(99 days)
Not Found
No
The summary describes a mechanical device for removing stenotic material and does not mention any AI/ML components or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML.
Yes
The device is described as treating artificial arteriovenous dialysis fistula stenosis, which is a medical condition.
No
Explanation: This device is described as a treatment system for removing stenotic material from artificial arteriovenous dialysis fistulae. It is designed to remove neointimal tissue causing stenosis, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly refers to a "System" and mentions mechanical testing and biocompatibility, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The description clearly states that the Orbital Atherectomy System is used to remove stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts). This is a therapeutic procedure performed within the body to treat a physical condition (stenosis).
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples, perform tests, or provide diagnostic information about a patient's health status. Its purpose is to physically modify tissue.
Therefore, the Orbital Atherectomy System is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
The Diamondback 360° ™ Orbital Atherectomy System (OAS) is intended for use in treatment of artificial ateriovenous dialysis fistula stenosis. An artificial arteriovenous dialysis fistula (A-V shunt) is placed sub-dermal to support kidney dialysis. A consequence of the body's reaction to the foreign material of the A-V shunt is to form clots and neointimal stenosis of the A-V Shunt. The most common location for the A-V shunt stenosis is at the shunt to vein anastomosis. It is this region that the Cardiovascular Systems, Inc. Orbital Atherectomy System (CSI OAS) is applied to remove neointimal tissue causing a stenosis in the A-V shunt.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
artificial arteriovenous dialysis fistulae (A-V Shunts)
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)
To verify that device design met its functional and performance requirements, representative sample of the device underwent mechanical testing and biocompatibility in accordance with ISO 10993.
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
K071427
2 of 1
AUG 3 0 2007
Section 5 – 510(k) Summary
| Submitter: | Cardiovascular Systems, Inc
651 Campus Drive, St. Paul, MN 55112 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cindy Setum, Ph.D., Vice President, Clinical Affairs
phone: 651-259-1650, fax: 651-259-1697 |
| Date Prepared: | May 22, 2007 |
| Trade Name: | Diamondback 360° ™ Orbital Atherectomy System for Treatment of A-
V Shunt Stenosis |
| Classification: | Class II
Peripheral Atherectomy Catheter
21 CFR §870.4875 |
| Product Code: | MCW |
| Predicate Device(s): | The subject device is equivalent to the following device: K041630,
Orbital Atherectomy System for Treatment of A-V Shunt Stenosis |
| Device Description: | The Diamondback 360° ™ Orbital Atherectomy System (OAS) is
intended for use in treatment of artificial ateriovenous dialysis fistula
stenosis. An artificial arteriovenous dialysis fistula (A-V shunt) is
placed sub-dermal to support kidney dialysis. A consequence of the
body's reaction to the foreign material of the A-V shunt is to form clots
and neointimal stenosis of the A-V Shunt. The most common location
for the A-V shunt stenosis is at the shunt to vein anastomosis. It is this
region that the Cardiovascular Systems, Inc. Orbital Atherectomy
System (CSI OAS) is applied to remove neointimal tissue causing a
stenosis in the A-V shunt. |
| Intended Use: | The Orbital Atherectomy System supports removal of stenotic material
from artificial arteriovenous dialysis fistulae (A-V Shunts). |
| Functional and Safety
Testing: | To verify that device design met its functional and performance
requirements, representative sample of the device underwent
mechanical testing and biocompatibility in accordance with ISO
10993. |
| Conclusion: | Cardiovascular Systems, Inc. considers the Diamondback 360° ™
Orbital Atherectomy System to be equivalent to the predicate device
listed above. This conclusion is based upon the devices' similarities in
principles of operation, technology, materials and indications for use. |
:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2007
Cardiovascular Systems, Inc. c/o Michael J. Kallok, Ph.D. Chief Scientific Officer 651 Campus Drive St. Paul, MN 55112-3495
Re: K071427
Diamondback 360°TM Orbital Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II (Two) Product Code: MCW Dated: August 3, 2007 Received: August 6, 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.
2
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 (QS) 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,
Duna R. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 4 - Indications For Use Statement
510(k) Number (if known): KO7 | 4 27
Device Name: Diamondback 360° ™ Orbitial Atherectomy System for Treatment of A-V Shunt Stenosis
Indications for Use:
The Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. de hnes
vision of Cardiovascular Devices
510(k) Number K071427