(367 days)
The SuMO™ Access and Tissue Resection System is intended to access, dissect, and resect soft tissue in endoscopic gastrointestinal procedures such as removal of flat polyps.
The Injection Needle is intended for endoscopic injection of solutions such as a procedural aid in endoscopic procedures.
The Tunneling Balloon is intended for soft tissue separation and dilation during endoscopic procedures.
The Dilation Balloon is intended for soft tissue separation and dilation during endoscopic procedures.
The Tissue Resection Tool is intended for endoscopic resection in the gastrointestinal tract.
The SuMO™ Snare is intended to remove polyps and small tumors from the gastrointestinal tract.
The Apollo Endosurgery SuMO Access and Tissue Resection System is a single-use system intended to access, dissect, and resect soft tissue in endoscopic gastrointestinal procedures.
The system is comprised of five component devices:
- Injection Needle ●
- Tunneling Balloon .
- Dilation Balloon .
- Tissue Resection Tool .
- SuMO Snare ●
The SuMO Access and Tissue Resection System underwent various testing to ensure it met acceptance criteria for its intended use.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not specified | Cytotoxicity: Met |
| Sensitization: Met | ||
| Intracutaneous Toxicity: Met | ||
| Sterilization (ETO) | SAL of 10^-6 | Achieved SAL of 10^-6 |
| ETO residuals met FDA and international requirements | ETO residuals met requirements | |
| Product Testing | Not specified | Dimensional: Met |
| Inflation/deflation: Met | ||
| Balloon size and reloading: Met | ||
| Resistivity: Met | ||
| Endoscope compatibility: Met | ||
| Electrical Safety & Electromagnetic Compatibility | Requirements of test standards | Met requirements of test standards |
2. Sample size used for the test set and the data provenance:
The document does not provide details on the sample size for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). It generally states that "Product testing was completed and met the acceptance criteria."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available in the provided document. The studies conducted are related to device performance and safety, not diagnostic accuracy requiring expert ground truth establishment.
4. Adjudication method for the test set:
Not applicable. The testing described is performance-based, not involving 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:
Not applicable. This is a medical device for tissue access and resection, not an AI or diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used:
For biocompatibility, the ground truth would be established by standard biological assays confirming the absence of adverse reactions. For sterilization, the ground truth is a sterility assurance level (SAL) of 10^-6. For product testing (dimensional, inflation/deflation, etc.), the ground truth would be the pre-defined engineering specifications and functional requirements for the device components. Electrical safety and EMC ground truth are defined by relevant international standards.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that would require a training set.
9. How the ground truth for the training set was established:
Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth.
§ 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.