(84 days)
Lotus Series 4 Ultrasonic Surgical System & Accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. Lotus Series 4 Ultrasonic Surgical System and Accessories may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint)
The SRA Developments Lotus Series 4 Ultrasonic Surgical System and Accessories consists of 3 main components - the power module which generates the ultrasonic energy and provides overall control of the device, the reusable part of the handset (Transducer and waveguide); and the disposable part of the handset (Handpiece). The Lotus Series 4 Ultrasonic Surgical System and Accessories employs torsional mode ultrasound at 35.8-36.6kHz to cut and coagulate soft tissue during laparoscopic or open surgery.
This document describes the 510(k) summary for the Lotus Series 4 Ultrasonic Surgical System & Accessories. It details the device's improvements, its legally marketed predicate device, and the performance testing conducted to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) summary for a medical device (ultrasonic surgical system), the "acceptance criteria" and "device performance" are typically framed in terms of demonstrating equivalence to a predicate device, rather than specific quantitative performance metrics against a defined threshold for AI/diagnostic algorithms. The study conducted here is a series of bench tests to demonstrate this equivalence.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Generator Output Equivalence | The new generator's output was compared to the Series 3 LOTUS generator. A transducer was driven by each generator, and the amplitude at the tip of the waveguide was recorded. Results showed the outputs were equivalent. |
| New Waveguide Design: Speed of Cutting Equivalence | The new, slimmer waveguide was tested for cutting speed using a standard production cutting test. Results showed equivalent performance to the existing laparoscopic waveguide. |
| New Waveguide Design: Hemostasis/Bleeding Control Equivalence | Cutting and bleeding control testing was undertaken using porcine tissue, comparing the new waveguide with an existing laparoscopic waveguide. Results demonstrated equivalence between the two waveguides for cutting and bleeding control. |
| New Waveguide Design: Fatigue Resistance Equivalence | The new waveguide design underwent fatigue resistance testing by simulating 50 surgical uses (300 seconds on-time per use, followed by autoclaving, repeated 50 times). All devices remained operational for the entire period, showing equivalence to other waveguide designs. |
| Handpiece Design: Durability Equivalence | The new handpieces were subjected to 600 clamping operations and then required to meet the standard performance test. This protocol was previously used for the Series 3 LOTUS. All devices passed the test, demonstrating equivalence in durability. |
| Technological Characteristics Equivalence | The Lotus Series 4 system uses the same transducers, torsional mode, frequency (35.8-36.6kHz), and intended use as the predicate. Waveguides are made from the same titanium alloy. Patient-contacting materials (Hastelloy, PTFE, stainless steel) and jaw operating mechanism remain the same. The generator's digital control system, digital frequency control, and output power (50W) remain the same. No new questions of safety and effectiveness are raised. |
| Electrical Safety and EMC (Electromagnetic Compatibility) Compliance | Electrical safety testing to EN 60601-1 and IEC 60601-1 by TÜV SÜD was completed. EMC testing was also completed. |
| Biocompatibility Equivalence | All patient-contacting materials remain the same as the previously cleared Series 3 LOTUS. No new biocompatibility concerns were raised. |
| Sterilization Process (for single-use Handpieces) and Shelf Life | Single-use Handpieces are supplied sterile via a validated EO process (SAL of 10-6). Residuals are within acceptable limits. Stated shelf life is 3 years. (This is a process validation, not direct comparison to predicate for sterilization, but ensuring safety for the device). |
| Transducer Sterilization (for reusable components) Equivalence | Transducer sterilization validations and instructions remain the same as Series 3 LOTUS. No further validations conducted as no change occurred. |
2. Sample size used for the test set and the data provenance
- Generator Output Equivalence: The document states "a Transducer was driven by each generator in turn". The exact number of transducers or measurements is not specified.
- New Waveguide Design (Cutting, Hemostasis, Fatigue):
- Cutting Speed: Tested using "our standard production cutting test". The number of waveguides or tests is not specified.
- Hemostasis/Bleeding Control: Tested on "porcine tissue". The number of samples or tests is not specified.
- Fatigue Resistance: Refers to "50 surgical uses" per device. "All devices" suggests more than one, but the exact number of tested waveguides is not specified.
- Handpiece Durability: "The handpieces were subjected to 600 clamping operations... All devices passed the test." The exact number of handpieces tested is not specified, but "all devices" suggests at least multiple.
Data Provenance: The studies were conducted by SRA Developments LTD, based in the United Kingdom. The tests are described as bench testing and in vitro (e.g., porcine tissue for hemostasis), indicating they are prospective tests performed in a controlled laboratory environment for the purpose of this submission. The origin of the tissue (e.g., country for porcine tissue) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of submission for an ultrasonic surgical system does not typically involve "experts establishing ground truth" in the way an AI diagnostic algorithm for image analysis would. The ground truth for performance is established through direct physical measurements (e.g., amplitude, cutting speed, visual assessment of hemostasis, functional testing for durability and fatigue). No human experts or their qualifications are mentioned in this context.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication by experts or a consensus method. Performance is determined by objective physical measurements and functional tests.
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 is a 510(k) submission for a surgical instrument, not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a surgical instrument, not an algorithm, so "standalone" performance in the context of AI is not relevant. The device operates independently of human "reading" or AI interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests was based on objective physical measurements and functional parameters such as:
- Amplitude measurements for generator output.
- Measured cutting speed.
- Observed hemostasis (bleeding control) on porcine tissue.
- Continued functionality after simulated usage cycles for fatigue resistance and durability.
- Compliance with electrical safety and EMC standards.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is an ultrasonic surgical system and not an AI/machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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