(87 days)
The Misonix Irrigation System Model BC20P is indicated for use in the delivery of fluids in the following surgical specialties: General Surgical Procedures. The Misonix Irrigation System (BC20P) is not intended for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.
The Misonix Irrigation System (BC20P) is a liquid transfer system. It is designed to utilize standard or custom tubing sets, which mate to IV bottles or bags, open reservoirs or other liquid canisters. The liquid is drawn through the pump head and then pressurized, allowing the liquid to be transferred from the source. The outlet of the tube set may be connected to a cannula or other orifice to allow flushing and cleaning of the site. It can be used to refill small containers from a larger reservoir. It is not intended for drug delivery or the administration of parenteral fluids.
The acceptance criteria and study proving the device meets them are detailed below, based on the provided 510(k) summary for the Misonix Irrigation System (Model BC20P).
This device, an irrigation system, is fundamentally different from a diagnostic AI device, therefore, many of the typical questions regarding AI/ML-based device evaluation (like human-in-the-loop studies, effect size of AI assistance, expert consensus for ground truth, and training data specifics) are not applicable. The evaluation focused on engineering performance and substantial equivalence to a predicate device.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
The provided document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail table as might be seen for a diagnostic device. Instead, the "acceptance criteria" are implicitly derived from the performance of the predicate device and Misonix's stated equivalence to it. The "reported device performance" is a confirmation that the Misonix Irrigation System (BC20P) meets the specifications and performs identically to the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: Be identical in all aspects to the LySonix Irrigation System (K974233) regarding design and manufacturing specifications. | The Misonix Irrigation System is identical in all aspects to the LySonix Irrigation System since both units have been designed and manufactured to the same specifications by Misonix. (Section 6) |
| Output Power: Deliver specified output power (No Load to Maximum Load). | (Implied) Measurements were performed and found acceptable during "Output Power Measurements (No Load to Maximum Load)". Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9) |
| Irrigation Flowrate: Deliver specified irrigation flowrate. | (Implied) Measurements were performed and found acceptable during "Irrigation Flowrate Measurements". Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9) |
| Life Cycle: Demonstrate acceptable device longevity and durability. | (Implied) "Life Tests" were performed and found acceptable. Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9) |
| Vacuum Performance: Deliver specified vacuum flowrate and pressure. | (Implied) Measurements were performed and found acceptable during "Vacuum Flowrate and Pressure Measurements". Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9) |
| Input Power: Operate within specified input power parameters. | (Implied) Measurements were performed and found acceptable during "Input Power Measurements". Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9) |
| Electromagnetic Interference (EMI): Comply with EMI standards. | (Implied) "EMI Tests" were performed and found acceptable. Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9) |
| Electrical Safety (Dielectric Tests): Meet dielectric test requirements on mains and patient circuits. | (Implied) "Dielectric Tests on Mains Circuits" and "Dielectric Tests on Patient Circuits" were performed and found acceptable. Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9) |
| Electrical Safety (Patient Current Leakage): Meet patient current leakage and patient sink current limits. | (Implied) "Patient Current Leakage and Patient Sink Current Measurements" were performed and found acceptable. Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9) |
| Electrical Safety (Power Line Ground Leakage): Meet power line ground leakage limits. | (Implied) "Power Line Ground Leakage Measurements" were performed and found acceptable. Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9) |
| Intended Use: Be suitable for fluid delivery in general surgical procedures, and not for drug delivery or parental fluids. | The device is indicated for use in the delivery of fluids in general surgical procedures. It is not intended for drug delivery or the administration of parenteral fluids. (Section 5, Indications for Use) This closely matches the predicate's implied intended use for an irrigation pump. |
| Environmental/Safety Compliance: Adhere to relevant voluntary consensus standards and hazard analysis. | "Voluntary Consensus Standard Investigations" and a "Hazard Analysis" were conducted. Conclusion: Device is substantially equivalent to predicate. (Section 9) |
Summary of the Study Proving Acceptance:
The study proving the device meets the acceptance criteria is primarily a non-clinical engineering and comparison study. The core of the demonstration is proving substantial equivalence to the predicate LySonix Irrigation System (K974233). This involved:
- Direct comparison: Stating that the Misonix system is "identical in all aspects" due to being designed and manufactured to the same specifications as the LySonix system.
- Engineering Tests: A series of functional and safety tests were performed to confirm performance characteristics. These tests included:
- Output Power Measurements (No Load to Maximum Load)
- Irrigation Flowrate Measurements
- Life Tests
- Vacuum Flowrate and Pressure Measurements
- Input Power Measurements
- EMI Tests
- Dielectric Tests on Mains Circuits
- Patient Current Leakage and Patient Sink Current Measurements
- Power Line Ground Leakage Measurements
- Dielectric Tests on Patient Circuits
- Analysis: An analysis of operating characteristic specifications, output of engineering tests, hazard analysis, and voluntary consensus standard investigations.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary for what appears to be a hardware device. The "test set" would refer to the physical units of the Misonix Irrigation System (Model BC20P) that underwent the engineering tests. Typically, for such devices, a small number of production or pre-production units are tested. The document does not specify the number of units tested or the provenance of the data beyond implying it was generated by Misonix.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable for this type of device. The "ground truth" for an irrigation pump is its physical performance characteristics (e.g., flow rate, power, safety parameters). These are measured directly through engineering tests, not established by expert consensus or interpretation as in medical imaging or diagnostic AI. The experts involved would be qualified engineers and technicians performing the tests and analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no subjective interpretation requiring adjudication. Performance is measured objectively.
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
This is not applicable. This is not an AI/ML device, nor is it a diagnostic tool requiring human interpretation or a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI/ML device. The device operates as a standalone irrigation pump.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used is objective engineering measurements and compliance with established specifications and safety standards, primarily benchmarks against the predicate device. It includes:
- Physical measurements (e.g., power output, flow rate, vacuum pressure).
- Electrical safety tests (e.g., dielectric tests, leakage current).
- Durability (life tests).
- Compliance with voluntary consensus standards.
- The fact that it was "designed and manufactured to the same specifications" as the legally marketed predicate device.
8. The sample size for the training set
This is not applicable. This is a hardware device, not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.