(167 days)
The Habib EUS RFA 6700 is indicated for coagulation 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 or 22 Gauge (G) endoscopic needles. The Habib EUS RFA 6700 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 an 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 mans of coagulation necrosis.
Here's an analysis of the acceptance criteria and study information based on the provided document:
This document is a 510(k) Pre-Market Notification for a medical device called "Habib EUS RFA 6700." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. As such, the "acceptance criteria" here are generally to demonstrate substantial equivalence through meeting performance, biocompatibility, and electrical safety standards comparable to the predicate devices. The "study" refers to the pre-clinical (bench) testing performed to show this.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail table for all performance tests. Instead, it states that the device "met the required specifications" and "performance clearly demonstrate that the Habib EUS RFA 6700 is safe and effective." The performance tests listed are qualitative descriptions of the tests performed.
However, we can infer some "acceptance criteria" for the device based on the tests conducted and the need to demonstrate substantial equivalence:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Performance | Met the required specifications. |
| Compatibility with endoscope needle | Tested and results reported; implies successful compatibility with 19 or 22 Gauge (G) endoscopic needles as described in Section 8. |
| Trackability and pushability | Tested and results reported. (Demonstrates ease of navigation through endoscope) |
| Consistency of heating zone | Tested and results reported; implies consistent and predictable tissue coagulation. |
| Abrasion resistance | Tested and results reported. (Ensures structural integrity during use) |
| Fatigue bending resistance | Tested and results reported. (Ensures durability against repeated bending during procedure) |
| Pull test | Tested and results reported. (Measures strength and integrity of connections/components) |
| Shipping and transportation stability | Tested and results reported. (Ensures device integrity during transit) |
| Package evaluation (burst test, visual inspection, seal dye) | Tested and results reported. (Ensures sterility and protection until use) |
| Functional validation for soft tissue indication | Tested and results reported. (Directly validates the primary indication for use: coagulation of soft tissue) |
| Biocompatibility | Met the required specifications. |
| Non-cytotoxic | Elution Cytotoxicity testing was performed. |
| Non-hemolytic | Hemolysis testing was performed. |
| Non-toxic (systemic, intracutaneous, implantation) | Implantation Test, Intracutaneous toxicity, Acute systemic injection tests were performed. |
| Electrical Safety & EMC | Met the required specifications. |
| Compliance with various IEC/EN/ANSI/CSA 60601-1 standards | Tested per IEC 60601-1:2006 + A1:2012, EN 60601-1:2006, ANSI/AAMI ES60601-1:2005 + C1:2009 + A2:2012 + A1:2010, CAN/CSA-C22.2 No. 60601-1:2014. |
| Compliance with IEC 60601-2-2 (HF Surgical Equipment) | Tested per IEC 60601-2-2:2009 + C1:2014. |
| Compliance with EN IEC 60601-2-18 (Endoscopic equipment) | Tested per EN IEC 60601-2-18:2009. |
| Compliance with various EMC standards (EN 55011, EN 61000-3-2, -3-3, -4-3, -4-8) | Tested per EN 55011:2007, EN 61000-3-2:2006, EN 61000-3-3:2006, EN 61000-4-3:2006, EN 61000-4-8:1993. |
2. Sample Size Used for the Test Set and Data Provenance
The document details a series of "Performance bench testing," "biocompatibility testing," and "electrical testing." However, it does not provide specific sample sizes (number of devices or tests performed) for these tests. It only lists the types of tests conducted.
For data provenance (country of origin, retrospective/prospective), the tests appear to be pre-clinical bench tests. This kind of testing generally occurs in a lab setting, likely where the device is manufactured or tested, which is EMcision Ltd. in the United Kingdom based on the submitter's address. It is not clinical data (retrospective or prospective from human subjects).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For pre-clinical bench testing, "ground truth" isn't typically established by clinical experts in the same way it would be for diagnostic AI. Instead, the "ground truth" for these tests would be the established scientific and engineering principles of the test methods (e.g., a pulling test measures force until failure, a biocompatibility test assesses cellular response). The personnel performing these tests would be engineers, lab technicians, and scientists qualified in their respective fields (materials science, electrical engineering, biology, etc.), but their specific number and qualifications are not mentioned.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided since the studies described are pre-clinical bench tests, not studies requiring expert adjudication of clinical outcomes or images. Adjudication methods like "2+1" or "3+1" are typical for clinical studies or studies involving human readers and ground truth establishment from multiple experts.
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
This information is not provided and not applicable. The document describes the pre-clinical validation of a physical medical device (an electrosurgical electrode), not an AI algorithm. Therefore, no MRMC study, human reader improvement with AI, or effect size is discussed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not provided and not applicable. The "Habib EUS RFA 6700" is a physical medical device. It is not an algorithm, and therefore, standalone algorithm performance is not relevant to this submission.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the performance and electrical bench tests, the "ground truth" is defined by the validated test methods and specifications themselves. For example:
- Functional tests: Adherence to physical properties (e.g., dimensions, strength, flexibility), consistent activation, and effective tissue coagulation as determined by engineering and material science principles.
- Biocompatibility tests: Adherence to biological safety standards as defined by ISO 10993 series and evaluated in laboratory settings (e.g., cell cultures for cytotoxicity, animal models for implantation).
- Electrical/EMC tests: Conformance to published international and national safety standards for medical electrical equipment (e.g., IEC 60601-1, IEC 60601-2-2, various EN standards for EMC).
There is no "expert consensus" or "pathology/outcomes data" ground truth in the context of these pre-clinical tests.
8. The Sample Size for the Training Set
This information is not provided and not applicable. The "Habib EUS RFA 6700" is a physical medical device, not an AI model or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and not applicable, as there is no training set for a physical medical device.
§ 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.