(100 days)
The ClearGrasp Snare is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.
ClearGrasp Snare is a monopolar electrosurgical instrument intended for EMR which is Endoscopic Mucosal Resection by applying high-frequency current during endoscopic electrosurgical procedures. It is used for grasping and resecting the targeted lesion within the digestive tract by opening and closing the loop. Users can choose an oval or a crescent type based on their preference and the characteristic of the lesion. The loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion. There is a stiff type distinguished by the strength of loop. The device consists of a flexible Rope Wire and various size of loop, which can be extended and rotated from the flexible Catheter Tube using two handle control knobs such as Handle and Slider. When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site. This device passes through the working channel of endoscope, and the average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
The provided text describes the 510(k) premarket notification for the "ClearGrasp Snare" device. It outlines the device's indications for use, its technical characteristics, and the non-clinical testing performed to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria for performance, a study proving the device meets specific performance criteria with reported device performance metrics, or details regarding ground truth establishment, sample sizes for test/training sets, expert qualifications, or adjudication methods typically found in studies for AI/software devices.
The document focuses on demonstrating substantial equivalence primarily through technical specifications, biocompatibility, and electrical safety testing, as is common for electrosurgical accessories. It does not present a study with specific performance metrics against defined acceptance criteria that would be relevant for an AI/software device.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to answer based on the available information, with clear indications where information is not present.
Acceptance Criteria and Study for ClearGrasp Snare
The provided 510(k) submission for the ClearGrasp Snare does not present a study with specific performance acceptance criteria and reported device performance metrics in the way a study for a diagnostic or AI device would. The submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, and non-clinical safety testing rather than a performance study against predefined numerical acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Passed (compliant with ISO 10993-5:2009) |
| Sensitization | Passed (compliant with ISO 10993-10:2010) |
| Intracutaneous reactivity | Passed (compliant with ISO 10993-10:2010) |
| Acute Systemic Toxicity | Passed (compliant with ISO 10993-11:2006) |
| Pyrogen Test | Passed (compliant with ISO 10993-11:2006) |
| Performance Testing: | |
| Appearance | Performed as per Finemedix's design control system (implies passed) |
| Dimension | Performed as per Finemedix's design control system (implies passed) |
| Continuity | Performed as per Finemedix's design control system (implies passed) |
| Tensile strength test of electrode cable | Compliant with IEC 60601-2-2:2017 and ANSI/AAMI HF18:2001 (implies passed) |
| Withstand voltage | Compliant with IEC 60601-2-2:2017 and ANSI/AAMI HF18:2001 (implies passed) |
| High frequency leakage current test of electrode cable | Compliant with IEC 60601-2-2:2017 and ANSI/AAMI HF18:2001 (implies passed) |
| Sterilization & Shelf Life: | |
| EO Sterilization residuals testing | Compliant with ISO 10993-7:2008 (implies passed) |
| EO Sterilization Validation Testing | Compliant with ISO 11737-1:2006 and ISO 11737-2:2009 (implies passed) |
| Shelf Life Testing | Compliant with ASTM F1980 (implies passed) |
Note: The document only states that these tests were performed and implies successful completion ("demonstrate that the subject device is substantially equivalent"). It does not provide specific numerical results or quantitative acceptance criteria (e.g., "tensile strength > X N") for most of these tests in the publicly accessible summary.
Regarding AI/Software specific details (Items 2-9):
The ClearGrasp Snare is described as a monopolar electrosurgical instrument intended for Endoscopic Mucosal Resection (EMR). It is a physical medical device (snare) and not an AI or software device. Therefore, the following requested information is not applicable to this submission, as it relates to the evaluation of AI/software performance, which is not the subject of this 510(k).
2. Sample size used for the test set and the data provenance: Not applicable; this is a physical device, not an AI/software being tested on a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable; this is a physical device, not an AI/software with a training set.
9. 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).