Search Results
Found 1 results
510(k) Data Aggregation
(264 days)
The D-KuttingTm LL Peripheral Scoring Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in the coronary vasculature.
The Peripheral Scoring Balloon Dilatation Catheter is an over the wire (OTW) catheter. It features a non-compliant balloon with 3 scoring elements mounted longitudinally on its outer surface. The scoring element is attached on the surface of balloon by adhesive. The scoring elements were tightly circled by a nitinol wire and the cross section of the scoring element is a triangular. The length of the scoring element is according to effective length of balloon. The catheter has two radiopaque marker bands, which fluoroscopically indicates the expanded part of the balloon and aid in the placement of the balloon and scoring element and to facilitate proper placement. The two radiopaque marker bands are located on the inner-lumen which is underneath the balloon. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the inflation site. A lubricious coating is applied at from the distal tip to shaft tubing to enhance insertion and withdrawal performance. The inner lumen in the shaft tubing and ends in a Y-connector manifold hub with 2 Luer lock fittings. The straight manifold port is used to pass the catheter over the suitable guidewire. The second side port communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The diameter and length of the balloon and the diameter of the compatible guide wire are printed on the hub. The balloon is folded an inserted in a PTFE casing to protect the balloon and scoring element. The Peripheral Scoring Balloon Dilatation Catheter is offered in balloon diameters ranging from 2.5mm-7.0mm and lengths are from 20mm to 150mm. The catheter length is 90cm, 135cm and 150cm and is compatible with 0.014″ or 0.018″ guide wires accordingly.
This 510(k) clearance letter pertains to a medical device, the D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter, rather than an AI/ML-driven device. As such, many of the requested categories related to AI/ML device testing (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable or cannot be extracted from this document.
However, I can provide the acceptance criteria and a summary of the study results for the non-clinical tests performed to demonstrate the device's substantial equivalence to a predicate device.
Acceptance Criteria and Reported Device Performance
The document states that "The subject device, the Peripheral Scoring Balloon Dilatation Catheter, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance and test protocols." However, the specific quantitative acceptance criteria for each test are not explicitly detailed in this summary. The reported performance is generally stated as having met these unquantified criteria.
| Category | Specific Test | Acceptance Criteria (Not explicitly quantified in document) | Reported Device Performance |
|---|---|---|---|
| Bench Testing | Visual verification | Implied: Device meets visual specifications (e.g., no defects, correct assembly). | Met all predetermined acceptance criteria. |
| Dimensional verification (balloon, catheter, scoring element, crossing profile, others) | Implied: Dimensions are within specified tolerances. | Met all predetermined acceptance criteria. | |
| Balloon compliance & RBP | Implied: Balloon compliance and rated burst pressure (RBP) meet specified requirements. | Met all predetermined acceptance criteria. | |
| Coating integrity (Pre & Post) | Implied: Coating remains intact and functional before and after use/handling. | Met all predetermined acceptance criteria. | |
| Simulated use | Implied: Device performs as intended under simulated clinical conditions. | Met all predetermined acceptance criteria. | |
| Balloon inflation/deflation time | Implied: Inflation/deflation times are within clinically acceptable limits. | Met all predetermined acceptance criteria. | |
| Balloon fatigue | Implied: Balloon withstands repeated inflation/deflation cycles without failure. | Met all predetermined acceptance criteria. | |
| Torque strength | Implied: Catheter shaft exhibits sufficient torqueability without kinking or breaking. | Met all predetermined acceptance criteria. | |
| Flexibility and kink | Implied: Catheter is sufficiently flexible and resistant to kinking. | Met all predetermined acceptance criteria. | |
| Catheter bond tensile strength | Implied: All bonds within the catheter system meet specified tensile strength requirements. | Met all predetermined acceptance criteria. | |
| Tip pull tensile | Implied: Distal tip has adequate tensile strength. | Met all predetermined acceptance criteria. | |
| Scoring performance | Implied: Scoring elements effectively score and dilate the target lesion. | Met all predetermined acceptance criteria. | |
| Particulate evaluation | Implied: Device releases minimal or no harmful particulates during use. | Met all predetermined acceptance criteria. | |
| Lubricity test | Implied: Lubricious coating provides adequate lubricity. | Met all predetermined acceptance criteria. | |
| Biocompatibility Testing | Cytotoxicity, Irritation, Sensitization, Intracutaneous reactivity, Systemic Toxicity (Acute), Pyrogen, Hemocompatibility (Hemolysis, Complement activation, in vivo thrombo resistance, Partial Thromboplastin Time) | Implied: Device materials are biocompatible and do not cause adverse biological reactions as per ISO 10993 series standards. | Met all predetermined acceptance criteria. |
| Animal Testing | In vivo safety and performance (acute and chronic) | Implied: Device is safe and effective in an animal model, not inferior to a control device. | Both subject and control devices were successfully deployed. In vivo safety and operability of the subject device is not inferior to that of the control device. |
| Sterilization | Sterility (SAL 10⁻⁶) | Implied: Achieves a Sterility Assurance Level (SAL) of 10⁻⁶. Validated according to EN ISO 11135:2014. | Product is sterile (SAL 10⁻⁶). Method validated per EN ISO 11135:2014. |
| Packaging/Shelf-life | Packaging validation, Simulated shipping, Accelerated aging, Real time aging | Implied: Packaging maintains device integrity and sterility through shipping and for the designated shelf-life. | Met all predetermined acceptance criteria. |
Study that Proves the Device Meets Acceptance Criteria
The study performed to prove the device meets acceptance criteria consists of a comprehensive set of non-clinical tests, including bench testing, biocompatibility testing, animal testing, sterilization validation, and packaging/shelf-life testing. The document states that these tests were performed "in accordance with the FDA Guidance Document titled Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters (April 14, 2023)".
1. A table of acceptance criteria and the reported device performance:
See table above. The document generally states that the device "met all predetermined acceptance criteria" for each category of tests but does not provide the quantitative criteria themselves.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the sample sizes used for the individual bench tests, biocompatibility tests, or animal tests.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the submitter is "DK Medical Technology Co., Ltd." located in "Suzhou Industrial Park, Jiangsu, China", it is highly probable that the testing, or at least the data generation, occurred in China. The animal study is prospective by nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a medical device (catheter) clearance, not an AI/ML device, so "ground truth" established by experts in the context of image interpretation or diagnosis is not relevant here. The "ground truth" for these tests would be objective measurements and observations determined by validated methods and trained technical personnel.
4. Adjudication method for the test set:
Not applicable. See point 3.
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 a medical device (catheter) clearance, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (catheter) clearance, not an AI/ML device.
7. The type of ground truth used:
For the non-clinical tests:
- Bench Testing: Objective measurements (e.g., dimensions, forces, times), visual inspections, and functional performance outputs, compared against engineering specifications and regulatory standards.
- Biocompatibility Testing: Laboratory results from in-vitro and in-vivo tests based on standardized toxicology and biological evaluation protocols (e.g., ISO 10993 series), indicating the biological safety of materials.
- Animal Testing: Clinical observations, procedural success rates, and potentially histological findings from acute and chronic animal models, compared against a control device.
8. The sample size for the training set:
Not applicable. This is a medical device (catheter) clearance, not an AI/ML device. There is no AI model "training set" mentioned or implied.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
Ask a specific question about this device
Page 1 of 1