(61 days)
No
The summary describes a mechanical atherectomy system and its components, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for use as "therapy in patients with occlusive atherosclerotic disease" and provides a "method of removing stenotic material" from peripheral arteries and A-V grafts, which directly addresses a medical condition.
No
The provided text describes the device as an atherectomy system intended for therapy (removing stenotic material) in patients, which is a treatment function, not a diagnostic one.
No
The device description clearly lists multiple hardware components including an atherectomy guide wire, Orbital Atherectomy Device (OAD), Saline Infusion Pump, and Atherectomy Lubricant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Stealth 360® Orbital PAD System and the Diamondback 360® Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems. Their intended use is to remove stenotic material from peripheral arteries and artificial arteriovenous dialysis fistulae/hemodialysis grafts within the body. This is an interventional procedure performed directly on the patient's anatomy.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any specimens taken from the body.
Therefore, the device falls under the category of an interventional medical device used for treatment within the body, not an in vitro diagnostic device used for analyzing specimens outside the body.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries, 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 FlexTip Guide Wire was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.
- 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
- 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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).
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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);
1
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 NW
Saint 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 Orbital
Atherectomy System and Stealth 360® PAD System) | | |
| Product Code:
Classification Regulation:
Stripper Classification:
Primary Predicate: | MCW—Catheter, Peripheral, Atherectomy
21 CFR 870.4875—Intraluminal Artery
II | | |
| | 510(k) Number:
Manufacturer:
Trade Name: | K151260
Cardiovascular Systems, Inc.
Stealth 360® PAD System and Diamondback
360® Peripheral Orbital Atherectomy System | |
Additional Reference Predicate:
| 510(k) Number: | K170792 |
|---|---|
| Manufacturer: | Cardiovascular Systems, Inc. |
| Trade Name: | Diamondback 360® Peripheral Orbital |
| Atherectomy System |
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 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
4
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
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.
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.
5
- 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
- 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.