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510(k) Data Aggregation
(260 days)
Wittich Nitinol Stone Basket
The Wittich Nitinol Stone Basket is intended for placement through a percutaneous tract for removal of stones (calculi) or stone fragments from anatomic structures such as the gallbladder, biliary tract, renal pelvis, and ureter.
The Wittich Nitinol Stone Basket is comprised of a basket catheter with a loading sleeve, an introducer sheath, and a dilator. The basket is designed with a six-wire bulb configuration and is manufactured from nitinol wire. The nitinol wires are soldered together to a stylet wire which is secured inside the basket catheter shaft. The loading sleeve is used to support the insertion of the basket catheter into the introducer sheath.
The introducer sheath is manufactured from radiopaque fluorinated ethylene propylene and is designed with a radiopaque tip near the distal end of the introducer for tip visibility. Additionally, the distal end of the introducer sheath is angled to facilitate directional control. The matched dilator is manufactured from polyethylene tubing and is tapered for a smooth transitional fit within the matched introducer sheath.
The provided text describes the Cook Incorporated Wittich Nitinol Stone Basket, a medical device for removing stones from anatomical structures. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria or extensive clinical study results for a new AI-powered device.
Therefore, much of the requested information regarding AI-specific criteria, human reader studies, and large-scale data provenance is not available in the provided text. The document primarily details mechanical and biocompatibility testing for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (if available) | Reported Device Performance |
|---|---|---|
| Dimensional and Compatibility | Adequate for clinical use (general) | Testing showed that dimensions and component compatibility was adequate for clinical use. |
| Multiple Stone Retrieval Testing | Able to track, deploy, and retrieve a simulated stone (approx. 8 mm diameter) ten times through a 90-degree bent tube without damage to the test article. (Per FDA 510(k) Checklist for Mechanical Lithotripters and Stone Dislodgers) | The Basket Catheter with Loading Sleeve and the Introducer Sheath was able to track, deploy, and retrieve a simulated stone (approximately eight (8) mm in diameter) ten times through a tube bent at approximately ninety degrees, without damage to the test article. |
| Basket Catheter Shaft, Basket-to-Basket Shaft Solder Joint, and Hub-To-Shaft Joint Tensile | Peak load greater than or equal to 10 N (in accordance with JIS T 3244:2011) | Testing showed the peak load of catheter shaft section was greater than or equal to 10 N. |
| Basket Catheter Single Loop and Silicone Sphere to Basket Wire Joint Tensile | Peak load greater than or equal to 10 N (in accordance with JIS T 3244:2011) | Testing showed the peak load of a single loop of the basket catheter and silicone sphere to basket wire joint was greater than or equal to 10 N. |
| Introducer Sheath Shaft, Introducer Sheath Hub-to-Shaft Tensile | Peak load greater than or equal to 15 N (in accordance with BS EN ISO 11070: 2014) | Testing showed the peak load of the introducer sheath shaft and introducer sheath hub-to-shaft bond were greater than or equal to 15 N. |
| Introducer Distal Tip Bond Tensile | Peak load greater than or equal to 15 N (in accordance with BS EN ISO 11070) | Testing showed the peak load of shaft-to-tip was greater than or equal to 15 N. |
| Radiopacity Testing | Radiopacity determined to be non-inferior to the selected comparative device (following ASTM F6540-12) | The radiopacity of the Wittich Nitinol Stone Basket introducer sheath was determined to be non-inferior to the radiopacity of the selected comparative device. |
| Introducer Sheath Kink Radius | Kink radius less than or equal to 30 mm | Testing showed the kink radius was less than or equal to 30 mm. |
| Dilator Shaft/Hub-to-Shaft Tensile | Peak load of dilator shaft greater than or equal to 10 N, and hub-to-shaft greater than or equal to 15 N (in accordance with BS EN ISO 11070) | Testing showed the peak load of the dilator shaft and the hub-to-shaft were greater than or equal to 10N and 15 N, respectively. |
| Biocompatibility | Met cytotoxicity, sensitization, intracutaneous irritation, and acute systemic toxicity requirements (Per ISO 10993-1 and FDA guidance) | Testing for cytotoxicity, sensitization, intracutaneous irritation, and acute systemic toxicity demonstrated the biocompatibility of the subject devices. All pre-determined acceptance criteria were met. The results of these tests showed that the subject devices met the design input requirements based on the intended use, and support the conclusion that these devices do not raise new questions of safety or effectiveness and support a determination of substantially equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes in-vitro (bench) testing simulating conditions. It does not refer to a "test set" in the context of clinical data for an AI algorithm.
- Sample Size: Not explicitly stated as a number of "samples" in a dataset sense. Instead, tests were performed a certain number of times (e.g., "ten times" for stone retrieval) or on individual components. The "test article" refers to the device itself or its components.
- Data Provenance: Not applicable as it is laboratory bench testing, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This is not applicable as the studies described are bench tests for a physical medical device, not a performance evaluation of an AI algorithm using expert-labeled data. The performance criteria are based on engineering standards and simulated physical properties, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
- Not applicable for bench testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This device is a physical stone retrieval basket, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This submission is for a physical medical device, not an AI algorithm. The performance described is for the device operating independently in a simulated environment.
7. The Type of Ground Truth Used
- The "ground truth" for these tests refers to established engineering standards, material properties, and physical performance metrics. For example:
- Tensile strength is measured against a standard (e.g., peak load in Newtons).
- Radiopacity is compared to a comparative device.
- Stone retrieval capability is measured by the ability to retrieve a simulated stone under specified conditions.
- Biocompatibility is assessed against recognized ISO standards and FDA guidance for toxicology (cytotoxicity, sensitization, irritation, systemic toxicity).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is not an AI algorithm.
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