(243 days)
The CORE-SNARE is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.
The CORE-SNARE is a disposable device for cuts out and removes the tissues such as polyps after entering a site to be treated during endoscopic procedures. The device consists of Snare-loop connected with catheter tube and Catheter tube pass through operating channel of endoscope and Handle connected with snare through the catheter tube. It is available in various sizes and working lengths. Users can choose an Oval or a Crescent or Diamond type based on their preference and the characteristic of the loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion. When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10t%). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
The provided document is a 510(k) premarket notification for a medical device called CORE-SNARE. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria in the context of an AI/ML powered device.
Therefore, the document does not contain the information requested in your prompt regarding:
- A table of acceptance criteria and reported device performance for an AI/ML algorithm.
- Sample sizes, data provenance, expert ground truth establishment, or adjudication methods for an AI/ML test set.
- MRMC studies or standalone AI performance.
- Training set details for an AI/ML algorithm.
The document primarily details the non-clinical performance testing to demonstrate the physical, electrical, and material safety and effectiveness of the CORE-SNARE, which is an electrosurgical snare for polyp removal.
Here's what the document does provide regarding its "acceptance criteria" and "study":
Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)
The "acceptance criteria" in this context are the limits and standards the physical device must meet during various non-clinical tests to be considered safe and effective and substantially equivalent to the predicate. The "study" refers to the bench testing performed.
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| I. Physical/Dimensional Tests | ||
| Dimension Test | Tolerance of nominal size should be ±10% of the standard. | "All dimensional values do not exceed the tolerance of ±10%." |
| Tensile Strength: Electrode Cable | Shall not be damaged from 40 N pulling and 0.64 J impact (in accordance with ANSI/AAMI HF 18 (2001) 4.2.5.5). | "There was no damaged from 40 N pulling and 0.64 J impact." |
| Tensile Strength: Inner Rope-Cutting Wire | Strength between inner rope and cutting wire should be not less than 15 lbs. | "It was confirmed the strength is more than 15 lbs." |
| Tensile Strength: Catheter Sheath-Handle | Strength between catheter sheath and handle should be not less than 2 lbs. | "There was more than 2 lbs." |
| II. Electrical Tests | ||
| Cable Withstand Voltage (Main frequency) | Must withstand a peak voltage of 1000V (large DC or Mains frequency) for 5 minutes (for rated accessory voltage). | "The proposed device was tested... and passed." |
| Cable Withstand Voltage (High frequency) | Must withstand for 30 seconds at a high frequency voltage of 120% of the rated accessory voltage (Maximum voltage of accessory is 920 Vp). | "The proposed device was tested... and passed." |
| High Frequency Leakage Current | Monopolar high-frequency leakage current of electrode cable shall not be more than 3.6 dfL mA; connection cord unwrapped/undamaged; no short circuits between individual conductors for multiconductor cables (in accordance with ANSI/AAMI HF 18(2001) 4.2.5.2). | "The proposed device was tested... and passed." |
| Conductive Inspection (Continuity Test) | Tips for connection with electrode tip must be electrically connected to each other (using electrical conduction circuit system). | "The proposed device was tested... and passed." |
| III. Sterility/Biocompatibility/Shelf Life | ||
| Sterility | Demonstrates a 10^-6^ SAL (Sterility Assurance Level) following ISO 11135. No microbial growth found. Meets ISO 10993-7 for ethylene oxide sterilization residuals. | "A sterility validation was completed following ISO 11135 requirements to demonstrate a 10^-6^ SAL." "No evidence of microbial growth is found, the test article to be examined complies with sterility test." Meets ISO 10993-7. |
| Biocompatibility | Passed tests for Cytotoxicity, Maximization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen test (in accordance with ISO 10993-1 for tissue contact |
§ 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).