(99 days)
The Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).
The Diamondback 360° ™ Orbital Atherectomy System (OAS) is intended for use in treatment of artificial ateriovenous dialysis fistula stenosis. An artificial arteriovenous dialysis fistula (A-V shunt) is placed sub-dermal to support kidney dialysis. A consequence of the body's reaction to the foreign material of the A-V shunt is to form clots and neointimal stenosis of the A-V Shunt. The most common location for the A-V shunt stenosis is at the shunt to vein anastomosis. It is this region that the Cardiovascular Systems, Inc. Orbital Atherectomy System (CSI OAS) is applied to remove neointimal tissue causing a stenosis in the A-V shunt.
Here's an analysis of the provided text regarding the Diamondback 360°™ Orbital Atherectomy System, focusing on acceptance criteria and the supporting study information:
Based on the provided snippets (K071427), it appears this submission is for a premarket notification (510(k)) that relies on substantial equivalence to a predicate device, not on a new clinical study with specific performance acceptance criteria. Therefore, the device performance is demonstrated through comparison to the predicate, and a traditional "study proving the device meets acceptance criteria" as might be seen for devices requiring clinical efficacy data is not explicitly detailed.
Here's what can be inferred and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) Scope) | Reported Device Performance |
|---|---|
| Functional and Performance Requirements Met | Device underwent mechanical testing and biocompatibility in accordance with ISO 10993 to verify design met requirements. |
| Material Equivalence | Uses similar materials to predicate device (K041630). |
| Technology Equivalence | Employs similar technology to predicate device (K041630). |
| Principles of Operation Equivalence | Operates on similar principles to predicate device (K041630). |
| Indications for Use Equivalence | Intended for use in treatment of artificial arteriovenous dialysis fistula stenosis, which is equivalent to the predicate device's indications. |
Explanation: In a 510(k) for substantial equivalence, the "acceptance criteria" are primarily met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The primary "performance" shown here is the successful completion of functional, mechanical, and biocompatibility testing, and the conclusion that these, along with similarities in design, materials, and intended use, establish equivalence.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided documents. The submission emphasizes mechanical testing and biocompatibility rather than a clinical human trial.
- Data Provenance: Not applicable in the context of a human clinical test set. The functional and safety testing would have been conducted internally by Cardiovascular Systems, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the submission does not detail a clinical study requiring expert-established ground truth. The "ground truth" for functional and safety testing would be based on engineering specifications and recognized standards (like ISO 10993).
4. Adjudication method for the test set
- Not applicable. There is no indication of a clinical test set requiring adjudication in these documents.
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 (a physical device for removing plaque), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related metrics are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- For the functional and safety testing (mechanical, biocompatibility), the ground truth is based on engineering specifications, standardized test methods (e.g., ISO 10993), and regulatory requirements for medical devices. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth in a clinical study context for this specific 510(k) submission.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" in this 510(k) context is primarily the pre-clinical functional and safety testing combined with the comparative analysis against the predicate device (K041630).
- Study Design: The submission indicates that "representative samples of the device underwent mechanical testing and biocompatibility in accordance with ISO 10993." This constitutes the primary evidence base presented.
- Purpose: To verify that the device design met its functional and performance requirements and to demonstrate substantial equivalence to the predicate device in terms of principles of operation, technology, materials, and indications for use.
- Conclusion: The sponsor concluded that the Diamondback 360°™ Orbital Atherectomy System is equivalent to the predicate device (K041630) based on these similarities and the successful completion of the pre-clinical testing. The FDA's issuance of the 510(k) clearance signifies agreement with this conclusion, deeming the device as safe and effective as the predicate.
This 510(k) summary focuses on demonstrating that the new device is "substantially equivalent" to an already legally marketed device – a common pathway for medical device clearance when significant new safety or effectiveness questions are not raised. Clinical efficacy data, detailed human study designs, or AI performance metrics are typically not required for such submissions unless the device introduces new technology or indications that fundamentally alter its risk/benefit profile compared to existing devices.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).