(23 days)
The Dyonics InteliJET Reusable Cannulas are indicated for use with the 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 document (K020947) is a 510(k) premarket notification for a medical device called the Dyonics InteliJET™ Reusable Cannulas. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data with detailed acceptance criteria and performance metrics typically found in novel device approvals.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., flow rate, pressure regulation with specific tolerances). Instead, the key "acceptance criterion" for this 510(k) appears to be demonstrating that a material modification to the existing Dyonics InteliJET Reusable Cannulas does not raise new issues of safety and effectiveness.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: The new material meets established requirements. | "The new material has been demonstrated to meet the requirements for biocompatibility established in ISO 10993-1: 1997." |
| Functional Equivalence: The basic technologies, design, and function are unchanged despite the material modification. | "The basic technologies, design and function of the Dyonics InteliJET Reusable Cannulas is not changed by the material modification described in this Premarket Notification Submission." |
| Safety and Effectiveness: The material change does not introduce new safety or effectiveness concerns compared to the predicate device. | "This change raises no new issues of safety and effectiveness." (This is a statement of conclusion rather than a reported performance metric, signifying that the biocompatibility and functional equivalence assessments supported this claim). |
| Substantial Equivalence: The modified device is substantially equivalent to the predicate device for its intended use. | The FDA's letter states: "We have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This is the ultimate outcome of a successful 510(k) submission, indicating that the device's performance, as demonstrated by the material and functional assessments, is comparable to the predicate. |
2. Sample size used for the test set and the data provenance
The document does not detail specific "test set" sample sizes or data provenance in the context of clinical studies. The assessment focuses on the material change.
- Sample Size: Not applicable in the context of clinical studies or test sets as described in the prompt. The assessment pertains to material properties and functional equivalence, likely involving laboratory testing of material samples.
- Data Provenance: Not applicable in the context of clinical studies. The biocompatibility standard (ISO 10993-1: 1997) is an international standard, indicating the testing methodologies would conform to these globally recognized guidelines.
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. Expert review for clinical ground truth is not typically a requirement or component of a 510(k) submission for a material modification of an existing device. The "ground truth" here is compliance with material standards and functional equivalence, which would be assessed by engineers and toxicologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical trials where multiple readers interpret clinical data. This submission focuses on material and engineering equivalency.
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
Not applicable. This is not an AI-assisted device, nor is it a comparative effectiveness study involving human readers. It is a re-submission for a material change to an existing cannula.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission revolves around:
- Biocompatibility Standards: Compliance with ISO 10993-1: 1997 for the new material. This standard itself defines the acceptable biological response of medical devices.
- Functional Equivalence: Engineering assessment and comparison to the predicate device's design and intended function.
There is no mention of clinical ground truth established by expert consensus, pathology, or outcomes data, as this is a material modification rather than a novel device requiring new clinical validation.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 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).