(176 days)
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 |
§ 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.