← Product Code [MCW](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW) · K041630 # ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS (K041630) _Cardiovascular Systems Incorporated · MCW · Jan 31, 2005 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K041630 ## Device Facts - **Applicant:** Cardiovascular Systems Incorporated - **Product Code:** [MCW](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW.md) - **Decision Date:** Jan 31, 2005 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 870.4875 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for Use The Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts). ## Device Story The Orbital Atherectomy System (OAS) is a peripheral atherectomy device used to treat neointimal stenosis in artificial arteriovenous (A-V) dialysis fistulae. The device utilizes a diamond-coated, eccentrically rotating cutting surface to ablate stenotic tissue. The mechanical action of the rotating head reduces the tissue into small particles that are absorbed by the body. The system is intended for use by clinicians to clear obstructions at the shunt-to-vein anastomosis, thereby maintaining fistula patency for dialysis access. ## Clinical Evidence No clinical data provided. Safety and effectiveness were supported by laboratory and animal testing. ## Technological Characteristics The device features a diamond-coated, eccentrically rotating cutting head. It is a mechanical atherectomy catheter designed for peripheral use. No specific materials, energy sources, or software/connectivity details are provided beyond the mechanical ablation principle. ## Regulatory Identification An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.) ## Predicate Devices - Arrow-Trerotola PTD ([K970080](/device/K970080.md)) - Rotablator Orbital Atherectomy System - Peripheral Use ([K901206](/device/K901206.md)) - Blue Max® 20™ Balloon Catheter ([K972357](/device/K972357.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. K041630 # 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 {4}------------------------------------------------ ## 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K041630](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K041630) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com