(100 days)
Not Found
No
The description focuses on mechanical action (orbital rotation, centrifugal force, differential sanding) and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is indicated for use "as therapy" in patients with occlusive atherosclerotic disease in peripheral arteries and occluded hemodialysis grafts. It removes stenotic material to restore luminal patency, which is a therapeutic action.
No
The device is described as a "peripheral orbital atherectomy system" intended for treatment (removing or reducing occlusive material) rather than diagnosis.
No
The device description clearly lists several hardware components: a reusable saline pump, a single-use orbital atherectomy device (including a handle and crown cartridge), single-use lubricant, and a single-use guidewire. The mechanism of action also describes a physical process involving an orbiting, diamond-coated crown.
Based on the provided information, the Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to physically remove occlusive material from blood vessels (peripheral arteries, dialysis fistulae, and grafts) using a mechanical process (orbital atherectomy). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a mechanical system with components like a pump, handle, crown, lubricant, and guidewire. These are tools used for a physical procedure.
- Mechanism of Action: The mechanism involves mechanical forces (centrifugal force, orbital rotation, sanding) to remove plaque.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, tissue, or other bodily fluids) to provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions.
In summary, the Diamondback 360 Peripheral Orbital Atherectomy System is a therapeutic medical device used for a surgical procedure, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
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)
Mechanism of Action
The Exchangeable Series mechanism of action is identical to the predicate device and 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.
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility Testing
The biocompatibility evaluation for the Exchangeable OAD device included the following tests:
● Cytotoxicity
● Sensitization
● Irritation/Intracutaneous Reactivity
● Systemic Toxicity
● Pyrogenicity
● Hemolysis Study
Performance/Bench Testing
The following bench tests on the Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series were conducted in accordance with applicable standards and guidance.
● Track Verification Testing
● Stall / Life and Tight Stenosis Verification Testing
● Device Pre-Conditioning Verification Testing
● Handle Potting and Switch Mount Base and Process Updates
● Handle Life Verification Testing
● Tensile Verification Testing
● Temperature and Saline Flow Life Verification Testing
● Dimensional and Weight Verification Testing
● Glide Start Up Life Verification Testing
● Orbit Characterization Testing
● Switch Logic Verification Testing
● Miscellaneous Verification Testing: Includes the following tests:
Ο Traverse Force
Ο Knob Lock Force
Ο Exchange Durability
Ο Guidewire Back Loading
● Usability/human factors 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.
Not Found
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).
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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2018
Cardiovascular Systems Inc. Kris Miller Sr. Regulatory Specialist 1225 Old Highway 8 NW St. Paul, Minnesota 55112
Re: K182397
Trade/Device Name: 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: November 6, 2018 Received: November 7, 2018
Dear Ms. 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.
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
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 2018.12.13 14:39:01 -05'00' For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182397
Device Name
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
Indications for Use (Describe)
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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Image /page/3/Picture/0 description: The image shows the logo for CSI, which features the letters "CSI" in a sans-serif font. The letters are a muted gray color. Below the letters, there is a curved green line that resembles a smile or an arc. The logo is simple and modern in design.
510(k) Summary / Statement
| 510k Number | K182397 |
|---|---|
| Submitter: | Cardiovascular Systems Inc. |
| 1225 Old Highway 8 NW | |
| St. Paul, MN 55112 | |
| Contact Person: | Kris Miller |
| Sr. Regulatory Affairs Specialist | |
| Cardiovascular Systems Inc. | |
| 1225 Old Highway 8 NW | |
| St. Paul, MN 55112 | |
| USA | |
| Phone: 651-259-1656 | |
| Fax: 651-259-2094 | |
| kmiller@csi360.com | |
| Date Prepared: | August 31, 2018 |
| Trade Name: | 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: | K152694 - Diamondback 360® Peripheral Orbital Atherectomy |
| System (Cardiovascular Systems, Inc.) | |
| Device Description: | 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: | |
| 1. 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)
Mechanism of Action |
| | The Exchangeable Series mechanism of action is identical to the
predicate device and 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. |
| Indications for Use: | 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. |
| Comparison with
Predicate Device: | The Exchangeable Series OAS has the same intended use,
mechanism of action and indications for use as the predicate
device.
All Exchangeable OADs use the same base handle to which a
crown cartridge is attached. The only differences between the
various crown cartridges are the length of the drive shaft and the
size and style of the crown on each model. With the
Exchangeable Series OAS, up to 3 crowns can be used with a
single handle.
An additional length of drive shaft has been added to the
DIAMONDBACK 360 Peripheral Orbital Atherectomy System
(OAS) Exchangeable Series. The 75cm drive shaft materials and
construction are identical to the currently cleared CSI drive shaft
devices. |
| | There has been a change in materials that are in the indirect |
| | patient contact pathway. These new components are located |
| | inside the cartridge housing. |
| | |
| Performance Data: | Biocompatibility Testing |
| | The biocompatibility evaluation for the Exchangeable OAD |
| | device included the following tests: |
| | ● Cytotoxicity |
| | ● Sensitization |
| | ● Irritation/Intracutaneous Reactivity |
| | ● Systemic Toxicity |
| | ● Pyrogenicity |
| | ● Hemolysis Study |
| | |
| | Performance/Bench Testing |
| | The following bench tests on the Diamondback 360 Peripheral |
| | Orbital Atherectomy System Exchangeable Series were |
| | conducted in accordance with applicable standards and |
| | guidance. |
| | ● Track Verification Testing |
| | ● Stall / Life and Tight Stenosis Verification Testing |
| | ● Device Pre-Conditioning Verification Testing |
| | ● Handle Potting and Switch Mount Base and Process |
| | Updates |
| | ● Handle Life Verification Testing |
| | ● Tensile Verification Testing |
| | ● Temperature and Saline Flow Life Verification Testing |
| | ● Dimensional and Weight Verification Testing |
| | ● Glide Start Up Life Verification Testing |
| | ● Orbit Characterization Testing |
| | ● Switch Logic Verification Testing |
| | ● Miscellaneous Verification Testing: Includes the |
| | following tests: |
| | Ο Traverse Force |
| | Ο Knob Lock Force |
| | Ο Exchange Durability |
| | Ο Guidewire Back Loading |
| | ● Usability/human factors 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. |
| | |
| Conclusion: | The data provided supports no new questions of safety or effectiveness of the Diamondback 360 Peripheral Orbital
Atherectomy System Exchangeable Series compared to the
predicate device. The mechanical testing results demonstrate that
the device should perform as intended in the specified use
conditions. |
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