(90 days)
Opta5 PTA Balloon Catheters are indicated for dilatation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Powerflex PTA Balloon Catheters are indicated for dilatation of stenoses in iliac, femoral, popliteal and renal arteries.
In addition, certain sizes of Opta5 and Powerflex catheters are also indicated for deployment of Palmaz and Palmaz-Schatz Balloon Expandable Stents for the biliary system.
Opta5 and Powerflex PTA Balloon Catheters are indicated for dilatation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
In addition, certain sizes of Opta5 and Powerflex catheters are also indicated for deployment of Palmaz and Palmaz-Schatz balloon expandable Stents for the biliary system.
Opta5 and Powerflex PTA Balloon Catheters are similar in design, construction and indications for use compared to commercially available PTA catheters.
This document is a 510(k) premarket notification for the "Opta5™ and PowerFlex™ PTA Balloon Catheters." The primary purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a predicate device already legally marketed. Therefore, the "acceptance criteria" and "study" described in the provided text are not in the context of device performance metrics or a clinical study proving superiority/non-inferiority, but rather are focused on demonstrating substantial equivalence to existing devices.
Here's a breakdown of the requested information based on the provided text, recognizing its context as a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
In a 510(k) submission, "acceptance criteria" generally refers to the characteristics and performance attributes that need to be comparable to predicate devices to establish substantial equivalence. "Reported device performance" would then be the results demonstrating that comparability.
| Acceptance Criteria (from text, implied for substantial equivalence) | Reported Device Performance (from text, as claimed) |
|---|---|
| Common Name and Proprietary Name: Clear identification. | Common Name: Peripheral Transluminal Angioplasty Balloon Catheter |
| Proprietary Name: Opta5 PTA Balloon Catheter, Powerflex PTA Balloon Catheter | |
| Classification: Adherence to regulatory classification. | Class: II |
| Intended Use: Similar indications for use. | Indications for Use: Dilatation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. |
| Certain sizes also indicated for deployment of Palmaz and Palmaz-Schatz balloon expandable stents for the biliary system. | |
| Material/Design/Construction similarity to predicates. | "Opta5 and Powerflex PTA Balloon Catheters are similar in design, construction and indications for use compared to commercially available PTA catheters." |
| Biocompatibility: Device materials must be biocompatible. | "All appropriate biocompatibility tests were successfully performed on Cordis' Opta5 and Powerflex PTA Balloon Catheters." |
| Performance Standards: No specific FDA performance standards apply. | "Performance Standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." |
The "study" that proves the device meets "acceptance criteria" in this context is the demonstration of substantial equivalence to the listed predicate devices. This is established by comparing the new device's design, materials, manufacturing processes, performance data (including biocompatibility), and intended use to those of the predicate devices. The document explicitly states: "Opta5 and Powerflex PTA Balloon Catheters are substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not specify a sample size for a test set or data provenance for any performance study that would resemble a clinical trial or algorithm validation. The reference to "biocompatibility tests" implies in-vitro and/or in-vivo (animal) testing, but no details on sample size, design, or provenance are given. For a 510(k), extensive clinical trials are often not required if substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.
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)
This information is not applicable or present in the provided 510(k) document. Establishing "ground truth" by experts is typically done for diagnostic accuracy studies, especially with AI algorithms. This submission is for a medical device (balloon catheter) that is not a diagnostic AI, and therefore, such expert-driven ground truth establishment wouldn't be part of its typical regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or present in the provided 510(k) document for the same reasons as (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
This information is not applicable or present in the provided 510(k) document. MRMC studies are specific to evaluating diagnostic performance, often for imaging devices or AI tools assisting human readers. The Opta5 and Powerflex PTA Balloon Catheters are interventional devices, not diagnostic or AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable or present in the provided 510(k) document. The device in question is a physical medical device (balloon catheter), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for diagnostic or AI validation studies does not directly apply in this 510(k) submission for a balloon catheter. The truth for this submission is whether the device is safe and effective when used as intended, and this is primarily established by demonstrating substantial equivalence to predicate devices, supported by:
- Biocompatibility testing results: (implied 'ground truth' of material safety)
- Engineering and design specifications: (implied 'ground truth' of functional performance)
- Comparison to predicate device characteristics: showing similar features and intended use.
8. The sample size for the training set
This information is not applicable or present in the provided 510(k) document. "Training set" refers to data used to train machine learning models, which is irrelevant for this physical medical device submission.
9. How the ground truth for the training set was established
This information is not applicable or present in the provided 510(k) document for the same reasons as (8).
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.