(29 days)
Not Found
No
The summary describes a mechanical atherectomy system and its components, with no mention of AI or ML technology in its operation or function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are "indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries" and "indicated as a therapy in patients with occluded hemodialysis grafts."
No
Explanation: The device is described as an atherectomy system used for therapy (removing stenotic material) in patients, which is a treatment rather than a diagnostic function.
No
The device description clearly outlines multiple hardware components including an atherectomy guide wire, Orbital Atherectomy Device (OAD), Saline Infusion Pump, and Atherectomy Lubricant. The performance studies also focus on bench testing of physical properties of the guide wire.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a therapeutic procedure to remove stenotic material from peripheral arteries and A-V grafts. This is a direct intervention on the patient's body.
- Device Description: The description details a mechanical system (atherectomy) that physically removes material from blood vessels. This is a surgical/interventional device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and therapeutic.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
MCW
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 sanding 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 guide wire was modified to update the distal spring tip, coil material, and core wire diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries and A-V graft (shunt) stenosis, artificial arteriovenous dialysis fistulae (AV shunt), hemodialysis grafts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ViperWire Advance Flex Tip Guide Wire was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device: Corrosion Testing, Life Testing, Tensile Strength, Tip Flexibility, Trackability, Orbit Testing, Torque Transfer, Combined Load Testing, Packaging/Simulated Distribution Testing, Biocompatibility (Cytotoxicity per ISO 10993-5, Systemic Toxicity per ISO 10993-11, Sensitization per ISO 10993-10, Irritation per ISO 10993-10, Pyrogenicity per ISO 10993-11, Hemocompatibility per ISO 10993-4).
All test results demonstrate that the materials chosen, the manufacturing processes, and the design utilized for the ViperWire Advance Flex Tip Guide Wire met the established specifications necessary for consistent performance during its intended use. The ViperWire Advance Flex Tip Guide Wire 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 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 or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110389, K122987, K131092, K133399, K150732
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of 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
June 10,2015
Cardiovascular Systems, Inc. c/o Ms. Kim Wallner Senior Regulatory Affairs Specialist 1228 Old Highway 8 NW Saint Paul, MN 55112
Re: K151260
Trade/Device Name: Stealth 360 Orbital PAD System and 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: May 11, 2015 Received: May 12, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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
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.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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
2
Indications for Use
510(k) Number (if known) K151260
Device Name
Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy 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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section. 6 510(k) Summary
| Company Name: | Cardiovascular Systems, Inc.
1225 Old Highway 8 NW
Saint Paul, MN 55112 | | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--|
| Contact: | Kim Wallner | | |
| Phone: | (651) 202-4917 | | |
| Fax: | (651) 305-7734 | | |
| Summary Date: | May 11, 2015 | | |
| Trade Name: | ViperWire Advance Flex Tip Peripheral Guide Wire
(OAS component that is part of the: Stealth 360 Orbital PAD System
and Diamondback 360 Peripheral Orbital Atherectomy System) | | |
| Product Code: | MCW—Catheter, Peripheral, Atherectomy | | |
| Classification Regulation: | 21 CFR 870.4875—Intraluminal Artery Stripper | | |
| Classification: | II | | |
| Predicate Devices: | | | |
| | 510(k) Numbers: | K110389, K122987, K131092 | |
| | Manufacturer: | Cardiovascular Systems, Inc. | |
| | Trade Name: | Stealth 360 Orbital PAD System | |
| | 510(k) Number: | K133399, K150732 | |
| | Manufacturer: | Cardiovascular Systems, Inc. | |
| | Trade Name: | Diamondback 360 Peripheral Orbital Atherectomy
System | |
4
6.1 Description of Device
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 sanding 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).
6.2 Description of Change
The guide wire was modified to update the distal spring tip, coil material, and core wire diameter.
6.3 Intended Use
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.
6.4 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 Flex Tip Guide Wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper
5
positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft.
This is the same technology that was cleared to market for use in the peripheral arteries for Stealth 360 Orbital PAD in 510(k) K110389, K122987, K131092 and for Diamondback 360 Peripheral OAS per K133399 and K150732.
6.5 Performance Data
The ViperWire Advance Flex Tip Guide Wire was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.
- Corrosion Testing ●
- Life Testing
- Tensile Strength
- Tip Flexibility ●
- Trackability ●
- Orbit Testing ●
- . Torque Transfer
- Combined Load Testing ●
- . Packaging/Simulated Distribution Testing
- Biocompatibility .
- o Cytotoxicity per ISO 10993-5
- Systemic Toxicity per ISO 10993-11 O
- Sensitization per ISO 10993-10 O
- Irritation per ISO 10993-10 o
- Pyrogenicity per ISO 10993-11 о
- Hemocompatibility per ISO 10993-4 o
All test results demonstrate that the materials chosen, the manufacturing processes, and the design utilized for the ViperWire Advance Flex Tip Guide Wire met the established specifications necessary for consistent performance during its intended use.
Conclusion 6.6
The ViperWire Advance Flex Tip Guide Wire 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 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 or better than the predicate device.