(29 days)
The SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper GI tract.
The SmartBand EMR Device is an endoscopic mucosal resection device that is provided as a kit or a pack that is designed for ligation assisted endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract. The SmartBand EMR Kit consists of the SmartBand Ligator Kit, supplied non-sterile and the SmartSnare EMR Hexagonal Snare, supplied sterile. The ligator kit contains a ligation handle, loading device, connector tube and a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand EMR Pack consists of a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand EMR Pack can be used when more bands are needed to complete a procedure. The SmartSnare EMR Hexagonal Snare consists of a handle, finger slide and a hexagonal snare loop on the distal end.
This document is a 510(k) summary for the STERIS SmartBand EMR Kit. It is a submission to the FDA regarding a modified device and argues for its substantial equivalence to a legally marketed predicate device. As such, it does not contain a study proving the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.
Instead, this document focuses on demonstrating that the modified device is as safe and effective as the predicate device by showing that the changes made do not affect the fundamental scientific technology or how it is used. The "acceptance criteria" here refer to the regulatory standard of substantial equivalence, and "performance" refers to non-clinical testing performed to support this claim.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined as numerical thresholds for clinical performance but rather are inferred from the requirements for demonstrating substantial equivalence to a predicate device. The "performance" reported is related to non-clinical testing to ensure safety and functionality of the modified components.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Non-Clinical) |
|---|---|
| Maintain Intended Use | Intended use is "Same" |
| Maintain Device Functionality | No negative impact from changes in device components (band color, universal connector, band lock, additional barrel diameter) |
| Materials of Construction are biocompatible and safe | Similar materials; new materials for Universal Connector and Band Lock do not affect intended use or fundamental technology. Biocompatibility testing performed per ISO 10993-4, -5, -10 and -11 and USP38-NF33. |
| Sterilization efficacy maintained | Sterilization method (Ethylene Oxide) and Assurance Level (10-6) are "Same". |
| Single use and energy compatibility maintained | Single use and diathermic energy use are "Same". Compatible with new electrosurgical generator (US Endoscopy gi4000) with no change to intended use or fundamental technology. |
| Manual application maintained | Manual application is "Same". |
| Packaging changes do not affect device performance | Band lock prevents band dislodgement during shipping; additional box for snare is a convenience. No effect on device use or fundamental technology. |
| Shelf life change maintained device integrity | Extended shelf life (24 months vs 12 months) provides greater flexibility with no effect on device use or fundamental technology. |
| Overall safety and effectiveness as predicate device | "Modified device is as safe and effective as the legally marketed predicate device." |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable in the context of a clinical performance study. The non-clinical testing would have involved specific numbers of devices or components for each test (e.g., specific number of devices for biocompatibility, simulated use, ship testing), but these numbers are not detailed in the summary.
- Data provenance: Not explicitly stated as country of origin, but it's internal testing conducted by STERIS Corporation. The nature of the tests (biocompatibility, simulated use) suggests laboratory or engineering testing. It is retrospective in the sense that the justification is made after the modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of submission. "Ground truth" in this context would likely refer to established engineering standards, regulatory guidelines (e.g., ISO for biocompatibility), and internal quality control specifications, rather than expert clinical consensus on patient data.
4. Adjudication method for the test set
Not applicable. This is a technical submission, not a clinical study requiring adjudication of diagnoses or 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
Not applicable. This device is a medical accessory for endoscopic mucosal resection, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI-related effectiveness was assessed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical testing would be established engineering specifications, material standards (e.g., for biocompatibility), and performance benchmarks derived from the predicate device's known characteristics. For example, the ground truth for biocompatibility is meeting the requirements of ISO 10993 standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).