(267 days)
Percutaneous System for adults
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults.
Percutaneous System for adults and pediatrics
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults and pediatrics >1month of age.
The Percutaneous Nephroscope System consists of the following:
- Minimally Invasive Percutaneous Nephrolithopaxy (MIP) Nephroscopes
- HOPKINS Telescopes for Percutaneous Nephrolithotomy (PCNL)
- Operating Sheaths
- One-Step Dilators
- Telescope Bougie Set
- Hollow Obturator and Fascial Dilator Applicators
- Biopsy and Grasping forceps
- Scissors
- Knives
- Insertion Aid
- Laser Hand Instrument
- Suction tube
- Adaptors
- Luer-Lock tube connectors
The provided text is a 510(k) summary for the KARL STORZ Percutaneous Nephroscope System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and a literature review for pediatric use.
Based on the provided text, the sections relating to acceptance criteria and the study that proves the device meets them are primarily about non-clinical bench testing and literature review, as opposed to a complex clinical study for AI or image analysis devices.
Here's a breakdown of the information requested, based only on the provided document:
1. A table of acceptance criteria and the reported device performance
The document states: "Comparative bench testing between the subject and predicate DEVICES demonstrated that the endoscopes in the Percutaneous Nephroscope System meets all its design specification and is substantially equivalent to its predicate device. Additional bench testing was performed for the subject device instruments (forceps and scissors) to ensure the device met its design specifications and is substantially equivalent to the predicate."
However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum insertion force, specific illumination levels) and the precise reported performance values are not explicitly detailed in this 510(k) summary. The summary only generally states that the device "meets all its design specification."
Therefore, a table of specific acceptance criteria and reported performance cannot be fully constructed from the provided text. The document refers to compliance with ISO and IEC standards, which would imply that the device met the performance requirements outlined in those standards.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary Statement) |
|---|---|
| Compliance with design specifications | "meets all its design specification" |
| Substantial equivalence to predicate device (endoscopes) | Demonstrated through comparative bench testing, the endoscopes in the system are "substantially equivalent to its predicate device." |
| Substantial equivalence to predicate device (instruments) | Demonstrated through additional bench testing for forceps and scissors, ensuring they "met its design specifications and is substantially equivalent to the predicate." |
| Biocompatibility | Met requirements of ISO 10993 series for Cytotoxicity, Acute Systemic Toxicity, Irritation, and Maximization Sensitization. |
| Thermal Safety | Met requirements of IEC 60601-2-18:2009. |
| Reprocessing (Cleaning and Sterilization) | Met requirements of AAMI and ISO standards (TIR12, TIR30, ST77, ST79, ISO 14937, DIN EN ISO 11138-1, ANSI/AAMI/ISO 17655-1) and FDA Guidance on Reprocessing Medical Device in Health Care Settings. |
| Safety and effectiveness for pediatric use (>1 month) | Supported by "Published literature... provided to support the safety and effectiveness of the Percutaneous Nephroscope system for use in pediatrics >1month of age." (Note: This is a clinical performance claim, but the supporting study is a literature review, not a new clinical trial reported within this document.) |
2. Sample size used for the test set and the data provenance
- Sample size: The document does not specify a "sample size" in the context of clinical testing of humans or images. The "test set" refers to the specific devices and instruments undergoing bench testing. The document implies that sufficient units were tested to demonstrate compliance with design specifications and substantial equivalence, but the exact number of devices tested is not stated.
- Data provenance: The document indicates non-clinical bench testing (likely performed internally by the manufacturer or contracted labs) and a literature review. The provenance of the literature is not specified beyond "Published literature." There is no mention of country of origin for any human data (as no new human clinical studies were performed). The testing is implicitly prospective in the sense that the manufacturer conducted the tests for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the data provided. The "ground truth" for this type of device submission (Percutaneous Nephroscope System) is established through engineering and performance specifications validated by bench testing and adherence to recognized standards. There isn't a "test set" of patient images or clinical cases requiring expert interpretation to establish ground truth in the way it would be for an AI diagnostic device. The "ground truth" for the pediatric indication was established through existing published literature, not by new expert consensus specifically for this submission.
4. Adjudication method for the test set
This information is not applicable as there are no human-read test sets requiring adjudication of interpretations. The tests are bench tests proving physical and functional characteristics.
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, an MRMC comparative effectiveness study was not done, and this type of study is not relevant to a Percutaneous Nephroscope System. This device is a surgical instrument, not an AI-assisted diagnostic or image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not applicable. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" is based on engineering design specifications, established performance standards (ISO, IEC, AAMI), and the performance of the predicate device. For the pediatric indication, the "ground truth" for safety and effectiveness was established from published literature, which likely includes clinical outcomes data, expert opinions, and various study types from prior research involving similar devices/procedures in pediatrics.
8. The sample size for the training set
This information is not applicable as there is no "training set" in the context of an AI/machine learning model for this device.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" in the context of an AI/machine learning model 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.