(108 days)
The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease (GERD) in patients who require and respond to pharmacological therapy.
The Medigus SRS is an Endoscopic Stapling System. The device consists of the following components and accessories:
- . The flexible endoscope combines a video camera, ultrasound sensor (range finder) and a stapler mechanism. The distal end of the endoscope is capable of retroflexion. The system enables creation of an endoluminally anterior partial fundoplication by stapling together the soft tissue of the fundus (upper part of the stomach) and the esophagus.
- The endoscopy suite includes the ISL (Insufflation, Suction and Light) console and the CCU . (Camera Control Unit) console.
- The associated accessories include: .
- Irrigation bottle with liquids for irrigation of the camera lens l
- Suction canister for extracting liquids during the procedure .
- . Silicon tubes for connecting the ISL and other accessories to the endoscope
- . Disposable air filter of the suction ISL input channel
- I Overtube for protecting patient's pharynx
The acceptance criteria and study proving the device meets them are detailed below, based on the provided text for the Medigus' SRS Endoscopic Stapling System (K120299).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety | Serious Adverse Events (SAEs) | - Ten patients with a total of ten SAEs reported. |
| - Four 'mild' (pain, fever), three 'moderate' (pneumothorax, pneumomediastinum, pneumoperitoneum - all resolved spontaneously), two 'severe' (esophageal perforation requiring drainage, suicidal thoughts - non-device/procedure related). | ||
| - One SAE (GI bleeding with transfusion) unclassified in intensity. | ||
| - Six SAEs considered related (one definitely, others possibly); three not related. | ||
| - Median time from procedure to SAE for related events: 1.5 days. | ||
| - No operations or re-operations needed for SAEs. | ||
| - SAE and overall safety profile similar to EsophyX predicate device (two perforations, one bleeding reported). | ||
| Adverse Events (AEs) | - Postoperative pain/discomfort: 33%. | |
| - Postoperative nausea: ~10%. | ||
| - Sore throat: 21%. | ||
| - AEs were mild or insignificant in most cases. | ||
| - Number of AEs similar to EsophyX and Plicator (e.g., 3 cases of fever vs. 3 for EsophyX; 32% chest pain vs. 17% for Plicator; 21% sore throat vs. 15% for Plicator, 8% for EsophyX). | ||
| Efficacy | Improvement in GERD-HRQL score (Primary Endpoint) | - 75% of patients had a >50% improvement in their GERD-HRQL score off PPI at six months compared to baseline. |
| - Study met primary endpoint with 95% confidence level. | ||
| - Median score reduction of 23.0 units (from 29.0 to 6.0), representing 79.3% improvement. This is almost identical to EsophyX (79.2%) and slightly better than Plicator (76.0%). | ||
| Reduction in Acid Exposure (Secondary Endpoint) | - Median percent of time pH |
§ 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.