The Diamondback 360° 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° Orbital Atherectomy System with ViperSlide is an orbital atherectomy system (OAS) that 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 OAS applies a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.

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

1. Orbital atherectomy device (OAD, air or electric powered)
1. Atherectomy guide wire
1. Atherectomy saline pump or controller
1. Atherectomy lubricant

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Diamondback 360® Orbital Atherectomy System with ViperSlide® Lubricant", focusing on the addition of an alternate ViperSlide lubricant formulation. The study conducted to prove the device meets acceptance criteria is a performance bench testing and biocompatibility testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Performance Bench Testing	Established specifications	All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Diamondback 360° Orbital Atherectomy System with ViperSlide met the established specifications necessary for consistent performance during its intended use.
- System Life Testing	Established specifications	Met established specifications for consistent performance during its intended use.
- Emulsion Admixture Stability	Established specifications	Met established specifications for consistent performance during its intended use.
Biocompatibility Testing	Biocompatible with biological tissue consistent with intended use	The biocompatibility test results show that the materials used in the design and manufacture of ViperSlide are biocompatible with the biological tissue consistent with its intended use.
- ISO MEM Elution Assay	Biocompatible	Biocompatible
- Hemolysis – Direct Contact Method	Biocompatible	Biocompatible
- In-vitro Hemocompatibility Assay	Biocompatible	Biocompatible
- ISO Acute Systemic Injection Test	Biocompatible	Biocompatible

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

The document does not specify a sample size for the test set used in the performance bench testing or biocompatibility testing. These appear to be laboratory-based tests rather than human clinical trials. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of patient data, as no patient data is mentioned in relation to these tests.

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

This information is not provided in the document. The ground truth for bench testing and biocompatibility is typically based on predefined engineering specifications, material standards (like ISO for biocompatibility), and established scientific methods, rather than expert consensus on patient cases.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable for the type of bench and biocompatibility testing described. Adjudication methods are typically used in clinical studies involving multiple readers or assessors of subjective outcomes.

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

There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study and no discussion of AI or human reader improvement. The submission pertains to a medical device (orbital atherectomy system and lubricant), not an AI diagnostic tool.

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

There is no mention of a standalone algorithm performance study. The device is a physical medical device, not a software algorithm.

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

The ground truth for the performance bench testing appears to be based on established engineering specifications, material properties, and functionality requirements. For biocompatibility, the ground truth is established by international standards (e.g., ISO) for material biocompatibility.

8. The Sample Size for the Training Set

There is no mention of a training set sample size. This document describes testing for a physical medical device, not a machine learning or AI model that typically involves training sets.

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

As there is no mention of a training set, this information is not applicable.

Summary

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Section. 6 510(k) Summary

JUL 2 6 2011

Company Name:	Cardiovascular Systems, Inc.651 Campus DriveSaint Paul, MN 55112
Contact:	Megan M. Brandt
Phone:	(651) 259-2805
Fax:	(651) 305-7734
Summary Date:	May 16, 2011
Trade Name:	Diamondback 360® Orbital Atherectomy System with ViperSlide®Lubricant
Common Name:	Peripheral Atherectomy Device
Classification Name:	Peripheral Atherectomy Catheter (21 CFR 870.4875; Product Code:MCW)
Predicate Devices:	510(k) Number:	K071350
	Manufacture:	Cardiovascular Systems, Inc.
	Trade Name:	Diamondback 360® Orbital Atherectomy System
	510(k) Number:	K071427
	Manufacture:	Cardiovascular Systems, Inc.
	Trade Name:	Diamondback 360® Orbital Atherectomy System
	510(k) Number:	K082981
	Manufacture:	Cardiovascular Systems, Inc.
	Trade Name:	Diamondback 360® Orbital Atherectomy Systemwith ViperSlide Lubricant
	510(k) Number:	K090521
	Manufacture:	Cardiovascular Systems, Inc.
	Trade Name:	Diamondback Predator 360® Orbital AtherectomySystem
	510(k) Number:	K110389
	Manufacture:	Cardiovascular Systems, Inc.
	Trade Name:	Stealth 360® Orbital PAD System

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K111388
P. 2 of 3

6.1 Description of Device

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

1. Orbital atherectomy device (OAD, air or electric powered)
1. Atherectomy guide wire
1. Atherectomy saline pump or controller
1. Atherectomy lubricant

6.2 Intended Use

6.3 Technology

The Diamondback 360° Orbital Atherectorny System with ViperSlide provides a method of removing occlusive atherosclerotic or stenotic material. The OAS applies a diamond coated, eccentrically rotating surface to ablate stenotic tissue. The ViperSlide lubricant is a lipid emulsion with soybean oil, egg phospholipid, and glycerin prepared with water for injection. ViperSlide is mixed with saline prior to treatment and acts as a lubricant to cool the OAD during use.

This 510(k) specifically addresses the addition of an alternate ViperSlide lubricant formulation for use with the Diamondback 360° Orbital Atherectomy System. The OAS technologies described in the previous submissions remain unchanged since the lubricants are interchangeable. The alternate ViperSlide formulation design and components are substantially equivalent to the predicate devices. The use of lubricant with the Diamondback 360° OAS was cleared to market for use in peripheral arteries in 510(k) K071350 and K082981, Predator 360° (originally cleared as 3X) per K090521, Stealth 360° per K110389, and for use in A-V grafts in 510(k) K071427.

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6.4 Performance Data

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

System Life Testing .
. Emulsion Admixture Stability

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

Biocompatibility testing on the proposed Diamondback 360° Orbital Atherectomy System with ViperSlide has been completed. The biocompatibility test results show that the materials used in the design and manufacture of ViperSlide are biocompatible with the biological tissue consistent with its intended use. The following biocompatibility tests were completed.

ISO MEM Elution Assay .
. Hemolysis – Direct Contact Method
In-vitro Hemocompatibility Assay .
ISO Acute Systemic Injection Test .

6.5 Conclusions

The Diamondback 360° Orbital Atherectomy System with ViperSlide 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° Orbital Atherectomy System with ViperSlide is substantially equivalent to the legally marketed predicate device and does not raise any new safety or effectiveness questions.

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

Cardiovascular Systems, Inc. c/o Megan M. Brandt 651 Campus Dr. St. Paul, MN 55112

JUL 2 6 2011

Re: K111388

Trade/Device Name: Diamondback 360 Orbital Atherectomy System (OAS) with ViperSlide Regulation Number: 21 CFR 870.4875 Regulation Name: Peripheral Atherectomy Catheters Regulatory Class: Class II Product Code: MCW Dated: May 16, 2011 Received: May 17, 2011

Dear Ms. Brandt:

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 coneerning 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 - Ms. Megan M. Brandt

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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, 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): K111388

Device Name: Diamondback 360® Orbital Atherectomy System with ViperSlide® Lubricant

Indications For Use:

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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1 .

vision of Cardiovascular Devices

510(k) Number K111388

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).