(229 days)
Not Found
No
The description focuses on a mechanical device for tissue removal and does not mention any software or algorithms that would suggest AI/ML.
Yes.
The device is used for the "treatment" of "stenosis" in "artificial arteriovenous dialysis fistulae (A-V Shunts)", which indicates a therapeutic purpose.
No.
The device description clearly states that the Orbital Atherectomy System "supports removal of stenotic material" and "provides a method of removing occlusive neointimal tissue." This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical system ("diamond coated, eccentrally rotating cutting surface") used to ablate tissue, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The Orbital Atherectomy System is a surgical device used within the body to physically remove stenotic material from artificial arteriovenous dialysis fistulae. It is a therapeutic device, not a diagnostic one.
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens. The device directly interacts with tissue within the body.
Therefore, the Orbital Atherectomy System falls under the category of 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
MCW
Device Description
The Orbital Atherectomy System (OAS) is intended for use in treatment of artificial arteriovenous 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 A-V shut stenosis is at the shunt to vein anastomosis. It is this region that the Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System is applied to remove neointimal tissue causing a stenosis in the A-V shunt.
The 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.
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)
Laboratory and animal data were provided to support the safety of the OAS for use in the treatment of A-V shunt stenosis. No new questions of safety or effectiveness are raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo features the letters "CSI" in a stylized font, with a curved line above the letters. Below the letters, the words "CARDIOVASCULAR SYSTEMS, INC." are written in a smaller, sans-serif font. The logo is simple and professional, and it effectively communicates the company's name and focus.
Summary of Safety and Effectiveness
JAN 3 1 2005
Company Name: Cardiovascular Systems, Inc. 2715 Nevada Avenue North New Hope (Minneapolis), MN 55427
Contact: Michael J. Kallok, Ph.D. President and CEO
Phone: (763) 544-1890
Fax: (763) 544-1892
Summary Date: June 10, 2004
Trade Name: Cardiovascular Systems, Inc. Orbital Atherectomy System (CSI OAS) for Treatment of A-V Shunt Stenosis
Common Name: Peripheral Atherectomy Device
Classification Name: 21 CFR 870.4875, Peripheral Atherectomy Catheter
Predicate Device:
| 510(k) Number: | K970080 |
|---|---|
| Manufacture: | Arrow |
| Trade Name: | Arrow-Trerotola PTD |
| 510(k) Number: | K901206 |
| Manufacture: | Boston Scientific (Acquired from Heart Technology, Inc.) |
| Trade Name: | Rotablator Orbital Atherectomy System - Peripheral Use |
| 510(k) Number: | K972357 |
| Manufacture: | Boston Scientific |
| Trade Name: | Blue Max® 20™ Balloon Catheter |
1.0 Description of Device
The Orbital Atherectomy System (OAS) is intended for use in treatment of artificial arteriovenous 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
2715 Nevada Avenue North ● New Hope, MN 55427 ● Tel. 763-544 1892
1
of the A-V shunt. The most common location for A-V shut stenosis is at the shunt to vein anastomosis. It is this region that the Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System is applied to remove neointimal tissue causing a stenosis in the A-V shunt.
2.0 Intended Use
The Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).
3.0 Technology
The 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.
4.0 Conclusions
The OAS is substantially equivalent to the predicate devices. Laboratory and animal data were provided to support the safety of the OAS for use in the treatment of A-V shunt stenosis. No new questions of safety or effectiveness are raised.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle-like emblem with three stylized lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2005
Cardiovascular Systems, Inc. c/o Mr. Gary Syring Principal Consultant Quality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589
Re: K041630
Trade Name: Orbital Atherectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Catheter, Peripheral, Atherectomy Regulatory Class: Class II Product Code: MCW Dated: December 23, 2004 Received: December 27, 2004
Dear Mr. Syring:
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.
3
Page 2 - Mr. Gary Syring
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substition with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decemination that your as rout of receral agencies. You must or any Federal Statules and regulations daminister on thot limited to: registration and listing (21 comply with all the Act s requirements, mercesses annufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 801), good and the may of any and and one of any of the electronic
forth in the quality systems (QS) regulation (21 CFR Party) (2001) 105 form in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Deceible 501 - 10 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - I his letter will anow you to begin marketing your avence of your devreits your device to a legally premarket notification. THE PDA miding of backannal volume 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 If you desire specific advice ior your as (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Complance at (217) 21 CFR Part 807.97). You may obtain "Misbranding by reference to premance notificanses in the Act from the Division of Small other general information on your responsible at its toll-free number (800) 638-204, or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duana P. Vochner
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K 04 | 6 30
Device Name: Orbital 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duana R. Wilmer
Page 1 of 1
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K041630