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510(k) Data Aggregation
(87 days)
Auryon Atherectomy System
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
The Auryon™ Atherectomy System consists of two sub-units: 1) a single use catheter ("Auryon catheter"); and 2) a laser console. The Auryon catheter is a single use catheter that is made of an array of optic fibers surrounded by a circumferential blunt blade at its distal tip. The Auryon™ catheter is connected to the laser system via its connector and transmits energy at pre-set fluence levels of 50 and 60 ml/mm² to the occluded or narrowed artery. The Auryon™ Atherectomy System must work over a commercially available 300cm 0.014" guide wire that crosses the lesion intra-luminally. The catheters are available in four sizes (0.9mm, 1.5mm, 2.0mm and 2.35mm), with and without hydrophilic coating.
For the small size catheters (i.e., 0.9mm and 1.5mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. The 0.9mm and 1.5mm catheters do not have an aspiration feature and have not been tested in ISR lesions.
The larger Auryon catheters (i.e., 2.0mm and 2.35mm) have an eccentric guidewire lumen, and include additional features consisting of an aspiration feature (both catheters) and an "off-center" feature 2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure. These devices are also indicated for treatment of In-Stent Restenosis (ISR) lesions.
The "off-center" feature is included in the 2.35 mm catheter only and is designed to facilitate debulking of lesions in blood vessels beyond the catheter's diameter.
The modification associated with this submission is to add a platinum/iridium marker band within the wall of the 0.9 mm coated and uncoated catheters adjacent to the existing stainless steel inner blade. This marker band will enhance the radiographic contrast of the device.
There are no changes to the Auryon Laser Console unit associated with this submission.
The provided text describes a 510(k) premarket notification for a medical device called the Auryon Atherectomy System. This submission is a "Special 510(k)" to introduce a slight modification to an already cleared device: adding a platinum/iridium marker band to the 0.9 mm catheter for enhanced radiographic image contrast.
The document states that the modified device was tested using the same methods and acceptance criteria as the predicate device (K220116). However, it does not explicitly state the acceptance criteria values nor the reported device performance for each criterion in numerical terms, only that the tests were conducted and support substantial equivalence. It also does not discuss any multi-reader multi-case (MRMC) comparative effectiveness studies, standalone algorithm performance, or details about training sets, as the modification is to a physical device for improved imaging, not an AI/ML algorithm.
Therefore, the following information is extracted based on what is available in the document, and where information is not present, it is explicitly stated.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the modified 0.9 mm Auryon Atherectomy Catheter was tested using the "same methods and acceptance criteria as was done in the predicate device 510(k)." While the specific numerical acceptance criteria and reported device performance are not explicitly detailed in this document, the types of performance tests conducted are listed.
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Catheter shaft ID, OD, and working length | Not explicitly detailed, but implied to meet criteria |
| Catheter guard tube length | Not explicitly detailed, but implied to meet criteria |
| Catheter trackability in simulated anatomical shape | Not explicitly detailed, but implied to meet criteria |
| Freedom from leakage during liquid infusion | Not explicitly detailed, but implied to meet criteria |
| Pull testing of all joints | Not explicitly detailed, but implied to meet criteria |
| Freedom from exposed optical fibers | Not explicitly detailed, but implied to meet criteria |
| Optical Functionality test | Not explicitly detailed, but implied to meet criteria |
| Catheter torque test | Not explicitly detailed, but implied to meet criteria |
| Evaluation of the hydrophilic coating of the catheters | Not explicitly detailed, but implied to meet criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "performance testing" of the modified catheter.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided as the device modification is physical (addition of a marker band) and the testing described relates to mechanical and functional performance, not diagnostic accuracy requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the testing primarily involves objective physical and functional measurements, not subjective interpretation requiring adjudication among experts.
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 or described. The submission is for a physical modification of an atherectomy catheter, not an AI/ML diagnostic system. The improvement mentioned is enhanced radiographic contrast, which facilitates device visualization rather than directly improving human reader diagnostic accuracy in a comparative study involving AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done or described. This submission pertains to a physical medical device.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/ML validation (e.g., expert consensus, pathology, outcomes data) is not applicable to the type of device modification and testing described in this document. The "tests" are for physical properties and functionality against predefined engineering specifications.
8. The Sample Size for the Training Set
This information is not applicable/not provided as the submission is for a physical medical device and does not involve AI/ML algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as the submission is for a physical medical device and does not involve AI/ML algorithms that require a training set and corresponding ground truth.
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(58 days)
Auryon Atherectomy System
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
The Auryon™ Atherectomy Catheters are single use catheters made of an array of optic fibers and surrounded by a circumferential blunt blade at its distal tip. The Auryon™ catheter is connected to the laser of the Auryon™ Atherectomy System via its connector and transmits energy at pre-set fluence levels of 50 and 60 ml/mm² to the occluded or narrowed artery. The Auryon™ Atherectomy Catheter must work over a commercially available 300cm 0.014" guide wire that crosses the lesion intra-luminally.
The Auryon™ Atherectomy catheters are available in four sizes (0.9mm, 1.5mm, 2.0mm and 2.35mm):
- For the small size catheters (i.e., 0.9mm and 1.5mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. The 0.9mm and 1.5mm catheters do not have an aspiration feature and have not been tested in ISR lesions.
- . The larger Auryon™ catheters (i.e., 2.0mm and 2.35mm) have an eccentric guidewire lumen, and include additional features consisting of an aspiration feature (both catheters) and an "offcenter" feature (2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure.
- . The "off-center" feature is included in the 2.35 mm catheter only and is designed to facilitate debulking of lesions in blood vessels beyond the catheter's diameter.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria, as one would find for a software or AI-powered medical device. Instead, it is a 510(k) premarket notification for the Auryon™ Atherectomy System, a physical medical device.
The document describes Indication for Use for a medical device (Auryon™ Atherectomy System) and asserts its Substantial Equivalence to a predicate device, rather than providing details of an AI-based system's performance metrics against acceptance criteria.
The key points from the document regarding the device and its testing are:
- Device: Auryon™ Atherectomy System (physical device, not AI/software)
- Purpose of 510(k): To revise the Indications for Use for the existing device. No physical or software changes were made to the device itself.
- Revised Indication: Specifically includes the ability for Auryon™ Atherectomy Catheters with aspiration to "aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries."
- Performance Testing for revised indication:
- Methodology: Fresh thrombus was created in simulated blood vessels and then removed using the Auryon™ Atherectomy System with aspiration.
- Efficacy Measurement: Thrombus removal efficacy was based on the weight of thrombus removed.
- Safety Measurement: Confirmation that emboli were not generated during thrombus removal was based on the absence of emboli in an in-line embolic protection device.
- Conclusion: This testing "confirmed that there are no new questions of safety or effectiveness" with the inclusion of thrombus removal in the Indications for Use.
Therefore, since the request is for details related to acceptance criteria and a study for an AI/software device, and the provided document is for a physical medical device and its updated indications for use, I cannot fulfill the request as specified. The document does not discuss:
- A table of acceptance criteria and reported device performance (for AI/software).
- Sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth for test set, training set sample size, or how ground truth was established for the training set.
These are all metrics and details relevant to AI/software validation, which are not present in this physical device 510(k) submission.
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(68 days)
Auryon Atherectomy System
The Auryon Atherectomy System is intended for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions, including in-stent restenosis (ISR).
The Auryon™ Atherectomy System consists of two sub-units: 1) a single use catheter ("Auryon catheter"); and 2) a laser system. The Auryon catheter is a single use catheter that is made of an array of optic fibers and surrounded by a circumferential blunt blade at its distal tip. The Auryon catheter is connected to the laser system via its connector and transmits energy at pre-set fluence levels of 50 and 60 ml/mm² to the occluded or narrowed artery. The Auryon™ Atherectomy System must work over a commercially available 300cm 0.014" guide wire that crosses the lesion intra-luminally. For the small size catheters (i.e., 0.9mm and 1.5mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. The 0.9mm and 1.5mm catheters do not have an aspiration feature and have not been tested in ISR lesions. These devices should not be used in ISR cases.
The larger B-Laser™ catheters (i.e., 2.0mm and 2.35mm) have an eccentric guidewire lumen, and include additional features consisting of an aspiration feature (both catheters) and an "offcenter" feature 2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure.
The "off-center" feature is included in the 2.35 mm catheter only and is designed to facilitate debulking of lesions in blood vessels beyond the catheter's diameter.
Here's an analysis of the provided text regarding the Auryon Atherectomy System, focusing on acceptance criteria and the study proving it meets them:
Device: Auryon Atherectomy System
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance document (K202835) is for a modification to an already cleared device (B-Laser Atherectomy System, K181642). Therefore, the "acceptance criteria" for this submission are primarily focused on demonstrating that the modified device performs equivalently to the predicate device and that the changes do not raise new questions of safety or effectiveness. The document states: "The modified 1.5 mm Auryon Atheter was tested using the same methods and acceptance criteria as was done in the predicate device 510(k)."
Therefore, the acceptance criteria are not explicitly detailed as specific numerical thresholds in this document, but rather as successful completion of the listed tests to demonstrate equivalent performance to the predicate device.
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Physical Dimensions & Integrity | |
| Catheter shaft ID, OD, and working length | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Catheter guard tube length | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Freedom from exposed optical fibers | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Mechanical Strength & Durability | |
| Freedom from leakage during liquid infusion | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Pull testing of all joints | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Catheter torque test | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Fatigue testing (ability to deliver maximum duration without | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Functional Performance | |
| Catheter trackability in simulated anatomical shape | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Optical Functionality test | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Laser output power stabilization performance | Compliant (Implied, as no issues were raised and deemed substantially equivalent). The device also includes "Dynamic stabilization of laser output power." |
| Electrical Safety & Compatibility | |
| Electrical safety and EMC testing | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes (e.g., number of catheters tested) for each of the performance tests listed. Since this is a 510(k) for a modification (changing fiber diameter and subtle length differences in the 1.5mm catheter), the testing would likely involve a statistically appropriate number of units of the modified device to demonstrate equivalence, but this detail is not present in the provided text.
The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that it's for regulatory submission, the testing would be conducted under controlled laboratory conditions, likely at the manufacturer's facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The listed tests are primarily engineering and bench-top performance tests, not clinical studies requiring expert ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable, as the tests are primarily objective physical and functional performance assessments, not subjective interpretations requiring adjudication.
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 device is not an AI diagnostic tool and does not involve human readers interpreting AI output. It is an atherectomy system (a physical medical device for removing plaque from arteries).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
For the engineering and bench-top performance tests, the "ground truth" is typically defined by engineering specifications, international standards (e.g., ISO, ASTM), and the performance characteristics of the predicate device. For example, "trackability" would be assessed against a defined force or successful navigation through a simulated tortuous path. "Fatigue testing" would have a defined duration or cycles to be met without failure.
8. The Sample Size for the Training Set
Not applicable. This device does not have a "training set" in the context of machine learning or AI models. It is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. Refer to point 8.
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