(82 days)
The OmniSonics Endoscopes are intended for visualization of body cavities, hollow organs, and canals. The OmniSonics Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The OmniSonics Endoscopes are indicated for the following applications: Ureteroscopy, Bronshoscopy, Thoracoscopy, Nasopharyngoscopy, Sinuscopy, General laparoscopy, Urology, Gynecological.
The OmniSonics Endoscopes are fiber optic designed endoscopes offered in a variety of lengths, diameters and configurations for user convenience. The fiberoptic endoscope functions by light being transmitted from a standard external high intensity light source through illumination fibers to the distal tip of the scope. The image is transmitted via a fiber-imaging bundle to an eyepiece. The image is viewed directly or transmitted through a video camera to a monitor. The device is provided with a reusable coupler and is also compatible with other standard couplers currently marketed.
The provided text is a 510(k) premarket notification for the OmniSonics Flexible Fiber Optic Endoscope and Coupler. It is a submission to the FDA seeking approval to market a medical device, asserting its substantial equivalence to already legally marketed devices.
Based on the provided information, the device is not a diagnostic AI device and therefore does not have the types of acceptance criteria and studies typically associated with AI/ML-driven diagnostic tools.
Here's a breakdown of why and what information is available:
This device is a traditional medical instrument (fiber optic endoscope), not an AI/ML-driven diagnostic device. The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices based on design, intended use, technological characteristics, and materials, rather than performance metrics for diagnostic accuracy.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable in this context.
Here's what can be extracted and inferred from the text regarding the device and its "testing":
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility of materials | All materials used are biocompatible. |
| Electrical Safety/Performance: Compliance with relevant standards | The OmniSonics Endoscopes conform to IEC 60601-2-18. |
| Functional Equivalence: Intended Use | "intended for visualization of body cavities, hollow organs, and canals." (Identical to predicates) |
| Design/Technological Characteristics: Materials, power source, configurations | "substantially similar in design, technological characteristics and materials to the above cited predicates. All of the devices on the market offer various configurations, lengths, diameters, use an external light source and are made of either stainless steel or polyamide." |
| Substantial Equivalence to Predicates | FDA found the device "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This submission does not describe a clinical performance study with a test set of data for diagnostic accuracy. The "testing" mentioned refers to engineering compliance and material biocompatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No diagnostic "ground truth" was established as this is not a diagnostic device in the AI sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 device, and therefore no MRMC study for AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" here is the established safety and performance requirements for endoscopes via standards (IEC 60601-2-18) and the established characteristics of predicate devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.