(237 days)
The BaroSense Endogastric Tube (EGT) is indicated for use with an endoscope where multiple endoscopic intubations are anticipated.
The EGT is a reusable overtube used in hospitals or surgery centers to provide a channel for the delivery and removal of endoscopic devices from the mouth to the stomach. It is intended for use when multiple endoscopic intubations, or endoscopic instrument/tool exchanges, are anticipated. A flexible Introducer Bougie has a tapered tip to assist in introduction of the EGT through the mouth and esophagus. The bougie has an internal lumen to accommodate a 5 mm endoscope. The EGT and Introducer Bougie are supplied non-sterile. The predicate device has identical technological characteristics. However, the predicate EGT is provided as a single-patient-use, disposable unit, with an internal bougie introducer included in the package. The modified device is provided as a reusable overtube and single-use bougie. The predicate device working tube is a PVC tube with an embedded stainless steel reinforcement coil, whereas the modified device is a Tecoflex tube with an embedded stainless steel reinforcement coil. The proximal handle of the modified device has an added feature to allow the endogastric tube to grip and seal to Introducer Bougie or other endoscopic devices. This gripping action prevents relative motion between the overtube and the other devices, e.g., the Introducer Bougie.
The BaroSense Endogastric Tube (EGT) is a reusable overtube used with an endoscope where multiple endoscopic intubations are anticipated. The 510(k) summary indicates that the device's safety and effectiveness were established through a series of bench and animal tests. However, it does not provide acceptance criteria, reported performance values, or specific details for these studies.
Here's a breakdown of the requested information based on the provided text, and where information is not available, it is noted:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993 standards | "Acceptable results" |
| Safety and Effectiveness | Not specified | "Acceptable results" |
| Comparison to predicate device | Substantial equivalence | "Identical technological characteristics" |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only mentions "bench and animal tests" but does not specify sample sizes for any test sets or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to a predicate device through bench and animal testing.
6. Standalone (Algorithm Only) Performance Study
This device is a medical instrument (Endogastric Tube), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable and not mentioned.
7. Type of Ground Truth Used
The ground truth for the "safety and effectiveness" appears to be based on the results of "bench and animal tests" and comparison to known biocompatibility standards (ISO 10993). However, the specific metrics for ground truth are not detailed.
8. Sample Size for the Training Set
As this is a physical medical device and not an AI or algorithm, there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/algorithm-based 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.