(7 days)
The RITA® Clips are used with Harvard 2 Syringe Pump to increase the syringe holding capacity of the Pump from two to five syringes to allow one Harvard 2 Syringe Pump to supply local delivery of saline through multiple irrigation ports of one RITA® Electrosurgical Device of the RITA® System. The RITA System is intended for use in percutaneous. laparoscopic, or intraoperative coagulation and ablation of soft tissue, including the partial or complete ablation of non-resectable liver lesions.
The RITA® Clips are a syringe holder accessory to the Harvard 2 Syringe Pump to accommodate five (5) 20-cc syringes.
The provided text describes the 510(k) summary for the RITA® Clips, an accessory for the Harvard 2 Syringe Pump. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device and establish the safety and effectiveness of the RITA® Clips.
Here's an analysis based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria in a typical "pass/fail" numerical fashion for a and clinical study. Instead, it mentions functional tests.
| Acceptance Criteria Category | Stated Verification | Reported Device Performance |
|---|---|---|
| Flow Rate Verification | Verify the flow rate of the RITA® Clips combined with the Harvard 2 Syringe Pump. | "The RITA® Clips and Harvard 2 Syringe Pump underwent testing to verify flow rate... The devices passed the test criteria." |
| Alarm Function Verification | Verify the alarm function of the RITA® Clips combined with the Harvard 2 Syringe Pump. | "The RITA® Clips and Harvard 2 Syringe Pump underwent testing to verify... alarm function. The devices passed the test criteria." |
| Biocompatibility (Patient Contact) | Not applicable as the device does not directly contact the patient. | "The RITA® Clips do not directly contact the patient therefore no biocompatibility testing was required." |
Interpretation: The acceptance criteria were broadly focused on ensuring the RITA® Clips did not negatively impact the fundamental functions (flow rate and alarm) of the associated Harvard 2 Syringe Pump. The document states these tests were "passed," implying the device met these functional requirements.
2. Sample Size Used for the Test Set and Data Provenance
The document describes performance data related to functional testing of the device rather than a clinical study with human subjects.
- Sample Size for Test Set: The document does not specify a numerical sample size for the "testing to verify flow rate and alarm function." It simply states "The RITA® Clips and Harvard 2 Syringe Pump underwent testing." This likely implies testing of a sufficient number of units to ensure consistent performance, but the exact quantity isn't provided.
- Data Provenance: The data provenance is prospective testing conducted by RITA Medical Systems to verify the functionality of the RITA® Clips when used with the Harvard 2 Syringe Pump. There is no mention of country of origin for, or retrospective use of, data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable to the provided information. The "testing to verify flow rate and alarm function" is a mechanical/electrical performance test, not a clinical study requiring expert assessment of ground truth. Ground truth in this context would be the actual flow rate or alarm activation, which is measured by instruments, not human experts.
4. Adjudication Method for the Test Set
This question is not applicable. Since the testing involved mechanical performance verification (flow rate and alarm function) rather than human interpretation or clinical outcomes, an adjudication method for a test set (e.g., 2+1, 3+1) is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The RITA® Clips are a mechanical accessory (syringe holder) for an infusion pump. The study described is a verification of its mechanical function (flow rate and alarm) rather than a clinical study evaluating diagnostic accuracy or reader improvement. Therefore, the concept of human readers, AI assistance, or effect size for such improvement is not relevant to this submission.
6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of the RITA® Clips.
- The RITA® Clips are a mechanical device, not an algorithm or software.
- The performance described is the physical functionality of the clips when attached to the pump, not an algorithm's output.
- There is no "human-in-the-loop" interaction in the described performance testing; it's about the device's inherent function.
7. The Type of Ground Truth Used
The ground truth used for the performance testing was objective mechanical measurements.
- For flow rate: The ground truth would be the accurately measured volume/time output from the pump system with the RITA® Clips installed, compared against the expected or desired flow rate.
- For alarm function: The ground truth would be the correct activation of the pump's alarm under specific (e.g., occlusion, end-of-infusion) conditions.
These are verifiable physical phenomena, not expert consensus, pathology, or outcomes data typically associated with diagnostic or therapeutic clinical trials.
8. The Sample Size for the Training Set
This question is not applicable. The RITA® Clips are a physical medical device, not an AI/ML algorithm or system that requires a "training set" in the computational sense. The described testing is performance verification of hardware.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of mechanical device.
§ 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).