Search Results
Found 1 results
510(k) Data Aggregation
(176 days)
STONE GRASPING BASKET, MODEL PD-T1 2115
The Stone Grasping Basket is a medical device indicated for use by qualified surgeons in the treatment of salivary gland diseases. It is used endoscopically to entrap and remove mobile stones and stone fragments smaller than 5mm from the salivary gland.
The stone grasping basket is a 30mm long, 4 wire, 10mm Nitinol Stone removal Basket, which is designed to pass through low diameter working channels of endoscopes for the purpose of retrieval of stones from the salivary gland.
The provided text describes a 510(k) premarket notification for the Sialo Modular Stone Grasping Basket, which is a medical device for removing stones from salivary glands. However, the document does not contain the detailed information necessary to complete the table and specific questions about acceptance criteria and a study proving device performance as requested.
Here's a breakdown of what is and is not in the document:
What is in the document:
- Device Description: A 30mm long, 4-wire, 10mm Nitinol Stone removal Basket designed for salivary gland stone removal.
- Intended Use/Indication for Use: Used endoscopically by qualified surgeons to entrap and remove mobile stones and stone fragments smaller than 5mm from the salivary gland.
- Predicate Devices: Several previously approved stone baskets from Karl Storz Endoscopy, Millennium Devices Inc., and Cook Inc.
- Performance Standards: None mentioned.
- Test Data: "The Stone Grasping Basket device has been subjected to safety and performance testing before release. Testing of the device included various performance tests designed to ensure that the device meets all its functional specifications and complies with safety standards." This is a general statement, not a detailed report.
- Substantial Equivalence Conclusion: "The results of the performance tests demonstrate that the stone grasping basket meets its specifications for efficacy and exhibits similar physical properties as the predicate devices."
What is NOT in the document (and therefore cannot be provided in the answer):
- Specific acceptance criteria (numerical thresholds, success rates, etc.)
- Reported device performance against specific criteria.
- Details of the study that proves the device meets acceptance criteria.
- Sample size used for the test set or its provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth establishment.
- Information about MRMC studies or effect sizes.
- Information about standalone (algorithm-only) performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set (as this is a mechanical device, not an AI/algorithm-based one, a "training set" in the machine learning sense is not applicable).
- How ground truth for the training set was established.
Based on the provided text, here is what can (and cannot) be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|
| Specific functional specifications (e.g., basket opening diameter accuracy, grasping force, material integrity, steerability, maximum stone size removal, compatibility with endoscope channels, durability) | General statement: "device meets all its functional specifications and complies with safety standards." |
| Safety standards compliance (e.g., biocompatibility, sterility, absence of sharp edges) | General statement: "complies with safety standards." |
| Similar physical properties to predicate devices | General statement: "exhibits similar physical properties as the predicate devices." |
| *Efficacy in entrapping and removing stones |
Ask a specific question about this device
Page 1 of 1