(262 days)
This device is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers, or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device.
The ORISE™ Gel device is a viscous dyed solution which is pre-filled into a standard luer lock syringe for use in submucosal injection to lift gastrointestinal mucosa during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, such as the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers and other pathological lesions by EMR, ESD or polypectomy. The Injection is injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope.
The ORISE™ Gel is a submucosal injection agent used in gastrointestinal endoscopic procedures to lift lesions prior to excision. The provided text outlines the performance data for the device, including acceptance criteria derived from comparative testing against a predicate device and safety/efficacy studies.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Predicate Device Performance | ORISE™ Gel Performance | Outcome |
|---|---|---|---|---|
| Bench Performance | Solution Viscosity | Not explicitly detailed but used as benchmark | Comparable to predicate | Pass |
| Solution Color | Not explicitly detailed but used as benchmark | Comparable to predicate | Pass | |
| Solution pH | Not explicitly detailed but used as benchmark | Comparable to predicate | Pass | |
| Solution Osmolality | Not explicitly detailed but used as benchmark | Comparable to predicate | Pass | |
| Injection Force | Not explicitly detailed but used as benchmark | Comparable to predicate | Pass | |
| Injection Force | N/A (General requirement) | Meets design specifications | Pass | |
| Connection Seal Integrity | N/A (General requirement) | Meets design specifications | Pass | |
| Connection Separation Force | N/A (General requirement) | Meets design specifications | Pass | |
| Ex-Vivo Performance | Initial Height (compared to predicate & dyed saline) | Used as benchmark | Comparable to predicate | Pass |
| Height at 5 min (compared to predicate & dyed saline) | Used as benchmark | Comparable to predicate | Pass | |
| Height at 10 min (compared to predicate & dyed saline) | Used as benchmark | Comparable to predicate | Pass | |
| Height at 20 min (compared to predicate & dyed saline) | Used as benchmark | Comparable to predicate | Pass | |
| Height at 30 min (compared to predicate & dyed saline) | Used as benchmark | Comparable to predicate | Pass | |
| Preclinical (Porcine Model) | Efficacy (submucosal lift during EMR/ESD) | Comparable to dyed saline control | Comparable to dyed saline control | Pass |
| Safety (adverse events during EMR/ESD) | Comparable to dyed saline control | Comparable to dyed saline control | Pass | |
| Biocompatibility | General Biocompatibility | N/A (Standard tests for intended use) | All tests passed | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: Not specified for individual tests, but comparative testing was conducted against the predicate device.
- Ex-Vivo Testing: Not specified, but direct comparison was made to the predicate (Eleview) and dyed saline.
- Preclinical Testing (Porcine Study):
- Test set for efficacy and safety:
- EMR procedures: 12 performed with ORISE™ Gel (Test Article) and 12 with dyed saline (Control Article). Total n=24.
- ESD procedures: 11 performed with ORISE™ Gel (Test Article) and 11 with dyed saline (Control Article). Total n=22.
- Overall total n=46 procedures.
- Data Provenance: The study was conducted in a porcine model, meaning it used animal subjects. This is a prospective study design, as procedures were performed specifically to evaluate the device. The country of origin of the data is not specified.
- Test set for efficacy and safety:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the given text. For a device like this, "ground truth" might refer to expert assessment of the quality of submucosal lift, ease of use, or adverse events. The text only states that a preclinical study was conducted, implying observational data collection rather than expert adjudication of a fixed dataset.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated in the provided text. In a porcine study, the assessment of efficacy (e.g., quality and duration of lift) and safety (e.g., signs of tissue damage) would typically be performed by trained veterinary or medical personnel involved in the study. It's unclear if multiple independent observers were used or if a consensus method was employed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The studies described are bench tests, ex-vivo tests, and a preclinical animal study. These types of studies do not involve human readers assessing cases. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. This device is a medical product (a gel), not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a medical product (submucosal injection gel), not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
- Bench Testing: Engineering specifications and direct measurements (e.g., viscosity, pH, osmolality, injection force, physical integrity tests). Comparison to predicate device performance served as a benchmark for equivalence.
- Ex-Vivo Testing: Direct measurement of tissue lift height and duration, likely against predetermined success criteria or direct comparison to the predicate and saline.
- Preclinical Testing (Porcine Study):
- Efficacy: Directly observed and measured submucosal lift, determined by the operative team and potentially recorded measurements (e.g., lift height, duration). The "ground truth" for efficacy was whether the gel produced a lift comparable to the control (dyed saline) that facilitated EMR/ESD.
- Safety: Direct observation of adverse events, tissue response, and macroscopic/microscopic examination of the treated areas in the porcine model. The "ground truth" for safety was the absence of significant adverse effects or comparability to the control.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product (a gel), not an AI model that requires a training set. The descriptions relate to product development and validation studies, not machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of 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.