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510(k) Data Aggregation
(90 days)
NC Quantum Apex PTCA Dilatation Catheter
NC Quantum Apex™ PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion NC Quantum Apex™ PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drugeluting).
Not Found
This document is a 510(k) premarket notification for a medical device called the NC Quantum Apex™ PTCA Dilatation Catheter. It is not an AI/ML device, therefore the requested information regarding AI/ML studies is not applicable.
However, I can provide available information regarding the non-clinical testing performed to demonstrate substantial equivalence for this device.
1. Table of Acceptance Criteria and Reported Device Performance
The document summarizes a range of non-clinical bench tests and biocompatibility tests. While specific acceptance criteria for each test (e.g., a specific numerical threshold for corrosion resistance or burst pressure) are not explicitly stated in this high-level summary, the general acceptance criterion is that the device demonstrates performance equivalent to the predicate device and is safe and effective for its intended use. The reported performance is that the device met these tests, providing reasonable assurance of conformance.
| Test Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Bench Testing | Corrosion Resistance, Proximal Shaft Marks, Midshaft Bond Tensile, Proximal Mark Abrasion Resistance, Repeat Inflation, Shaft and Bond Burst Pressure | "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing." |
| Biocompatibility and Chemical Characterization Tests | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Injection, Materials Mediated Pyrogenicity, Mutagenicity, Hemolysis, Partial Thromboplastin Time, In Vitro Hemocompatibility, Complement Activation, USP Physicochemical, Latex Assay, Nonvolatile Residue, SEM | "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each non-clinical bench test or biocompatibility test. These are typically described in detail in the full test reports submitted to the FDA, but not in the 510(k) summary. The data provenance is from internal Boston Scientific Corporation testing, which is standard for premarket submissions. These are prospective tests conducted on manufactured device samples.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. This is a medical device for physical intervention, not an AI/ML diagnostic device requiring expert interpretation of outputs for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable. The tests are bench tests or laboratory assays, not requiring human adjudication in the context of diagnostic interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML device.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is not an AI/ML device.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established engineering principles, industry standards (e.g., ISO standards for medical devices, USP for physicochemical tests, ASTM for material properties), and regulatory requirements. For example:
- Bench tests: Performance metrics (like burst pressure, tensile strength, corrosion resistance) are compared against predetermined functional specifications derived from the predicate device's performance or engineering requirements.
- Biocompatibility tests: Compliance with standards like ISO 10993 (Biological evaluation of medical devices) is the "ground truth" to ensure the materials are safe for human contact.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/ML device.
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(68 days)
NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter is intended for dilatation of stenosis in coronary arteries or bypass grafts and for post-delivery expansion of balloon expandable stents (bare metal and drug-eluting.)
The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. NC Quantum Apex Monorail PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
The Boston Scientific NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The NC Quantum Apex Monorail PTCA Dilatation Catheter is available with balloon diameters of 2.00 mm to 5.00 mm and balloon lengths of 6 mm to 30 mm.
The provided text describes a 510(k) premarket notification for a medical device, the NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance metrics typically seen for AI/ML devices. Therefore, much of the requested information regarding AI/ML study components (sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's technical specifications and the non-clinical performance testing conducted to support its substantial equivalence.
Device Acceptance Criteria and Reported Performance (Non-Clinical Testing)
The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to the predicate device, meaning its performance should be comparable to or within acceptable limits of the predicate. The document lists various non-clinical tests performed. While specific numeric acceptance criteria and reported performance values are not provided in the summary, the successful completion of these tests suggests the device met the pre-defined criteria for substantial equivalence.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Implied by successful testing for substantial equivalence) |
|---|---|
| Physical and Mechanical Performance | |
| Effective Length | Met requirements comparable to predicate and reference devices. |
| Proximal Shaft Profile | Met requirements comparable to predicate and reference devices. |
| Shaft and Bond Burst Pressure | Met requirements comparable to predicate and reference devices. |
| Catheter Bond Strength | Met requirements comparable to predicate and reference devices. |
| Flexibility and Kink | Met requirements comparable to predicate and reference devices. |
| Balloon Deflation Time | Met requirements comparable to predicate and reference devices. |
| Corrosion Resistance | Met requirements comparable to predicate and reference devices. |
| Torque Strength | Met requirements comparable to predicate and reference devices. |
| Particulate Evaluation | Met requirements comparable to predicate and reference devices. |
| Biocompatibility | |
| Biocompatibility | Met requirements for biological safety. |
Information Regarding AI/ML Study Components (Not applicable to this 510(k))
As this submission is for a physical medical device (PTCA Dilatation Catheter) and not an AI/ML algorithm, the following sections are not relevant and the requested information cannot be found in the provided text:
- Sample sizes used for the test set and the data provenance: Not applicable. This is not an AI/ML study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML analysis is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Nature of the Study and Device
The K121667 submission describes a PTCA Dilatation Catheter, which is a physical, invasive medical device used in coronary angioplasty. The "study" referenced in the document is a non-clinical design verification testing program aimed at demonstrating substantial equivalence to an existing predicate device (NC Quantum Apex™ PTCA Dilatation Catheter) and reference devices (Emerge™ PTCA Dilatation Catheter and Quantum™ Maverick™ PTCA Dilatation Catheter).
The document explicitly states: "Design verification testing was performed to demonstrate that the performance of the modified NC Quantum Apex Monorail PTCA Dilatation Catheter remains substantially equivalent to the predicate device." This means the purpose of the testing was to confirm that the minor modifications to the device (related to the hypotube, midshaft component, proximal shaft marks, and removal of accessory kit components) did not negatively impact its safety and effectiveness compared to the already approved devices.
The tests conducted are typical for mechanical and material aspects of a catheter: Effective Length, Proximal Shaft Profile, Shaft and Bond Burst Pressure, Catheter Bond Strength, Flexibility and Kink, Balloon Deflation Time, Corrosion Resistance, Torque Strength, Particulate Evaluation, and Biocompatibility. The successful completion of these tests formed the basis for the FDA's determination of substantial equivalence.
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