(310 days)
Centurion Peripheral Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, post-deployment dilatation of peripheral vascular stents and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The catheter is not for use in coronary arteries.
The Opti-Plast Centurion 5.5F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal end. One lumen accommodates the insertion guidewire and the other provides a channel for inflation and deflation of the balloon with contrast media. The catheter is designed to be used in conjunction with a 0.035" diameter guidewire. There are two radiopaque marker bands secured on the catheter body to indicate the position of the balloon within the vasculature. The balloon inflates to the labeled diameter and length at a 10 atmosphere Operating Pressure. The Rated Burst Pressure of the device ranges from 17-20 atmospheres, depending on balloon diameter (see attached table).
The provided text describes a medical device, the Opti-Plast® Centurion 5.5F PTA Catheter, and its performance testing for substantial equivalence to predicate devices, rather than a study using AI or digital health technology. Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this document.
However, I can extract information related to the device's technical specifications and the bench testing performed.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for each performance test. Instead, it presents a comparison of technological characteristics between the proposed device and two predicate devices. The "reported device performance" are the characteristics of the proposed device itself, and the implicit acceptance criterion for the premarket notification (510(k)) is that these characteristics demonstrate substantial equivalence to legally marketed predicate devices, and that there are no new safety or effectiveness issues.
| Feature | Acceptance Criteria (Implied: Substantial Equivalence to Predicate Devices & No New Safety/Effectiveness Issues) | Reported Device Performance (Opti-Plast® Centurion 5.5F PTA Catheter) |
|---|---|---|
| Indicated Use | Similar to predicate devices, expanding on specific applications. | PTA of femoral, iliac and renal arteries, post-deployment dilatation of peripheral vascular stents and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for coronary arteries. |
| Material/Construction | Similar to predicate devices, ensuring safety and performance. | |
| - Balloon Material | Nylon (matching one predicate) | Nylon |
| - Catheter Shaft, Tip, Collar, Extensions Material | Nylon Co-polymer | Nylon Co-polymer |
| - Coating on Shaft | Glissando (new, but no new safety/effectiveness issues) | Glissando |
| - Radiopaque Shaft | Yes | Yes |
| - Marker Bands | Yes, with clear visibility | Yes, Gold |
| Dimensions | Comparable to predicate devices. | |
| - Inflated Balloon Diameters | 4 mm - 10 mm | 4 mm - 10 mm |
| - Inflated Balloon Length | 2 cm - 4 cm (shorter than one predicate, but within typical ranges) | 2 cm - 4 cm |
| - Catheter Shaft Diameter | 5.5 French | 5.5 French |
| - Shaft Length | 50 cm - 140 cm (wider range than one predicate, comparable to another) | 50 cm - 140 cm |
| - Tip Length | 3 mm (shorter than predicate) | 3 mm |
| - Guidewire Capability | 0.035 inch diameter | 0.035 inch diameter |
| Performance Characteristics | Demonstrated functionality and safety. | |
| - Recommended Operating Pressure | 10 atmospheres (higher than one predicate) | 10 atmospheres |
| - Rated Burst Pressure | 17 atmospheres - 20 atmospheres (higher than predicates) | 17 atmospheres - 20 atmospheres |
| - Shaft configuration | Double lumen | Double lumen |
Performance Data (Bench Testing):
The document states: "The test results indicate that the Opti-Plast Centurion 5.5F PTA Catheter is substantially equivalent to the stated predicate device, that there are no new safety or effectiveness issues, and that the device can be utilized for its stated indication."
Bench testing was conducted for the following characteristics:
- Balloon burst strength
- Balloon distensibility
- Balloon inflation/deflation time
- Balloon fatigue
- Joints and material strength
- Catheter balloon profile
- Introducer sheath compatibility
- Catheter flow rate and maximum injection pressure
- Deflatability and trackability
- Tip torque performance
- Puncture resistance ("toughness")
- Balloon scratch resistance
- Balloon fatigue (cycling to rated burst pressure) within a stent
- Balloon burst within a stent
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes bench testing of a physical medical device, not a study involving a test set of data (e.g., medical images, patient records). No human or animal data were used. The tests were performed in a laboratory setting. No country of origin for the data is specified, but the applicant is a US company.
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. This is a physical device testing, not a study requiring expert ground truth for interpretation of results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical device testing, not a study requiring adjudication of interpretations.
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 document pertains to a physical medical device (catheter) and no AI or human-in-the-loop performance studies were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical medical device (catheter); there is no algorithm involved.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For bench testing of physical characteristics, the "ground truth" generally refers to physical measurements and engineering specifications, not expert consensus or medical outcomes. For example, balloon burst strength is measured against a specified pressure.
8. The sample size for the training set
Not applicable. There is no training set as this is a physical medical device, not an AI/algorithm-based product.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).