(99 days)
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
| Acceptance Criteria Category | Specific Criteria (as described/implied) | Reported Device Performance |
|---|---|---|
| Safety Standards | Compliance with IEC 60601-1 (General Safety) | Compliant to all applicable clauses of each standard |
| Compliance with IEC 60601-1-1 (Safety for Medical Electrical Systems) | Compliant to all applicable clauses of each standard | |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility) | Compliant to all applicable clauses of each standard | |
| Compliance with ISO 10079-1 (Electrically Powered Suction Equipment Safety) | Compliant to all applicable clauses of each standard | |
| Software Safety/Effectiveness | Software proven to be safe and effective to pre-determined acceptance criteria | Software was proven to be safe and effective when tested to pre-determined acceptance criteria |
| Substantial Equivalence | Identical in design, materials, and indications for use to predicate devices | Verified as substantially equivalent to other legally marketed surgical suction systems. |
| Intended Use | Ability to collect and dispose of liquid waste | "The Dornoch Transposal Ultra System is self-powered suction / vacuum pump intended to collect and dispose of liquid waste..." |
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.
§ 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.