(267 days)
Intended for use in the cutting of soft tissue using radiofrequency current, the coagulation (hemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.
The Creo Medical Electrosurgical System with Speedboat surgical instrument comprises:
- Electrosurgical Generator (7-EMR-050)
- Footswitch (2-EMR-032)
- Interface Cable Procedure Pack (cable with sterile sheath) (7-RS2-210)
- Speedboat RS2 instrument (7-RS2-001)
- Speedboat RS2 8 Fr instrument (7-RS2-003)
- Speedboat SB1 instrument (7-RS2-001)
The Electrosurgical Generator is deliver bipolar radiofrequency (RF) energy and microwave energy for the purpose of cutting and coagulating tissue. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cut; the other pedal activates the microwave energy output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable.
The Interface Cable connects electrosurgical instruments to the Electrosurgical Generator and is for single-use and is supplied with a sterile sheath that is fitted over its distal end during connection to the surgical accessory.
Speedboat is an electrosurgical instrument for use with the Creo Medical Electrosurgical Generator only. Speedboat instrument is for endoscopic use and provides cutting, coagulation and injection of fluids incorporated in a single device. Speedboat Instrument is for single-use only and is provided sterile via EO sterilization.
Speedboat SB1 instrument is a line addition to the system, designed to be used in endoscopes with a minimum working channel of 2.8 mm.
The provided document is a 510(k) summary for the Creo Medical Speedboat Flush SB1 Instrument. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of its performance against specific acceptance criteria in a clinical setting with human subjects.
Therefore, the requested information, particularly regarding specific performance metrics with acceptance criteria, sample sizes for test sets (including data provenance, expert involvement, and adjudication methods), MRMC studies, standalone algorithm performance, and training set details, is not available in the provided text.
The document primarily covers bench testing to demonstrate that design changes (fluid injection, shaft diameter, distal tip dimensions, handle design) do not negatively impact device performance compared to the predicate device.
However, I can extract the general "acceptance criteria" through the lens of device validation and the types of performance testing mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) summary, the acceptance criteria are implicitly met by "passing" the various bench tests and demonstrating substantial equivalence. Explicit numerical targets are not provided within this document.
| Acceptance Criteria Category | Reported Device Performance (as per bench tests) |
|---|---|
| Fluid Injection Functionality | Ability to produce a jet (constant stream) of saline from the device tip at minimum pressure, determined to be equivalent to the needle injection of the predicate. |
| Shaft Diameter/Compatibility | Performances evaluated via bench tests and determined to be substantially equivalent to the predicate device, despite smaller diameter. |
| Distal Tip Dimensions/Performance | Lifetime cut and coagulation performance evaluated and demonstrated to be substantially equivalent to the predicate device. |
| Handle Design Functionality | Function of the handle unchanged; incorporates same connections (QMA, luer lock). Evaluated via bench tests and determined to be substantially equivalent. |
| Overall Design Specifications | Meets all design specifications, risk mitigation requirements, and applicable medical device standard requirements. |
| Sterilization Assurance Level (SAL) | 10⁻⁶ (as per ISO 11135:2014 and AAMI TIR28:2016). |
| Shelf-life | 1 year (12 months). |
| Biocompatibility | Meets all required biological endpoints (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute systemic toxicity, Hemocompatibility) as per ISO 10993-1. |
| Electrical Safety, Microwave Safety, EMC | Complies with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-6 (safety) and IEC 60601-1-2 (EMC). |
| Software Verification & Validation | Conducted and documented as per FDA guidance; "major" level of concern addressed. |
| Lifetime Cut & Coagulation | Passed acceptance criteria (implicitly, by demonstrating substantial equivalence). |
| Connection Latch & Retention | Passed acceptance criteria. |
| Minimum Bend Radius | Passed acceptance criteria. |
| Connector Rotation | Passed acceptance criteria. |
| Device Rotation | Passed acceptance criteria. |
| Device & Injection Fluid Temperature | Passed acceptance criteria. |
| Endoscope Insertion & Withdrawals | Passed acceptance criteria. |
| Vector Network Analysis (VNA) | Passed acceptance criteria. |
| Hot Tissue Damage | Passed acceptance criteria. |
| Cutting Speed & Thermal Margin | Passed acceptance criteria. |
| Distal Tip Shear Force | Passed acceptance criteria. |
| Components & Sub-assemblies Strength | Passed acceptance criteria. |
2. Sample size used for the test set and the data provenance
Not specified in the document. The document describes various bench tests (e.g., Lifetime Cut & coagulation, Fluid injection, Hot tissue damage) but does not provide details on the number of samples tested for each or the specific "data provenance" as one would expect for clinical data. These are likely performed in a lab setting rather than with human or animal data for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. For bench testing of physical device characteristics, human expert "ground truth" setting in the context of interpretation (like radiology) is not relevant. The "ground truth" is typically defined by engineering specifications, physical measurements, and performance benchmarks.
4. Adjudication method for the test set
Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessments. This document describes bench testing, where outcomes are typically objective measurements against engineering specifications.
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 an electrosurgical instrument, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical electrosurgical device; it does not have a standalone "algorithm-only" performance that would be evaluated in this manner. Software verification and validation were conducted for the generator's control software, which is part of the integrated system.
7. The type of ground truth used
For the bench tests, the "ground truth" would be engineering specifications, physical and electrical standards, and predetermined performance benchmarks established during device design and validated against the predicate device. For biocompatibility, the ground truth is established by the relevant ISO standards and FDA guidance.
8. The sample size for the training set
Not applicable. This document describes a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI model. For the software verification and validation, the "ground truth" would be the software requirements specifications and expected functional behavior.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).