The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

Device Description

The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Diamondback 360 uses an eccentrically rotating sanding surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body.

The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:

1. Orbital Atherectomy Device (OAD)
1. Atherectomy Guide Wire (e.g., ViperWire Advance)
1. Saline Infusion Pump (SIP)
1. Atherectomy Lubricant (e.g., ViperSlide)

AI/ML Overview

The provided text is a 510(k) Summary for a medical device and does not contain the detailed information typically found in a clinical study report. Therefore, I cannot fully answer all aspects of your request as the information is not present in the document.

However, I can extract the available information regarding acceptance criteria and the type of evaluation performed.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states that the device was evaluated using performance bench testing and that "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Diamondback 360 Peripheral Orbital Atherectomy System met the established specifications necessary for consistent performance during its intended use." It also states, "The Diamondback 360 Peripheral Orbital Atherectomy System met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs."

However, the specific numerical acceptance criteria for each test and the corresponding reported performance values are not provided in this summary.

Here's a table summarizing the tests performed, as listed in the document, and the general statement of performance:

Test Name	Acceptance Criteria (Not detailed in document)	Reported Device Performance
System Life Testing D	Established specifications for consistent performance	Met established specifications and predetermined acceptance criteria
Stall Testing	Established specifications for consistent performance	Met established specifications and predetermined acceptance criteria
Introducer Compatibility Testing	Established specifications for consistent performance	Met established specifications and predetermined acceptance criteria
Contrast Injection Testing	Established specifications for consistent performance	Met established specifications and predetermined acceptance criteria
Temperature Testing	Established specifications for consistent performance	Met established specifications and predetermined acceptance criteria
Tensile Testing	Established specifications for consistent performance	Met established specifications and predetermined acceptance criteria
Flexibility Testing	Established specifications for consistent performance	Met established specifications and predetermined acceptance criteria
Delivered Torque Testing	Established specifications for consistent performance	Met established specifications and predetermined acceptance criteria
Orbit Testing	Established specifications for consistent performance	Met established specifications and predetermined acceptance criteria
Flow Testing	Established specifications for consistent performance	Met established specifications and predetermined acceptance criteria
Track Testing	Established specifications for consistent performance	Met established specifications and predetermined acceptance criteria
Packaging/Simulated Distribution Testing	Established specifications for consistent performance	Met established specifications and predetermined acceptance criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes bench testing, not human clinical studies. Therefore, concepts like "test set sample size" in the context of human data, country of origin, or retrospective/prospective study design are not applicable and not provided. The "sample size" would refer to the number of devices or components tested during the bench tests, which is not specified.

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 applicable and not provided. The evaluation involved bench testing against established engineering specifications, not expert interpretation of medical data where "ground truth" is established by medical professionals.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are relevant in clinical studies where expert consensus is needed.

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 applicable and not provided. This summary describes a physical medical device (orbital atherectomy system) and its mechanical performance through bench testing, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable and not provided. This is for a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench testing, the "ground truth" would be the established engineering specifications, standards, and test protocols.

8. The sample size for the training set

This information is not applicable and not provided. As this is a physical device undergoing bench testing, there is no "training set" in the context of machine learning or AI models. The design and manufacturing processes are iterative, but a formal "training set" as you'd find in AI development is not relevant here.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the reasons stated in point 8.

Summary

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FEB 2 8 2014

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K133999 p. 1 of 3

Section. 6	510(k) Summary
------------	----------------

Company Name:	Cardiovascular Systems, Inc.651 Campus DriveSaint Paul, MN 55112
Contact:	Blair Buth
Phone:	(651) 259-2032
Fax:	(651) 305-7734
Summary Date:	February 28, 2014
Trade Name:	Diamondback 360® Peripheral Orbital Atherectomy System
Product Code:	MCW—Catheter, Peripheral, Atherectomy
Classification Regulation:	21 CFR 870.4875—Intraluminal Artery Stripper
Classification:	II
Predicate Devices:
	510(k) Numbers:Manufacturer:Trade Name:	K110389, K122987, & K131092Cardiovascular Systems, Inc.Stealth 360® Orbital PAD System, Model PRD-SC30-125
	510(k) Number:Manufacturer:Trade Name:	K133399Cardiovascular Systems, Inc.Diamondback 360® Peripheral OrbitalAtherectomy System, Model DBP-125MICRO145

Description of Device 6.1

The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

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K133999 p. 2 of 3

The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:

1. Orbital Atherectomy Device (OAD)
1. Atherectomy Guide Wire (e.g., ViperWire Advance)
1. Saline Infusion Pump (SIP)
1. Atherectomy Lubricant (e.g., ViperSlide)

6.2 Description of Change

The Diamondback 360 Peripheral 60cm Orbital Atherectomy Device overall length was decreased to 60 centimeters (cm). The OAD driveshaft, saline sheath, and nosecone cap were modified to accommodate the shorter length. The updated OAD will be available in a 1.25 Micro and 1.25 Solid crown configuration. The 1.25 Micro OAD crown remains unchanged and the 1.25 Solid OAD crown was modified for compatibility with the smaller diameter drive shaft. The Diamondback 360 Peripheral 60cm OAD requires use of a smaller ViperWire Advance Atherectomy Guide Wire (0.012").

6.3 Intended Use

6.4 Technology

The Diamondback 360 Peripheral Orbital Atherectomy System provides a method of removing or reducing occlusive atherosclerotic or stenotic material. The OAS applies a diamond coated, eccentrically rotating sanding surface to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body. This is the same technology that was cleared to market for use in the peripheral arteries for Stealth 360° in 510(k) K110389, K122987, K131092 and for Diamondback 360° Peripheral per K133399.

6.5 Performance Data

The Diamondback 360 Peripheral Orbital Atherectomy System was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.

System Life Testing including guide wire .
Stall Testing .
Introducer Compatibility Testing .
. Contrast Injection Testing

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. Temperature Testing
Tensile Testing .
. Flexibility Testing
Delivered Torque Testing .
Orbit Testing .
. Flow Testing
Track Testing .
Packaging/Simulated Distribution Testing ●

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Diamondback 360 Peripheral Orbital Atherectomy System met the established specifications necessary for consistent performance during its intended use.

6.6 Conclusions

The Diamondback 360 Peripheral Orbital Atherectomy System met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs. Testing results demonstrate that the Diamondback 360 Peripheral Orbital Atherectomy System is substantially equivalent to the legally marketed predicate devices and does not raise any new safety or effectiveness questions.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 28, 2014

Cardiovascular Systems, Inc. c/o Mr. Blair Buth Regulatory Affairs Manager 651 Campus Drive Saint Paul, MN 55112

Re: K133999

Trade/Device Name: Diamondback 360® Peripheral Orbital Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: January 30, 2014 Received: January 31, 2014

Dear Mr. Buth:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Blair Buth

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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours, Kent

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/1 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a bold, sans-serif font, with a curved line underneath the letters. To the right of the letters is the text "CARDIOVASCULAR SYSTEMS, INC." in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and other communications.

Indications for Use Statement Section. 5

510(k) Number: _K133999

Device Name: Diamondback 360° Peripheral Orbital Atherectomy System

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/5/Picture/12 description: The image shows the name "Kenneth J. Cavanaugh -S" in bold, black font. The name is written in a clear, legible typeface. The text is horizontally aligned and appears to be part of a document or label. The letters are evenly spaced, and the overall impression is professional and easy to read.

Cardiovascular Systems, Inc. (CSI)

Diamondback 360® Peripheral Orbital Atherectorny System

Regulation Number and Section

§ 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).