(59 days)
The Dyonics InteliJet Reusable Cannulas are indicated for use with the Dyonics InteliJet Fluid Management System during arthroscopic surgical procedures of the knee, shoulder and small joints to regulate flow of irrigation fluids through the joint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.
The Dyonics InteliJet Reusable Cannulas are used to establish portals to the surgical site during arthroscopic surgical procedures. The Dyonics InteliJet Reusable Cannulas are designed to work in conjunction with the InteliJet Fluid Management System to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.
This submission is for a material change to an existing device, the Dyonics InteliJet Reusable Cannula. The 510(k) summary indicates that the change "has no impact on the designed safety and efficacy" of the device.
Here's an analysis of the provided information, noting what can be extracted and what is not available due to the nature of this particular 510(k) summary (which focuses on a material change to an already approved device rather than a de novo submission):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain designed safety and efficacy after material change | Supported by biocompatibility and flow curve analysis |
2. Sample Size Used for the Test Set and Data Provenance
Specific sample sizes for the "biocompatibility and flow curve analysis" are not provided in this summary. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of 510(k) submission. A material change primarily relies on engineering and scientific testing (biocompatibility, flow analysis) rather than clinical expert ground truth for medical image analysis or diagnostic performance. No experts were used in this context.
4. Adjudication Method
This information is not applicable. No expert adjudication was performed for this type of testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of a material change submission for a cannula.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not done. This device is a mechanical cannula, not an algorithm, so this type of study isn't relevant.
7. Type of Ground Truth Used
The "ground truth" for this material change involved engineering and scientific measurements corresponding to the device's functional and safety characteristics. Specifically:
- Biocompatibility: Likely involved testing against relevant ISO standards to ensure the new material is not toxic or reactive.
- Flow Curve Analysis: Involved measuring fluid flow properties through the cannula to ensure it meets the original design specifications for maintaining intra-articular pressure and fluid delivery.
8. Sample Size for the Training Set
This information is not applicable. This is a hardware device, not an AI or machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).