(21 days)
.014 PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, infrapopliteal, popliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The .014 PTA Balloon Dilatation Catheters have a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in (0.36 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter. The working lengths of the balloon catheter are 90 cm and 150 cm.
This is a medical device submission for a .014 Monorail and OTW PTA Balloon Dilatation Catheter. This type of submission (510k) focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "study" are framed around this concept.
Here's an analysis of the provided text based on your requested information:
Acceptance Criteria and Device Performance
The core of the acceptance criteria is demonstrating substantial equivalence to existing predicate devices. This is achieved by showing that the new device has similar technological characteristics, materials, manufacturing processes, and performance data, and that it raises no new safety or performance issues.
| Acceptance Criteria Category | Description of How Met (Reported Device Performance) |
|---|---|
| Technological Characteristics | Substantially equivalent in design, materials, packaging, fundamental technology, manufacturing processes, sterilization processes, and intended use as predicate devices (Sterling ES and Sterling SL). Specific comparisons were made for manifold, strain relief, catheter shafts, bumper tip, balloon, bonding method, forming process, marker bands, coating, balloon protector, and proximal shaft outer diameter. |
| Material & Manufacturing | Demonstrated substantial equivalence to predicate devices for all components mentioned above. Any differences were deemed minor or serving the same function. |
| Balloon & Catheter Dimensions | Similar or same balloon diameters, balloon lengths, rated burst pressure (RBP), catheter length, recommended introducer sheath compatibility, and recommended guidewire as predicate devices. |
| Sterilization & Packaging | Same sterilization method, same sterility assurance level (SAL), and same packaging material and configuration as predicate devices. |
| Biocompatibility | Completed a comprehensive set of biocompatibility tests (MEM Elution / Cytotoxicity, Hemolysis / Direct Contact, Guinea Pig Maximization Sensitization, Complement Activation, Intracutaneous Reactivity, Partial Thromboplastin Time, Acute Systemic Toxicity, In Vitro Hemocompatibility, Materials Mediated Rabbit Pyrogen). Results provided reasonable assurance of conformance. |
| In-vitro Performance | Completed a comprehensive set of in-vitro performance tests (Balloon Multiple Inflation, Distal Shaft Profile, Balloon Compliance (Distension), Flexibility and Kink Test, Balloon Diameter at Nominal Pressure, Folded Balloon Crossing Profile, Balloon Length Dimensions (mm), Particulates Evaluation, Balloon Rated Burst Pressure, Proximal Shaft Profile MR, Bond Tensile, Proximal Shaft Profile OTW, Burst Mode, Radiopacity, Catheter Length Dimensions, Sheath Insertion and Withdrawal Force, Distal Inner Shaft ID). Results provided reasonable assurance of conformance. |
| No New Safety/Performance Issues | Testing confirmed that no new safety or performance issues were raised. |
Study Details for Acceptance Criteria
The provided document describes bench testing and biocompatibility testing to support the claim of substantial equivalence. This is not a clinical study in the typical sense (e.g., comparing patient outcomes).
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document lists types of tests (biocompatibility and in-vitro performance), implying laboratory-based testing on device samples, not patient data. The number of individual devices or components tested for each specific test (e.g., how many balloons for burst pressure) is not provided.
- Data Provenance: Not applicable in the context of country of origin of data or retrospective/prospective, as this describes lab testing, not human or observational data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context would be defined by engineering specifications, material standards, and regulatory requirements, not expert consensus on clinical cases. The tests are designed to verify adherence to these predefined criteria.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations of clinical data or images. These are objective engineering and biological tests conducted in a laboratory setting against established pass/fail criteria.
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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 MRMC or comparative effectiveness study was done, nor is it relevant for this type of device submission. This is a medical device for angioplasty, not an AI or imaging device involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI or software algorithm; it is a physical medical device. The "standalone" performance refers to the device's functional integrity as demonstrated through bench and biocompatibility tests.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission are objective, pre-defined engineering specifications, material standards, and regulatory requirements (e.g., ISO standards for biocompatibility). Performance is measured against these established quantitative and qualitative criteria.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device. There is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this 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).