(197 days)
Used to establish a percutaneous tract into the renal pelvis for catheter placement or stone manipulation.
Used under fluoroscopy or ultrasound for initial location and positioning within the renal collecting system during a percutaneous nephrostomy.
The Percutaneous Entry Set is comprised of a Skinny Needle® with Chiba Tip, a Disposable Two-Part Trocar Needle, 8 dilators and a wire guide.
The Skinny Needle® is comprised of a stainless steel stylet inserted through a hubbed stainless steel cannula. The cannula has gauge size of 22 with a length of 20 centimeters. The distal end of the cannula is a Chiba tip, beveled at a 30° angle.
The Disposable Two-Part Trocar Needle is comprised of a stainless steel beveled stylet which can be inserted through a hubbed stainless steel cannula. The cannula comes in a gauge of 18 with lengths in 15 and 20 centimeters. When the beveled stylet is inserted through the cannula, the length from the distal endpoint of the cannula to the proximal starting point of the bevel on the wire is 0-2 millimeters. Needles have an optional Echotip® design, consisting of a series of very small dimples on the surface of the needle tip that enables it to be visible under ultrasound.
The dilators are manufactured from polyethylene tubing in 6.0, 7.0, 8.0, 9.0, 10.0, 12.0, 14.0 and 16.0 French sizes. All dilators measure 20 centimeters in length and have 8 to 15 millimeter taper with a 0.040 inch diameter thru hole.
The wire guide is characterized by a heavy-duty shaft, with a gradual transition to a very flexible distal tip. This wire guide type is manufactured in a 0.038 inch diameter, and measures 80 centimeters in length with a 3 millimeter Safe-T-J tip. This wire guide is constructed of a polytetrafluoroethylene coated stainless steel.
The Percutaneous Entry Set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a 3-year shelf life.
The Skinny Needle® with Chiba Tip is also available for sale individually.
The Skinny Needle® with Chiba Tip will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a 3-year shelf life.
The Disposable Two-Part Trocar Needle is also available for sale individually.
The Disposable Two-Part Trocar Needle will be supplied sterile and is intended for onetime use. The set is packaged in a peel-open pouch with a 3-year shelf life.
Here's an analysis of the provided text regarding the acceptance criteria and study for the medical device:
Please note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report evaluating the performance of a new AI algorithm. Therefore, many of the typical questions regarding AI-specific acceptance criteria, test sets, ground truth establishment, or clinical effectiveness studies are not applicable directly to this submission.
The device in question is a Percutaneous Entry Set, Skinny Needle® with Chiba Tip, Disposable Two-part Trocar Needle, which is a physical medical device (needles, dilators, wire guides), not an AI software.
Therefore, the provided document does not contain information to answer questions 1, 2, 3, 4, 5, 6, 7, 8, and 9 in the context of an AI-powered device.
Instead, the document details performance data of the physical device to demonstrate its safety and effectiveness and substantial equivalence to a predicate device.
Acceptance Criteria and Study for the Percutaneous Entry Set and Needles (Physical Device)
This section outlines the performance testing done to ensure the physical device meets its intended design requirements and is substantially equivalent to a predicate device.
1. A table of acceptance criteria and the reported device performance
The document lists types of tests performed but does not provide specific numerical acceptance criteria (e.g., "tensile strength must be > X N") nor the quantitative results ("tensile strength was Y N"). It only states that the devices "met applicable design requirements" and that "the results of these tests provide reasonable assurance that the devices will perform as intended."
| Acceptance Criteria Category | Reported Device Performance Assessment |
|---|---|
| Biocompatibility | Met applicable design requirements |
| Sterilization | Met applicable design requirements |
| Packaging: Distribution & Stability | Met applicable design requirements |
| Shelf-life | Met applicable design requirements |
| Component Compatibility | Met applicable design requirements |
| Dilators: Tensile Test | Met applicable design requirements |
| Dilators: Tip Integrity Test | Met applicable design requirements |
| Dilators: Radiopacity Test | Met applicable design requirements |
| Needles: Hub Union Strength Test | Met applicable design requirements |
| Needles: Fluid Injection Test | Met applicable design requirements |
| Needles: Echogenicity Test | Met applicable design requirements |
| Needles: Corrosion Test | Met applicable design requirements |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each test. It mentions that testing was performed internally by the manufacturer (Cook Incorporated) and in accordance with recognized standards (ASTM F 623-99 (2013) and FDA's Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters). There is no mention of external data provenance (e.g., country of origin, retrospective/prospective clinical data) as these are non-clinical, bench-top, and lab-based tests of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical instrument, and its performance is evaluated through engineering and materials testing, not by expert interpretation of images or data to establish a "ground truth." The ground truth for these types of tests is generally defined by engineering specifications and recognized test methods.
4. Adjudication method for the test set
Not applicable, for the same reasons as point 3. Testing involves objective measurements against established specifications.
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
Not applicable. This is not an AI device, and therefore no MRMC study was performed to assess AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
For the safety and performance tests (e.g., tensile strength, corrosion, biocompatibility), the "ground truth" is typically defined by:
- Engineering specifications: Pre-defined thresholds and requirements based on the intended use and material properties.
- Recognized standards: Compliance with industry standards like ASTM F 623-99 (2013) and FDA guidance documents.
- Predicate device characteristics: Performance levels comparable to the legally marketed predicate device (K844090).
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device that requires a training set.
Summary for the Substantial Equivalence Determination:
The submission demonstrates substantial equivalence by showing that the subject devices (Percutaneous Entry Set, Skinny Needle® with Chiba Tip, Disposable Two-part Trocar Needle) have:
- Similar indications for use.
- Similar methods of operation.
- Similar fundamental technological characteristics as the predicate device (Percutaneous Nephrostomy Trocar System, American Edward Laboratories, K844090).
- Differences in design specifications, dimensions, and materials are supported by a battery of performance tests that confirm the devices "met applicable design requirements" and "will perform as intended," without raising new questions of safety or effectiveness.
N/A