(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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
November 19, 2020
Cardiovascular Systems Inc. Nikita Basandra Principal Regulatory Affairs Specialist 1225 Old Highway 8 NW Saint Paul, Minnesota 55112
Re: K203008
Trade/Device Name: DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: September 30, 2020 Received: October 7, 2020
Dear Nikita Basandra:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203008
Device Name
Diamondback 360® Peripheral Orbital Atherectomy System Diamondback 360® Peripheral Orbital Atherectomy System. Exchangeable Series Stealth 360® Peripheral Orbital Atherectomy System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Submitter: | Cardiovascular Systems, Inc.1225 Old Highway 8 NWSaint Paul, MN 55112 |
|---|---|
| ContactPerson: | Nikita BasandraPrincipal Regulatory Affairs SpecialistCardiovascular Systems, Inc.1225 Old Highway 8 NWSaint Paul, MN 55112Ph: 651-259-8206nbasandra@csi360.com |
| DatePrepared: | September 30, 2020 |
| TradeName: | • DIAMONDBACK 360 Peripheral Orbital Atherectomy System• DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series• Stealth 360 Peripheral Orbital Atherectomy System |
| CommonName: | Intraluminal Artery Stripper |
| Classification: | Class II, 21 CFR 870.4875 |
| ProductCode: | MCW |
| PredicateDevice(s): | • K190634 - DIAMONDBACK 360® and Stealth 360® Peripheral Orbital Atherectomy Systems (Cardiovascular Systems, Inc.)• K182397 - DIAMONDBACK 360® Peripheral Orbital Atherectomy System Exchangeable Series |
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| DeviceDescription: | The DIAMONDBACK 360 Peripheral OAS, Stealth 360 Peripheral OAS, andDIAMONDBACK 360 OAS Exchangeable Series are designed to remove orreduce occlusive material and restore luminal patency by using an orbiting,diamond-coated, eccentrically mounted crown. Each OAS consists of thefollowing main components:1. Reusable Saline Pump (provided non-sterile)2. Single-use Orbital Atherectomy Device (OAD)(provided sterile). The Exchangeable Series OADconsists of a physician-operated handle and aninterchangeable crown cartridge.3. Single-use Atherectomy lubricant (provided sterile)4. Single-use Atherectomy guide wire (provided sterile)Mechanism of ActionThe Diamondback, Stealth, and Exchangeable Series OAS mechanism ofaction is identical to the predicate device and is defined by:• Centrifugal force• Orbital rotation• Differential sanding• Bi-directional sandingThe proposed device has the same intended use, mechanism of action, andindications for use as the predicate. The proposed device differs inmanufacturing process and supplier of a device component. |
|---|---|
| Indicationsfor Use: | The Diamondback 360® [Stealth 360®] Peripheral Orbital AtherectomySystem [Exchangeable Series] is a percutaneous orbital atherectomysystem indicated for use as therapy in patients with occlusiveatherosclerotic disease in peripheral arteries and who are acceptablecandidates for percutaneous transluminal atherectomy.The [Exchangeable Series] OAS supports removal of stenotic material fromartificial arteriovenous dialysis fistulae (AV shunt). The system is apercutaneous orbital atherectomy system indicated as a therapy in patientswith occluded hemodialysis grafts who are acceptable candidates forpercutaneous transluminal angioplasty. |
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| Comparisonto Predicate: | DIAMONDBACK 360Peripheral OAS(Predicate Device) | DIAMONDBACK 360Peripheral OAS, Stealth 360Peripheral OAS, andDIAMONDBACK 360 OASExchangeable Series(Subject Device) | |
|---|---|---|---|
| Indications for Use | The OAS is a percutaneousorbital atherectomy systemindicated for use as therapy inpatients withocclusive atheroscleroticdisease in peripheral arteriesand who are acceptablecandidates for percutaneoustransluminal atherectomy. TheOAS supports removal ofstenotic material fromartificial arteriovenous dialysisfistulae (AV shunt). The OASis a percutaneous orbitalatherectomysystem indicated as a therapyin patients with occludedhemodialysis grafts who areacceptable candidates forpercutaneous transluminalangioplasty. | Same | |
| Crown Styles | SolidClassicMicro | Same | |
| Crown Sizes (mm) | 1.251.501.752.00 | Same | |
| OAD driveshaftlengths (cm) | 75145180200 | Same | |
| Sterile | Yes | Same | |
| Single Use | Yes | Same | |
| Principles ofOperation | Same | Same | |
| Operation | Yes | Same | |
| Used in conjunctionwith• OAS Pump• CSI PeripheralGuide Wires• ViperSlideLubricant |
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| Performance Data: | Biocompatibility TestingThe biocompatibility evaluation for the DIAMONDBACK 360 PeripheralOAS, Stealth 360 Peripheral OAS, and DIAMONDBACK 360 OASExchangeable Series included the following tests:Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Systemic Toxicity Pyrogenicity Hemolysis Study Complement Activation Assay Platelet and Leukocyte Counts Partial Thromboplastin Time |
|---|---|
| Bench TestingThe following bench tests were conducted in accordance withapplicable standards and guidance.Corrosion Resistance Testing Orbit Characterization Testing Particulate Testing Radiopacity Assessment Tensile Verification Testing These tests performed are intended to verify that the designmeets all product specifications and address the potential safetyhazards that have been identified. | |
| Conclusion: | The data provided supports no new questions of safety or effectiveness for theDIAMONDBACK 360 Peripheral Orbital Atherectomy System, the Stealth360 Peripheral Orbital Atherectomy System, and the DIAMONDBACK 360Peripheral Orbital Atherectomy System Exchangeable Series compared to thepredicate device. The testing results demonstrate that the devices shouldperform as intended under the specified use conditions. |
§ 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).