The Stealth 360® Orbital PAD System and the Diamondback 360® Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems 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 atherectomy guide wire is a component that is part of the Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy System. The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System (OAS) are 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 and the Diamondback 360 use an eccentrically rotating 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. In addition to the atherectomy guide wire, the Stealth 360® Orbital PAD System and the Diamondback 360® Peripheral Orbital Atherectomy System consists of the following components: Orbital Atherectomy Device (OAD), Saline Infusion Pump, and Atherectomy Lubricant (e.g., ViperSlide). The ViperWire Advance FlexTip Guide Wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. These extended length guide wires use the same technology as the previously cleared Stealth 360® Orbital PAD.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "ViperWire Advance Flex Tip Peripheral Guide Wire" and its associated atherectomy systems. The submission seeks to prove substantial equivalence to a predicate device, rather than demonstrate meeting specific acceptance criteria in a clinical study with performance metrics like sensitivity, specificity, etc. This is a common regulatory pathway for devices that are similar to already approved ones.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics like those typically associated with AI/software devices (e.g., sensitivity, specificity, accuracy) is not applicable in the context of this 510(k) submission for a guide wire and atherectomy system.

Instead, the submission focuses on bench testing to demonstrate that the modified device performs similarly to its predicate and meets established engineering specifications for safety and effectiveness.

Here’s a breakdown of the information that is available, reframed to address the spirit of your request where possible, and clearly indicating when information is not present:

Acceptance Criteria and Device Performance (Based on Bench Testing for Substantial Equivalence)

The "acceptance criteria" for this device are its ability to meet established specifications through a series of bench tests, confirming its safety and performance is comparable to the predicate device. The "reported device performance" is that it met these criteria. Specific quantitative performance metrics (e.g., specific failure loads, deviation tolerances) are not provided in this summary but would have been part of the detailed 510(k) submission.

Acceptance Criterion Category	Reported Device Performance
Mechanical Performance	- Manual Track Testing: Met established specifications. - Torque Transfer Testing: Met established specifications. - Torque Strength Testing: Met established specifications. - Life Testing: Met established specifications. - Orbit Testing: Met established specifications. - Tensile Testing (ISO 11070): Met established specifications. - Tip Flexibility Testing: Met established specifications. - Transfer Force Test: Met established specifications.
Material & Durability	- ISO Corrosion, Flex, and Fracture Test (ISO 11070): Met established specifications. - Particulate (USP <788>): Met established specifications.
Biocompatibility	- Biocompatibility (ISO 10993): Met established specifications.
System Functionality	- OAS Flow Tests: Met established specifications. - OAS Pump Functional Tests: Met established specifications.
Electrical Safety	- IEC 60601-1-2:2014 (4th edition) Compliance: Met established specifications (for the OAS pump updates).
Overall Conclusion	All test results demonstrate that the materials chosen, the manufacturing processes, and the design utilized for the ViperWire Advance FlexTip Guide Wire and OAS pump met the established specifications necessary for consistent performance during its intended use. The device met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs. Performance is substantially equivalent to the predicate.

Additional Requested Information:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable for a clinical study with human data in this 510(k) summary. The testing described is bench testing of physical devices. The "sample size" would refer to the number of individual guide wires or pump units tested according to engineering protocols. This specific number is not disclosed in the summary, but it would have been defined in the test protocols.
- Data Provenance: Not specified, but generally, bench testing data for FDA submissions is generated within the manufacturing and testing facilities of the submitting company or certified contract labs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. This submission is not based on expert-adjudicated ground truth from clinical data. Performance is assessed through engineering tests against predefined specifications.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. See point 2.
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 hardware medical device (guide wire and atherectomy system), not an AI/software device that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering specifications and standards: The "ground truth" for this type of submission is the predefined engineering specifications derived from relevant industry standards (e.g., ISO 11070, ISO 10993, IEC 60601-1-2), internal design requirements, and performance data from the legally marketed predicate device.
The sample size for the training set
- Not applicable. This is a hardware device; there is no "training set" in the context of machine learning. The design and manufacturing processes are validated through the described bench testing.
How the ground truth for the training set was established
- Not applicable. See point 7.

Summary

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April 17, 2018

Cardiovascular Systems, Inc. Ms. Susan Wolf Regulatory Affairs Manager 1225 Old Highway 8 NW Saint Paul, Minnesota 55112

Re: K180416

Trade/Device Name: ViperWire Advance Flex Tip Peripheral Guide Wire (OAS component of: Diamondback 360 Peripheral Orbital Atherectomy System and Stealth 360 PAD System) Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: February 14, 2018 Received: February 15, 2018

Dear Ms. Wolf:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Hillemann

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) K180416

Device Name

ViperWire Advance Flex Tip Peripheral Guide Wire

(OAS component of: Diamondback 360 Peripheral Orbital Atherectomy System and Stealth 360 PAD System)

Indications for Use (Describe)

The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems 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.

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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Image /page/3/Picture/1 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a bold, sans-serif font, with a green arc underneath. To the right of the letters is a vertical line, followed by the words "CARDIOVASCULAR SYSTEMS, INC." in a smaller, sans-serif font. The overall design is clean and modern.

510(K) SUMMARY

Company Name:	Cardiovascular Systems, Inc.1225 Old Highway 8 NWSaint Paul, MN 55112
Contact:	Susan Wolf, RAC
Phone:	(651) 202-4149
Fax:	(612) 259-2094
Summary Date:	April 16, 2018
Trade Name:	ViperWire Advance Flex Tip Peripheral Guide Wire(OAS component of: Diamondback 360® Peripheral OrbitalAtherectomy System and Stealth 360® PAD System)
Product Code:Classification Regulation:Stripper Classification:Primary Predicate:	MCW—Catheter, Peripheral, Atherectomy21 CFR 870.4875—Intraluminal ArteryII
	510(k) Number:Manufacturer:Trade Name:	K151260Cardiovascular Systems, Inc.Stealth 360® PAD System and Diamondback360® Peripheral Orbital Atherectomy System

Additional Reference Predicate:

510(k) Number:	K170792
Manufacturer:	Cardiovascular Systems, Inc.
Trade Name:	Diamondback 360® Peripheral OrbitalAtherectomy System

Description of Device

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360 and the Diamondback 360 use an eccentrically rotating 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. In addition to the atherectomy guide wire, the

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Stealth 360® Orbital PAD System and the Diamondback 360® Peripheral Orbital Atherectomy System consists of the following components: Orbital Atherectomy Device (OAD), Saline Infusion Pump, and Atherectomy Lubricant (e.g., ViperSlide).

Description of Change

Guide wire component modification and additional guidewire lengths and updates to the OAS pump to comply with IEC 60601-1-2:2014 (4th edition).

Indications For Use

Technology

The Stealth 360® Orbital PAD System and the Diamondback 360® Peripheral Orbital Atherectomy System provide 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. The ViperWire Advance FlexTip Guide Wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. These extended length guide wires use the same technology as the previously cleared Stealth 360® Orbital PAD.

Specifications
			VPR-GW-ELFT14	VPR-GW-ELFT18
VIPERWIRE ADVANCE Guide Wire Specifications
Guidewire Length	335 cm	335 cm	475 cm	475 cm
Guidewire Coating	Silicone	Silicone	Silicone	Silicone
Core wire diameter	.014"	.014"	.014"	.014"
Core wire material	Stainless Steel	Stainless Steel	Stainless Steel	Stainless Steel
Spring Tip Length	3 cm	3 cm	3 cm	3 cm
Spring Tip	.014"	.018"	.014"	.018"
Diameter
Spring Tip Material	Platinum/Tungsten	Platinum/Tungsten	Platinum/Tungsten	Platinum/Tungsten
Spring Tip Shape	Straight	Straight	Straight	Straight

Snecifications

Performance Data

The ViperWire Advance FlexTip Guide Wire was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.

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Manual Track Testing ●
Torque Transfer Testing
Torque Strength Testing ●
Life Testing
Orbit Testing
Tensile Testing ISO 11070
Tip Flexibility Testing
Transfer Force Test ●
ISO Corrosion, Flex, and Fracture Test ISO 11070
Particulate USP <788>
Biocompatibility ISO 10993
. OAS Flow Tests
OAS Pump Functional Tests
IEC 60601-1-2:2014 (4th edition) ●

All test results demonstrate that the materials chosen, the manufacturing processes, and the design utilized for the ViperWire Advance FlexTip Guide Wire and OAS pump met the established specifications necessary for consistent performance during its intended use.

Conclusion

The ViperWire Advance Flex Tip Guide Wire and OAS pump 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 ViperWire AdvanceFlex Tip Guide Wire and OAS pump used with the Stealth 360® Orbital PAD System and Diamondback 360® Peripheral Orbital Atherectomy System is substantially equivalent to the legally marketed predicate device, does not raise any new safety or effectiveness questions, and performs as well as the predicate device.

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).