(28 days)
The USGI g-Prox EZ Endoscopic Grasper is intended for use in minimally Invasive procedures to facilitate tissue grasping and manipulation.
The g-Prox EZ Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is available in two jaw lengths. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments. It is comprised of a polycarbonate proximal handle, flexible shaft made of medical grade polymers and distal stainless steel jaws. It has a nominal working length and outer diameter of 111 cm and 5.5 mm, respectively.
This 510(k) summary (K103688) describes the g-Prox EZ Endoscopic Grasper, a sterile, single-patient-use device intended for tissue grasping and mobilization in minimally invasive procedures.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device Integrity | Non-clinical performance testing, including bond joint strength testing, was conducted. Test data confirmed that the modified g-Prox EZ device demonstrated equivalent safety and performance to the predicate device. |
| Functionality | Non-clinical performance testing was conducted. Test data confirmed that the modified g-Prox EZ device demonstrated equivalent safety and performance to the predicate device. This likely includes the ability to grasp and mobilize tissue, and for the g-Prox EZ, specifically the ability to cut G-Cath anchor suture tails. |
| In Vivo Simulated Use | Non-clinical performance testing, including in vivo simulated use testing, was conducted. Test data confirmed that the modified g-Prox EZ device demonstrated equivalent safety and performance to the predicate device. |
| Equivalence to Predicate Device (g-Prox Endoscopic Grasper - K093018) | The g-Prox EZ Endoscopic Grasper demonstrated equivalent safety and performance to the predicate device in terms of intended use, technology, materials, and overall function. Specific comparisons include: |
- Identical shaft and distal jaw materials and sizes.
- Identical intended use and principles of operation.
- Identical lumen for accepting other instruments.
- New suture cutting component in g-Prox EZ jaw. |
2. Sample Size Used for the Test Set and Data Provenance
The submission states that "Non-clinical performance testing was conducted." While it details the types of tests performed (device integrity, functionality, in vivo simulated use), it does not explicitly state the sample size for these tests or the data provenance (e.g., country of origin, retrospective or prospective). This information is typically found in the detailed test reports which are part of the full 510(k) submission but not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe the use of human experts to establish ground truth for the non-clinical performance testing. The evaluation focused on engineering and performance characteristics of the device itself rather than human interpretation of medical images or conditions.
4. Adjudication Method for the Test Set
Not applicable. This device's performance was evaluated through non-clinical engineering and functional testing, not through a process requiring expert adjudication of results.
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
No, an MRMC comparative effectiveness study was not performed. This device is a surgical instrument (grasper), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of improving human readers with AI assistance does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical instrument and does not involve an algorithm or AI component in its operation. Its performance is entirely mechanical/physical, used by a human operator.
7. The Type of Ground Truth Used
The "ground truth" for this device's testing was based on engineering specifications, material properties, and functional requirements. For example:
- Device Integrity: "Ground truth" would be the predetermined acceptable limits for bond joint strength or other integrity measures.
- Functionality: "Ground truth" would be the successful demonstration of tissue grasping, mobilization, and suture cutting (for the EZ model) according to design specifications.
- In Vivo Simulated Use: "Ground truth" would involve successful and safe operation within a simulated biological environment, meeting predetermined performance criteria.
8. The Sample Size for the Training Set
Not applicable. As described in point 6, this device is a physical surgical instrument and does not involve any AI algorithms or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As described in point 8, there is no training set for this 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.