(113 days)
The IntelliCartTM System is a self-powered suction / vacuum pump intended to collect and dispose of liquid waste within hospital operating rooms, pathology labs, surgical outpatient centers, and doctor's Offices.
The IntelliCartTM System is a self-powered suction / vacuum pump intended to collect and dispose of liquid waste within hospital operating rooms, pathology labs, surgical outpatient centers, and doctor's offices.
The IntelliCartTM System (System) consists of a Fluid Cart (Cart) and Evac Station (Evac).
Carts are mobile devices used during surgery to collect patient fluids. Evacs are stationary devices used to process and clean Carts. The System's closed design significantly reduces employee exposure to potentially infectious surgical fluids, while eliminating up to 70% of operating room red bag waste.
Carts are equipped with large volume fluid reservoirs, a single regulated vacuum pump, and a height-adjustable IV pole. A single-use manifold (REF 00-5140-201-00) serves as the interface between a Cart's fluid reservoir and sterile patient suction tubing. A Cart model equipped with a bracket to hold a Smoke Evacuator is also available.
The provided document describes the IntelliCart™ System, a self-powered suction/vacuum pump. The document mainly focuses on demonstrating substantial equivalence to a predicate device, the Dornoch Ultra Suction Cart and Evac (K133786), rather than a clinical study evaluating diagnostic performance. Therefore, many of your requested points regarding clinical study design (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance) are not directly applicable or available in this document, as the device is a piece of medical equipment for fluid waste collection and disposal, not an AI/diagnostic software.
However, I can extract the acceptance criteria and performance data for the non-clinical tests conducted to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Standard or Test Type | Predetermined Acceptance Criteria | Reported Device Performance (IntelliCart™ System) |
|---|---|---|
| IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Yes (Implied "Pass") | Pass |
| IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and Tests | Yes (Implied "Pass") | Pass |
| IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Yes (Implied "Pass") | Pass |
| ISO 10079-1 Medical suction equipment - Part 1: Electrically powered suction equipment | Yes (Implied "Pass") | Pass |
| ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Not required - no direct or indirect patient contact | N/A (not applicable) |
| Electrical Safety, Electromagnetic compatibility (EMC) | Predetermined acceptance criteria (explicitly stated) | Passed all tests |
| Software Verification and Validation (e.g., reservoir overflow protection, cart reservoir processing using validated cycles, watchdog safety transducer, safety start-up warning screen) | Predetermined acceptance criteria (explicitly stated) | Passed all tests |
| Mechanical Verification and Validation - Suction Performance (adjustable vacuum pressure at manifold port, 0-600mmHg, up to 12 hours continuous use) | Predetermined acceptance criteria (explicitly stated) | Demonstrated operation capability |
| Mechanical Verification and Validation - Safety Features (Closed System Design, Interactive controls including de-bounce feature, Fluid Backflow Protection, Watchdog Safety Transducer, Wash Fluid leak-free seals, User Interface Vacuum Start Up Warning) | Predetermined acceptance criteria (explicitly stated) | Met all acceptance criteria with passing results |
| Fluid Path - Chemical Resistance (against compatible enzymatic cleaners, bleach, and Bactisure™) | Predetermined acceptance criteria (explicitly stated) | Met all acceptance criteria with passing results |
| Disposable Manifold (vacuum seal in the reservoir when installed) | Predetermined acceptance criteria (explicitly stated) | Met all acceptance criteria with passing results |
| IV Pole Function and Support (maximum bagged fluid support, automatic function for power IV pole) | Predetermined acceptance criteria (explicitly stated) | Met all acceptance criteria with passing results |
| Outer Body Shell and Fluid Capacity (portability, 36" door thresholds, directly viewable fluid measurements, easily viewable touchscreen, chemical resistance of exterior surfaces) | Predetermined acceptance criteria (explicitly stated) | Met all acceptance criteria with passing results |
| Fluid Reservoir Concealment (ConSeal™ technology for concealment of collected waste fluid) | Predetermined acceptance criteria (explicitly stated) | Met all acceptance criteria with passing results |
| Overflow Protection Warning | Alert user when reservoir is 3000mL and 1500mL from full capacity | Warning provided appropriately |
| Overflow Protection Automatic Shut-off | Automatic shut off when canisters have reached full capacity | Automatic shut off performed |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical engineering and performance testing. It does not refer to a "test set" in the context of diagnostic data. The tests were performed on the IntelliCart™ System itself. No specific sample sizes for units tested are provided, but it implies standard product validation through testing. Data provenance is implied to be from internal testing by the manufacturer, Dornoch Medical Systems, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study requiring expert clinical review to establish ground truth for a diagnostic outcome. The "ground truth" for the engineering tests is compliance with defined standards and functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of non-clinical engineering and performance validation.
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 device is a fluid management system, not a diagnostic AI tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as it's not a diagnostic algorithm. The device's performance stands alone in its mechanical and software functionalities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance validation is based on adherence to recognized international electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6), suction equipment standards (ISO 10079-1), and the manufacturer's own pre-established acceptance criteria for specific functionalities (e.g., fluid path resistance, manifold seal, IV pole support, overflow protection).
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.