(268 days)
The LAGIS Endoscopic Instruments-Grasper has applications in a variety of minimally invasive procedures to facilitate grasping and mobilization of tissue.
The LAGIS Endoscopic Instruments - Grasper is a single use device sterilized by ethylene oxide. It is composed of an insulating shaft, a rotation knob, grasping forceps, and a ratchet handle. The 5 mm diameter insulating shaft is designed for use through appropriate size trocars. The rotation knob located on the handle rotates the insulating shaft 360 degrees in either direction for better maneuverability. With the ratchet handle, the grasping forceps are allowed to be locked in place. The grasping forceps are activated by compression and release of the ring of the handle.
The provided text is a 510(k) Summary for the LAGIS Endoscopic Instruments - Grasper. This type of FDA submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study that would involve assessing diagnostic or treatment effectiveness.
Therefore, the information typically requested in your prompt (such as acceptance criteria for diagnostic performance, sample sizes for test sets, expert qualifications, and ground truth establishment) is not applicable to this document. This document focuses on demonstrating that the new device is as safe and effective as a previously cleared predicate device based on design characteristics, material similarities, and bench testing of functional performance.
Here's an breakdown of the relevant information provided in the document based on your prompt, with an explanation of why certain criteria are not met by the available text:
1. A table of acceptance criteria and the reported device performance
There isn't a table of specific acceptance criteria in the sense of diagnostic performance or clinical outcomes. Instead, the "performance" section describes the types of bench tests conducted to ensure the device functions as intended and is comparable to the predicate device. The general acceptance criterion is that the device "performed acceptably compared to the predicate device."
| Acceptance Criteria (Implied from testing) | Reported Device Performance |
|---|---|
| Biocompatibility standards per ISO 10993 and 21 CFR Part 58 | Materials used were tested for cytotoxicity, sensitization, irritation, and systemic toxicity, demonstrating compliance. |
| Sterilization validation | Sterilization by ethylene oxide was validated. |
| Material characteristics match predicate or perform acceptably | Materials are "similar to those in the predicate device." Tested for various characteristics. |
| Functional performance (e.g., grasping force, tip hardness, corrosion resistance, bending performance, mobilization) | "Test results showed that the device performed acceptably compared to the predicate device in terms of grasping force, tip hardness, corrosion resistance, mobilization, and bending performance, among other parameters." |
| Mechanical integrity and functionality (e.g., rotation, locking) | The device's design features (rotation knob, ratchet handle) imply these functions were tested and validated to perform as intended. "These studies included assessments of (...) functional performance, along with bending and ex vivo tissue testing." |
| No new safety or effectiveness concerns compared to predicate | Minor differences (additional tip types, wider tip opening, longer shaft, greater grip force) are stated not to "raise any safety or performance issues" or "introduce new questions regarding safety or effectiveness," as confirmed by performance testing. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. Bench testing typically involves a set number of devices to demonstrate consistency and compliance, but specific numbers are not mentioned here.
- Data Provenance: The tests are "Performance bench tests" conducted by Lagis Enterprise Co., Ltd. The document does not specify a country of origin for data in the sense of patient data, as this is a device for grasping tissue and not a diagnostic or AI-driven tool. The data is from laboratory testing. It is a pre-market submission, not a post-market study or clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an endoscopic instrument for grasping tissue, not a diagnostic tool that requires human expert interpretation for ground truth establishment. The "ground truth" for this device's performance would be engineering specifications and validated test methods.
4. Adjudication method for the test set
Not applicable for the reasons mentioned above.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical surgical instrument.
7. The type of ground truth used
The "ground truth" for this device would be established engineering specifications, material standards, and functional performance benchmarks (e.g., a certain force must be achieved, a certain bending radius must be tolerated). The document states that "performance bench tests were conducted to verify the design characteristics and confirm that the device functions as intended." This implies adherence to pre-defined engineering and safety standards rather than a clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.