(171 days)
The Polypectomy Snares are used endoscopically in the removal of diminutive polyps, and pedunculated polyps within the GI tract.
The proposed device Polypectomy Snare is a sterile, single-use endoscopic device, intended to be used endoscopically in the removal diminutive polyps, sessile polyps, and pedunculated polyps from within the GI tract.
The Polypectomy Snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a handle. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop. The proposed device has eighteen (18) specifications; the main differences of these specifications are dimension and if the loop can be rotatable with the rotation of the handle.
The document describes the Micro-Tech (Nanjing) Co., Ltd. Polypectomy Snare, which is equivalent to the GIP/MEDI-GLOBE POLYPECTOMY SNARES cleared under K943935.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" but includes a "Comparison of Technology Characteristics" table for substantial equivalence. The "Acceptance Criteria" here are inferred to be "Similar" or "Same" to the predicate device's performance characteristics.
| Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Proposed Device) | Outcome (vs. Predicate) |
|---|---|---|
| Product Code: FDI | FDI | Same |
| Regulation No: 876.4300 | 876.4300 | Same |
| Class: 2 | 2 | Same |
| Indications for Use: Remove polyps and small tumors from the gastrointestinal tract with high frequency current. | Used endoscopically in the removal diminutive polyps, sessile polyps, and pedunculated polyps from within the GI tract. | Similar |
| Single Use: Yes | Yes | Same |
| Configuration: Loop, outer tube, High-Frequency, and Handle | Loop, outer tube, High-Frequency, and Handle | Same |
| Energy used/Delivered: Monopolar Radio Frequency Current | Monopolar Radio Frequency Current | Same |
| Loop Shape: Oval, Hexagonal, Asymmetric | Oval | Similar |
| Loop Diameter: Oval: 15mm, 20mm, 25mm, 35mm, 50mm; Hexagonal: 15mm, 25mm, 35mm; Asymmetric: 15mm, 25mm | Oval: 10mm, 15mm, 20mm, 24mm, 30mm, 36mm | Similar |
| Outer Tube Diameter: 2.5mm | 2.3mm | Similar |
| Minimal Working Channel: 2.8mm | 2.8mm | Same |
| Working Length: 1800mm, 2300mm | 2300mm | Similar |
| Electrode contact impedance: 13.64±0.90 | 13.46±0.68 | Similar |
| Cutting: 23.42±1.62 | 23.75±1.14 | Similar |
| Pushability: 3.38±0.81 | 3.08±0.64 | Similar |
| Performance: Electrode contact impedance, Cutting, Pushability and Tensile Strength | Electrode contact impedance, Cutting, Pushability and Tensile Strength | Same |
| Patient-contact Material: Stainless steel SUS304 (With Dow Corning® MDX4-4159, 50% Medical Grade Dispersion) and Polytetrafluoroethylene (PTFE) | Stainless steel SUS304 (With Dow Corning® MDX4-4159, 50% Medical Grade Dispersion) and Polytetrafluoroethylene (PTFE) | Same |
| Biocompatibility: Comply with ISO 10993-5, ISO 10993-10 and USP . | Comply with ISO 10993-5, ISO 10993-10 and USP . | Same |
| Sterilization: EO Sterilized, SAL: 10-6 | EO Sterilized, SAL: 10-6 | Same |
| Shelf Life: Five years | Three years | Similar |
| Labeling: Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | Same |
2. Sample size used for the test set and the data provenance:
The document states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
It does not provide specific sample sizes for the "test set" for each non-clinical test. The data provenance is primarily from non-clinical testing conducted by Micro-Tech (Nanjing) Co., Ltd. in China. The study is retrospective in the sense that it relies on established standards and comparative data with a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for this device's performance is established through adherence to recognized international and national standards for medical devices and electrosurgical equipment (e.g., ASTM, IEC, ANSI/AAMI, ISO, USP). There is no mention of human experts establishing a ground truth for a test set in the traditional sense of a clinical study.
4. Adjudication method for the test set:
Not applicable. As this is a non-clinical study based on engineering compliance and comparison to a predicate, there is no mention of an adjudication method involving experts. The compliance is against predetermined standards.
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. This is a non-clinical evaluation of a medical device (polypectomy snare), not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a surgical instrument and does not involve an algorithm. The performance is the device's physical and electrical characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests is based on established industry standards and regulatory requirements (e.g., ASTM, IEC, ISO, AAMI, USP) for seal integrity, biocompatibility, electrical safety, sterilization, and material properties. The comparative analysis against the predicate device also serves as a benchmark for equivalence.
8. The sample size for the training set:
Not applicable. This is a non-clinical evaluation of a medical device, not a machine learning model. Therefore, there is no training set in the context of AI.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set mentioned in the document.
§ 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).