(131 days)
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.
§ 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.