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Found 8 results
510(k) Data Aggregation
(47 days)
The Diamondback 360® Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS supports removal of stenotic from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The Stealth 360® Peripheral Orbital Atherectorny System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The Diamondback 360® Peripheral Orbital Atherectomy System Exchangeable Series is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The Exchangeable Series OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The DIAMONDBACK 360 Peripheral OAS, Stealth 360 Peripheral OAS, and DIAMONDBACK 360 OAS Exchangeable Series are designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. Each OAS consists of the following main components:
- Reusable Saline Pump (provided non-sterile)
- Single-use Orbital Atherectomy Device (OAD) (provided sterile). The Exchangeable Series OAD consists of a physician-operated handle and an interchangeable crown cartridge.
- Single-use Atherectomy lubricant (provided sterile)
- Single-use Atherectomy guide wire (provided sterile)
The provided text describes a 510(k) summary for the DIAMONDBACK 360® Peripheral Orbital Atherectomy System, DIAMONDBACK 360® Peripheral Orbital Atherectomy System, Exchangeable Series, and Stealth 360® Peripheral Orbital Atherectomy System.
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance:
The document states:
- "Functional and Safety Testing: Only software verification and associated testing was required as the software updates do not affect the device performance and hardware."
- "The modified devices are different from the predicate device in that the software has been updated to include additional cybersecurity protection. Also, a hypotube was added to the Exchangeable driveshaft and a coupler was updated to accommodate the change. The hypotube and coupler are located within a fully enclosed, non-patient contacting portion of the device inside the cartridge."
- "The hypotube/coupler update does not impact the functionality of the device to ablate the lesion nor its intended use."
- "The subject devices are substantially equivalent to the predicate devices and the devices continue to perform as intended."
Given this, the acceptance criteria are implicitly that the software updates for cybersecurity and the mechanical changes (hypotube/coupler) do not adversely affect the device's original performance specifications and intended use. The performance reported is that the device continues to perform as intended and its functionality for lesion ablation and intended use are not impacted.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software updates for cybersecurity do not affect device performance. | Software updates do not affect device performance. |
| Hardware modifications (hypotube/coupler) do not affect device performance, functionality, or intended use. | Does not impact the functionality of the device to ablate the lesion nor its intended use. |
| Device maintains substantial equivalence to predicate devices. | Subject devices are substantially equivalent to predicate devices and continue to perform as intended. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify a separate "test set" in the context of clinical or performance data for the device's atherectomy function. The primary testing mentioned is "software verification and associated testing" and evaluation of the impact of mechanical changes. No sample size for patients or clinical data is provided, nor is data provenance mentioned, as this submission focuses on modifications rather than new clinical claims.
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):
Not applicable. The submission does not detail an expert-reviewed ground truth for a clinical test set. The evaluation seems to be based on engineering and functional assessments rather than clinical opinion.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There is no mention of an adjudication method for a clinical test set.
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 an atherectomy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. The device has software for cybersecurity, but its primary function is mechanical.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" used for this 510(k) submission appears to be regulatory and engineering standards, and the performance characteristics of the previously cleared predicate devices. The modifications were assessed against the existing performance specifications and intended use of the predicate devices.
8. The sample size for the training set:
Not applicable. There is no mention of a training set as this is not an AI model.
9. How the ground truth for the training set was established:
Not applicable. There is no mention of a training set.
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(200 days)
The Diamondback 360® Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The Stealth 360® Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The Diamondback 360 and Stealth 360 Peripheral Orbital Atherectomy Systems (OAS) are designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown.
The OAS consists of the following main components:
- Reusable Saline Pump (provided non-sterile)
- Single-use Orbital Atherectomy Device (OAD) (provided sterile)
- Single-use Atherectomy lubricant (provided sterile)
- Single-use Atherectomy guide wire (provided sterile)
Mechanism of Action
The Diamondback and Stealth OAS mechanism of action is defined by:
• Centrifugal force
• Orbital rotation
• Differential sanding
• Bi-directional sanding
The rapidly rotating eccentric crown creates a centrifugal force that presses the diamond-coated crown against the calcified plaque. With each pass of the crown, plaque is reduced and the diameter of the orbit increases.
The provided text is an FDA 510(k) summary for a medical device (Diamondback 360® Peripheral Orbital Atherectomy System, Stealth 360® Peripheral Orbital Atherectomy System). It details the device's purpose, components, mechanism of action, and comparison to a predicate device.
However, the document does not contain information about the acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML-driven device. The content focuses on the substantial equivalence of a modified atherectomy system to a previously cleared predicate device, based on functional and safety testing of the hardware components (e.g., motor, bearings, grease).
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device, as this information is not present in the provided text. The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are specific to the evaluation of AI/ML algorithms, which is not the subject of this 510(k) summary.
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(30 days)
The WIRION® is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION® may be used with commercially available 0.014" guide wires.
WIRION® is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.
I am sorry, but the provided text from the FDA 510(k) K210282 letter and summary for the WIRION® Embolic Protection System does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI-based or statistical classification system.
The document is a traditional 510(k) submission for a physical medical device (an embolic protection system), not a software or AI-driven diagnostic device that would typically involve acceptance criteria related to sensitivity, specificity, or reader studies.
The "Functional and Safety Testing" section mentions:
- Biocompatibility testing
- Simulated use
- Bond and torque strength testing
- Package testing
These are standard engineering and safety tests for a physical medical device, not performance metrics for an AI algorithm.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert involvement, MRMC study details, etc.) from the provided text because it is not relevant to the type of device described in the document.
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(49 days)
The Diamondback 360® Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The Stealth 360® Peripheral Orbital Atherectorny System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The Diamondback 360® Peripheral Orbital Atherectomy System Exchangeable Series is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The Exchangeable Series OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The DIAMONDBACK 360 Peripheral OAS, Stealth 360 Peripheral OAS, and DIAMONDBACK 360 OAS Exchangeable Series are designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. Each OAS consists of the following main components:
- Reusable Saline Pump (provided non-sterile)
- Single-use Orbital Atherectomy Device (OAD) (provided sterile). The Exchangeable Series OAD consists of a physician-operated handle and an interchangeable crown cartridge.
- Single-use Atherectomy lubricant (provided sterile)
- Single-use Atherectomy guide wire (provided sterile)
The provided text is a 510(k) summary for the DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, and Stealth 360 Peripheral Orbital Atherectomy System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the context of an AI/ML medical device.
Therefore, much of the requested information (acceptance criteria table, sample sizes for test and training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance) is not present in the provided text.
The document states that the proposed device differs from the predicate device only in its "manufacturing process and supplier of a device component," and that its "intended use, mechanism of action, and indications for use" are the same as the predicate. The performance data presented is limited to bench testing and biocompatibility testing, which are standard for hardware medical devices to ensure safety and functionality, not to assess AI/ML algorithm performance.
Here's what can be extracted based on the provided text:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria in a table format for performance metrics relevant to AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, it lists performance data based on conventional medical device testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Passed Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Pyrogenicity, Hemolysis Study, Complement Activation Assay, Platelet and Leukocyte Counts, Partial Thromboplastin Time. |
| Bench Testing | Passed Corrosion Resistance Testing, Orbit Characterization Testing, Particulate Testing, Radiopacity Assessment, Tensile Verification Testing. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not mentioned. The testing described is for physical characteristics and biocompatibility, not for an AI/ML algorithm's performance on a dataset.
- Data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable, as this device is not an AI/ML algorithm requiring expert ground truth for image interpretation or similar tasks. The ground truth for biocompatibility and bench testing would be established by laboratory standards and measurements.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable for the type of testing described.
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:
- MRMC study: No, an MRMC study was not done, as this is not an AI/ML-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone performance: No, this is not an AI/ML algorithm.
7. The type of ground truth used:
- Type of ground truth: For biocompatibility, the ground truth would be established by standardized biological assays and observation of cellular/tissue responses against established safety thresholds. For bench testing, the ground truth is established through physical measurements, engineering specifications, and adherence to relevant industry standards.
8. The sample size for the training set:
- Sample size for training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- How ground truth was established: Not applicable.
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(112 days)
The Diamondback 360® Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The Stealth 360® Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The Diamondback 360 and Stealth 360 Peripheral Orbital Atherectomy Systems (OAS) are designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown.
The OAS consists of the following main components:
- Reusable Saline Pump (provided non-sterile)
- Single-use Orbital Atherectomy Device (OAD) (provided sterile)
- Single-use Atherectomy lubricant (provided sterile)
- Single-use Atherectomy guide wire (provided sterile)
Mechanism of Action
The Diamondback and Stealth OAS mechanism of action is identical to the predicate device and is defined by:
• Centrifugal force
• Orbital rotation
• Differential sanding
• Bi-directional sanding
The rapidly rotating eccentric crown creates a centrifugal force that presses the diamond-coated crown against the calcified plaque. With each pass of the crown, plaque is reduced, and the diameter of the orbit increases.
This document is a 510(k) premarket notification for the Diamondback 360 Peripheral Orbital Atherectomy System and Stealth 360 Peripheral Orbital Atherectomy System. It compares the proposed device to a predicate device (K152694 - Diamondback 360 Peripheral Orbital Atherectomy System).
The information provided in the document refers to physical and mechanical performance testing of the device, rather than a clinical study evaluating its diagnostic or therapeutic effectiveness using AI. Therefore, most of the requested points regarding acceptance criteria and study details for an AI/device performance study (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device submission as described.
The performance data listed (Bench Testing, Track Verification Testing, Stall / Life and Tight Stenosis Verification Testing, etc.) are primarily engineering and hardware verification tests, not clinical performance or AI algorithm performance assessments. The conclusion explicitly states that the device has the "same technological characteristics as the predicate device" and that "testing results demonstrate that the devices perform as intended under the specified use conditions." This focuses on demonstrating equivalence to an existing device through non-clinical means.
Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from the provided document. The document describes a medical device with mechanical action for atherectomy, not an AI-powered diagnostic or therapeutic device.
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(100 days)
The Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The Exchangeable Series OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The DIAMONDBACK 360 Peripheral Orbital Atherectomy System (OAS) Exchangeable Series is designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. The DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series consists of the following main components:
- Reusable Saline Pump (provided non-sterile)
- Single-use Orbital Atherectomy Device (OAD) (provided sterile). The Exchangeable Series OAD consists of a physician-operated handle and an interchangeable crown cartridge.
- Single-use Atherectomy lubricant (provided sterile)
- Single-use Atherectomy guide wire (provided sterile)
This document describes the Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (K182397) and its acceptance criteria as proven by a study.
Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific, quantifiable acceptance criteria values or a direct table comparing them to reported device performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K152694) through a series of performance/bench tests and biocompatibility tests. The conclusion states that the data supports "no new questions of safety or effectiveness...compared to the predicate device" and that "the mechanical testing results demonstrate that the device should perform as intended in the specified use conditions."
Therefore, the acceptance criteria implicitly involve the device successfully passing all listed performance and biocompatibility tests, demonstrating performance comparable to the predicate device, and not raising new safety or effectiveness concerns.
Given the information, a table of acceptance criteria and reported device performance would be structured as follows, with the "Reported Device Performance" reflecting the successful completion of these tests:
| Acceptance Criteria Category | Specific Test/Criterion | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Passed |
| Sensitization | Passed | |
| Irritation/Intracutaneous Reactivity | Passed | |
| Systemic Toxicity | Passed | |
| Pyrogenicity | Passed | |
| Hemolysis Study | Passed | |
| Device Performance/Bench Testing | Track Verification Testing | Passed |
| Stall / Life and Tight Stenosis Verification Testing | Passed | |
| Device Pre-Conditioning Verification Testing | Passed | |
| Handle Potting and Switch Mount Base and Process Updates | Verified/Passed | |
| Handle Life Verification Testing | Passed | |
| Tensile Verification Testing | Passed | |
| Temperature and Saline Flow Life Verification Testing | Passed | |
| Dimensional and Weight Verification Testing | Passed | |
| Glide Start Up Life Verification Testing | Passed | |
| Orbit Characterization Testing | Passed | |
| Switch Logic Verification Testing | Passed | |
| Miscellaneous Verification Testing: Traverse Force, Knob Lock Force, Exchange Durability, Guidewire Back Loading | Passed | |
| Usability/human factors Testing | Passed |
Study Information
The document describes performance (bench) testing and biocompatibility testing to demonstrate substantial equivalence, rather than a clinical study with human subjects.
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of devices. For bench testing, typically multiple units are tested to ensure consistency and robustness, but the exact quantity is not detailed in this summary. For biocompatibility tests, samples of materials from the device are used.
- Data Provenance: The document does not specify the country of origin for the data directly, but the submission is from "Cardiovascular Systems Inc." located in "St. Paul, MN, USA". The testing is described as "bench tests" and "biocompatibility evaluation," indicating laboratory-based studies, not retrospective or prospective human subject data.
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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 question is not applicable in the context of this submission. The "ground truth" for demonstrating substantial equivalence of a medical device like this relies on objective engineering and scientific principles, validated test methods, and compliance with applicable standards and guidance (e.g., ISO standards for biocompatibility). There are no "experts" establishing a subjective ground truth for a test set in the way one might for diagnostic imaging.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are typically used in clinical trials involving human endpoints or expert interpretation of data. For bench and biocompatibility testing, the results are typically objectively measured and evaluated against predetermined pass/fail criteria, not adjudicated by a panel of experts.
-
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 is not applicable. MRMC studies are specific to diagnostic imaging devices where human readers interpret medical images. This submission is for an atherectomy system, not an imaging device with AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The Diamondback 360 Peripheral Orbital Atherectomy System is a physical medical device for performing a surgical procedure, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is based on objective engineering measurements and scientific principles, verified through standardized bench testing and biocompatibility assessments, and evaluated against established performance specifications and regulatory standards. The goal is to demonstrate that the device performs equivalently to the predicate device in terms of safety and effectiveness, based on its physical and biological properties.
-
The sample size for the training set:
- This is not applicable. There is no mention of a "training set" as this is not an artificial intelligence/machine learning device. The device itself is subject to performance testing, not trained on data.
-
How the ground truth for the training set was established:
- This is not applicable, as there is no training set mentioned in the context of this device.
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(61 days)
The Stealth 360® Orbital PAD System and the Diamondback 360® Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The atherectomy guide wire is a component that is part of the Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy System. The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System (OAS) are intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis. The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360 and the Diamondback 360 use an eccentrically rotating surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body. In addition to the atherectomy guide wire, the Stealth 360® Orbital PAD System and the Diamondback 360® Peripheral Orbital Atherectomy System consists of the following components: Orbital Atherectomy Device (OAD), Saline Infusion Pump, and Atherectomy Lubricant (e.g., ViperSlide). The ViperWire Advance FlexTip Guide Wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. These extended length guide wires use the same technology as the previously cleared Stealth 360® Orbital PAD.
The provided text describes a 510(k) premarket notification for a medical device called the "ViperWire Advance Flex Tip Peripheral Guide Wire" and its associated atherectomy systems. The submission seeks to prove substantial equivalence to a predicate device, rather than demonstrate meeting specific acceptance criteria in a clinical study with performance metrics like sensitivity, specificity, etc. This is a common regulatory pathway for devices that are similar to already approved ones.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics like those typically associated with AI/software devices (e.g., sensitivity, specificity, accuracy) is not applicable in the context of this 510(k) submission for a guide wire and atherectomy system.
Instead, the submission focuses on bench testing to demonstrate that the modified device performs similarly to its predicate and meets established engineering specifications for safety and effectiveness.
Here’s a breakdown of the information that is available, reframed to address the spirit of your request where possible, and clearly indicating when information is not present:
Acceptance Criteria and Device Performance (Based on Bench Testing for Substantial Equivalence)
The "acceptance criteria" for this device are its ability to meet established specifications through a series of bench tests, confirming its safety and performance is comparable to the predicate device. The "reported device performance" is that it met these criteria. Specific quantitative performance metrics (e.g., specific failure loads, deviation tolerances) are not provided in this summary but would have been part of the detailed 510(k) submission.
| Acceptance Criterion Category | Reported Device Performance |
|---|---|
| Mechanical Performance | - Manual Track Testing: Met established specifications. - Torque Transfer Testing: Met established specifications. - Torque Strength Testing: Met established specifications. - Life Testing: Met established specifications. - Orbit Testing: Met established specifications. - Tensile Testing (ISO 11070): Met established specifications. - Tip Flexibility Testing: Met established specifications. - Transfer Force Test: Met established specifications. |
| Material & Durability | - ISO Corrosion, Flex, and Fracture Test (ISO 11070): Met established specifications. - Particulate (USP <788>): Met established specifications. |
| Biocompatibility | - Biocompatibility (ISO 10993): Met established specifications. |
| System Functionality | - OAS Flow Tests: Met established specifications. - OAS Pump Functional Tests: Met established specifications. |
| Electrical Safety | - IEC 60601-1-2:2014 (4th edition) Compliance: Met established specifications (for the OAS pump updates). |
| Overall Conclusion | All test results demonstrate that the materials chosen, the manufacturing processes, and the design utilized for the ViperWire Advance FlexTip Guide Wire and OAS pump met the established specifications necessary for consistent performance during its intended use. The device met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs. Performance is substantially equivalent to the predicate. |
Additional Requested Information:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable for a clinical study with human data in this 510(k) summary. The testing described is bench testing of physical devices. The "sample size" would refer to the number of individual guide wires or pump units tested according to engineering protocols. This specific number is not disclosed in the summary, but it would have been defined in the test protocols.
- Data Provenance: Not specified, but generally, bench testing data for FDA submissions is generated within the manufacturing and testing facilities of the submitting company or certified contract labs.
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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)
- Not applicable. This submission is not based on expert-adjudicated ground truth from clinical data. Performance is assessed through engineering tests against predefined specifications.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. See point 2.
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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
- Not applicable. This is a hardware medical device (guide wire and atherectomy system), not an AI/software device that assists 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 a hardware medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering specifications and standards: The "ground truth" for this type of submission is the predefined engineering specifications derived from relevant industry standards (e.g., ISO 11070, ISO 10993, IEC 60601-1-2), internal design requirements, and performance data from the legally marketed predicate device.
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The sample size for the training set
- Not applicable. This is a hardware device; there is no "training set" in the context of machine learning. The design and manufacturing processes are validated through the described bench testing.
-
How the ground truth for the training set was established
- Not applicable. See point 7.
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(30 days)
The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.
The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Diamondback 360 uses an eccentrically rotating sarface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body.
The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:
-
- Orbital Atherectomy Device (OAD)
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- Atherectomy Guide Wire (e.g., ViperWire Advance)
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- Saline Infusion Pump (SIP)
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- Atherectomy Lubricant (e.g., ViperSlide)
The provided 510(k) summary (K152694) for the Diamondback 360 Peripheral Orbital Atherectomy System details the acceptance criteria via performance bench testing and concludes that the device meets these criteria. However, it does not involve a study in the traditional sense of clinical trials or AI/ML evaluations with human experts. Instead, it focuses on verifying the device's physical and functional properties against established specifications.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance bench testing categories that served as the acceptance criteria. The device performance is generally reported as meeting these criteria, implying successful execution within established specifications.
| Acceptance Criteria (Test Category) | Reported Device Performance |
|---|---|
| - System Life Testing (including guidewire) | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Diamondback 360 Peripheral Orbital Atherectomy System met the established specifications necessary for consistent performance during its intended use.""The Diamondback 360 Peripheral Orbital Atherectomy System met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs." |
| - Stall Testing | |
| - Introducer Compatibility Testing | |
| - Temperature Testing | |
| - Tensile Testing | |
| - Flexibility Testing | |
| - Delivered Torque Testing | |
| - Orbit Testing | |
| - Guidewire Brake Testing | |
| - Saline Flow Testing | |
| - Track Testing | |
| - Packaging/Simulated Distribution Testing | |
| - Biocompatibility (Cytotoxicity per ISO 10993-5) | |
| - Biocompatibility (ASTM Hemolysis per ISO 10993-4) | |
| - Biocompatibility (Chemical Characterization per ISO 10993-18) |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each bench test. The "test set" in this context refers to the manufactured device components or systems subjected to the various physical and chemical tests. The data provenance is internal to the manufacturer (Cardiovascular Systems, Inc.) as these are internal design verification and validation tests. There's no mention of external data or geographic origin beyond the manufacturer's location in Saint Paul, MN. All testing described is retrospective in the sense that it evaluates a designed product, not prospective observational or interventional studies on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to the presented data. The "ground truth" for bench testing is typically defined by engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and internal quality control criteria. These are established by engineering and quality assurance teams, not clinical experts for diagnostic accuracy.
4. Adjudication method for the test set
Not applicable. Bench testing results are compared against predetermined numerical or qualitative specifications, not adjudicated by a panel in the way clinical diagnostic accuracy studies are.
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 is a submission for a mechanical atherectomy device, not an AI/ML-driven diagnostic or assistive device where MRMC studies with human readers would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical, mechanical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" is based on:
- Engineering Specifications: Designed parameters and tolerances for device components and system performance (e.g., tensile strength, flexibility limits, torque values, flow rates).
- International Standards: e.g., ISO 10993 for biocompatibility (Cytotoxicity, Hemolysis, Chemical Characterization).
- Test Protocols: Internally developed experimental procedures to evaluate specific performance characteristics.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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