(100 days)
No
The description focuses on mechanical ablation and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is indicated for use "as therapy in patients with occlusive atherosclerotic disease in peripheral arteries," directly stating its therapeutic purpose.
No
The device is used for treatment (removing stenotic material from arteries), not for diagnosis.
No
The device description explicitly lists three significant hardware components: an Orbital Atherectomy Device, a Guide Wire, and a Controller. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Diamondback 360° Orbital Atherectomy System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is a "percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries". This describes a therapeutic intervention performed on the patient's body, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description details a system that physically removes stenotic material from arteries using a diamond-coated cutting surface. This is a mechanical treatment, not a diagnostic process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Diamondback 360° Orbital Atherectomy System is a therapeutic device used to treat a condition within the body.
N/A
Intended Use / Indications for Use
The 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 are who are acceptable candidates for percutaneous transluminal atherectomy.
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
The Diamondback 360° Orbital System (OAS) is intended for use in the treatment of peripheral artery stenosis also referred to as Peripheral Artery Disease (PAD). PAD is the result of a stenosis of peripheral arteries, typically in the legs.
The OAS provides a method of removing stenotic material from peripheral arteries. The OAS applies a diamond coated, eccentrically rotating cutting 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,
-
- Guide Wire, and
-
- Controller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries
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)
Laboratory animal and clinical data were provided to support the safety of the Diamondback 360° Orbital Atherectomy System.
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).
0
K07135⁰
510(k) Summary
AUG 2 2 2007
Company Name: Cardiovascular Systems, Inc. 651 Campus Drive St. Paul, MN 55112
Contact: Michael Kallok PhD, FACC, Chief Scientific Officer
Phone: (651) 259-1610
Fax: (651) 259-1696
Summary Date: May 9, 2007
Trade Name: Diamondback 360° Orbital Atherectomy System
Common Name: Peripheral Atherectomy Device
Classification Name: 21 CFR 870.4875, Peripheral Atherectomy Catheter
Predicate Device:
| 510(k) Number: | K901206 |
|---|---|
| Manufacture: | Heart Technologies (Acquired by Boston Scientific |
| Trade Name: | Rotablator Peripheral Atherectomy Device |
| 510(k) Number: | K043553 |
| Manufacture: | Fox Hollow, Inc. |
| Trade Name: | Silver Hawk Peripheral Plaque Excision System |
| 510(k) Number: | K041630 |
| Manufacture: | Cardiovascular Systems, Inc. |
| Trade Name: | CSI A-V Graft System |
1.0 Description of Device
The Diamondback 360° Orbital System (OAS) is intended for use in the treatment of peripheral artery stenosis also referred to as Peripheral Artery Disease (PAD). PAD is the result of a stenosis of peripheral arteries, typically in the legs.
1
The OAS provides a method of removing stenotic material from peripheral arteries. The OAS applies a diamond coated, eccentrically rotating cutting surface to ablate stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body.
The technology of applying a rotating abrasive surface to remove a peripheral stenotic material has a technology predicate. The Cardiovascular Systems, Inc. (CSI) rotational atherectomy system, commercial name CSI A-V Graft System, was reviewed and cleared to market for use in A-V Grafts by 510(k) K041630. This same device, with modifications to the indication for use and additions of disposable device variations is applied for use in atherectomy of peripheral arteries.
The Diamondback 360° Orbital Atherectomy System consists of the following three significant components:
-
- Orbital Atherectomy Device,
-
- Guide Wire, and
-
- Controller.
2.0 Intended Use
The 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 are who are acceptable candidates for percutaneous transluminal atherectomy.
3.0 Technology
The Diamondback 360° Orbital Atherectomy System (OAS) provides a method of removing occlusive neointimal tissue. The OAS applies a diamond coated, eccentrically rotating cutting surface to ablate neointimal tissue. The resulting particles of removed neointimal tissue are very small and can be absorbed by the body. This same technology was cleared to market for use in A-V Grafts, reference K041630.
2
4.0 Conclusions
The OAS is substantially equivalent to the predicate devices. Laboratory animal and clinical data were provided to support the safety of the Diamondback 360° Orbital Atherectomy System. No new questions of safety or effectiveness are raised.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2007
Cardiovascular Systems, Inc. c/o Michael J. Kallok, Ph.D. Chief Scientific Officer 651 Campus Drive St. Paul, MN 55112-3495
Re: K071350
Diamondback 360°™ Orbital Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II (Two) Product Code: MCW Dated: July 27, 2007 Received: July 30, 2007
Dear Dr. Kallok:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 – Michael J. Kallok, Ph.D.
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. lochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure -
5
Indications for Use 510(k) Number (if known): K()71,55
Device Name: Diamondback 360° Orbital Atherectomy System
Indications for Use:
The 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 are who are acceptable candidates for percutaneous transluminal atherectomy.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dune R. Whitney
Sign-Off
Cardiovascular Devices
STU(K) Number_K071350
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