(112 days)
No
The description focuses on mechanical components and physical mechanisms (centrifugal force, orbital rotation, differential sanding) for plaque removal. There is no mention of AI or ML in the device description, mechanism of action, or performance studies.
Yes
The device is explicitly indicated for "use as therapy" in patients with specific medical conditions (occlusive atherosclerotic disease, occluded hemodialysis grafts, artificial arteriovenous dialysis fistulae (AV shunt)) and works to remove or reduce occlusive material to restore luminal patency, which are therapeutic actions.
No
The device is described as a "percutaneous orbital atherectomy system indicated for use as therapy" to remove occlusive material, not to diagnose conditions.
No
The device description explicitly lists hardware components (Reusable Saline Pump, Single-use Orbital Atherectomy Device, Single-use Atherectomy lubricant, Single-use Atherectomy guide wire) and describes a mechanical mechanism of action involving an orbiting crown. While software verification is mentioned in the performance studies, the device is clearly not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Diamondback 360 and Stealth 360 Peripheral Orbital Atherectomy Systems are used therapeutically to remove occlusive material from blood vessels and grafts within the patient's body. This is an interventional procedure, not a diagnostic test performed on a sample outside the body.
- Mechanism of Action: The mechanism involves physical removal of plaque using an orbiting crown, which is a mechanical action performed directly on the anatomical site.
- Lack of Diagnostic Information: The device's purpose is to treat a condition (occlusive disease), not to provide diagnostic information about the patient's health status based on analyzing a sample.
Therefore, the Diamondback 360 and Stealth 360 Peripheral Orbital Atherectomy Systems are therapeutic medical devices, not In Vitro Diagnostic devices.
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.
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
The Diamondback 360 and Stealth 360 Peripheral Orbital Atherectomy Systems (OAS) are designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown.
The OAS consists of the following main components:
- Reusable Saline Pump (provided non-sterile)
- Single-use Orbital Atherectomy Device (OAD) (provided sterile)
- Single-use Atherectomy lubricant (provided sterile)
- Single-use Atherectomy guide wire (provided sterile)
Mechanism of Action
The Diamondback and Stealth 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)
Bench Testing
The following bench tests were conducted in accordance with applicable standards and guidance.
- Track Verification Testing .
- Stall / Life and Tight Stenosis Verification Testing ●
- Device Pre-Conditioning Verification Testing
- Tensile Verification Testing ●
- Temperature and Saline Flow Verification Testing ●
- Glide Start Up Verification Testing
- Software Verification ●
- Electromagnetic Compatibility ●
- Electrical Safety ●
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).
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July 2, 2019
Cardiovascular Systems Inc. Kris Miller Sr. Regulatory Specialist 1225 Old Highway 8 NW St. Paul, MN 55112
Re: K190634
Trade/Device Name: Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System Regulation Number: 21 CFR 840.4875 Regulation Name: Intramural Artery Stripper Regulatory Class: Class II Product Code: MCW
Received: May 29, 2019
Dated: May 28, 2019
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
1
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 (OS) 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,
For
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)
K190634
Device Name
Diamondback 360® Peripheral Orbital Atherectomy System 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 atherectorny 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.
| 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. (CSI)
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
Phone: 651-259-1656
Fax: 651-259-2094
kmiller@csi360.com |
| Date Prepared: | March 8, 2019 |
| 510(k) Number: | K190634 |
| Trade Name: | Diamondback 360® Peripheral Orbital Atherectomy System
Stealth 360® Peripheral Orbital Atherectomy System |
| 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 and Stealth 360 Peripheral Orbital
Atherectomy Systems (OAS) are designed to remove or reduce
occlusive material and restore luminal patency by using an
orbiting, diamond-coated, eccentrically mounted crown.
The OAS consists of the following main components:
- Reusable Saline Pump (provided non-sterile)
- Single-use Orbital Atherectomy Device (OAD) (provided sterile)
- Single-use Atherectomy lubricant (provided sterile)
- Single-use Atherectomy guide wire (provided sterile) |
| | Mechanism of Action |
| | Traditional 510(k) Pre-market Notification
Diamondback 360 and Stealth 360 OAS |
| | The Diamondback and Stealth 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. |
| Indications for Use: | The Diamondback 360® [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. |
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Technologic Characteristic Comparison:
| | DiamondBack
(Predicate Device)
K152694 | Proposed Device
DiamondBack OAS | Proposed Device
Stealth OAS | Impact of
Difference on
Safety and
Effectiveness | |
|-----------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--|
| Crown Styles | Micro
Solid
Classic | Same as predicate | 1.25 Micro crown is
new to Stealth.
Solid and Classic
are same as
predicate | No Impact to
Safety and
Effectiveness as
this crown style
is identical to
the predicate
device. | |
| Crown Sizes
(mm) | 1.25
1.50
1.75
2.00 | Same as predicate | 1.25 Micro crown is
new to Stealth. All
other sizes are the
same as predicate. | No Impact to
Safety and
Effectiveness as
this crown size
is identical to
the predicate
device. | |
| | DiamondBack
(Predicate Device)
K152694 | Proposed Device
DiamondBack OAS | Proposed Device
Stealth OAS | Impact of
Difference on
Safety and
Effectiveness | |
| OAD
driveshaft
lengths (mm) | 145
180
200 | Same as predicate | Same as predicate | NA - No difference | |
| OAD driveshaft diameter (in.) | .0285 | Same as predicate | New to Stealth
(same as predicate) | No Impact to
Safety and
Effectiveness as
this is
comparable to
the currently
marketed
1.25MICRO145 | |
| 1.25Solid145 | .029 | Same as predicate | Same as predicate | NA - No difference | |
| 1.50Solid145 | .029 | Same as predicate | Same as predicate | NA - No difference | |
| 2.00Solid145 | .031 | Same as predicate | Same as predicate | NA - No difference | |
| 1.50Classic145 | .0335 | Same as predicate | Same as predicate | NA - No difference | |
| 2.00Classic145 | .0335 | Same as predicate | Same as predicate | NA - No difference | |
| 1.25Solid200 | .029 | Same as predicate | Same as predicate | NA - No difference | |
| 1.50Solid200 | .029 | Same as predicate | Same as predicate | NA - No difference | |
| 1.75Solid180 | .029 | Same as predicate | Same as predicate | NA - No difference | |
| Sheath Size | 4 Fr | Same as predicate | Same as predicate | No Impact to
Safety and
Effectiveness as
this is
comparable to
the currently
marketed
1.25MICRO145 | |
| 1.25Solid145 | 4 Fr | Same as predicate | 6 Fr | The Stealth
sheath size is
unchanged from | |
| | DiamondBack
(Predicate Device)
K152694 | Proposed Device
DiamondBack OAS | Proposed Device
Stealth OAS | Impact of
Difference on
Safety and
Effectiveness | |
| 1.50Solid145 | 5 Fr | Same as predicate | 6 Fr | the currently
cleared device.
The Stealth
sheath size is
unchanged from
the currently
cleared device. | |
| 2.00Solid145 | 5 Fr | Same as predicate | 6 Fr | The Stealth
sheath size is
unchanged from
the currently
cleared device. | |
| 1.50Classic145 | 5 Fr | Same as predicate | 6 Fr | The Stealth
sheath size is
unchanged from
the currently
cleared device. | |
| 2.00Classic145 | 5 Fr | Same as predicate | 6 Fr | The Stealth
sheath size is
unchanged from
the currently
cleared device. | |
| 1.25Solid200 | 5 Fr | Same as predicate | Same as predicate | NA - No
difference | |
| 1.50Solid200 | 5 Fr | Same as predicate | Same as predicate | NA – No
difference | |
| 1.75Solid180 | 5 Fr | Same as predicate | Same as predicate | NA - No
difference | |
| | Filar Count(x) and Wire Diameter | | | | |
| 1.25Micro145 | 3x.0061 | Same as predicate | Same as predicate | NA – No
difference | |
| 1.25Solid145 | 3x.0067 | Same as predicate | Same as predicate | NA – No
difference | |
| 1.50Solid145 | 3x.0067 | Same as predicate | Same as predicate | NA – No
difference | |
| 2.00Solid145 | 6x.0060 | Same as predicate | Same as predicate | NA – No
difference | |
| 1.50Classic145 | 3x.0070 | Same as predicate | Same as predicate | NA – No
difference | |
| 2.00Classic145 | 3x.0070 | Same as predicate | Same as predicate | NA – No
difference | |
| | DiamondBack
(Predicate Device)
K152694 | Proposed Device
DiamondBack OAS | Proposed Device
Stealth OAS | Impact of
Difference on
Safety and
Effectiveness | |
| 1.25Solid200 | 7x.0060 | Same as predicate | Same as predicate | NA – No
difference | |
| 1.50Solid200 | 7x.0060 | Same as predicate | Same as predicate | NA – No
difference | |
| 1.75Solid180 | 7x.0060 | Same as predicate | Same as predicate | NA – No
difference | |
| Rotational
Speed Range | Low (60 kRPM)
Medium (90 kRPM)
High (120 kRPM)
High (140 kRPM -
classic crowns only) | Same as predicate | Same as predicate | NA – No
difference | |
| GllideAssist | (cleared in K182397) | Same as predicate | 1.25MICRO145
only | No impact. This
function was
cleared in
K182397. | |
| Sterile | Yes | Same as predicate | Same as predicate | NA – No
difference | |
| Single Use | Yes | Same as predicate | Same as predicate | NA – No
difference | |
| Used in
conjunction
with | • OAS Saline
Pump
• CSI Peripheral
Guide Wires
• ViperSlide
Lubricant | Same as predicate | Same as predicate | NA – No
difference | |
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Image /page/6/Picture/0 description: The image shows the logo for CSI. The logo consists of the letters "CSI" in a gray, rounded font. Below the letters is a green curved line. The letters are spaced apart, and the "I" has a small trademark symbol next to it.
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Performance Data:
Bench Testing
The following bench tests were conducted in accordance with applicable standards and guidance.
- Track Verification Testing .
- Stall / Life and Tight Stenosis Verification Testing ●
- Device Pre-Conditioning Verification Testing
- Tensile Verification Testing ●
- Temperature and Saline Flow Verification Testing ●
- Glide Start Up Verification Testing
- Software Verification ●
- Electromagnetic Compatibility ●
- Electrical Safety ●
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Performance data and software verification was collected and verified that the design meets all product specifications and address the potential safety hazards that have been identified.
The Diamondback 360 Peripheral Orbital Atherectomy System and Conclusion: the Stealth 360 Peripheral Orbital Atherectomy System have the same indications for use and the same technological characteristics as the predicate device. The testing results demonstrate that the devices perform as intended under the specified use conditions. Based on this and data provided in this pre-market notification, the subject and predicate devices have been shown to be substantially equivalent.