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510(k) Data Aggregation
(30 days)
The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.
The Flash PTA Balloon Dilatation Catheter is designed for the dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design, which prevents distal migration of the balloon during angioplasty. The distal semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
The Flash PTA Balloon Dilatation Catheter underwent in vitro performance bench testing to confirm its characteristics compared to a predicate device.
1. Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Category | Specific Test | Reported Device Performance |
---|---|---|
Biocompatibility | ISO MEM Elution Assay | Met established specifications; materials are non-toxic and non-sensitizing. |
ASTM Hemolysis Assay | Met established specifications; materials are non-toxic and non-sensitizing. | |
Materials Mediated Rabbit Pyrogen | Met established specifications; materials are non-toxic and non-sensitizing. | |
ISO Guinea Pig Maximization Sensitization | Met established specifications; materials are non-toxic and non-sensitizing. | |
Complement Activation C3a and SC5b-9 Assay | Met established specifications; materials are non-toxic and non-sensitizing. | |
Thromboresistance Evaluation | Met established specifications; materials are non-toxic and non-sensitizing. | |
Pyrogen (LAL) Chromogenic | Met established specifications; materials are non-toxic and non-sensitizing. | |
ISO Acute Systemic Injection Test | Met established specifications; materials are non-toxic and non-sensitizing. | |
ISO Intracutaneous Reactivity Test | Met established specifications; materials are non-toxic and non-sensitizing. | |
In-vitro Performance | Balloon Crossing Profile | All test results demonstrate that the device materials, manufacturing process, and design met the established specifications necessary for consistent performance according to its intended use. |
Catheter Shaft Diameter | (Same as above) | |
Angioplasty Balloon Rated Burst Pressure | (Same as above) | |
Anchoring Balloon Burst Volume | (Same as above) | |
Angioplasty Balloon Compliance | (Same as above) | |
Balloon Inflation Time | (Same as above) | |
Balloon Deflation Time | (Same as above) | |
Angioplasty Balloon Rated Burst Pressure (in Stent) | (Same as above) | |
Anchoring Balloon Fatigue (in Stent) | (Same as above) | |
Anchoring Balloon Burst Volume (in Stent) | (Same as above) | |
Angioplasty Balloon Fatigue | (Same as above) | |
Anchoring Balloon Fatigue | (Same as above) | |
Catheter Bond Strength | (Same as above) | |
Catheter Tip Pull Strength | (Same as above) | |
Catheter Torque Strength | (Same as above) | |
Simulated Use | (Same as above) | |
Flexibility and Kink Resistance | (Same as above) | |
Radiopacity | (Same as above) | |
Angioplasty Balloon Fatigue (in Stent) | (Same as above) |
2. Sample Size and Data Provenance for Test Set:
The document does not specify the exact sample size for each performance test. It broadly states that "The Flash PTA Balloon Dilatation Catheter was evaluated using the following in-vitro performance bench testing." The data provenance is in-vitro bench testing, implying laboratory-controlled conditions. No information on country of origin or retrospective/prospective nature is provided for this specific testing, as it's not clinical data.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
Not applicable. The study involved in-vitro bench testing and biocompatibility assessments, not a diagnostic task requiring expert interpretation for ground truth establishment.
4. Adjudication Method for Test Set:
Not applicable. This was bench testing against established engineering specifications, not a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The testing focused on device performance against a predicate and established specifications, not human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance:
Not applicable. The Flash PTA Balloon Dilatation Catheter is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used:
The ground truth for the in-vitro performance bench testing was based on established specifications and comparison to the predicate device. For biocompatibility testing, the ground truth was based on the requirements of ISO 10993 and other relevant biological evaluation standards.
8. Sample Size for Training Set:
Not applicable, as this refers to a physical medical device and its manufacturing/performance characteristics, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
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(72 days)
The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.
The Flash PTA Balloon Dilatation Catheter is designed for dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
This document describes the acceptance criteria and the study conducted for the Flash PTA Balloon Dilatation Catheter.
1. Table of Acceptance Criteria and Reported Device Performance
Performance Characteristic | Acceptance Criteria | Reported Device Performance |
---|---|---|
Biocompatibility | Materials used in design and manufacture are non-toxic and non-sensitizing to biological tissues, consistent with intended use, as per ISO-10993 and Blue Book Memorandum May 1, 1995. | All biocompatibility test results demonstrated that the materials in the design and manufacture are non-toxic and non-sensitizing to biological tissues consistent with its intended use. |
ISO MEM Elution Assay | Met established specifications. | Results met established specifications. |
ASTM Hemolysis Assay | Met established specifications. | Results met established specifications. |
Complement Activation C3a and SC5b-9 Assay | Met established specifications. | Results met established specifications. |
Thromboresistance Evaluation | Met established specifications. | Results met established specifications. |
Materials Mediated Rabbit Pyrogen | Met established specifications. | Results met established specifications. |
ISO Guinea Pig Maximization Sensitization | Met established specifications. | Results met established specifications. |
ISO Acute Systemic Injection Test | Met established specifications. | Results met established specifications. |
ISO Intracutaneous Reactivity Test | Met established specifications. | Results met established specifications. |
Pyrogen (LAL) Chromogenic | Met established specifications. | Results met established specifications. |
In-vitro Performance Bench Testing | Performance characteristics confirm equivalence to the predicate device and meet established specifications for consistent performance according to its intended use. | All test results demonstrated that the device materials, the manufacturing process, and the design met the established specifications necessary for consistent performance according to its intended use. |
Balloon Crossing Profile | Met established specifications. | Results met established specifications. |
Catheter Shaft Diameter | Met established specifications. | Results met established specifications. |
Angioplasty Balloon Rated Burst Pressure | Met established specifications. | Results met established specifications. |
Anchoring Balloon Burst Volume | Met established specifications. | Results met established specifications. |
Angioplasty Balloon Compliance | Met established specifications. | Results met established specifications. |
Balloon Inflation Time | Met established specifications. | Results met established specifications. |
Balloon Deflation Time | Met established specifications. | Results met established specifications. |
Angioplasty Balloon Rated Burst Pressure (in Stent) | Met established specifications. | Results met established specifications. |
Anchoring Balloon Burst Volume (in Stent) | Met established specifications. | Results met established specifications. |
Angioplasty Balloon Fatigue | Met established specifications. | Results met established specifications. |
Anchoring Balloon Fatigue | Met established specifications. | Results met established specifications. |
Catheter Bond Strength | Met established specifications. | Results met established specifications. |
Catheter Tip Pull Strength | Met established specifications. | Results met established specifications. |
Catheter Torque Strength | Met established specifications. | Results met established specifications. |
Simulated Use/Flexibility/Kink | Met established specifications. | Results met established specifications. |
Radiopacity | Met established specifications. | Results met established specifications. |
Angioplasty Balloon Fatigue (in Stent) | Met established specifications. | Results met established specifications. |
Anchoring Balloon Fatigue (in Stent) | Met established specifications. | Results met established specifications. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify a separate "test set" in the context of clinical data or patient samples. The study described is a series of in-vitro performance bench tests and biocompatibility tests. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) and sample size in terms of clinical cases is not applicable here. The samples for these tests would be physical devices or materials, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The "ground truth" for the in-vitro and biocompatibility tests would be established through predefined scientific and engineering specifications, and validated laboratory methodologies, rather than human expert consensus on clinical findings.
4. Adjudication Method for the Test Set
Not applicable. As described above, the acceptance criteria are based on pre-defined specifications and validated laboratory testing, not human-reviewed clinical cases that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes laboratory (in-vitro) and biocompatibility testing, not clinical studies involving human readers or patient cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical medical device (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on:
- Established Scientific and Engineering Specifications: For the in-vitro performance bench testing, the device's performance characteristics (e.g., burst pressure, inflation/deflation time, fatigue) must meet predetermined quantitative and qualitative standards.
- Regulatory Standards and Guidelines: For biocompatibility, the ground truth is defined by compliance with international standards such as ISO-10993 and FDA guidelines (e.g., Blue Book Memorandum May 1, 1995) which specify acceptable biological responses to the device materials.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set was used.
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