(141 days)
The NCircle Nitinol Tipless Stone Extractor is intended for the manipulation, entrapment, and extraction of calculi and other foreign bodies in the salivary ducts, and to minimize migration during intracorporeal lithotripsy and/or other interventional procedures.
The NGage Nitinol Stone Extractor is intended for the manipulation, entrapment, and extraction of calculi and other foreign bodies in the salivary ducts, and to minimize migration during intracorporeal lithotripsy and/or other interventional procedures.
The NCircle Nitinol Tipless Stone Extractor and NGage Nitinol Stone Extractor are sterile, single use baskets which are used to manipulate, entrap, and extract calculi and other foreign bodies in the salivary ducts and to minimize migration during intracorporeal lithotripsy and/or other interventional procedures. The NCircle or NGage will be inserted into a salivary duct under direct visualization through a sialendoscope or introducer sheath to reach the calculi or other foreign body. The device can then snare the object and withdraw it from the body or help to maintain its position during lithotripsy prior to removal. The NCircle and NGage devices are intended for short-term use.
The provided 510(k) summary for the Cook Incorporated NCircle Nitinol Tipless Stone Extractor and NGage Nitinol Stone Extractor describes the device's technical characteristics and intended use, and states that substantial equivalence was determined based on comparisons to predicate devices and verification testing. However, it does not contain details of specific acceptance criteria or a study that directly proves the device meets those criteria in a clinical or performance study setting with human data.
Instead, the submission focuses on design, material, processing, and intended use equivalence to predicate devices, along with engineering verification tests.
Here's an breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in terms of measurable performance thresholds. | Substantially equivalent to predicate devices based on design, materials, and processing. |
| Verification Testing: | |
| Tensile testing (basket wires) | Performed to demonstrate reliable design and performance. |
| Tensile testing (sheath to handle) | Performed to demonstrate reliable design and performance. |
| Biocompatibility testing | Performed to demonstrate reliable design and performance. |
| Tensile testing (basket assembly to handle) | Performed to demonstrate reliable design and performance. |
| Mechanical integrity testing | Performed to demonstrate reliable design and performance. |
| Sterilization testing | Performed to demonstrate reliable design and performance. |
Explanation: The document states that "To demonstrate reliable design and performance," the listed verification tests were presented. It implies that successful completion of these tests (meeting internal specifications or industry standards not detailed here) served as the acceptance criteria for the engineering aspects. There are no performance metrics like sensitivity, specificity, or successful stone extraction rates from a clinical study mentioned.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. The document refers to engineering verification testing, not a clinical or performance study with a "test set" of patients or images. The "test set" for the engineering tests would refer to the number of devices or components tested, which is not specified.
- Data Provenance: Not applicable. No clinical data is presented, so no country of origin or retrospective/prospective nature is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. No ground truth based on expert review of clinical cases is mentioned or implied. The verification tests performed are laboratory-based engineering tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no clinical "test set" requiring adjudication.
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. This device is a physical medical instrument (stone extractor), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission focuses on engineering specifications and regulatory compliance. It relies on:
- Predicate device characteristics: The technological characteristics are stated to be "identical in design, materials, and processing" to prior devices.
- Internal engineering specifications/standards: Successful completion of tensile, biocompatibility, mechanical integrity, and sterilization tests. The specific standards or acceptance limits for these tests are not provided in the summary.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this device's development as it is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. No training set for a machine learning model is involved.
Summary of Device Acceptance Approach in K120468:
The 510(k) submission for the NCircle and NGage stone extractors relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This equivalence is established through:
- Direct comparison of technological characteristics: The new devices are stated to be "identical in design, materials, and processing" to their predicate counterparts (NCircle Tipless Stone Extractor and NGage Nitinol Stone Extractor).
- Comparison of intended use: The stated intended uses are also substantially equivalent to the KSEA Sialoendoscopy accessory stone basket and the predicate Cook Medical devices.
- Engineering verification testing: A series of laboratory tests (tensile, biocompatibility, mechanical integrity, sterilization) were conducted to demonstrate "reliable design and performance." The specific acceptance criteria for these tests are not detailed in the summary, but their successful completion contributed to establishing the safety and effectiveness for substantial equivalence.
This approach is typical for many Class II medical devices where a direct predicate device exists, and the new device does not introduce new technological aspects or different intended uses that would necessitate extensive new clinical data or performance studies with human subjects.
§ 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.