(63 days)
The device is intended for use by a trained physician in conjunction with the SonixGPS Needle Sensor to assist in vessel cannulation.
The SonixGPS™ Vascular Access Needle Kit includes: Vascular Access Needle: Disposable sterile vascular access needle Sensor Introducer: Disposable sterile sensor introducer into which the needle sensor (K111818) is inserted Cover: Disposable sterile cover provides a barrier to prevent transfer of microorganisms, body fluids and' particulate material to the reusable component.
The SonixGPS™ Vascular Access Needle Kit underwent performance testing to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Applicable Standard | Test | Acceptance Criteria Met? |
|---|---|---|
| ISO 10993-5:2009 | Cytotoxicity | Yes |
| ISO 10993-7:2008 | Ethylene Oxide Sterilization Residuals | Yes |
| ISO 10993-10:2009 | Sensitization | Yes |
| ISO 10993-10:2010 | Irritation or intracutaneous reactivity | Yes |
| ISO 10993-11 | Systemic toxicity (acute) | Yes |
| ASTM F756-08 | Hemolysis | Yes |
| FDA guideline on | LAL Bacterial Endotoxins Testing | Yes |
| USP 33:2010 | Bacterial Endotoxins Test | Yes |
| ISO 11607-1:2006 & | Sterile Packaging Validation | Yes |
| ISO 11607-2:2006 | ||
| ISO 11135-1:2007 | ETO Sterilization Validation | Yes |
| ISO 7864:1993 | Sterile Hypodermic Needles for Single Use | Yes |
| ISO 9626:1991 | Stainless Steel Needle Tubing for | Yes |
| ASTM F1140-07 | Standard Test Methods for Internal | Yes |
| ASTM F1980-07 | Standard Guide for Accelerated Aging of | Yes |
| ASTM F2096-04 | Standard Test Method for Detecting Gross | Yes |
| ASTM F88-09/F88M-09 | Standard Test Method for Seal Strength of | Yes |
| EN 556-1:2001+AC:2006 | Sterilization of medical devices - | Yes |
| AAMI TIR 28:2009 | Product adoption and process equivalency | Yes |
| ISO 14971:2007 | Medical devices - Application of risk | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document details performance testing for various aspects (biocompatibility, sterilization, packaging, mechanical) but does not specify the exact sample sizes for each test in the provided text. The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond "Animal performance testing was conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the specific performance tests listed. These tests are primarily laboratory and standardized evaluations against pre-defined criteria.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method as it applies to human interpretation or decision-making on a test set. The performance tests are objective evaluations against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or mentioned in the provided text. The device is a physical medical kit (needle, sensor introducer, cover), not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study
The performance testing listed (biocompatibility, LAL, packaging, sterilization, mechanical) can be considered "standalone" in that they evaluate the device itself against established criteria, without requiring human interaction or interpretation beyond conducting the test and recording results. However, the animal performance testing was conducted to demonstrate the combined function of the SonixGPS™ Vascular Access Needle Kit with the Sonix Ultrasound Scanners and SonixGPS™ Needle Sensor. This implies an evaluation of the system as a whole, rather than the needle kit in strict isolation, in a functional setting.
7. Type of Ground Truth Used
For the various performance tests (biocompatibility, sterilization, packaging, mechanical), the ground truth is established by the specified international standards and guidelines (e.g., ISO, ASTM, USP, FDA guidelines). For the "Animal performance testing," the ground truth was the observable function of the device in assisting vessel cannulation without impairing the function or raising new safety/effectiveness concerns.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or machine learning. The device is a physical medical device kit and not an AI or software product that would typically undergo training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for this device.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).