(29 days)
The IntelliCart™ 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 IntelliCart™ 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 IntelliCart™ 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 IntelliCart™ System is a closed self-powered suction device providing various levels of suction, as selected by the user, ranging from 0-600 mmHg at maximum flow volume, and collection of up to 34L of liquid surgical waste into cart canisters equipped with a viewing window for display of canister contents shown in 100ml increments. The suction cart is portable, equipped with caster type wheels with a profile able to pass through 36 inch minimum wide doorways and allows for connection to a standard 120V/60Hz/15A facility power supply and connection to facility wall suction when necessary. Cart Canisters are integrated with a window tint feature that visually restricts canister contents during transport.
The IntelliCart™ System is operated using a back lit LCD touch screen display monitor equipped with lateral adjustment capabilities and provides digital display confirmation of total fluid capacity used as well as a functional interface for suction selection/adjustment and cart cleaning.
Single use manifolds are equipped with hydrophobic filters which turn color after wash cycle is completed, giving visual indication of a manifold which must be discarded.
The Evac Station is equipped with a coupler that connects to the Suction Cart and, using compatible bleach and enzymatic solutions to break down solid waste, empties, cleans and disinfects cart canisters. After emptying and cleaning cart canisters, the Evac Station allows for draining surgical waste into facility drains.
The IntelliCart™ System can be equipped with a powered or manual IV pole, supporting up to 12,000mL of bagged fluid and allows mounting of a compatible smoke evacuation device.
The provided text describes the IntelliCart System, a self-powered suction/vacuum pump, and its comparison to a predicate device. The information primarily focuses on establishing substantial equivalence to a previously cleared device (K162421) rather than detailing a de novo study proving the device meets specific clinical acceptance criteria. Instead, the document outlines performance tests against engineering and safety standards and acceptance criteria related to its operation and design.
Here's an organized breakdown of the relevant information:
1. A table of acceptance criteria and the reported device performance
The document provides a table of applicable performance standards and states that both the predicate and modified devices passed these standards, indicating they met the acceptance criteria corresponding to these standards.
| Standard or Test Type | Predetermined Acceptance Criteria | Predicate Device (IntelliCart™ System (K162421) Results | Modified Device (IntelliCart™ System) Results |
|---|---|---|---|
| IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Yes | 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 | Pass | Pass |
| IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Yes | Pass | Pass |
| ISO 10079-1 Medical suction equipment - Part 1: Electrically powered suction equipment | Yes | 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 | N/A |
In addition to the table, other performance aspects were tested against "predetermined acceptance criteria" and universally reported as "met all predetermined acceptance criteria with passing results." These include:
- Electrical Safety, Electromagnetic compatibility (EMC) and Usability: Passed tests according to IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-6. Also, identified issues from usability studies were managed and mitigated.
- Software and Display Verification and Validation: Passed all predetermined acceptance criteria, including reservoir overflow protection, cart reservoir processing, low-level disinfection using validated cycles, watchdog safety transducer, and safety start-up warning screen.
- Suction Performance: Evaluated according to ISO 10079-1 and FDA Guidance for Powered Suction Pump 510(k)s. Demonstrated adjustable vacuum pressure at the manifold port up to 12 hours of continuous use at 600mmHg.
- Safety Features: Tested for Closed System Design, Interactive controls, Fluid Backflow Protection, Watchdog Safety Transducer, Wash Fluid leak-free seals, and User Interface Vacuum Start Up Warning. All met acceptance criteria.
- Fluid Path Chemical Resistance: Tested against compatible enzymatic cleaners, bleach, and Bactisure™ and met acceptance criteria.
- Disposable Manifold: Tested for vacuum seal in the reservoir when installed and met acceptance criteria.
- IV Pole Function and Support: Tested for maximum bagged fluid support and automatic function (power IV pole) and met acceptance criteria.
- Outer Body Shell and Fluid Capacity: Tested for portability (casters, brakes, 36″ door thresholds), directly viewable fluid measurements, easily viewable touchscreen monitor, and chemical resistance of exterior surfaces to hospital wipes. All met acceptance criteria.
- Fluid Reservoir Concealment: ConSeal™ technology evaluated for concealment of collected waste fluid and met acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the described performance tests. The data provenance is also not mentioned. These appear to be in-house engineering and bench tests rather than clinical studies with human participants or large datasets.
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 information is not provided. The evaluations are based on engineering standards and internal testing, not expert-adjudicated ground truth as typically seen in AI/diagnostic device studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. The evaluations described are not based on human reviewer adjudication.
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
An MRMC comparative effectiveness study was not conducted. This device is a powered suction pump, not an AI diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the IntelliCart System, which is a physical medical device (suction pump). Performance tests demonstrate the device's functional and safety capabilities in isolation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests described (e.g., electrical safety, EMC, software functionality, suction performance) is defined by the predetermined acceptance criteria of relevant international and FDA-specified engineering standards (e.g., IEC 60601-1, ISO 10079-1) and the manufacturer's own design specifications.
8. The sample size for the training set
This information is not applicable. The IntelliCart System is a hardware device; thus, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this device.
§ 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.