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510(k) Data Aggregation
(117 days)
The SafeAir Combi is an electrosurgical generator containing an integrated surgical smoke evacuator. The unit is intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. When used with an electrosurgical pencil capable of surgical smoke evacuation, the console is also intended to remove and filtrate smoke generated during electrosurgical procedures.
SafeAir Combi (model: SFR-Combi-US) is an electrosurgical generator with the added functionality of smoke evacuation. This device is a non-sterile medical device, indicated to be used in operating theatres for use during general surgical procedures. SafeAir Combi uses 5 different output modes: 2 cut modes (Pure and Blend), 2 coagulation modes (Fulguration and Spray) and 1 mode for bipolar accessories. The device operates with a power range of 5-200 Watts for cut modes, 5-120 Watts for coagulation modes and 5-100 Watts for the bipolar mode. The device is intended to be used as a system together with monopolar or bipolar active accessories with a neutral electrode, however this submission is only intended to cover the electrosurgical generator and smoke evacuation feature and dedicated footswitch, without any active surgical accessories. Device is intended to be operated by healthcare professionals in hospitals and clinics where electrosurgical procedures are typically performed.
Here's a summary of the acceptance criteria and study information for the SafeAir combi (SFR-combi-US) device based on the provided text, where available:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list a table of acceptance criteria with numerical targets. Instead, it refers to general performance testing and compliance with standards. However, it does provide a detailed comparison with predicate and reference devices, highlighting several operational characteristics and their similarity/difference. I'll construct a table based on the comparative performance characteristics mentioned and the implied "acceptance" of substantial equivalence.
| Feature / Criteria (Implied) | Acceptance Criteria (Implied from Predicate/Reference) | Reported Device Performance (SafeAir combi) | Comparison |
|---|---|---|---|
| Electrosurgical Performance | |||
| Output Modes (MONOPOLAR Cut) | 3 Different CUT modes, including Pure (300W max, 300 Ohm, CF 1.5, 390 kHz) and Blend (200W max, 300 Ohm, CF 2.5, 390 kHz) (Predicate) | 2 Different CUT modes: Pure (200 W max, 400 Ω, CF 1.5, 472 kHz) Blend (200 W max, 400 Ω, CF 2.1, 472 kHz) | Different |
| Output Modes (MONOPOLAR Coag) | 4 Different COAG Modes, including Fulgurate (120W max, 500 Ohm, CF 7.0, 470 kHz) and Spray (120W max, 500 Ohm, CF 8.0, 470 kHz) (Predicate) | 2 Different COAG modes: Fulg (120 W max, 400 Ω, CF 6.6, 472 kHz) Spray (120 W max, 400 Ω, CF 7.5, 472 kHz) | Different |
| Output Modes (BIPOLAR) | 3 Different BiPolar modes, including Standard (70W max, 100 Ohms, CF 1.5, 470 kHz) (Predicate) | BIPOLAR: 100 W max, 100 Ω, CF 1.6, 472 kHz | Different |
| CQM (Resist. Range) | 5 to 135 Ohms, or up to 40% increase in initial contact resistance (Predicate) | 10 to 130 Ohms, or up to 30% increase in initial contact resistance (whichever is less) | Different |
| Instant response technology | Automatically senses resistance and adjusts output voltage to maintain consistent effect (Predicate) | Automatically senses resistance and adjusts output voltage to maintain consistent effect | Similar |
| Power ON self diagnostics | Alarm sounds and number displayed on front panel if system alarm conditions (Predicate) | Self testing procedure on ON/OFF, alarms presented on screen if problems, generator cannot be activated | Similar |
| Smoke Evacuation Performance | |||
| Filtration rate | ULPA filter is 99.999% with efficiency at 0.1 microns (Reference) | ULPA filter is 99.999% with efficiency at 0.1 microns | Identical to reference device |
| Filter Life | 5 hours (Reference) | 5 hours | Identical to reference device |
| Levels of smoke evacuation | 10 levels (Reference) | 10 levels | Identical to reference device |
| Levels of smoke evacuation stop delay | 10 levels (Reference) | 10 levels | Identical to reference device |
| Maximum flow rate at filter (claimed in IFU) | 110 l/min (Reference) | 110 l/min | Identical to reference device |
| Maximum flow rate measured on pencil tip | 97.8 l/min (Reference) | 94.2 l/min | Similar to reference device |
| Electrical Safety/EMC | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 | Device demonstrated appropriate electrical safety and electromagnetic compatibility profile | Met (Implied) |
| General Performance | Safety & Effectiveness comparable to predicate device | Design Verification and Validation confirmed device meets specifications and performs as intended | Met (Implied) |
2. Sample size used for the test set and the data provenance
The document does not specify the precise sample sizes for each performance test. It mentions "Comparative performance testing" and "Design Verification and Validation activities".
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in terms of comparing the device against established predicate and reference device characteristics and regulatory standards. The testing itself would have been prospective (conducted specifically for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described focuses on engineering and functional performance (e.g., electrical safety, thermal effects, smoke evacuation flow rates) rather than clinical diagnostic accuracy requiring ground truth established by medical experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the studies described are technical performance tests, not clinical studies requiring expert adjudication of outcomes.
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. The device is an electrosurgical generator with smoke evacuation, not an AI-powered diagnostic or assistive 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 hardware (electrosurgical generator and smoke evacuator), not a standalone algorithm. Its performance is inherent in its operation and is evaluated through bench testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the test set predominantly relies on:
- Engineering specifications and regulatory standards: For electrical safety and EMC (IEC 60601 series).
- Physical measurements: For factors like power output, flow rates, filtration efficiency.
- Comparison to predicate/reference device characteristics: For functional aspects and parameter ranges.
- FDA Guidance: "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" for specific tests like thermal effects on tissue and ESU performance.
8. The sample size for the training set
This is not applicable. The SafeAir combi is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
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