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 atherectomy 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Diamondback 360® Peripheral Orbital Atherectomy System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list quantitative acceptance criteria with specific numerical targets. Instead, it states that the device "met the established specifications necessary for consistent performance during its intended use" and "met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs."

However, based on the performance bench testing conducted, we can infer the categories of acceptance criteria:

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	All tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility) showed materials are non-toxic and non-sensitizing, consistent with intended use.
Durability/Life Cycle	System Life Testing met established specifications.
Functionality (High Load)	Stall Testing met established specifications.
Compatibility	Introducer Compatibility Testing met established specifications.
Fluid Management	Contrast Injection Testing met established specifications.
Thermal Performance	Temperature Testing met established specifications.
Mechanical Strength	Tensile Testing met established specifications.
Mechanical Flexibility	Flexibility Testing met established specifications.
Power/Movement Delivery	Delivered Torque Testing met established specifications.
Operational Mechanism	Orbit Testing met established specifications.
Safety Mechanism	Guide Wire Brake Testing met established specifications.
Fluid Dynamics	Flow Testing met established specifications.
Navigation/Advancement	Track Testing met established specifications.
Packaging Integrity	Packaging/Simulated Distribution Testing met established specifications.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes bench testing and biocompatibility testing, not clinical trials involving human subjects or data sets in the traditional sense of AI/diagnostic device evaluation. Therefore, there is no "test set" of patient data, nor is there information on data provenance (country of origin, retrospective/prospective) for such a test set. The "test set" here refers to the physical devices and materials undergoing various engineering and biological assessments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This is not applicable as the study involved bench testing and biocompatibility testing of a physical medical device, not the evaluation of an algorithm against a ground truth established by experts.

4. Adjudication Method for the Test Set:

This is not applicable for the same reasons as #3. The results of the mechanical and biological tests are objective measurements, not subject to expert adjudication.

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 is not applicable. The device is an orbital atherectomy system, a physical interventional medical device, not an AI or diagnostic tool that assists human readers. No MRMC study was conducted or would be relevant for this type of device.

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

This is not applicable. The device is a physical orbital atherectomy system, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance evaluation of this device is based on established engineering specifications, material science standards, and biological safety standards. For example:

Biocompatibility: Conformance to ISO standards for biocompatibility, assessed through laboratory tests (cytotoxicity, sensitization, etc.).
Mechanical Performance: Measurements against predefined engineering specifications for torque, tensile strength, flexibility, etc., derived from industry standards and internal design requirements.
System Life: Durability testing against a specified number of cycles or operational hours.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the same reason as #8.

Summary

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NOV 22222013

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:	November 05, 2013
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 Device:

510(k) Number:	K110389, K122987, & K131092
Manufacturer:	Cardiovascular Systems, Inc.
Trade Name:	Stealth 360 ° ® Orbital PAD System

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.

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)

6-1

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K133389

6.2 Intended Use

6.3 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) K131092, K122987, K110389 and Predator 360° (originally cleared as 3X) per K090521.

6.4 Performance Data

Biocompatibility testing for the modified 1.25 Micro OAD (Diamondback 360 Peripheral Orbital Atherectomy System) has been completed. The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissue consistent with its intended use. The following biocompatibility tests were completed.

. Cytotoxicity
Sensitization ●
Irritation ●
. Acute Systemic Toxicity
. Pyrogenicity
. Hemocompatibility

The modified 1.25 Micro OAD (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 .
. Stall Testing
. Introducer Compatibility Testing
Contrast Injection Testing ●
. Temperature Testing
Tensile Testing ●
Flexibility Testing .

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K133399

6-3

Delivered Torque Testing .
Orbit Testing o
Guide Wire Brake 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 modified 1.25 Micro OAD (Diamondback 360 Peripheral Orbital Atherectomy System) met the established specifications necessary for consistent performance during its intended use.

ર.ક 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 device and does not raise any new safety or effectiveness questions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol consisting of three curved lines, which are meant to represent the human form. The image is in black and white.

Public Health Service

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

November 22, 2013

Cardiovascular Systems, Inc. Mr. Blair Buth Regulatory Affairs Manager 651 Campus Drive St. Paul, MN 55112

Re: K133399

Trade/Device Name: Diamondback 360 Peripheral Orbital Atherectorny System -Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: November 5, 2013 Received: November 6, 2013

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

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Page 2 - Mr. Blair Buth

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 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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Bram D. Zuckerman -S

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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K133399

Indications for Use Statement Section. 5

510(k) Number: _K133399

Device Name: Diamondback 360° Peripheral Orbital Atherectomy System

Indications for Use:

The Diamondback 360 Peripheral Orbital Atherectomy System is a perculaneous 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bram D. Zuckerman -S 2013.1

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).