(47 days)
Not Found
No
The description focuses on the mechanical action of the device (orbiting, diamond-coated crown) and mentions only software verification for updates that don't affect hardware or performance. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as therapy" to treat various conditions like occlusive atherosclerotic disease and occluded hemodialysis grafts.
No
Explanation: The device is described as a "percutaneous orbital atherectomy system indicated for use as therapy" to remove or reduce occlusive material, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a reusable saline pump, single-use orbital atherectomy device (including a handle and crown cartridge), single-use atherectomy lubricant, and a single-use atherectomy guide wire. The performance studies section mentions "software verification and associated testing" but also states that the software updates "do not affect the device performance and hardware," implying the existence of hardware.
Based on the provided text, 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 and grafts. This is an intervention performed directly on the patient's body.
- Device Description: The device components are described as tools used for this physical intervention (pump, atherectomy device, lubricant, guide wire).
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for treatment.
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 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 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 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 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)
Only software verification and associated testing was required as the software updates do not affect the device performance and hardware.
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).
0
Image /page/0/Picture/0 description: The image shows 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.
March 1, 2022
Cardiovascular Systems Inc. Nikita Basandra Regulatory Affairs Manager 1225 Old Highway 8 NW Saint Paul, Minnesota 55112
Re: K220109
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: January 12, 2022 Received: January 13, 2022
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 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,
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220109
Device Name
Diamondback 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 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K220109
Device Name Stealth 360® Peripheral Orbital Atherectomy System
Indications for Use (Describe)
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 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K220109
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
Image /page/5/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a bold, sans-serif font, with a green arc underneath. To the right of the letters, separated by a vertical line, is the company name "CARDIOVASCULAR SYSTEMS, INC." in a smaller, sans-serif font.
l 510(K) SUMMARY (K220109)
| Submitter: | Cardiovascular Systems, Inc.
1225 Old Highway 8 NW
Saint Paul, MN 55112 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Nikita Basandra
Regulatory Affairs Manager
Cardiovascular Systems, Inc.
1225 Old Highway 8 NW
Saint Paul, MN 55112
Ph: 651-259-8206
nbasandra@csi360.com |
| Date
Prepared: | January 20, 2022 |
| 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 |
| Regulation
Number: | 21 CFR 870.4875 |
| Classification: | Class II |
| 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 |
| 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 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. | |
| Intended
Use: | The Diamondback 360® Peripheral Orbital Atherectomy System
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. |
| | Stealth 360® Peripheral Orbital Atherectomy System
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 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. |
| | Diamondback 360® Peripheral Orbital Atherectomy System Exchangeable
Series |
| | 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
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 and indications for use Same vessel diameter range and anatomic location of use Same design and materials Same hardware Same principles of operation Same sterilization method and SAL Same number of uses per device (single use) Same performance specifications The modified devices are different from the predicate device in that the
software has been updated to include additional cybersecurity protection.
Also, a hypotube was added to the Exchangeable driveshaft and a coupler was
updated to accommodate the change. The hypotube and coupler are located
within a fully enclosed, non-patient contacting portion of the device inside the
cartridge. The driveshaft continues to be identical in length, material, filar
count, tip, and crown to the predicate driveshaft. |
| Functional
and Safety
Testing: | Only software verification and associated testing was required as the software
updates do not affect the device performance and hardware. |
6
Image /page/6/Picture/0 description: The image contains the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a bold, sans-serif font, with a green arc underneath the "S" and "I". To the right of the letters, there is a vertical line separating the letters from the words "CARDIOVASCULAR SYSTEMS, INC.", which are stacked on top of each other in a smaller, sans-serif font.
7
Image /page/7/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a stylized font, with a green arc underneath. To the right of the letters is a vertical line, followed by the words "CARDIOVASCULAR SYSTEMS, INC." in a smaller, sans-serif font. The logo is simple and modern, and the use of green suggests a focus on health and wellness.
This confidential document is the property of Cardiovascular Systems, Inc. and shall not be reproduced, disclosed or used without the express written consent of Cardiovascular Systems, Inc.
8
Image /page/8/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a gray, sans-serif font, with a green arc underneath the letters. To the right of the letters is a vertical line, followed by the words "CARDIOVASCULAR SYSTEMS, INC." in a smaller, gray, sans-serif font. The logo is simple and modern, and it is likely used to represent the company's brand.
The hypotube/coupler update does not impact the functionality of the device to ablate the lesion nor its intended use. The subject devices are substantially equivalent to the predicate devices and Conclusion: the devices continue to perform as intended.