with a human operator, not a standalone algorithm.

7. The Type of Ground Truth Used

Not explicitly stated for the Site~Rite IV.

For the predicate Site~Rite 2 device, the "clinical studies" likely established "usefulness" in needle placement based on medical outcomes or expert observation during procedures ("clinical utility"). This would generally fall under outcomes data or expert observation/clinical assessment from the real-world use of the device for its intended purpose.

8. The Sample Size for the Training Set

Not applicable/provided.

This is a traditional medical imaging device, not a machine learning or AI-based system that would typically have a "training set" in the context of algorithm development.

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

Not applicable/provided.

As above, this concept does not apply to the type of device and submission described.

Summary of Device Performance and Equivalence Argument:

The SiteRite IV Ultrasound Scanner demonstrates its "performance" and meets regulatory requirements by demonstrating substantial equivalence to its predicate devices (SiteRite 3 and Site~Rite II).

• Identical Indications for Use: The SiteRite IV has the same intended uses as the SiteRite 3.
• Technological Characteristics: Similar to predicates, with updates for manufacturability and reliability, particularly a digital design (like SiteRite 3) compared to the analog SiteRite II.
• Transducers: Unchanged from currently marketed products. The submission lists 3.5 MHz, 5.0 MHz, 7.5 MHz, and 9.0 MHz probes, each with various B-mode clinical applications (Abdominal, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Peripheral Vascular, Conventional Musculo-skeletal, and Pediatric for some).
• Testing: Electrical safety, electromagnetic emissions, and acoustic output testing were performed, and the results demonstrate equivalence with predicate devices and meet FDA guidance recommendations.
• Clinical Studies (Predicate Device): Usefulness for needle placement was shown with the SiteRite 2 device, which uses the same transducers and image processing algorithms as the SiteRite IV. This supports the clinical utility and performance of the underlying imaging technology.

In essence, the "study that proves the device meets the acceptance criteria" in this case is the demonstration of substantial equivalence through comparative analysis with predicate devices and adherence to relevant FDA guidance and safety standards, rather than a de-novo study with specific quantitative acceptance criteria for image quality or diagnostic accuracy for the Site~Rite IV itself.

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The Site-Rite 3 ultrasound system with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously. The Site~Rite 3 is not intended for opthalmic applications.

The Site-Rite 3 pulsed echo ultrasound system is a lightweight, lowoutput, portable, real-time, B-mode, ultrasound scanner designed primarily to assist physicians in gaining vascular access to major veins and arteries. It is a unique scanner that offers high resolution imaging to the depth of 18 cm. Site-Rite is portable and thus easy to use at the bedside and in a variety of clinical scenarios: intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. The Site-Rite 3 ultrasound scanner can be operated on battery or AC power. It utilizes only proprietary probes manufactured and currently marketed by Dymax, with frequencies ranging from 3.5 MHz to 9.0 MHz. Image depth depends on the choice of probe and ranges from a minimum of 0.5 cm with the 9.0 MHz probe to a maximum of 18 cm with the 3.5 MHz probe. The disposable items, supplied in sterile packs, are currently marketed products.

The provided text does not contain detailed acceptance criteria and a study specifically designed to demonstrate that the Site-Rite 3 Ultrasound Scanner meets these criteria with reported performance metrics in a structured table or clinical trial format.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and general safety and performance testing.

Here's an analysis based on the information provided, highlighting what is present and what is missing based on your request:

Acceptance Criteria and Device Performance

• The document does not explicitly state specific quantitative acceptance criteria for the Site-Rite 3 Ultrasound Scanner's performance (e.g., specific imaging resolution, penetration depth accuracy, or needle guidance success rates).
• It does not report specific device performance data in a structured table format against predefined criteria.

The information related to performance is qualitative and comparative:

• Claim: "Performance data are presented in the 510(k) and these data demonstrate equivalence." (Section D)
• Claim: "Clinical studies carried out using the SiteRite 2 device, which uses the same transducers and image processing algorithms, has shown the usefulness of the SiteRite for needle placement in a number of different vascular and non-vascular applications. These studies are summarized and reports are included in the 510(k)." (Section F)

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

Study Information Based on Provided Text:

Since a dedicated new clinical study for the Site-Rite 3 demonstrating performance against acceptance criteria is not described in detail, the following points address the mention of studies and the basis for equivalence.

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

• Not explicitly stated for a new study on Site-Rite 3. The document refers to "Clinical studies carried out using the Site~Rite 2 device" which are summarized elsewhere in the 510(k). The sample sizes and data provenance for these previous studies are not detailed here.

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

• Not described. The document mentions "usefulness for needle placement" but does not detail how ground truth was established or by whom in the context of the studies cited for the Site-Rite 2.

4. Adjudication method for the test set:

• Not described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• No, this type of study was not performed or described. The device is an ultrasound scanner, not an AI-based interpretation tool. The document refers to "human readers" (physicians using the device) for guidance, not interpretation.

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

• Not applicable in the AI sense. The device is an imaging tool designed to assist human operators in real-time. It does not perform automated classification or diagnosis in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not explicitly stated for the cited Site-Rite 2 studies. The mention of "usefulness for needle placement" implies success rates or accuracy in reaching target structures, which would likely be determined by direct observation or confirmation (e.g., successful cannulation, fluid aspiration, or post-procedure imaging).

8. The sample size for the training set:

• Not applicable. The device is a hardware imaging system, not a machine learning algorithm that requires a "training set" in the context of AI. Its design and validation rely on engineering principles, predicate device comparison, and clinical utility demonstrated by its predecessor.

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

• Not applicable. (See point 8)

Summary of what the K993624 submission does rely on for substantial equivalence:

• Predicate Device Comparison: The Site-Rite 3 is compared to the Site-Rite 2 (cleared as Dymax Plus 1 Scanner, K862127) and the Dymax Plus 1 (cleared as Dymax TM18, K850478).
• Technological Characteristics: The primary difference is the shift from analog to digital electronics. Crucially, the transducers are unchanged from currently marketed products.
• Non-Clinical Testing: Electrical safety, electromagnetic emissions, and acoustic output testing demonstrated equivalence.
• Clinical Utility (leveraged from predicate): The submission relies on "Clinical studies carried out using the Site~Rite 2 device," which used the same transducers and image processing algorithms (implying the imaging performance relevant to "usefulness for needle placement" is conserved, despite the digital electronics). These studies are summarized and included in the full 510(k) submission, though details are not present in this excerpt.

In essence, the device's clearance is based on the argument that the core imaging performance affecting its intended use (vascular access guidance) is fundamentally unchanged due to the reuse of transducers and comparable image processing, backed by new electrical and acoustic characteristic testing for the revised digital platform.

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