(22 days)
No
The summary describes a mechanical atherectomy system and does not mention any AI or ML components or functionalities.
Yes
The document explicitly states that the device is "indicated for use as therapy" in patients with occlusive atherosclerotic disease and also indicates "as a therapy" in patients with occluded hemodialysis grafts.
No.
The document describes a device used for therapy to remove stenotic material, not for diagnosing a condition.
No
The device description explicitly lists three significant hardware components: an orbital atherectomy device, an orbital atherectomy controller, and an atherectomy guidewire. The 510(k) is for modifications to the crown, shaft, and guidewire, which are also hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a therapeutic procedure performed directly on a patient's peripheral arteries and A-V grafts to remove stenotic material. This is an interventional treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system for physically removing material from within blood vessels using a diamond-coated sanding surface. This is a mechanical intervention, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The device is a surgical/interventional tool used for treating a condition within the body, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Diamondback 360° Global 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 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.
Product codes
MCW
Device Description
The Diamondback 360°TM Orbital Atherectomy System (OAS) with 3X Solid Crown is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.
OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. OAS applies a diamond coated, eccentrically rotating sanding surface to ablate stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body.
The Diamondback 360° Orbital Atherectomy System consists of the following three significant components:
-
- Orbital atherectomy device
-
- Orbital atherectomy controller, and
-
- Atherectomy guidewire.
This 510/k) is for the same device with modifications to the crown ,shaft and guidewire for improved sanding efficiency.
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
Laboratory and animal tests were performed to support the safety profile of the modification to the Diamondback 360°™ Orbital Atherectomy System.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K071350, K071427, K072748, K081944
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
Section. 5 510(k) Summary
| Company Name: | Cardiovascular Systems, Inc.
651 Campus Drive
St. Paul, MN 55112 | | MAK 20 2009 |
|----------------------|------------------------------------------------------------------------|----------------------------------------------|-------------|
| Contact: | David D. Brooke | | |
| Phone: | (651) 259-2061 | | |
| Fax: | (651) 259-1696 | | |
| Summary Date: | February 25, 2009 | | |
| Trade Name: | 3X Solid Crown Diamondback 360°™ Orbital Atherectomy System | | |
| Common Name: | Peripheral Atherectomy Device | | |
| Classification Name: | Peripheral Atherectomy Catheter (21 CFR 870.4875; Product Code: MCW) | | |
| Predicate Device: | 510(k) Number: | K072748 | |
| | Manufacture: | Cardiovascular Systems, Inc. | |
| | Trade Name: | Diamondback 360°™ Orbital Atherectomy System | |
| | 510(k) Number: | K071350 | |
| | Manufacture: | Cardiovascular Systems, Inc. | |
| | Trade Name: | Diamondback 360°™ Orbital Atherectomy System | |
| | 510(k) Number: | K081944 | |
| | Manufacture: | Cardiovascular Systems, Inc. | |
| | Trade Name: | Sidewinder Diamondback 360°™ Orbital | |
5.1 Description of Device
The Diamondback 360°TM Orbital Atherectomy System (OAS) with 3X Solid Crown is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.
OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. OAS applies a diamond coated, eccentrically rotating sanding surface to ablate
1
stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body.
The Diamondback 360° Orbital Atherectomy System consists of the following three significant components:
-
- Orbital atherectomy device
-
- Orbital atherectomy controller, and
-
- Atherectomy guidewire.
This 510/k) is for the same device with modifications to the crown ,shaft and guidewire for improved sanding efficiency.
5.2 Intended Use
The 3X Solid Crown Diamondback 360°™ 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 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.
5.3 Technology
The 3X Solid Crown Diamondback 360°™ Orbital Atherectomy System provides a method of removing occlusive atherosclerotic or stenotic material. The OAS applies a diamond coated, eccentrically rotating sanding surface to ablate stenotic tissue. The resulting particles of removed stenotic tissue are very small and can be absorbed by the body. This same technology was cleared to market for use in peripheral arteries in 510(k) K071350, A-V grafts per K071427, Solid Crown per K072748, and Solid Crown with Sidewinder Shaft per K081944.
5.4 Conclusions
The 3X Solid Crown Diamondback 360°™ Orbital Atherectomy System is substantially equivalent to the predicate devices. Laboratory and animal tests were performed to support the safety profile of the modification to the Diamondback 360°™ Orbital Atherectomy System. No new questions of safety or effectiveness were raised.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardiovascular Systems, Inc. c/o Mr. David Brooke Senior Regulatory Manager 651 Campus Drive St. Paul, MN 55112
MAR 2 0 2009
Re: K090521
3X Solid Crown Diamondback 360° Orbital Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: February 25, 2009 Received: February 26, 2009
Dear Mr. Brooke:
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).