(256 days)
The BaroSense EGT is indicated for use with an endoscope where multiple endoscopic intubations are anticipated.
The BaroSense EGT is a single use, disposable, 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.
The EGT is supplied non-sterile and is provided with a removable, flexible introducer with a tapered tip that assists in introduction of the EGT through the mouth and esophagus.
The provided text is a 510(k) Summary for the BaroSense Endogastric Tube (EGT). This document primarily focuses on establishing substantial equivalence to existing predicate devices based on device description, indications for use, and biocompatibility.
Crucially, the document does NOT contain information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), or any study that directly reports on such performance data. It briefly mentions "bench tests" but does not detail their methodology, results, or specific acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies, as these details are not present in the provided text.
Based on the available information, here's what can be extracted:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| However, based on the context of a 510(k) for an overtube, implicit performance criteria would likely include: | Implicitly, the device successfully met these criteria, as substantial equivalence was determined. |
| Biocompatibility requirements per ISO 10993 | "All patient contacting components of the EGT are composed of materials of known biocompatibility tested to the requirements of ISO 10993." (Stated as met) |
| Functional performance characteristics (e.g., ease of insertion, ability to create a channel for endoscopic devices, durability during intended use, compatibility with endoscopes, prevention of kinking/collapse) | "The safety and effectiveness of the device was further established through a series of bench tests. All testing yielded acceptable results." (Stated as met, but no specific results are provided) |
| Dimensional specifications (length, diameter, compatibility with typical endoscopes) | Not explicitly stated as an acceptance criterion, but would be assessed in bench testing. |
| Sterilization (if applicable, though stated as non-sterile) | Not applicable as the device is supplied non-sterile. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "a series of bench tests," but provides no details on sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not specified. This device is an Endogastric Tube (overtube), not an AI/imaging diagnostic device that would typically involve expert ground truth for performance evaluation in the context of the questions asked. Its evaluation relied on engineering bench tests and biocompatibility testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. See point 3.
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. This is not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/imaging diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Adherence to ISO 10993 standards and material conformance.
- For functional performance: Engineering specifications and testing protocols for items like material strength, flexibility, dimensions, and ease of use in simulated environments. The "ground truth" would be whether the device met its pre-defined engineering specifications and performed as intended in bench simulations.
8. The sample size for the training set:
- Not applicable. This is a hardware medical device (an overtube), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of Device and 510(k) Logic:
The BaroSense Endogastric Tube (EGT) is a single-use, disposable overtube intended to provide a channel for endoscopic procedures requiring multiple intubations or instrument exchanges. Its 510(k) clearance (K082589) was based on demonstrating substantial equivalence to existing predicate devices (Guardus™ Disposable Overtube, NDO Surgical Overtube, CR Bard Endoscopic Overtube).
The evidence for substantial equivalence primarily relied on:
- Similar Indications for Use: "use with an endoscope where multiple endoscopic intubations are anticipated."
- Similar Device Description: Single-use, disposable overtube with an introducer.
- Biocompatibility: Confirmation that all patient-contacting components met ISO 10993 requirements.
- Bench Testing: A series of unspecified "bench tests" were performed, with acceptable results, presumably demonstrating functional performance characteristics consistent with predicate devices and safety for intended use.
The 510(k) process for this device focused on confirming that it did not raise new safety or effectiveness concerns compared to already marketed devices, rather than establishing novel performance metrics or conducting clinical trials as might be seen for a new drug or high-risk implant.
§ 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.