(58 days)
No
The description focuses on the mechanical action of the device (orbiting, diamond-coated crown) and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as "a percutaneous orbital atherectomy system indicated for use as therapy" to treat specified medical conditions, which aligns with the definition of a therapeutic device.
No
The device is described as a "percutaneous orbital atherectomy system indicated for use as therapy in patients" with occlusive diseases. Its purpose is to remove or reduce occlusive material and restore patency, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly lists hardware components such as a reusable saline pump, a single-use orbital atherectomy device, a single-use atherectomy lubricant, and a single-use atherectomy guide wire. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic procedure to remove occlusive material from blood vessels. IVDs are used to diagnose diseases or conditions by examining samples from the body (like blood, urine, or tissue).
- Device Description: The device description details a mechanical system for removing material, not a system for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is a therapeutic medical device used for atherectomy in peripheral arteries and dialysis fistulae.
N/A
Intended Use / Indications for Use
The Diamondback 360® Peripheral Orbital Atherectorny System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerosis disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS SOLID, CLASSIC and MICRO crowns support 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 2.00 Max Crown has not been tested to support removal of stenovenous dialysis fistulae (AV shunt).
The Stealth 360® Peripheral Orbital Atherectony 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 SOLID, CLASSIC and MICRO crowns support 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 2.00 Max Crown has not been tested to support removal of stenotic materiovenous dialysis fistulae (AV shunt).
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 OAS SOLID, CLASSIC and MICRO crowns support 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 2.00 Max Crown has not been tested to support removal of stenovenous dialysis fistulae (AV shunt).
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
This document describes the Diamondback [STEALTH] [Exchangeable Series] Peripheral Orbital Atherectomy Systems (OAS). The OAS is designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. The document lists the main components of the OAS, including a reusable saline pump, a single-use orbital atherectomy device, a single-use atherectomy lubricant, and a single-use atherectomy guide wire. The document also describes the mechanism of action and indications for use of the OAS.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries, artificial arteriovenous dialysis fistulae (AV shunt), hemodialysis grafts. The current 2.00 Solid Crown and the proposed 2.00 Max Crown may be used to treat lesions in larger vessels such as the Superior Femoral Artery (SFA) or Common Femoral Artery (CFA).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional and Safety Testing:
Biocompatibility Testing including: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Pyrogenicity, Hemocompatibility.
Bench Testing performed in accordance with applicable standards and guidance: Stall, Tight Stenosis, Life, Coating Integrity, Tensile Verification Testing, Orbit Characterization Testing, Temperature and Flow Verification Testing, Particulate Testing, Corrosion Testing, GLP Animal Testing. These tests performed are intended to verify that the design meets all product specifications and address the potential safety hazards that have been identified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
April 27, 2022
Cardiovascualr Systems Inc. Kris Miller Principal Regulatory Specialist 1225 Old Highway 8 NW New Brighton, Minnesota 55112
Re: K220568
Trade/Device Name: Diamondback 360® Peripheral Orbital Atherectomy System, Stealth 360® Peripheral Orbital Atherectomy System, Diamondback 360® Peripheral Orbital Atherectomy System, Exchangeable Series Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: February 25, 2022 Received: February 28, 2022
Dear Kris Miller:
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.
1
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 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 mediation-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.
For
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
2
Indications for Use
510(k) Number (if known)
K220568
Device Name Diamondback 360® Peripheral Orbital Atherectomy System Stealth 360® Peripheral Orbital Atherectomy System Diamondback 360® Peripheral Orbital Atherectomy System, Exchangeable Series
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 atherosclerosis disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS SOLID, CLASSIC and MICRO crowns support 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 2.00 Max Crown has not been tested to support removal of stenovenous dialysis fistulae (AV shunt).
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 SOLID, CLASSIC and MICRO crowns support 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 2.00 Max Crown has not been tested to support removal of stenotic materiovenous dialysis fistulae (AV shunt).
The Diamondback 360® Peripheral Orbital Atherectorny 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 OAS SOLID, CLASSIC and MICRO crowns support 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 2.00 Max Crown has not been tested to support removal of stenovenous dialysis fistulae (AV shunt).
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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Image /page/3/Picture/0 description: The image shows the logo for CSI. The logo consists of the letters "CSI" in a sans-serif font, with the "C" and "S" connected and the "I" standing separately. Below the letters is a curved green line, resembling a smile or an arc. The letters are in a muted gray color.
510(k) Summary
| Submitter: | Cardiovascular Systems Inc. (CSI)
1225 Old Highway 8 NW
St. Paul, MN 55112 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kris Miller
Principal Regulatory Affairs Specialist
Cardiovascular Systems Inc.
1225 Old Highway 8 NW
St. Paul, MN 55112
Phone: 612-999-3749
kmiller@csi360.com |
| Date Prepared: | February 25, 2022 |
| Trade Name: | Diamondback 360® Peripheral Orbital Atherectomy System Stealth 360® Peripheral Orbital Atherectomy System Diamondback 360® Peripheral Orbital Atherectomy System Exchangeable Series |
| Common Name: | Intraluminal Artery Stripper |
| Classification: | Class II, 21 CFR 870.4875 |
| Product Code: | MCW |
| Predicate Device(s): | Diamondback/Stealth = K203008 Exchangeable = K203008 Reference Device Predator = K090521 |
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K220568
Image /page/4/Picture/3 description: This document describes the Diamondback [STEALTH] [Exchangeable Series] Peripheral Orbital Atherectomy Systems (OAS). The OAS is designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. The document lists the main components of the OAS, including a reusable saline pump, a single-use orbital atherectomy device, a single-use atherectomy lubricant, and a single-use atherectomy guide wire. The document also describes the mechanism of action and indications for use of the OAS.
5
Image /page/5/Picture/0 description: The image shows the logo for CSI. The logo consists of the letters "CSI" in a gray, sans-serif font. Below the letters is a curved, green shape that resembles a wave or an arc. The letters are slightly rounded, giving the logo a modern and approachable feel.
| Functional and
Safety Testing: | Biocompatibility Testing
The biocompatibility evaluation includes the following tests: |
|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Systemic Toxicity Pyrogenicity Hemocompatibility |
| Bench Testing
The following bench tests were conducted in accordance with
applicable standards and guidance. | |
| | Stall, Tight Stenosis, Life, Coating Integrity, Tensile Verification Testing Orbit Characterization Testing Temperature and Flow Verification Testing Particulate Testing Corrosion Testing GLP Animal Testing |
| | These tests performed are intended to verify that the
design meets all product specifications and address the
potential safety hazards that have been identified. |
6
| K220568 | |
|---|---|
| Comparison to | |
| Predicate Device: | The modified Diamondback 360® [Stealth 360®] Peripheral |
| Orbital Atherectomy System [Exchangeable Series] devices | |
| are identical to the predicate devices as follows: | |
| • Same regulation number, product code and classification | |
| • Same intended use | |
| • Same vessel diameter range and anatomic location of use | |
| • Same principles of operation | |
| • Same sterilization method and SAL | |
| • Same number of uses per device (single use) | |
| • Same performance specifications | |
| The only difference between the cleared crown in the | |
| predicate device and the currently marketed 2.00 Solid | |
| crown is the size of the diamonds used in the crown coating. | |
| The currently marketed crowns are coated with 30-micron | |
| diamonds whereas the proposed crown will use 70-micron | |
| diamonds. | |
| The crown diamond coating process is intended to leave | |
| approximately one-third of the diamond exposed, such that | |
| a 30-micron diamond has about 10-microns exposed as a | |
| sanding surface. Therefore, the change from 30-micron to | |
| 70-micron diamonds results in an approximately 13- | |
| microns in exposed diamond on the crown surface. | |
| There is a minor update to the Indications for Use statement | |
| as the 2.00 Max Crown has not been tested to support | |
| removal of stenotic material from artificial arteriovenous | |
| dialysis fistulae (AV shunt). | |
| No other changes will be made to the devices. The current | |
| 2.00 Solid Crown and the proposed 2.00 Max Crown may | |
| be used to treat lesions in larger vessels such as the Superior | |
| Femoral Artery (SFA) or Common Femoral Artery (CFA). | |
| In these larger vessels, lesions tend to be less calcified. | |
| Conclusion: | The data provided supports substantial equivalence for the |
| Diamondback [STEALTH] [Exchangeable Series] 360® | |
| Peripheral Orbital Atherectomy System compared to the | |
| predicate device. The testing results demonstrate that the devices | |
| perform as intended under the specified use conditions |