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 sarface (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 510(k) summary (K152694) for the Diamondback 360 Peripheral Orbital Atherectomy System details the acceptance criteria via performance bench testing and concludes that the device meets these criteria. However, it does not involve a study in the traditional sense of clinical trials or AI/ML evaluations with human experts. Instead, it focuses on verifying the device's physical and functional properties against established specifications.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance bench testing categories that served as the acceptance criteria. The device performance is generally reported as meeting these criteria, implying successful execution within established specifications.

Acceptance Criteria (Test Category)	Reported Device Performance
- System Life Testing (including guidewire)	"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.""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."
- Stall Testing
- Introducer Compatibility Testing
- Temperature Testing
- Tensile Testing
- Flexibility Testing
- Delivered Torque Testing
- Orbit Testing
- Guidewire Brake Testing
- Saline Flow Testing
- Track Testing
- Packaging/Simulated Distribution Testing
- Biocompatibility (Cytotoxicity per ISO 10993-5)
- Biocompatibility (ASTM Hemolysis per ISO 10993-4)
- Biocompatibility (Chemical Characterization per ISO 10993-18)

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each bench test. The "test set" in this context refers to the manufactured device components or systems subjected to the various physical and chemical tests. The data provenance is internal to the manufacturer (Cardiovascular Systems, Inc.) as these are internal design verification and validation tests. There's no mention of external data or geographic origin beyond the manufacturer's location in Saint Paul, MN. All testing described is retrospective in the sense that it evaluates a designed product, not prospective observational or interventional studies on human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to the presented data. The "ground truth" for bench testing is typically defined by engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and internal quality control criteria. These are established by engineering and quality assurance teams, not clinical experts for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. Bench testing results are compared against predetermined numerical or qualitative specifications, not adjudicated by a panel in the way clinical diagnostic accuracy studies are.

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

Not applicable. This is a submission for a mechanical atherectomy device, not an AI/ML-driven diagnostic or assistive device where MRMC studies with human readers would be relevant.

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

Not applicable. The device is a physical, mechanical medical device.

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

For the bench testing, the "ground truth" is based on:

Engineering Specifications: Designed parameters and tolerances for device components and system performance (e.g., tensile strength, flexibility limits, torque values, flow rates).
International Standards: e.g., ISO 10993 for biocompatibility (Cytotoxicity, Hemolysis, Chemical Characterization).
Test Protocols: Internally developed experimental procedures to evaluate specific performance characteristics.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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October 01, 2021

Cardiovascular Systems Inc. Kim Wallner Senior Regulatory Affairs Specialist 1225 Old Highway 8 NW Saint Paul, Minnesota 55112

Re: K152694

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

Dear Kim Wallner:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 21, 2015. Specifically, FDA is updating this SE Letter because of a typo in the 510(k) Summary header, as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, gregory.oconnell@fda.hhs.gov.

Sincerely,

For

Sara M. Digitally signed by
Sara M. Royce -S
Date: 2021.10.01
Royce -S 13:43:30 -04'00'
11

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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

October 21, 2015

Cardiovascular Systems, Inc. Ms. Kim Wallner Senior Regulatory Affairs Specialist 1225 Old Highway 8 NW Saint Paul, MN 55112

Re: K152694

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: September 18, 2015 Received: September 21, 2015

Dear Ms. Wallner:

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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Kenneth J. Cavanaugh -S

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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Indications for Use

510(k) Number (if known) K152694

Device Name

Diamondback 360 Peripheral Orbital Atherectomy Sytstem

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Company Name:	Cardiovascular Systems, Inc.1225 Old Highway 8 NWSaint Paul, MN 55112
Contact:	Kim Wallner
Phone:	(651) 202-4917
Fax:	(651) 305-7734
Summary Date:	September 18, 2015
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
Primary Predicate Device:
	510(k) Number:Manufacturer:Trade Name:	K110389Cardiovascular Systems, Inc.Stealth 360® Orbital PAD System
Reference Devices:
	510(k) Numbers:Manufacturer:Trade Name:	K122987, K131092, K151260Cardiovascular Systems, Inc.Stealth 360® Orbital PAD System
	510(k) Number:Manufacturer:Trade Name:	K150732, K151260Cardiovascular Systems, Inc.Diamondback 360® Peripheral OrbitalAtherectomy System

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Description of Device

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)

Description of Change

The 1.50 Solid Peripheral Orbital Atherectomy Device was modified to reduce the diameter of the shaft (drive shaft, drive shaft tip bushing, and saline sheath) including modification of the crown for compatibility with the smaller diameter drive shaft. In addition, the saline sheath material and design for the 1.50 Solid, 2.00 Solid, 1.50 Classic and 2.00 Classic OAD configurations were changed and an updated glue plug component was added to accomodate the new saline sheath design.

Intended Use

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 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

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Orbital PAD System in 510(k) K110389, K122987, and K131092 and for Diamondback 360 Peripheral OAS in 510(k) K150732.

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 ●
Temperature Testing ●
Tensile Testing ●
Flexibility Testing
Delivered Torque Testing ●
Orbit Testing
Guide Wire Brake Testing
Saline Flow Testing
o Track Testing
Packaging/Simulated Distribution Testing
o Biocompatibility
- Cytotoxicity per ISO 10993-5 o
- ASTM Hemolysis per ISO 10993-4 O
- Chemical Characterization per ISO 10993-18 O

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.

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.

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).