(159 days)
The auxiliary instruments for ureteroscopes and uretero-renoscopes are used for preliminary procedures in the ureter and kidney, as well as for procedures in the urethra and bladder.
Flexible and rigid auxiliary instruments can be used in connection with single or double instrument ports.
Various diagnostic and therapeutic procedures can be performed, for example:
- transurethral extraction of uretero calculi
- biopsy for tumor diagnostics
- removal of foreign bodies, e.g. ureteral stents
The interventions are carried out by trained and experienced surgeons who consider the general condition and the anatomic specialties of the patient in their diagnosis.
The forceps are used for endoscopically controlled grasping and obtaining tissue specimens for diagnosis. Both flexible and rigid forceps are available.
The stone extractors (graspers) are used to grasp stones or stone calculi and extract them out of urological tract. The stone extractor is also used to immobilize the calculus while disintegrating the stone.
The stone extractors are intended for minimally invasive, diagnostic and therapeutic interventions. They are used e.g. in conjunction with ureteroscopes and uretero-renoscopes.
Various electrodes are used for controlling bleeding and for removing or destruction of tissue by use of unipolar high-frequency current under endoscopic view.
The bougies are used for the atraumatic distention of tubular organs. The flexible hollow dilators can be inserted over a guide wire, for example into the renal pelvis.
The bougies are intended for minimally invasive, diagnostic and therapeutic interventions.
The submitted auxiliary instruments for URS are accessories for the ureterrenoscopy. These are rigid or flexible biopsy, grasping, and foreign body forceps, stone extractors, unipolar electrodes for high frequency applications, and bougies.
The provided K971315 submission describes auxiliary instruments for ureteroscopes and uretero-renoscopes. It is a 510(k) premarket notification for traditional medical devices rather than an AI/ML-enabled device, thus the standard acceptance criteria for AI devices and associated studies are not directly applicable.
However, I can extract the performance data and the methods used to demonstrate substantial equivalence for these instruments.
Here's an interpretation based on the provided text:
Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical and sterilization testing to ensure the new design maintains safety and efficacy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No breakage or functional impairment under normal use conditions (mechanical integrity) | Mechanical load test of the forceps and stone graspers show that there is no breakage of the jaw or other parts of the instrument if used normally. |
| No adverse effect on functional performance after sterilization (sterilization compatibility) | The steam sterilization in clinical use and tests performed by Richard Wolf show that the steam sterilization has no influence on the functional performance of the submitted instruments when using the fractional method. |
| Performance similar to predicate devices despite design changes (e.g., smaller diameter, shorter jaws) | The basic design is "similar to devices sold prior to 1976 and to competitor's products." Changes (smaller diameter, shorter jaws) were made to "ensure the same stability" and adapt to anatomy. Performance data indirectly supports this by showing no breakage and functional integrity after sterilization. |
Study Details (Interpreted for traditional device testing)
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes (number of instruments tested) for the mechanical load tests or sterilization tests.
- Data Provenance: The tests were "performed by Richard Wolf," indicating internal company testing. The country of origin for the data is implicitly the USA, where the company is located. The study is prospective in the sense that the tests were conducted specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML-enabled device requiring expert ground truth for classification or detection. The "ground truth" here is the objective measurement of mechanical failure or functional performance.
- The "experts" involved would be the engineers and technicians conducting the mechanical and sterilization testing, presumably qualified in those fields.
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Adjudication method for the test set:
- Not applicable for this type of mechanical/sterilization testing. Performance is measured against engineering specifications or established protocols rather than expert consensus on diagnostic outcomes.
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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 is not an AI/ML-enabled device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML-enabled device. The performance tests evaluate the physical device's integrity and function, not an algorithm.
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The type of ground truth used:
- For mechanical tests: "Ground truth" is the objective state of the device (intact vs. broken, functional vs. non-functional) under specified load conditions.
- For sterilization tests: "Ground truth" is the objective state of the device's functional performance after sterilization.
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The sample size for the training set:
- Not applicable. This is not an AI/ML-enabled device and does not involve training data.
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How the ground truth for the training set was established:
- Not applicable.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.