Search Results

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".

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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

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.

Ask a specific question about this device

The Dornoch Transposal Ultra System is 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 Transposal Ultra System (Ultra System) provides a closed, self-contained, reusable cylinder suction system intended to collect and dispose of waste fluids produced through surgical procedures. The Ultra System is composed of two essential components, the Ultra Suction Cart and the Ultra Evac. The Ultra Cart can be used repeatedly until either 33L (Duo) or 52L (Quad) of fluid has been collected. Once full, the Cart is moved from the OR to the Ultra Evac. The two systems are connected together with the coupler unit on the Ultra Evac. The cleaning / wash cycle is then initiated and the automatic emptving and cleaning occurs.

The provided documentation for the Dornoch Ultra Suction Cart and Evac (K133786) does not contain comprehensive information on acceptance criteria or a detailed study proving the device meets specific performance metrics in the way typically expected for medical imaging AI devices, for example.

This device is a Class II powered suction pump, which falls under different regulatory requirements than more complex diagnostic AI systems. The approval is based on achieving substantial equivalence to existing legally marketed predicate devices, rather than meeting specific performance thresholds derived from clinical outcomes or expert consensus.

Here's an analysis based on the information provided, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical performance metrics (e.g., suction pressure, flow rate, volume capacity, cleaning efficacy rates, failure rates) are not provided as "acceptance criteria" in this summary. The "acceptance criteria" for software are mentioned but not detailed.
• The actual "reported device performance" is largely framed as compliance with safety standards and substantial equivalence, rather than quantitative performance against specific predefined functional benchmarks.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable in the context of this device's approval pathway. There isn't a "test set" in the sense of a clinical dataset for performance evaluation against ground truth, as would be common for AI/diagnostic devices.
• Data Provenance: The testing focused on compliance with international safety and performance standards (IEC, ISO). This is laboratory-based testing rather than data from human subjects or clinical settings, or retrospective/prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This is not applicable. The device's approval is based on engineering and safety standard compliance, and substantial equivalence to established devices. Ground truth from experts (like radiologists for an imaging device) is not part of this type of regulatory submission. The "ground truth" here is adherence to engineering specifications and safety standards, likely evaluated by engineers and regulatory bodies.

4. Adjudication Method for the Test Set

• Not applicable. Since there's no clinical "test set" in the usual sense, there's no adjudication method involving multiple human readers.

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

• No. This device is a fluid management system, not a diagnostic or AI-driven system designed to assist human readers. Therefore, an MRMC study is not relevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. The device itself is a standalone medical device (suction system). It does not contain an "algorithm" in the AI sense, nor does it require human-in-the-loop performance measurement as one would describe an AI diagnostic tool. Its performance is inherent to its mechanical and electrical function.

7. The Type of Ground Truth Used

• The "ground truth" in this context is adherence to international safety and performance standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, ISO 10079-1), and internal software acceptance criteria defined by the manufacturer.
• It also relies on a comparison to predicate devices, where the "ground truth" is that the predicate devices are legally marketed and considered safe and effective.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set, there is no ground truth established for one.

Conclusion:

The Dornoch Ultra Suction Cart and Evac (K133786) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices and compliance with recognized electrical and medical suction equipment safety standards. The "performance data" refers to successful completion of these standard-specific tests and internal software validation, rather than clinical performance data against a "ground truth" derived from patient outcomes or expert consensus in a clinical study format common for more complex diagnostic devices (especially AI/ML-enabled ones). Clinical data and conclusions were explicitly stated as "not needed for this device" due to its nature and regulatory classification.

Ask a specific question about this device

The Dornoch Transposal Ultra System is 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 Dornoch Transposal Ultra System is self-powered suction / vacuum pump.

The provided text is a 510(k) premarket notification letter from the FDA for a device called the "Dornoch Ultra Suction System," which is a powered suction pump. This document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or study details as requested in the prompts.

Therefore, I cannot fulfill your request for this specific document.

Ask a specific question about this device

The Dornoch Transposal Ultra System is 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 Transposal Ultra System (Ultra System) collects and disposes of waste fluids produced through surgical procedures. The Ultra System is a closed, self contained reusable suction system.

The Ultra Cart System can simultaneously collect fluids from up to four sources without mixing of the fluids. The Ultra Cart System is composed of two pieces of equipment the Transposal Ultra Cart (suction cylinder unit) and the Transposal Ultra Evac (removal and cleaning unit). The Ultra Carts can be used until 52L of fluids are collected. Once full, the Ultra Cart is attached to the Ultra Evac for automatic disposal into the hospital sanitary sewer and cleaning of the reservoir cylinders. Upon completion of the cleaning process, the cylinder lids are then replaced and the Ultra Cart is ready for use.

The Transposal Ultra Roll Stand consists of a vacuum system and up to four reusable canisters. The fluid can be collected in each canister until 2.8L of fluids are collected. The canisters are then transported to the Transposal Safety Station where they are emptied and cleaned.

The provided text pertains to the FDA 510(k) submission for the "Transposal Ultra System," a medical device designed for collecting and disposing of liquid waste in healthcare settings. However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance studies.

Specifically, the document states:
"To verify that device design has meet the functional and performance requirements representative samples of the device underwent electrical, mechanical, software, and functional testing in accordance with IEC-60601-1, IEC-60601-1-1, IEC-60601-1-2, IEC-60529, ISO 10079-1 and ISO 10079-3."

This indicates that testing was performed to verify compliance with relevant standards, but it does not provide the specific acceptance criteria, reported performance, or details of a study setup as requested.

Therefore, I cannot provide the complete answer based on the provided text. I can, however, extract the information that is present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with reported device performance. It only states that functional and safety testing was conducted to verify that the device design met "functional and performance requirements" in accordance with several IEC and ISO standards. The specific requirements from these standards and the corresponding test results are not detailed in this summary.

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 document.

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 in the document. The device is a physical system for waste collection, not an diagnostic imaging or AI system that typically requires expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. It is not relevant for this type of device testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not done for this device. This type of study is relevant for AI-powered diagnostic or decision-support systems, not for a physical fluid collection and disposal system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For this device, "ground truth" would refer to the objective, measurable performance of the system against its stated functional requirements and applicable safety standards (e.g., vacuum pressure, fluid containment, cleaning effectiveness, electrical safety). The document only states that testing was done to verify these requirements.

8. The sample size for the training set

This information is not provided and is not applicable as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not provided and is not applicable as this is not an AI/machine learning device.

Summary of available information regarding the study:

• Study Purpose: To verify that the device design meets functional and performance requirements.
• Testing Conducted: Electrical, mechanical, software, and functional testing.
• Standards Followed: IEC-60601-1, IEC-60601-1-1, IEC-60601-1-2, IEC-60529, ISO 10079-1, and ISO 10079-3.
• Device Type: A self-powered suction/vacuum pump system for waste fluid collection and disposal.

The document is a "Non-Confidential Summary of Safety and Effectiveness" for an FDA 510(k) submission, which typically provides high-level information rather than detailed study protocols and results.

Ask a specific question about this device