(57 days)
The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.
The Habib EndoHPB is also intended for use to ablate malignant or benign tissue, notably to perform endoscopic biliary drainage or decompression, prior to stent placement or afterwards, to clear occluded stent.
The Habib EndoHPB is an 8F RF bipolar catheter that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel. It has an attached cable which connects the device to an RF Generator. RF is applied to the two electrodes at the top of the catheter so that heat is applied to tissue surrounding the catheter.
This document, a 510(k) Pre-market Notification for the Habib EndoHPB, details the device's substantial equivalence to a predicate device, focusing on its expanded indications for use. It outlines the performance and clinical data submitted to support these expanded uses.
Acceptance Criteria and Reported Device Performance
The provided document does not contain a typical "acceptance criteria" table with specific quantitative thresholds for device performance (e.g., sensitivity, specificity, accuracy) akin to what might be seen for diagnostic AI devices. Instead, the "acceptance criteria" for this device, which is a therapeutic radiofrequency (RF) catheter, are implicitly demonstrated through:
- Substantial Equivalence: The primary acceptance criterion for a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This involves showing that the device is as safe and effective as the predicate.
- Performance Data: Non-clinical (bench) testing to confirm fundamental device properties, such as shelf-life and compatibility with new generators.
- Clinical Data: Studies to demonstrate the safety and effectiveness of the device for its expanded indications for use, particularly for the ablation of tissue in pancreatic and and biliary tracts, and for clearing occluded stents.
Therefore, the table below summarizes the differences and the justification for substantial equivalence, which serves as the "acceptance criteria" framework for this type of device submission.
| Acceptance Criterion (implicitly demonstrated through substantial equivalence) | Reported Device Performance/Justification |
|---|---|
| Expanded Indications for Use (Safety and effectiveness for new target anatomical sites and therapeutic actions) | Reported Performance: The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. It is also intended for use to ablate malignant or benign tissue, notably to perform endoscopic biliary drainage or decompression, prior to stent placement or afterwards, to clear occluded stent. |
Justification: "Multiple clinical studies are being submitted to demonstrate that the Habib EndoHPB is as safe and effective as the predicate. All the clinical studies provided within this submission have been performed using the subject device and clearly support the new intended use." The subject device has the same fundamental technology, design attributes, materials, and functions as the predicate. |
| Extended Shelf-Life (Device functionality and safety maintained over 3 years) | Reported Performance: New claimed shelf-life of 3 years.
Justification: "The results obtained support the claimed 3-year shelf-life." This implies non-clinical testing was performed (e.g., accelerated aging, real-time aging studies) to confirm material degradation, sterility, and functional performance over the extended period. |
| Compatibility with New Generators (Safe and effective operation when connected to additional RF generators) | Reported Performance: Compatibility with additional generators: Olympus ESG-100, Genii GI 4000, ERBE VIO 200, ERBATOM ICC 200, 300, 350. (The predicate was compatible with RITA Medical Systems 1500, RITA Medical Systems 1500X, Radionics Cosman Coagulator CC-1).
Justification: "The results obtained support... the compatibility with new generators." This implies testing was performed to ensure that the device performs as intended and safely (e.g., no overheating, appropriate power delivery, no electrical hazards) when used with these new generators, meeting relevant electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18). |
| Fundamental Technological Equivalence (No significant changes in design, material, energy source, or manufacturing process that raise new questions of safety or effectiveness) | Reported Performance: "Compared to the predicate device, there has been no change or modification in design, material, energy source or manufacturing process in the subject device." The device remains an 8F RF bipolar catheter with 2 ring electrodes, stainless steel active electrode material, delivered endoscopically, single-use, and ETO sterilized. The core mechanism of action (bipolar RF energy ablation) is unchanged.
Justification: The 510(k) submission states that "the evidence collected in the table above clearly demonstrate that, except for insignificant differences, the subject device, the Habib EndoHPB, is identical to the previously cleared Habib EndoHPB (K083292) in terms of fundamental technology, design attributes, materials, features, functions, and performance." |
| Electrical Safety and Electromagnetic Compatibility (EMC) (Compliance with recognized international standards for medical electrical equipment) | Reported Performance: "Electromagnetic compatibility and electrical safety testing have been performed on the Habib EndoHPB to validate that it meets the requirements of the latest Recognized Consensus Standards."
Justification: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18. |
Study Proving Device Meets Acceptance Criteria
The document states that "multiple clinical studies are being submitted to demonstrate that the Habib EndoHPB is as safe and effective as the predicate" for its new intended use. However, the details of these specific studies (e.g., design, endpoints, results) are not provided within this 510(k) summary. This summary only states that such studies were submitted and supported the new intended use.
Based on the provided text, the following information regarding the study cannot be definitively extracted:
- Sample sizes used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. This is a therapeutic device, not a diagnostic AI device requiring expert consensus for ground truth on images. The "ground truth" would relate to clinical outcomes (e.g., successful ablation, stent clearance, complication rates).
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/specified.
- 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 therapeutic device, not an AI-assisted diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a therapeutic device that works with a human operator.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While not explicitly stated, for a therapeutic device performance, the ground truth for clinical studies would typically involve outcomes data such as:
- Successful ablation (e.g., histological confirmation if biopsies are taken, imaging follow-up)
- Successful biliary drainage/decompression
- Successful stent clearance
- Complication rates (e.g., perforation, bleeding, pancreatitis)
- Adverse event rates
- Patient survival/quality of life (if long-term follow-up was part of the study).
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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).