(49 days)
No
The summary describes a mechanical atherectomy system and does not mention any AI or ML components or functions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries" and "indicated as a therapy in patients with occluded hemodialysis grafts." This directly identifies its purpose as therapeutic.
No
The device is an atherectomy system designed for therapy (removing occlusive material) in peripheral arteries and dialysis fistulae, not for diagnosing conditions.
No
The device description explicitly lists physical components such as a reusable saline pump, single-use orbital atherectomy device, lubricant, and guide wire, indicating it is a hardware-based system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for therapy in patients with occlusive atherosclerotic disease and occluded hemodialysis grafts. It describes a treatment procedure (percutaneous orbital atherectomy) to remove material and restore patency.
- Device Description: The device is a mechanical system designed to physically remove material using an orbiting, diamond-coated crown. It includes components like a saline pump, orbital atherectomy device, lubricant, and guide wire.
- Mechanism of Action: The mechanism of action is described as physical processes (centrifugal force, orbital rotation, differential sanding, bi-directional sanding) to remove material.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
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.
Product codes
MCW
Device Description
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)
Mechanism of Action
The Diamondback, Stealth, and Exchangeable Series OAS mechanism of action is identical to the predicate device and is defined by:
• Centrifugal force
• Orbital rotation
• Differential sanding
• Bi-directional sanding
The proposed device has the same intended use, mechanism of action, and indications for use as the predicate. The proposed device differs in manufacturing process and supplier of a device component.
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 DIAMONDBACK 360 Peripheral OAS, Stealth 360 Peripheral OAS, and DIAMONDBACK 360 OAS Exchangeable 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 Testing
The following bench tests were conducted in accordance with applicable 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 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
1
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
2
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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3
510(k) Summary
| Submitter: | Cardiovascular Systems, Inc.
1225 Old Highway 8 NW
Saint Paul, MN 55112 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Nikita Basandra
Principal Regulatory Affairs Specialist
Cardiovascular Systems, Inc.
1225 Old Highway 8 NW
Saint Paul, MN 55112
Ph: 651-259-8206
nbasandra@csi360.com |
| Date
Prepared: | September 30, 2020 |
| Trade
Name: | • DIAMONDBACK 360 Peripheral Orbital Atherectomy System
• DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series
• Stealth 360 Peripheral Orbital Atherectomy System |
| Common
Name: | Intraluminal Artery Stripper |
| Classificatio
n: | Class II, 21 CFR 870.4875 |
| Product
Code: | MCW |
| Predicate
Device(s): | • K190634 - DIAMONDBACK 360® and Stealth 360® Peripheral Orbital Atherectomy Systems (Cardiovascular Systems, Inc.)
• K182397 - DIAMONDBACK 360® Peripheral Orbital Atherectomy System Exchangeable Series |
4
| Device
Description: | 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)
Mechanism of Action
The Diamondback, Stealth, and Exchangeable Series OAS mechanism of
action is identical to the predicate device and is defined by:
• Centrifugal force
• Orbital rotation
• Differential sanding
• Bi-directional sanding
The proposed device has the same intended use, mechanism of action, and
indications for use as the predicate. The proposed device differs in
manufacturing process and supplier of a device component. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use: | The Diamondback 360® [Stealth 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. |
5
| Comparison
to Predicate: | | DIAMONDBACK 360
Peripheral OAS
(Predicate Device) | DIAMONDBACK 360
Peripheral OAS, Stealth 360
Peripheral OAS, and
DIAMONDBACK 360 OAS
Exchangeable Series
(Subject Device) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for Use | The OAS 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. | Same |
| | Crown Styles | Solid
Classic
Micro | Same |
| | Crown Sizes (mm) | 1.25
1.50
1.75
2.00 | Same |
| | OAD driveshaft
lengths (cm) | 75
145
180
200 | Same |
| | Sterile | Yes | Same |
| | Single Use | Yes | Same |
| | Principles of
Operation | Same | Same |
| | Operation | Yes | Same |
| | Used in conjunction
with
• OAS Pump
• CSI Peripheral
Guide Wires
• ViperSlide
Lubricant | | |
6
| Performance Data: | Biocompatibility Testing
The biocompatibility evaluation for the DIAMONDBACK 360 Peripheral
OAS, Stealth 360 Peripheral OAS, and DIAMONDBACK 360 OAS
Exchangeable 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 Testing
The following bench tests were conducted in accordance with
applicable 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 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 for the
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, the Stealth
360 Peripheral Orbital Atherectomy System, and the DIAMONDBACK 360
Peripheral Orbital Atherectomy System Exchangeable Series compared to the
predicate device. The testing results demonstrate that the devices should
perform as intended under the specified use conditions. |