(58 days)
The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
mode ultrasonic pulsed echo imaging system designed primarily to assist physicians in gaining vascular access to major veins and arteries. The SiteRite® 6 Ultrasound System is portable and therefore easy to use at the bedside and in a variety of clinical scenarios, including intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. In addition, the SiteRite® 6 Ultrasound System is designed with simple operating controls to facilitate easy operation.
The Pinpoint™ GT Technology is designed to track and display the location and trajectory of a needle under ultrasound guidance. The technology consists of software installed on an ultrasound system and sensors incorporated into the ultrasound probe. The sensors detect a passive magnetic field emitted from a needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.
This document is a 510(k) summary for the Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology, indicating its substantial equivalence to predicate devices for ultrasound guidance and imaging.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists several standards that the device met. It does not provide specific numerical acceptance criteria or performance metrics for the Pinpoint™ GT Technology itself beyond confirming it met "predetermined performance requirements." The listed standards are primarily for general medical electrical equipment, usability, software, and biological evaluation, rather than specific performance metrics for the needle tracking feature.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| IEC 60601-1:2005, CORR. 1(2006), CORR 2(2007) (Medical Electrical Equipment - Basic Safety and Essential Performance) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 60601-1-2:2007 (Medical Electrical Equipment - Electromagnetic Compatibility) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 60601-2-37:2007 (Particular Requirements for Ultrasonic Medical Diagnostic and Monitoring Equipment) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 60601-1-6:2010 (Medical Electrical Equipment – Usability) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 62304:2006 (Medical Device Software - Software Life Cycle Processes) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 62366:2007 (Medical Devices - Application of Usability Engineering) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| ISO 10993-1:2009 (Biological Evaluation of Medical Devices) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that "Verification and validation activities were designed and performed to demonstrate that the subject Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology met predetermined performance requirements." However, specific sample sizes for any test sets used to evaluate the Pinpoint™ GT Technology are not provided.
The data provenance (e.g., country of origin of the data, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications:
This information is not provided in the document. The filing discusses engineering standards rather than clinical trial data involving expert interpretations for ground truth.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on showing substantial equivalence through adherence to technical standards and comparison to predicate devices, rather than measuring human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
The document describes the Pinpoint™ GT Technology as "software installed on an ultrasound system and sensors incorporated into the ultrasound probe" that "interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display." This implies that the technology functions as an algorithm providing visual tools for tracking. However, a specific standalone performance study comparing the algorithm's output against a defined ground truth for the needle tracking functionality is not explicitly detailed with performance metrics. The evaluation appears to be integrated into the overall system's verification and validation.
7. Type of Ground Truth Used:
Given the nature of the evaluation mentioned (adherence to technical standards and comparison to predicate devices for imaging features and needle tracking visualization), the "ground truth" would likely involve physical measurements and phantom studies for accuracy and precision of needle tracking and imaging quality, rather than expert consensus on diagnostic interpretations, pathology, or outcomes data in a clinical setting. However, the specific methods for establishing ground truth for the Pinpoint™ GT Technology's performance are not explicitly stated beyond meeting technical requirements.
8. Sample Size for the Training Set:
This document is a 510(k) summary for a medical device (ultrasound system with a needle tracking technology). The listed studies are for verification and validation, primarily addressing compliance with electrical, safety, usability, and software standards. There is no mention of a training set in the context of machine learning, as this document predates broad discussions of AI/ML in FDA filings in this manner. The "technology" refers to creating a virtual image from sensor data, which is more likely a deterministic algorithm than a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set for the reasons stated above, this information is not applicable and therefore not provided in the document.
§ 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.