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510(k) Data Aggregation
(28 days)
IntelliCartTM System
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.
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(113 days)
IntelliCartTM System
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.
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