(67 days)
The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.
The Ostial Pro Stent Positioning System is a medical grade, disposable guidewire system. The Ostial Pro Stent Positioning System will be used by interventional cardiologists and interventional radiologists to ensure precise stent implantation in aorta-ostial procedures. The product will be used in coronary and renal stenting procedures. This product is provided sterile and intended for single use. This finished product will be compatible with 6, 7 and 8 French catheters.
The provided 510(k) summary for the Ostial Pro Stent Positioning System (K122089) states that no performance standards have been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act for this type of device.
Instead, the submission relies on performance testing conducted based on a risk analysis and in accordance with various FDA guidance documents and international standards for medical device sterilization, packaging, and biological evaluation, along with specific guidance for guidewires and stents.
The testing conducted was primarily non-clinical engineering tests to demonstrate the device's safety and performance and its substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text, noting where specific details are not available as this is a medical device and not an AI/software device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Sterilization | AAMI/ANSI/ISO 11135-1: 2007 (Ethylene oxide sterilization) | Met pre-determined acceptance criteria for safety and efficacy. |
| Packaging | AAMI/ANSI/ISO 11607-1: 2006 (Packaging for terminally sterilized medical devices) | Met pre-determined acceptance criteria for safety and efficacy. |
| ISO 2233:2000 (Packaging complete, filled transport packages) | Met pre-determined acceptance criteria for safety and efficacy. | |
| ASTM D4169-09 (Performance testing of shipping containers) | Met pre-determined acceptance criteria for safety and efficacy. | |
| ASTM F1980:2007 (Accelerated Aging of Sterile Barrier Systems) | Met pre-determined acceptance criteria for safety and efficacy. | |
| Biocompatibility | AAMI/ANSl/ISO 10993-7: 2008 (Ethylene Oxide Sterilization Residuals) | Met pre-determined acceptance criteria for safety and efficacy. |
| Device Design & Function | Coronary and Cerebrovascular Guidewire Guidance Jan 1995 | Met pre-determined acceptance criteria for safety and efficacy. |
| Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents (April 2010) | Met pre-determined acceptance criteria for safety and efficacy. | |
| Design Verification (Dimensions, Torque Strength, Torque-Ability, Feet Deflection Force, Body Af Test, Wire Af Test, Coating Adherence/Integrity, Catheter Compatibility, Radio-opacity, Feet Force Deflection/Compression, Fatigue Loading of Feet, Linear Tensile Strength, Angular Tensile Strength) | The results "demonstrated that the subject Ostial Pro Stent Positioning System met the pre-determined acceptance criteria applicable to the safety and efficacy of the device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for each test. The testing described is primarily for the physical and material characteristics of the device, not clinical performance data from a patient population. Therefore, terms like "test set," "data provenance," and "country of origin" as typically used for AI/software evaluations are not applicable here. The "data" refers to the results of engineering and laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the "ground truth" for this type of device is established through adherence to engineering standards and laboratory testing protocols, not through expert consensus on clinical cases. The "experts" would be the engineers and technicians performing the tests and comparing results against established technical specifications.
4. Adjudication Method for the Test Set
This is not applicable for this type of device testing. Adjudication methods like 2+1 or 3+1 typically refer to a process for resolving discrepancies in expert interpretations of clinical data, which is not relevant for the engineering tests performed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not the subject of this 510(k) summary for a physical medical device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical stent positioning system, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Engineering specifications and design requirements: Each physical property (e.g., dimensions, torque strength, radio-opacity) has a defined acceptable range or performance target.
- International standards and FDA guidance documents: These documents define the testing methodologies and acceptable limits for various aspects like sterilization, packaging integrity, and biocompatibility.
- Comparison to predicate device characteristics: Substantial equivalence implies that the new device performs similarly to or better than the legally marketed predicate device across critical parameters.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI or machine learning system. Therefore, there is no "training set" in the context of data used to train an algorithm. The device design and manufacturing process are validated through engineering principles and quality control.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set."
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.