(28 days)
For dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
The 7.0/8.0mm x 40mm AngioSculpt PTA Scoring Balloon Catheters are comprised of a conventional balloon catheter that incorporates a nitinol scoring element over the balloon. The balloon is designed to expand to a specified diameter at a specified pressure. The catheter has radiopaque markers to aid in positioning of the balloon in the stenosis. The catheter has two lumens; one lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a quide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The product is provided in the over-the-wire (OTW) delivery platform. The catheters have a sheath compatibility of 6F and guidewire compatibility of 0.018". The catheter is single-use only and provided sterile to the user.
Here's the information regarding the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:
This device is an AngioSculpt PTA Scoring Balloon Catheter, and its 510(k) submission is for an expansion of existing product lines (new sizes 7.0/8.0mm x 40mm) of an already cleared device model (AngioSculpt PTA Scoring Balloon Catheters, K133998 and K091966). Therefore, the demonstration of substantial equivalence relies heavily on design verification and validation testing rather than new clinical trials or complex performance studies typically associated with novel devices.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by successful completion of the design verification and validation testing, demonstrating that the new device models perform comparably to the predicate devices and meet established engineering standards. The summary states that the subject device (7.0/8.0mm x 40mm AngioSculpt PTA Scoring Balloon Catheter) is "substantially equivalent" to the predicate devices because they share substantially the same indications for use, device operation, material type, basic design configuration, and overall technical and functional capabilities.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance/Conclusion |
|---|---|---|
| Physical Dimensions | - Catheter Diameter and Balloon Profile |
- Catheter Diameter and Balloon Profile (post deflation)
- Catheter Effective Length | Implied to meet specifications and be comparable to predicate devices. The new models are larger (7.0/8.0mm) but perform consistently with the established design principles. |
| Mechanical Performance | - Balloon Preparation, Deployment and Retraction - Rated Burst Pressure (RBP)
- Device Fatigue
- Balloon Compliance (Diameter vs. Pressure)
- Balloon Inflation/ Deflation Time
- Bond (Tensile) Strength
- Tip Pull Strength
- Catheter Flexibility and Kink
- Torque Strength
- Pushability, Trackability and Secure Edges
- Freedom from Stent Interference
- Focal Force | Implied to meet established engineering and safety standards, demonstrating functional equivalence to the predicate devices. The new sizes are expected to exhibit similar force application, durability, and handling characteristics. |
| Device Compatibility | - Radiopacity - Guide Wire Compatibility
- Luer Compatibility
- Catheter Surface Appearance | Implied to be compatible with standard interventional tools and imaging techniques. Radiopacity would ensure visibility during procedures, and guidewire compatibility is specified (0.018"). |
| Sterilization | - Product adoption equivalency per AAMI TIR:28 2009 | Sterilization process is validated as equivalent to established standards, ensuring the device is sterile for use. |
| Biocompatibility | - Cytotoxicity - Sensitization
- Irritation
- Systemic Toxicity
- Hemocompatibility
- Genotoxicity (all based on predicate device testing) | "The materials used in the subject device pose no greater significant biocompatibility challenge than the current AngioSculpt products." Biocompatibility test results of the currently marketed product, conducted according to current standards (e.g. ISO 10993-5), were used to confirm the biocompatibility due to similarities in design, materials, manufacturing, sterilization, and intended use. The device is considered biocompatible. |
Study Details
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Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for each individual test conducted (e.g., how many balloons were tested for RBP or fatigue). These are typically standard engineering tests with defined sample sizes per test method.
- Data Provenance: Not explicitly stated, but these are preclinical design verification and validation tests conducted by the manufacturer (Spectranetics). The tests are performed on the device itself (new and predicate models) in a controlled laboratory setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. This submission primarily relies on engineering and preclinical performance data, not on clinical evaluations requiring expert interpretation of ground truth (e.g., image-based diagnosis). The "ground truth" here is the adherence to specifications and performance standards established by internal testing and regulatory guidelines.
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Adjudication method for the test set:
- Not applicable. No adjudication method is described because the tests are objective measurements against predefined specifications, not subjective interpretations requiring expert consensus.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (balloon catheter) for angioplasty, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to AI/software performance, which is not relevant to this physical device submission.
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The type of ground truth used:
- The "ground truth" for this submission is based on:
- Engineering specifications and standards: The device performance parameters (e.g., burst pressure, tensile strength, inflation/deflation time, dimensions) are measured against predefined engineering specifications and relevant ISO/ASTM standards.
- Biocompatibility standards: ISO 10993-5 series for biocompatibility.
- Comparison to predicate device performance: The performance of the new sizes is demonstrated to be equivalent to that of the previously cleared predicate devices under similar test conditions.
- The "ground truth" for this submission is based on:
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device's evaluation. This is not a machine learning or AI product.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set or associated ground truth establishment method is relevant for this conventional medical 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).