(173 days)
The nephroscope, with its accessories, is used, with suction, for the disintegration and removal / extraction of kidney and bladder stones. The stones are removed, under endoscopic control, through percutaneous or transurethal passages, in conjuction with intercorporeal pneumatic, ultrasound, electrohydraulic or laser lithotriptors.
For diagnosis and therapy with endoscopic accessories in the upper and lower urogenital tract when performed by trained and qualified medical personnel.
The universal nephroscope has a reduced sheath diameter and an expanded working channel to accommodate auxiliary instruments and irrigation. The submitted nephroscope design has been modified to optimize user handling.
The submitted nehproscope can be held by the elongated right angled light connected which has been designed with a recessed grip and a thumb ring. An automatic valve for instrument insertion and an automatic locking mechanism between the endoscope and sheath is part of the submitted design. Accessory instruments have been adapted to the longer nephroscope.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the K994223 Nephroscope Set:
Based on the provided K994223 510(k) summary, the device is a conventional medical instrument, not a software algorithm or AI-driven diagnostic device. Therefore, many of the typical performance study elements requested for AI/ML devices (like sample sizes for training/test sets, ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this submission.
The 510(k) process for traditional devices primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and raises no new safety or effectiveness questions.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: For traditional medical devices like this nephroscope, "acceptance criteria" and "device performance" are typically demonstrated through design verification and validation (often in-house testing) and adherence to recognized standards, rather than clinical performance metrics like sensitivity, specificity, or AUC as would be seen for AI/ML diagnostic tools. The document explicitly states "Clinical tests were not performed."
| Acceptance Criteria Category | Specific Criteria (as implied or stated) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Safety & Effectiveness | Device is safe and effective when used according to instructions. | "These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual." |
| Technological Characteristics | No diminished safety or effectiveness compared to predicates due to new features (reduced sheath diameter, expanded working channel, elongated right-angled light connector with recessed grip and thumb ring, automatic valve, automatic locking). | "The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices..." |
| Material Conformance | Conforms to relevant international electrical safety and European medical device standards. | "The devices conform to international standards IEC 601-2-18 and to the relevant provisions of the European Device Directive 93/42/EEC." |
| Intended Use | Suitable for disintegration and removal/extraction of kidney and bladder stones under endoscopic control. | The device is intended for this use, and its design supports this functionality (e.g., expanded working channel for auxiliary instruments). |
| Substantial Equivalence | Device is substantially equivalent to predicate devices. | Claimed substantial equivalence to: 1. Fiber Kight Operating Laparoscope 4937 (Richard Wolf, pre-enactment) 2. Pylescope System (Richard Wolf, K770729) 3. Operating Syet for Percutaneous Removal of Kidney Stones 27090 / 27092 / 27093 (Karl Storz) 4. Rigid Percutaneous Nephroscope MRO-20 (Circon ACMI) |
2. Sample size used for the test set and the data provenance
Not applicable. This device is a surgical instrument. There is no "test set" in the context of data for an AI/ML algorithm. Performance is demonstrated through in-house lab testing, design verification, and adherence to standards, not human data sets. The document explicitly states "Clinical tests were not performed" and "No known performance standards" in the context of human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" establishment in the context of human data for this type of device submission. The safety and effectiveness are established through engineering design, material selection, manufacturing controls, and bench testing to demonstrate functionality and meet design specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or human data requiring adjudication for this device type.
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 device is not an AI/ML diagnostic tool and does not involve "human readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of medical device, "ground truth" is defined by engineering specifications, material properties, and functional performance benchmarks demonstrated through non-clinical testing (e.g., mechanical strength, fluid flow rates, optical clarity, compatibility with accessories).
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or "ground truth" in the AI/ML sense for this 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.