(10 days)
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 Site
Rite 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 Site
Rite 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 Site
Rite 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.
§ 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.