(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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.