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510(k) Data Aggregation
(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.
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(58 days)
The Habib EUS RFA 6700 is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator.
The Habib EUS RFA 6700 is a catheter that is delivered during an EUS procedure, through 19 Gauge (G) endoscopic needles. The subject device is monopolar configuration and thus, must be used in conjunction with patient grounding pad. RF energy is produced by connecting the catheter to a compatible RF generator via accessory cable. When attached to a generator, RF current is emitted from the exposed portion of the electrode and this current translates into ion agitation within the surrounding tissue, which is converted by friction into heat and induces cellular death by means of coagulation necrosis.
The provided text describes a 510(k) submission for the Habib EUS RFA 6700 device, asserting its substantial equivalence to a predicate device (K150029). The submission outlines various performance, biocompatibility, and electrical tests conducted to demonstrate that the device meets required specifications.
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Performance Bench Tests | Trackability and Pushability Test | Met required specifications for design verification |
| Consistency of Heating Zone and Temperature Test | Met required specifications for design verification | |
| Abrasion Test | Met required specifications for design verification | |
| Mechanical Tests on the Electrical Assembly (Pull Test, Three Points Bending, Compression Test, Fatigue Resistance Test, Peel Resistance Test) | Met required specifications for design verification | |
| Transport Simulation and Package Integrity | Met required specifications for design verification | |
| Accelerated Aging | Met required specifications for design verification | |
| Seal Integrity (visual inspection) | Met required specifications for design verification | |
| Bubble Test (package integrity) | Met required specifications for design verification | |
| Peel Test (seal strength) | Met required specifications for design verification | |
| Ambient Preconditioning | Met required specifications for design verification | |
| Controlled Conditioning | Met required specifications for design verification | |
| Distribution Simulation | Met required specifications for design verification | |
| Design and Usability Validation | Met required specifications for design verification | |
| Functional Validation for Soft Tissue Indication | Met required specifications for design verification | |
| Label Inspection | Met required specifications for design verification | |
| Usability of Pouch | Met required specifications for design verification | |
| Functional testing of catheter insertion in the endoscope needle | Met required specifications for design verification | |
| Deflection Test | Met required specifications for design verification | |
| Mechanical Tests on the Positioning Guide | Met required specifications for design verification | |
| IPX2 Test | Met required specifications for design verification | |
| Biocompatibility Tests | ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process | Met required specifications for biocompatibility tests |
| ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity | Met required specifications for biocompatibility tests | |
| ISO 10993-7:2008 Biological Evaluation of Medical Devices Part 7: Ethylene oxide sterilization residuals | Met required specifications for biocompatibility tests | |
| ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization | Met required specifications for biocompatibility tests | |
| Electrical Testing | IEC 60601-1:2006: Medical electrical equipment - part 1: General requirements for basic safety and essential performance | Met required specifications for electrical tests |
| IEC 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | Met required specifications for electrical tests | |
| IEC 60601-2-18:2009 Endoscopic equipment | Met required specifications for electrical tests |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for any of the performance tests. The tests appear to be laboratory-based bench tests and biocompatibility tests, rather than clinical studies with patient data. Therefore, details regarding country of origin or retrospective/prospective nature of patient data are not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The evaluations described are primarily engineering and biocompatibility tests, not interpretations of clinical data requiring expert consensus or ground truth establishment in that context.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are objective engineering and biological assessments, not subjective interpretations requiring adjudication.
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 done. This device is an electrosurgical tool, not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical electrosurgical catheter and not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed can be considered the established scientific and engineering standards outlined by the various ISO and IEC standards cited (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety). The performance bench tests would have had internal engineering specifications as their "ground truth."
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI algorithm that requires a training set.
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