(230 days)
The Sialo Balloon dilatation catheter is a medical device for use by qualified surgeons in the treatment of salivary gland diseases.
The Sialo Balloon Dilatation Catheter is designed to allow dilatation of the salivary duct under endoscopic or radiological guidance. Dilatation can be therapeutic by itself (for duct strictures), or provide endoscopic access for stone removal.
The provided 510(k) summary for the Sialo Balloon Dilatation Catheter (K072749) does not contain information about specific acceptance criteria or an associated study that proves the device meets those criteria in the way typically expected for an AI device.
This document describes a surgically invasive medical device (a balloon catheter), not an AI/ML software device. The regulatory submission focuses on demonstrating substantial equivalence to predicate devices through performance testing related to the physical device's safety and functional specifications, rather than clinical performance metrics in the context of an AI algorithm.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, ground truth for training set) are not applicable to this type of device and are not present in the provided text.
However, I can extract the relevant information regarding performance testing that was conducted.
Summary of Performance Testing for K072749: Sialo Balloon Dilatation Catheter
| Section | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. Acceptance Criteria & Performance | Device met all its functional specifications. | "extensive safety, performance, and validation testing before release." |
| "various performance tests designed to ensure that the device met all its functional specifications." | ||
| "Tests have been performed to ensure the device complies with industry and safety standards." |
Study Details (based on available information):
- 2. Sample size used for the test set and data provenance:
- Not applicable/Not provided. The testing described is for the physical device's performance (e.g., mechanical properties, sterility, integrity) rather than clinical data analysis with a test set.
- 3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable/Not provided. Ground truth in this context would relate to clinical outcomes or diagnoses, which is not the focus of the described device performance testing.
- 4. Adjudication method for the test set:
- Not applicable/Not provided.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
- 7. The type of ground truth used:
- Not applicable/Not provided in the sense of clinical ground truth for diagnostic accuracy. The "ground truth" for this device's performance would relate to engineering specifications and safety standards (e.g., balloon integrity, catheter flexibility, material biocompatibility, burst pressure).
- 8. The sample size for the training set:
- Not applicable/Not provided. This is not an AI device that would have a "training set."
- 9. How the ground truth for the training set was established:
- Not applicable/Not provided.
Additional Information from the document:
- Type of Study: The submission describes "extensive safety, performance, and validation testing" including "various performance tests designed to ensure that the device met all its functional specifications" and compliance with "industry and safety standards." It also mentions a "Literature review describing device use in other countries." These are typical for medical device regulatory submissions that focus on physical and functional characteristics.
- Intended Use: Dilatation of the salivary duct for therapeutic purposes (strictures) or to provide endoscopic access for stone removal.
- Predicate Devices:
- The Salivary Duct Dilator (Cook Medical) - a rigid rod for mechanical dilatation.
- KSEA Sialoendoscope and accessories (Karl Storz Endoscopy) - an endoscopic device.
- Dilatation Catheter Ascend™ Balloon (K970041) (Cook Urological).
- Conclusion of the Submission: The Sialo Balloon dilatation device is substantially equivalent in safety and efficacy to the predicate devices listed.
§ 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.