(11 days)
The Smith & Nephew DYONICS 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip, and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.
The Smith & Nephew DYONICS 25 Fluid Management System is a centrifugal fluid management pump used in arthroscopic surgery to regulate the flow of irrigation fluids through the joint to maintain intra-articular pressure for distension and visualization of the surgical site. This is accomplished using an electronic pressure control feedback loop between the control unit and the tube set cassettes.
The Smith & Nephew DYONICS 25 Fluid Management System includes -
- . control unit
- . inflow tube set
- . inflow /outflow tube set
- inflow/outflow tube set with forked suction lines
- . day-tube set
- . patient tube set
- . wired/wireless (IR) remote control (optional)
- . Luer to colder Connector (optional)
Additionally, the Smith & Nephew LEVELERT II Fluid Level Sensors (K060123) as well as a shaver system interface cable, U.S. and international power cords can be used with the Smith & Nephew DYONICS 25 Fluid Management System (DYONICS 25).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew DYONICS 25 Fluid Management System:
This document is a 510(k) Summary of Safety and Effectiveness Information for a medical device. It's important to understand that a 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials as might be required for a novel device. The "acceptance criteria" here refer to meeting performance specifications and relevant standards to demonstrate equivalence, not necessarily clinical outcome measures.
Description of Acceptance Criteria and Study to Prove Device Meets Them
The Smith & Nephew DYONICS 25 Fluid Management System is a centrifugal fluid management pump used in arthroscopic surgery. The current submission (K171794) is for a modified version of a previously cleared device (K051326). The "acceptance criteria" for this submission are primarily that the modified device performs comparably to the predicate device and meets relevant performance specifications and recognized consensus standards, without raising new questions of safety or effectiveness due to the design changes.
The study proving the device meets these criteria is a series of bench and engineering tests and software verification and validation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description of Criteria (Implied from the document) | Reported Device Performance |
|---|---|---|
| Functional Performance | Maintain intra-articular pressure for uniform distension and clear visualization of the surgical site during arthroscopic joint surgery. (This is the core intended use and functional expectation). | Testing demonstrated that the system "has met the performance specifications." (Specific metrics are not detailed in this summary). |
| Package/Performance Testing | Ensure integrity and functionality after packaging and during typical use/handling. | Conducted. |
| Environmental Testing | Demonstrate performance over expected environmental conditions (temperature, humidity, etc.). | Conducted. |
| Fluids Testing | Verify proper interaction and handling of irrigation fluids. | Conducted. |
| EMC Testing | Compliance with electromagnetic compatibility standards to ensure proper operation without interference and without causing interference to other devices. Specifically, IEC 60601-1-2:2015. | Meets IEC 60601-1-2:2015. |
| Safety Testing | Compliance with general requirements for basic safety and essential performance. Specifically, IEC 60601-1. | Meets IEC 60601-1. |
| Software Verification & Validation | Ensure the updated operating system, drivers, and software function correctly and safely according to specifications, and that changes to printed circuit boards (PCBs) and the new touch-screen LCD display operate as intended. Compliance with IEC 62304 for medical device software lifecycle. | Conducted, and meets IEC 62304:2006. |
| Substantial Equivalence | Demonstrated that the device has the same indications for use, utilizes the same principle of operation and fundamental scientific technology, incorporates the same basic design, and incorporates the same materials as the predicate device (K051326), despite updated PCBs, new touch-screen LCD display, and software updates. | No major differences from the predicate device that would raise new safety/effectiveness questions. Found substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify a "sample size" in the context of patient data or a test set of clinical images. The testing described (Package/Performance, Environmental, Fluids, EMC, Safety, Software V&V) are bench and engineering tests, performed on the device itself or its components. Therefore, terms like "test set," "data provenance," or "country of origin for data" are not applicable in the typical sense of a clinical study or AI model evaluation.
- Sample size: Not applicable as it's not a clinical or image-based study. The "sample" would be the device units or components tested.
- Data provenance: Not applicable. The data is from internal engineering and bench testing.
- Retrospective/Prospective: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not a study requiring expert readers or consensus to establish ground truth. The "ground truth" for the engineering and performance tests is defined by the technical specifications, international standards (e.g., IEC), and the functional requirements of the device.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication process for bench and engineering tests. The results are typically pass/fail based on predefined technical criteria and standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is common for evaluating diagnostic imaging devices or AI systems, especially when comparing human performance with and without AI assistance. This device is a fluid management pump, not a diagnostic or AI-powered imaging device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device does not feature an "algorithm only" component in the sense of an AI/ML system that would operate autonomously. While it has software and a feedback loop for pressure control, its operation is an integral part of an arthroscopic surgical procedure that always involves a human surgeon. The "software verification & validation" conducted is the closest equivalent to testing the "standalone" performance of its control logic.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Technical specifications derived from the intended function of the device (e.g., maintaining pressure, regulating flow).
- International consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304) which define safety and performance requirements.
- Comparison to the predicate device's established performance.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a "training set" of data in the common sense. The software development process involves coding, verification, and validation, but not training on a dataset to learn patterns.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted in point 8, there is no "training set" for this device.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.