(283 days)
The Advance® Salivary Balloon Catheter is intended for the dilation of lesions and strictures in the submandibular and parotid salivary ducts.
The Advance® Salivary Balloon Catheter is an over-the-wire catheter available with an inflated balloon diameter of 1.5. 2.0, 2.5 and 3.0 millimeters in a balloon length of 2 centimeters. The catheter is available in an outer diameter of 2.5 French and in a length of 30 centimeters. Hydrophilic coating is applied to the distal 15 centimeters of the catheter shaft, which provides a lubricious surface when wetted. The balloon catheter is supplied with a 0.014 inch (0.36 millimeter) diameter stainless steel mandrel wire guide in a length of 50 centimeters. It is sterile and intended for one-time use.
Acceptance Criteria and Device Performance Study
The provided text describes the Advance® Salivary Balloon Catheter with Wire Guide and the studies conducted to demonstrate its reliable design and performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bond Strength | Tensile force during proper clinical use should not fracture or rupture the balloon catheter bonds. Conforms to ISO 10555-1. | Predetermined acceptance criteria were met. |
| Balloon Minimum Burst Strength | Balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. | Predetermined acceptance criterion was met. |
| Balloon Fatigue | Balloons are free from leakage and damage on inflation after 10 cycles of inflation and deflation. | Predetermined acceptance criteria were met. |
| Inflation and Deflation Time | Balloon will inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds. | Predetermined acceptance criteria were met. |
| Resistance to Corrosion | After being subjected to a corrosive environment, the wire guide withstands a tensile force greater than or equal to 5 N. | Predetermined acceptance criterion was met. |
| Visual and Dimensional Analysis | Visually and dimensionally, the wire guide and balloon catheter meet the design requirements. | Predetermined acceptance criteria were met. |
| Simulated Use | Wire guide and balloon catheter pass through a simulated stricture, and the force required to remove the balloon catheter is less than 0.95 lbf. | Predetermined acceptance criteria were met. |
| Balloon Working Length and Catheter Integrity | After simulated use testing, the catheter shows no signs of damage, and the balloon length is 2.0 centimeters ± 0.1 centimeter. | Predetermined acceptance criteria were met. |
| Simulated Clinical Use (Human cadaver model) | Balloon catheter has an atraumatic tip, safely and reliably introduces and tracks to the intended location, is compatible with the wire guide, can be removed from the salivary duct and/or sheath, and its location is verifiable within the salivary duct. | Predetermined acceptance criteria were met. |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes for each of the performance tests. It refers to "testing shows" and implies that sufficient samples were tested to meet the predetermined acceptance criteria for each test. The data provenance is not specified beyond the tests being conducted for regulatory submission for a device to be marketed in the USA. Given the nature of these engineering and performance tests, they are typically conducted in a controlled laboratory environment. The "Simulated Clinical Use" test specifically mentions a "human cadaver model," implying prospective testing in a controlled lab setting, likely in the country of manufacture (USA, given the applicant is Cook Incorporated in Bloomington, IN).
3. Number of Experts and Qualifications for Ground Truth for Test Set
Not applicable for most of the tests. The tests are engineering and performance-based, not reliant on expert interpretation for ground truth. For the "Simulated Clinical Use" test using a human cadaver model, while clinical utility is being assessed, the document does not specify the number or qualifications of experts who established the "ground truth" or evaluated the performance of the device in this context. It simply states that the "predetermined acceptance criteria were met," which would likely align with successful navigation and deployment as observed by the testing personnel.
4. Adjudication Method for Test Set
Not applicable. The tests described are objective, quantitative, or pass/fail engineering and performance tests, not requiring an adjudication method akin to clinical studies where multiple readers interpret results.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The studies described are focused on the device's inherent design and performance characteristics, not on a comparison of human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was performed. The entire section "Technological Characteristics" details various tests conducted on the device itself (e.g., bond strength, burst strength, fatigue, inflation/deflation time, corrosion resistance, visual/dimensional analysis, simulated use, balloon working length/catheter integrity, simulated clinical use). These tests assess the algorithm/device's performance in isolation from a human-in-the-loop scenario.
7. Type of Ground Truth Used
The ground truth used for these tests is based on engineering specifications, predetermined quantitative thresholds, and observable physical properties. For example:
- Bond Strength: Conformance to ISO 10555-1 standards.
- Balloon Minimum Burst Strength: Bursting at or above a specified pressure.
- Inflation and Deflation Time: Within 60 seconds.
- Resistance to Corrosion: Withstanding a tensile force greater than or equal to 5 N.
- Simulated Use: Catheter passing through a simulated stricture, removal force less than 0.95 lbf.
- Balloon Working Length: 2.0 cm ± 0.1 cm.
- Simulated Clinical Use: Observable successful introduction, tracking, compatibility, removal, and verifiable location in a cadaver model.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument (catheter, balloon, wire guide), not an AI algorithm or a device that uses a "training set" in the machine learning sense. The "training set" concept is not relevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of medical 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.