FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Cystoscope Used to examine the urinary tract, and, 1) using additional accessories, to perform various diagnostic and therapeutic procedures.
1. Choledochoscope - Used to examine the bile ducts, and using, additional accessories, to perform various diagnostic and therapeutic procedures.
Ureteroscope Used to examine the ureter, and using 3) additional accessories, to perform various diagnostic and therapeutic procedure.
4 ) Nephroscope - Used to examine the kidney, and with additional accessories, to perform various diagnostic and therapeutic accessories.
1. Uretero-renoscope - Used to examine the ureter and kidney, and additional accessories, to perform various diagnostic and therapeutic procedures.
  Accessory Indications for use.
1. Flexible Biopsy Forceps - Used to obtain small biopsies from tissue.
Flexible Grasping Forceps For grasping calculi, both 7) renal and biliary.
Button Electrode Used for unipolar coagulation. 8)
ರಿ ) Dormia Stone Extractor - Used for grasping and removal of calculi, both renal and biliary.
Three Pronged Grasper Used for grasping and removal of 10) calculi, both renal and biliary.

Device Description

The flexible mini-fiberscopes are endoscopes with working channels that allow physician control of the tip position and accessory instruments.

AI/ML Overview

The provided text describes a medical device, flexible mini-fiberscopes, and discusses its safety and effectiveness. However, it does not include information about acceptance criteria for device performance, nor a study proving it meets such criteria in the way typically expected for AI/ML device evaluations.

Here's a breakdown of why it's not possible to fulfill the request based on the provided text, and what information is available:

1. A table of acceptance criteria and the reported device performance

Not Available: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its functional performance.
Available Performance Data: The document mentions that "Tests were performed to assure:"
- (a) continued flexibility after repeated (2000) flexs
- (b) ability to withstand repeated (10,000) insertions
- (c) that no thermal hazard exists
- (d) that the fiberscopes do not present a High Frequency Hazard.
- Note: While these are performance aspects, they are not presented as acceptance criteria with specific numerical thresholds for success, but rather as statements that these characteristics were "assured."

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/Not Available: This question is relevant to studies involving test sets of patient data, which the document explicitly states was not obtained. The performance tests mentioned (flexibility, insertions, thermal/HF hazard) would involve testing the physical devices themselves, not patient data.

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: Since no clinical data or patient data test set was used, there was no need for experts to establish ground truth in the context of diagnostic or interpretive performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable: No clinical test set.

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 a physical medical device (fiberscope), not an AI/ML algorithm. Therefore, no MRMC study involving human readers or AI assistance was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No: This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable: No clinical data or patient-related ground truth was established for this device's evaluation as described. The "ground truth" for the physical performance tests would be whether the device physically met engineering specifications (e.g., did it break after 2000 flexes? Did it exceed a certain temperature?).

8. The sample size for the training set

Not Applicable: This is a physical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not Applicable: No training set.

Summary based on the provided text:

The document describes a traditional medical device (flexible endoscope) and focuses on its physical and mechanical performance, as well as material safety and sterilization. It explicitly states that "No clinical data was obtained." Therefore, criteria, studies, and data related to diagnostic accuracy, AI performance, or human reader effectiveness are not present in this submission. The "study" mentioned refers to engineering tests on the device's durability and safety characteristics.

Summary

Regulation Number and Section

§ 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.