The Stealth 360° Orbital PAD 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 Stealth 360™ Orbital PAD System 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 Stealth 360° uses an electrically driven shaft to apply 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 Stealth 360° Orbital PAD System consists of the following components:

1. Orbital atherectomy device
1. Atherectomy guide wire
1. Externally operated saline pump
1. Atherectomy Lubricant (e.g. ViperSlide)

AI/ML Overview

The provided document describes the Stealth 360™ Orbital PAD System, a peripheral atherectomy device. This 510(k) summary focuses on validating the device's substantial equivalence to previously cleared predicate devices through extensive bench testing and biocompatibility studies, rather than clinical performance studies involving human subjects or AI algorithms. As such, many of the requested criteria, such as MRMC comparative effectiveness studies, ground truth establishment for training sets, or expert adjudication, are not applicable to the information provided.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Biocompatibility	ISO MEM Elution Assay	Met established specifications; non-toxic and non-sensitizing.
	ASTM Hemolysis Assay	Met established specifications; non-toxic and non-sensitizing.
	Material Mediated Rabbit Pyrogenicity	Met established specifications; non-toxic and non-sensitizing.
	ISO Guinea Pig Maximization Sensitization	Met established specifications; non-toxic and non-sensitizing.
	ISO Acute Systemic Injection Test	Met established specifications; non-toxic and non-sensitizing.
	ISO Intracutaneous Reactivity Test	Met established specifications; non-toxic and non-sensitizing.
	Complement Activation C3a and SC5b-9 Assay	Met established specifications; non-toxic and non-sensitizing.
	Partial Thromboplastin Time	Met established specifications; non-toxic and non-sensitizing.
Performance Bench Testing	System Life Testing	Met established specifications for consistent performance.
	Stall Testing	Met established specifications for consistent performance.
	Introducer Compatibility Testing	Met established specifications for consistent performance.
	Temperature Testing	Met established specifications for consistent performance.
	Tensile Testing	Met established specifications for consistent performance.
	Flexibility Testing	Met established specifications for consistent performance.
	Delivered Torque Testing	Met established specifications for consistent performance.
	Orbit Testing	Met established specifications for consistent performance.
	Device User Interface Controls Testing	Met established specifications for consistent performance.
	Switch Logic Testing	Met established specifications for consistent performance.
	Guide Wire Brake Testing	Met established specifications for consistent performance.
	Flow Testing	Met established specifications for consistent performance.
	AV Graft Testing	Met established specifications for consistent performance.
	Motor Control Board Testing	Met established specifications for consistent performance.
	Track Testing	Met established specifications for consistent performance.
	Package Testing (Handle and Pump)	Met established specifications for consistent performance.
	EN 60601-1 Electrical Testing (Handle and Pump)	Met established specifications for consistent performance.
	EN 60601-1-2 EMC Testing (Handle and Pump)	Met established specifications for consistent performance.
	Saline Pump Functional Testing	Met established specifications for consistent performance.
	Saline Pump Physical Testing	Met established specifications for consistent performance.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of biocompatibility assays and comprehensive performance bench tests. The report concludes that "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Stealth 360° Orbital PAD System met the established specifications necessary for consistent performance during its intended use."

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

Sample Size for Test Set: Not specified. The document refers to "bench testing" and "test results" but does not provide precise sample sizes for each specific test.
Data Provenance: The data provenance is from laboratory and bench testing performed by the manufacturer, Cardiovascular Systems, Inc. This is not derived from human patient data, therefore, it cannot be classified as retrospective or prospective in that context, nor does it have a country of origin in terms of patient data.

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

Not Applicable. This device submission relies on engineering specifications, material science, and safety standards rather than clinical expert consensus for establishing ground truth. The "ground truth" here is adherence to these predefined technical and safety standards.

4. Adjudication Method for the Test Set

Not Applicable. As the evaluation is based on objective measurements against engineering and safety specifications, an adjudication method for a test set (as typically seen in clinical studies with human interpretative components) is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with vs. without AI Assistance

No. This type of study is not relevant to the clearance of this mechanical atherectomy device, which does not involve AI or human interpretation of medical images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a mechanical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to pre-defined engineering specifications, international and national biocompatibility standards (e.g., ISO, ASTM, EN 60601), and the performance characteristics of the predicate devices. The device's performance was compared against these established technical criteria to demonstrate safety and effectiveness.

8. The Sample Size for the Training Set

Not Applicable. This is a mechanical device, not an AI model requiring a training set.

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

Not Applicable. This is a mechanical device, not an AI model, so there is no training set or associated ground truth establishment process in that context.

Summary

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1110389

MAR 1 1 2011

Section. 6 510(k) Summary

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:	February 9, 2011
Trade Name:	Stealth 360™ Orbital PAD System
Common Name:	Peripheral Atherectomy Device
Classification Name:	Peripheral Atherectomy Catheter (21 CFR 870.4875; Product Code:MCW)
Predicate Devices:	510(k) Number:Manufacture:Trade Name:510(k) Number:Manufacture:Trade Name:	K071350Cardiovascular Systems, Inc.Diamondback 360® Orbital Atherectomy SystemK090521Cardiovascular Systems, Inc.Diamondback Predator 360® Orbital AtherectomySystem

6.1 Description of Device

The Stealth 360™ Orbital PAD System is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The Stealth 360° Orbital PAD System consists of the following components:

1. Orbital atherectomy device
1. Atherectomy guide wire
1. Externally operated saline pump
1. Atherectomy Lubricant (e.g. ViperSlide)

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6.2 Intended Use

6.3 Technology

The Stealth 360° Orbital PAD System provides a method of removing occlusive atherosclerotic or stenotic material. The OAS applies a diamond coated, eccentrically rotating sanding surface to ablate stenotic tissue. The stenotic particles that are removed are small enough to be absorbed by the body. This same technology was cleared to market for use in peripheral arteries in 510(k) K071350 and Predator 360° (originally cleared as 3X) per K090521. The primary difference is that the drive shaft containing the sanding crown is driven by a brushless electric motor rather than an air turbine (energy type). The Stealth 360° is available in both Predator Solid crown and Diamondback Classic crown models.

6.4 Performance Data

Biocompatibility testing on the proposed Stealth 360° Orbital PAD 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 nonsensitizing to biological tissue consistent with its intended use. The following biocompatibility tests were completed.

ISO MEM Elution Assay .
. ASTM Hemolysis Assay
. Material Mediated Rabbit Pyrogenicity
. ISO Guinea Pig Maximization Sensitization
. ISO Acute Systemic Injection Test
ISO Intracutaneous . Reactivity Test
. Complement Activation C3a and SC5b-9 Assay
. Partial Thromboplastin Time

The proposed Stealth 360° Orbital PAD 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
Temperature Testing .
Tensile Testing ●
Flexibility Testing .
Delivered Torque Testing .
Orbit Testing ●

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. Device User Interface Controls Testing
Switch Logic Testing .
. Guide Wire Brake Testing
Flow Testing ◆
. AV Graft Testing
. Motor Control Board Testing
. Track Testing
Package Testing (Handle and . Pump)
EN 60601-1 Electrical . Testing (Handle and Pump)
EN 60601-1-2 EMC Testing . (Handle and Pump)
Saline Pump Functional . Testing
Saline Pump Physical Testing .

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

6.5 Conclusions

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

Cardiovascular Systems, Inc. c/o Ms. Megan Brandt Regulatory Affairs Manager 651 Campus Drive St. Paul, MN 55112

MAR 1 1 2011

Re: K110389

Trade/Device Name: Stealth 360 Orbital PAD System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: February 9, 2011 Received: February 10, 2011

Dear Ms. Brandt:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premained is substantially equivalent (for the indications
referenced above and have determined the device is substant in interstate referenced above and have determined the device is succes marketed in interstate for use stated in the enclosure) to regally manced production Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drue, commerce prior to May 28, 1970, the enactinent and or or visions of the Federal Food, Drug, devices that have been reclassified in accordance with approval application (PMA).
and Cosmetic Act (Act) that do not require approval as provisions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject to the gointer seamual registration, listing of
general controls provisions of the Act include requirements for annual registra general controls provisions of the Act meration squinst misbranding and devices, good manufacturing practice, nabeling, and promotion related to contract liability.
adulteration. Please note: CDRH does not evaluation related to contract liability adulteration. Please note: CDKH Gocs not evaluations and misleading.
warranties. However, we remind you 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
If your device is classified (See above) into entiler elass II (Spockate - Canada Control our device can be

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Page 2 - Ms. Megan Brandt

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 (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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Dma R. Vahner

Bram 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 Statement Section. 5

510(k) Number: K10389

Device Name: Stealth 360TM Orbital PAD 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)

Duna D. Vc. Lunes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K110389

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).