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 (OAD)
1. Atherectomy Guide Wire
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 supporting study for the Stealth 360° Orbital PAD System:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (as per 510(k) Summary)
Mechanical/Physical Performance	"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." Specific tests include: - Life/Stall Testing - Orbit Testing - Switch Logic/End of Life Testing - Distribution Testing - Shelf Life Testing
Biocompatibility	"ISO MEM Elution Assay" "ISO Intracutaneous Reactivity Test"
Electrical Safety	"Electrical Safety Testing"
Electromagnetic Compatibility (EMC)	"Electromagnetic Compatibility (EMC) Testing"
Software/Firmware Performance	"Firmware testing: Modular, Integration, Functional"
Overall Equivalence	"The Stealth 360° Orbital PAD System with the CSI developed PCBA 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 with the CSI developed PCBA is substantially equivalent to the legally marketed predicate device and does not raise any new safety or effectiveness questions."

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

The provided 510(k) summary focuses on performance bench testing rather than clinical study data involving human subjects or extensive retrospective/prospective data. Therefore, the concept of "test set sample size" in the context of patients/data provenance as typically understood for AI/diagnostic devices is not directly applicable here.

Sample Size: Not explicitly stated in terms of individual devices tested for each bench test, but implied to be sufficient for each specific test mentioned (e.g., "Life/Stall Testing," "Orbit Testing"). These would likely involve a statistically relevant number of devices or components to demonstrate reliability and performance metrics, but the exact number isn't quantified in the summary.
Data Provenance: This relates to bench testing performed by the manufacturer, Cardiovascular Systems, Inc. The data is thus internal, from a controlled environment, rather than clinical patient data from specific countries. It is prospective in the sense that the tests were designed and executed to verify the modified device's performance against pre-defined criteria.

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

Not applicable. This device is a mechanical atherectomy system, and the "testing" described is bench testing of physical, electrical, and firmware components, along with biocompatibility tests. The "ground truth" for these tests is established by engineering specifications, international standards (e.g., ISO), and functional requirements, not by expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. As the testing involves objective, quantifiable bench tests (e.g., electrical measurements, mechanical endurance, orbital rotation, elution assays), there is no need for expert adjudication in the way it would be applied to subjective clinical evaluations or image interpretations. Test results are compared directly against pre-defined acceptance limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for diagnostic devices, particularly those involving human readers interpreting outputs (e.g., radiologists reading images with or without AI assistance). This 510(k) is for a mechanical surgical device and its modification. Clinical effectiveness is typically established via larger clinical trials, not solely MRMC studies, although this 510(k) relies on substantial equivalence primarily through bench testing. The summary does not provide any information about human readers or their improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

Not applicable. This device is a mechanical and electrical system, not an AI algorithm. Its performance is inherent to its design and manufacturing, and while it has "firmware," it doesn't function as a standalone diagnostic algorithm in the way this question implies for AI or software as a medical device. Its operation is always "human-in-the-loop" as it's a surgical tool operated by a physician.

7. The Type of Ground Truth Used

For the bench tests: Engineering specifications, design requirements, and compliance with recognized industry standards (e.g., ISO for biocompatibility, electrical safety standards) serve as the "ground truth." For example, a "Life/Stall Test" would have an established number of cycles or operating hours the device must withstand before failure, and passing this threshold is the "ground truth."

8. The Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of machine learning. The design and validation are based on traditional engineering principles, physical testing, and prior knowledge of the predicate device.

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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K131092

2013

Section. 5	510(k) Summary
Company Name:	Cardiovascular Systems, Inc.651 Campus DriveSaint Paul, MN 55112
Contact:	Maureen McDonnell
Phone:	(651) 259-1644
Fax:	(651) 305-7734
Summary Date:	April 17, 2013
Trade Name:	Stealth 360°® Orbital PAD System
Product Code:	MCW—Catheter, Peripheral, Atherectomy
Classification:	21 CFR 870.4875—Intraluminal Artery Stripper
Predicate Device:	510(k) Number:Manufacturer:Trade Name:	K110389 & K122987Cardiovascular Systems, Inc.Stealth 360°® Orbital PAD System

5.1 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 (OAD)
1. Atherectomy Guide Wire
1. Saline Infusion Pump (SIP)
1. Atherectomy Lubricant (e.g. ViperSlide)

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5.2 Intended Use

5.3 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 510(k) K122987, K110389, K071350, and Predator 3600 (originally cleared as 3X) per K090521.

The current printed circuit board assembly (PCBA) used in the OAD is developed and purchased externally. A CSI developed board was created that will allow for additional Input/Output (I/O) points to enable future expandability options. The modified device will use one of the additional I/O points to add a saline prime button to the device handle that functions in the same way as the existing prime button on the saline infusion pump. The instructions for use were updated to include information about use of the prime button on the OAD.

5.4 Performance Data

The modified Stealth 360° Orbital PAD System was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.

Life/Stall Testint ●
Orbit Testing .
Switch Logic/End of Life Testing ●
. Distribution Testing
Shelf Life Testing .
ISO MEM Elution Assay
. ISO Intracutaneous Reactivity Test
Electrical Safety Testing .
Electromagnetic Compatibility (EMC) Testing .
0 Firmware testing: Modular, Integration, Functional

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.

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5.5 Conclusions

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

Stealth 360°® Orbital PAD System

5-3

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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

June 24, 2013

Cardiovascular Systems. Inc. c/o Ms. Maureen McDonnell Sr. Regulatory Affairs Specialist 651 Campus Drive St. Paul, MN 55112

Re: K131092

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: June 3, 2013 Received: June 4, 2013

Dear Ms. McDonnell:

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. 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 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

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Page 2 - Ms. Maureen McDonnell

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/Resourcesfor You/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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Section. 4 Indications for Use Statement

510(k) Number: K131092

Device Name: Stealth 360°® Orbital PAD System

Indications for Use:

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)

4-1

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).