(28 days)
The IntelliCartTM System is a self-powered suction/vacuum pump intended to collect and dispose of liquid waste within Hospitals, 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 hospitals, 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.
This document describes the IntelliCart™ System, a self-powered suction/vacuum pump. The provided text is a 510(k) Summary for regulatory submission. It details the device's characteristics, intended use, and comparison to a predicate device, focusing on non-clinical performance data.
Here's the breakdown of the requested information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several standards and test types with "Predetermined Acceptance Criteria" and "Results" for both the predicate device and the K190789 IntelliCart™ System. In all cases, the acceptance criteria are simply "Yes" indicating the standard is applicable, and the results are "Pass".
| Standard or Test Type | Predetermined Acceptance Criteria | Reported Device Performance (K190789 IntelliCart™ System) |
|---|---|---|
| IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Yes | 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 |
| IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Yes | Pass |
| ISO 10079-1 Medical suction equipment - Part 1: Electrically powered suction equipment | Yes | 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 |
| Electrical Safety (IEC 60601-1) | Met predetermined acceptance criteria | Pass |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Met predetermined acceptance criteria | Pass |
| Human Factors/Usability (IEC 60601-1-6 & FDA Guidance) | All identified issues managed and mitigated to an acceptable level; Met predetermined acceptance criteria | Pass |
| Software Verification and Validation (FDA Guidance for Software Contained in Medical Devices) | Met predetermined acceptance criteria (reservoir overflow protection, cart reservoir processing and low level disinfection using validated cycles, watchdog safety transducer and safety start up warning screen) | Pass |
| Suction Performance (ISO 10079-1 & FDA Guidance for Powered Suction Pump) | Adjustable vacuum pressure at manifold port to predetermined acceptance criteria; operation capable of providing adjustable vacuum up to 12 hours of continuous use at 600mmHg | Pass |
| Safety Features (Closed System Design, Interactive controls, Fluid Backflow Protection, Watchdog Safety Transducer, Wash Fluid leak free seals, User Interface Vacuum Start Up Warning) | Met predetermined acceptance criteria | Pass |
| Fluid Path Chemical Resistance (against compatible enzymatic cleaners, bleach and Bactisure™) | Met predetermined acceptance criteria | Pass |
| Disposable Manifold Vacuum Seal (in the reservoir when installed) | Met predetermined acceptance criteria | Pass |
| IV Pole Function and Support (maximum bagged fluid support and automatic function) | Met predetermined acceptance criteria | Pass |
| Outer Body Shell and Fluid Capacity (portability, casters/brakes, 36" door thresholds, viewable fluid measurements, touchscreen, chemical resistance to wipes) | Met predetermined acceptance criteria | Pass |
| Fluid Reservoir Concealment (ConSeal™ technology) | Met predetermined acceptance criteria | Pass |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify sample sizes for any of the tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) for the non-clinical performance data. The tests described are laboratory performance and engineering tests, not clinical studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and therefore not available in the provided text. The "ground truth" in this context refers to engineering and performance specifications and regulatory standards (e.g., passing IEC 60601-1). These are established through design, manufacturing, and testing processes against predefined criteria, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
This is not applicable for the type of non-clinical performance testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple experts evaluate ambiguous cases to reach a consensus on ground truth. The tests here are objective measurements against fixed criteria.
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
There is no MRMC comparative effectiveness study mentioned in the document. This device is a medical suction pump, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is an electro-mechanical system, not an algorithm, and the tests described are for its functional performance and safety, not for standalone algorithmic performance.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is the predetermined acceptance criteria derived from recognized national and international standards (e.g., IEC 60601-1, ISO 10079-1) and FDA guidance documents. These are objective engineering and performance specifications.
8. The Sample Size for the Training Set
This is not applicable. The IntelliCart™ System is not an AI/Machine Learning device that requires a training set. The software verification and validation refer to traditional software development and testing, not AI model training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI/Machine Learning algorithm mentioned in the document.
§ 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.