(229 days)
The Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).
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.
This document is a 510(k) premarket notification for the Cardiovascular Systems, Inc. Orbital Atherectomy System (CSI OAS). It focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating performance against such criteria. The "Summary of Safety and Effectiveness" primarily discusses the device's technical aspects, intended use, and comparison to predicate devices, rather than data from a performance study with defined acceptance criteria.
Therefore, many of the requested elements for describing acceptance criteria and a study demonstrating device performance cannot be extracted directly from the provided text.
Here's an attempt to answer the questions based on the available information, noting the missing details:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The document primarily focuses on establishing substantial equivalence based on intended use and technology, rather than presenting a performance study with specific acceptance criteria and results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document. The document mentions "Laboratory and animal data" but does not provide details on sample sizes, provenance, or study design (retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not present in the provided document. The device is a physical medical device (atherectomy system), not an AI-based diagnostic tool, so an MRMC study related to human reader performance with AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present and not applicable as the device is a physical atherectomy system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document refers to "Laboratory and animal data" as support for safety. It's highly probable that pathology/histology and direct observation of animal tissue would have been used as ground truth for assessing the efficacy of tissue removal and safety aspects in the animal studies. However, explicit details are not provided.
8. The sample size for the training set
This information is not present in the provided document. The concept of a "training set" is typically associated with AI/machine learning models and is not relevant for this type of physical medical device submission.
9. How the ground truth for the training set was established
This information is not present and not applicable for a physical medical device.
{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
{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
§ 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).