(112 days)
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 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.
This document is a 510(k) premarket notification for the Diamondback 360 Peripheral Orbital Atherectomy System and Stealth 360 Peripheral Orbital Atherectomy System. It compares the proposed device to a predicate device (K152694 - Diamondback 360 Peripheral Orbital Atherectomy System).
The information provided in the document refers to physical and mechanical performance testing of the device, rather than a clinical study evaluating its diagnostic or therapeutic effectiveness using AI. Therefore, most of the requested points regarding acceptance criteria and study details for an AI/device performance study (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device submission as described.
The performance data listed (Bench Testing, Track Verification Testing, Stall / Life and Tight Stenosis Verification Testing, etc.) are primarily engineering and hardware verification tests, not clinical performance or AI algorithm performance assessments. The conclusion explicitly states that the device has the "same technological characteristics as the predicate device" and that "testing results demonstrate that the devices perform as intended under the specified use conditions." This focuses on demonstrating equivalence to an existing device through non-clinical means.
Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from the provided document. The document describes a medical device with mechanical action for atherectomy, not an AI-powered diagnostic or therapeutic device.
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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 and 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.
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
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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
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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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Image /page/3/Picture/0 description: The image shows the logo for CSI. The logo is in gray and green. The letters "CSI" are in gray, and there is a green arc below the letters.
510(k) Summary
| Submitter: | Cardiovascular Systems Inc. (CSI)1225 Old Highway 8 NWSt. Paul, MN 55112 |
|---|---|
| Contact Person: | Kris MillerSr. Regulatory Affairs SpecialistCardiovascular Systems Inc.1225 Old Highway 8 NWSt. Paul, MN 55112Phone: 651-259-1656Fax: 651-259-2094kmiller@csi360.com |
| Date Prepared: | March 8, 2019 |
| 510(k) Number: | K190634 |
| Trade Name: | Diamondback 360® Peripheral Orbital Atherectomy SystemStealth 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 AtherectomySystem (Cardiovascular Systems, Inc.) |
| Device Description: | The Diamondback 360 and Stealth 360 Peripheral OrbitalAtherectomy Systems (OAS) are designed to remove or reduceocclusive material and restore luminal patency by using anorbiting, diamond-coated, eccentrically mounted crown.The OAS consists of the following main components:1. Reusable Saline Pump (provided non-sterile)2. Single-use Orbital Atherectomy Device (OAD) (provided sterile)3. Single-use Atherectomy lubricant (provided sterile)4. Single-use Atherectomy guide wire (provided sterile) |
| Mechanism of Action | |
| Traditional 510(k) Pre-market NotificationDiamondback 360 and Stealth 360 OAS | |
| The Diamondback and Stealth OAS mechanism of action isidentical to the predicate device and is defined by:• Centrifugal force• Orbital rotation• Differential sanding• Bi-directional sandingThe rapidly rotating eccentric crown creates a centrifugal force thatpresses the diamond-coated crown against the calcified plaque.With each pass of the crown, plaque is reduced, and the diameterof the orbit increases. | |
| Indications for Use: | The Diamondback 360® [Stealth 360®] Peripheral OrbitalAtherectomy System is a percutaneous orbital atherectomy systemindicated for use as therapy in patients with occlusiveatherosclerotic disease in peripheral arteries and who areacceptable candidates for percutaneous transluminal atherectomy. |
| The OAS supports removal of stenotic material from artificialarteriovenous dialysis fistulae (AV shunt). The system is apercutaneous orbital atherectomy system indicated as a therapy inpatients with occluded hemodialysis grafts who are acceptablecandidates for percutaneous transluminal angioplasty. |
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Technologic Characteristic Comparison:
| DiamondBack(Predicate Device)K152694 | Proposed DeviceDiamondBack OAS | Proposed DeviceStealth OAS | Impact ofDifference onSafety andEffectiveness | ||
|---|---|---|---|---|---|
| Crown Styles | MicroSolidClassic | Same as predicate | 1.25 Micro crown isnew to Stealth.Solid and Classicare same aspredicate | No Impact toSafety andEffectiveness asthis crown styleis identical tothe predicatedevice. | |
| Crown Sizes(mm) | 1.251.501.752.00 | Same as predicate | 1.25 Micro crown isnew to Stealth. Allother sizes are thesame as predicate. | No Impact toSafety andEffectiveness asthis crown sizeis identical tothe predicatedevice. | |
| DiamondBack(Predicate Device)K152694 | Proposed DeviceDiamondBack OAS | Proposed DeviceStealth OAS | Impact ofDifference onSafety andEffectiveness | ||
| OADdriveshaftlengths (mm) | 145180200 | 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 toSafety andEffectiveness asthis iscomparable tothe currentlymarketed1.25MICRO145 | |
| 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 toSafety andEffectiveness asthis iscomparable tothe currentlymarketed1.25MICRO145 | |
| 1.25Solid145 | 4 Fr | Same as predicate | 6 Fr | The Stealthsheath size isunchanged from | |
| DiamondBack(Predicate Device)K152694 | Proposed DeviceDiamondBack OAS | Proposed DeviceStealth OAS | Impact ofDifference onSafety andEffectiveness | ||
| 1.50Solid145 | 5 Fr | Same as predicate | 6 Fr | the currentlycleared device.The Stealthsheath size isunchanged fromthe currentlycleared device. | |
| 2.00Solid145 | 5 Fr | Same as predicate | 6 Fr | The Stealthsheath size isunchanged fromthe currentlycleared device. | |
| 1.50Classic145 | 5 Fr | Same as predicate | 6 Fr | The Stealthsheath size isunchanged fromthe currentlycleared device. | |
| 2.00Classic145 | 5 Fr | Same as predicate | 6 Fr | The Stealthsheath size isunchanged fromthe currentlycleared device. | |
| 1.25Solid200 | 5 Fr | Same as predicate | Same as predicate | NA - Nodifference | |
| 1.50Solid200 | 5 Fr | Same as predicate | Same as predicate | NA – Nodifference | |
| 1.75Solid180 | 5 Fr | Same as predicate | Same as predicate | NA - Nodifference | |
| Filar Count(x) and Wire Diameter | |||||
| 1.25Micro145 | 3x.0061 | Same as predicate | Same as predicate | NA – Nodifference | |
| 1.25Solid145 | 3x.0067 | Same as predicate | Same as predicate | NA – Nodifference | |
| 1.50Solid145 | 3x.0067 | Same as predicate | Same as predicate | NA – Nodifference | |
| 2.00Solid145 | 6x.0060 | Same as predicate | Same as predicate | NA – Nodifference | |
| 1.50Classic145 | 3x.0070 | Same as predicate | Same as predicate | NA – Nodifference | |
| 2.00Classic145 | 3x.0070 | Same as predicate | Same as predicate | NA – Nodifference | |
| DiamondBack(Predicate Device)K152694 | Proposed DeviceDiamondBack OAS | Proposed DeviceStealth OAS | Impact ofDifference onSafety andEffectiveness | ||
| 1.25Solid200 | 7x.0060 | Same as predicate | Same as predicate | NA – Nodifference | |
| 1.50Solid200 | 7x.0060 | Same as predicate | Same as predicate | NA – Nodifference | |
| 1.75Solid180 | 7x.0060 | Same as predicate | Same as predicate | NA – Nodifference | |
| RotationalSpeed Range | Low (60 kRPM)Medium (90 kRPM)High (120 kRPM)High (140 kRPM -classic crowns only) | Same as predicate | Same as predicate | NA – Nodifference | |
| GllideAssist | (cleared in K182397) | Same as predicate | 1.25MICRO145only | No impact. Thisfunction wascleared inK182397. | |
| Sterile | Yes | Same as predicate | Same as predicate | NA – Nodifference | |
| Single Use | Yes | Same as predicate | Same as predicate | NA – Nodifference | |
| Used inconjunctionwith | • OAS SalinePump• CSI PeripheralGuide Wires• ViperSlideLubricant | Same as predicate | Same as predicate | NA – Nodifference |
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Image /page/5/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 logo is simple and modern.
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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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Image /page/8/Picture/0 description: The image shows the logo for CSI. The logo consists of the letters "CSI" in a rounded, sans-serif font. The letters are gray. Below the letters is a green arc. The arc is curved upwards, suggesting a smile or a rising line.
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.
§ 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).