(85 days)
Not Found
No
The description focuses on the mechanical aspects of the device (eccentrically orbiting sanding surface, drive shaft lengths, guide wires) and performance testing related to these mechanical functions. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as therapy" in patients with specific conditions.
No
The device is described as a "percutaneous orbital atherectomy system indicated for use as therapy" to remove stenotic material, making it a therapeutic device, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including the Orbital Atherectomy Device (OAD), Atherectomy Guide Wire, Saline Pump, and Atherectomy Lubricant. The performance studies also focus on bench testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system. It is used directly within the patient's body to remove stenotic material from peripheral arteries and A-V grafts.
- Mechanism of Action: The device physically removes material from the vessel wall using an orbiting sanding surface. This is a therapeutic intervention performed in vivo, not a diagnostic test performed in vitro on a sample.
The device is a therapeutic medical device used for treating occlusive atherosclerotic disease and stenosis in hemodialysis grafts.
N/A
Intended Use / Indications for Use
The Diamondback 360 Peripheral Orbital Atherectomy 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.
Product codes
MCW
Device Description
The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) 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 Diamondback 360 uses an eccentrically orbiting 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.
The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:
-
- Orbital Atherectomy Device (OAD)
-
- Atherectomy Guide Wire (e.g., ViperWire Advance)
-
- Saline Pump (OAS Pump)
-
- Atherectomy Lubricant (e.g., ViperSlide)
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 Diamondback 360 Peripheral Orbital Atherectomy System was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.
- System Life Testing including guide wire
- Stall Testing
- Introducer Compatibility Testing
- Switch Logic Testing
- Dimensional Analysis
- Tactile Feedback
- Temperature Testing
- Tensile Testing
- Flexibility Testing
- Delivered Torque Testing
- Orbit Testing
- Guide Wire Brake Testing
- Saline Flow Testing
- Track Testing
- Packaging/Simulated Distribution Testing for Guide Wire
- Guide Wire Tip Flexibility
- Guide Wire Trackability
- Guide Wire Torque Transfer
- Guide Wire Torque Strength
- Particulate Inspection
- Effluent Particulate Analysis
All test results demonstrate that the materials, manufacturing process, and design utilized for the Diamondback 360 Peripheral Orbital Atherectomy System met the established specifications necessary for consistent performance during its intended use.
Testing results demonstrate that the Diamondback 360 Peripheral Orbital Atherectomy System is substantially equivalent to the legally marketed predicate devices and does not raise any new safety or effectiveness questions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "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, with flowing lines representing hair or clothing.
June 9, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cardiovascular Systems, Inc. Ms. Kara Cutshall Regulatory Affairs Specialist 1225 Old Highway 8 NW Saint Paul, Minnesota 55112
Re: K170792
Trade/Device Name: Diamondback 360 Peripheral Orbital Atherectomy System Regulation Number: 21 CFR 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: May 10, 2017 Received: May 12, 2017
Dear Ms. Cutshall:
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
1
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 Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
Sincerely,
Fernando
Aguel-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) K170792
Device Name
Diamondback 360 Peripheral Orbital Atherectomy System
Indications for Use (Describe)
The Diamondback 360 Peripheral Orbital Atherectomy 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.
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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3
510(k) Summary
| Company Name: | Cardiovascular Systems, Inc.
1225 Old Highway 8 NW
Saint Paul, MN 55112 | | |
|----------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--|
| Contact: | Kara Cutshall | | |
| Phone: | (651) 202-4886 | | |
| Summary Date: | March 15, 2017 | | |
| Trade Name: | 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) Number:
Manufacturer:
Trade Name: | K152694
Cardiovascular Systems, Inc.
Diamondback 360® Peripheral Orbital
Atherectomy System | |
6.1 Description of Device
The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) 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 Diamondback 360 uses an eccentrically orbiting 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.
4
The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:
-
- Orbital Atherectomy Device (OAD)
-
- Atherectomy Guide Wire (e.g., ViperWire Advance)
-
- Saline Pump (OAS Pump)
-
- Atherectomy Lubricant (e.g., ViperSlide)
6.2 Description of Proposed
Additional 1.25 Solid, 1.50 Solid, and 1.75 Solid Diamondback 360 Peripheral Orbital Atherectomy Devices (OADs) with increased drive shaft lengths of 180 cm and 200 cm are proposed as additional length options to accommodate patient vessel anatomy and physicians preferred access methodology, for example radial access. The proposed OADs are designed to maintain 5Fr compatibility. Additional accessories to accommodate the increased drive shaft lengths were necessitated such as additional saline sheaths with increased lengths and additional lengths of ViperWire Advance Peripheral guide wires to accommodate the working length of the proposed OADs. The proposed 0.014 in core guide wires are 475 cm in length and compatible with the 180 cm and 200 cm length drive shafts. The proposed 0.014 in core guide wires are designed with a 0.014 in or 0.018 in distal spring tip options. The proposed dimensions of the 1.75 Solid crown are configured to accommodate the smaller diameter drive shaft while maintaining 5Fr compatibility. Packaging dimensions were increased in comparison to that of the predicate packaging to accommodate for the increased OAD and guide wire lengths.
6.3 Indications for Use
The Diamondback 360 Peripheral Orbital Atherectomy 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.
The Intended Use has not changed from the predicate/current Diamondback 360 Peripheral Orbital Atherectomy System.
6.4 Technology
The Diamondback 360 Peripheral Orbital Atherectomy System provides a method of removing or reducing occlusive atherosclerotic or stenotic material. The OAS applies a diamond coated, eccentrically rotating sanding surface to reduce or remove stenotic
5
material on the vessel wall. The stenotic particles are small enough to be absorbed by the body. The proposed OADs and guide wires have the same mechanism of operation, materials, chemical composition, and energy source characteristics that were cleared to market for use in the peripheral arteries for Diamondback 360 Peripheral OAS in 510(k) K152694. The proposed OADs and guide wires have increased lengths as options to accommodate patient vessel anatomy and physicians preferred access methodology.
| Characteristic | Predicate
OADs and Guide Wires | Proposed
OADs and Guide Wires | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | OAD | CSI | Same |
| Guide Wires | CSI | Same | |
| Indication for Use | The Diamondback 360
Peripheral Orbital
Atherectomy System is a
percutaneous orbital
atherectomy system
indicated for use as a
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
system is a percutaneous
orbital atherectomy
system indicated as a
therapy in patients with
occluded hemodialysis
grafts who are acceptable
candidates for
percutaneous
transluminal angioplasty. | Same | |
| Characteristic | | Predicate
OADs and Guide Wires | Proposed
OADs and Guide Wires |
| Orbital Atherectomy Device Platform | | Electrically driven, diamond crown, atherectomy catheter | Same |
| Design/Construction | Crown
Assembly | Eccentric crown assembly bonded to a concentric drive shaft | Same |
| | Drive
Mechanism | Brushless DC Electric Motor | Same |
| | Guide Wire | 0.014 in atherectomy guide wire designs compatible with 145 cm drive shaft lengths | 0.014 in atherectomy guide wire designs compatible with 180 cm and 200 cm drive shaft lengths |
| Materials | OAD | Drive Shaft: 304V Stainless Steel Saline Sheath: Nylon body and Pebax distal end | Same |
| | Guide Wire | Core Material: 304V Stainless Steel Support Coil: 304V Stainless Steel | Same |
| Packaging | OAD | 1 unit per package | Same Increase in length of drive shaft dispenser coil to accommodate the 180 cm and 200 cm length drive shafts |
| | Guide Wire | 5 units packaged per shelf carton | Same Increase in the dimensions of the guide wire dispenser coil, guide wire pouch, shelf carton, and shipper box to accommodate the 475 cm guide wires Increase in the density of the shelf carton |
| Characteristic | | Predicate | Proposed |
| | | | OADs and Guide Wires OADs and Guide Wires |
| | Drive Shaft | · Length: 145 cm | Length: 180 cm and |
| | | • OD: 0.029 in; 0.031 in | 200 cm |
| | | ID: 0.0156 in; 0.019
● | OD: 0.029 in |
| | | in | ID: 0.017 in
● |
| Specifications | Saline
Sheath | Introducer Size
● | Introducer Size
● |
| | | Compatibility: 4 Fr; 5 | Compatibility: 5Fr |
| | | Fr; 6 Fr | · Length: 70.92 in; |
| | | Length: 57.26 in;
● | 78.75 in |
| | | 57.35 in | • OD: 0.063 in |
| | | · OD: 0.052 in; | ID: 0.049 in |
| | | 0.063 in | |
| | | ID: 0.041 in; 0.049 in | |
| | Guide Wire | Core: 0.014 in | Core: Same |
| | | Spring Tip: 0.014 in; | Spring Tip: 0.014 in;
● |
| | | 0.017 in | 0.018 in |
| | | Length: 335 cm | Length: 475 cm |
| Sterilization | | Ethylene oxide | Same |
6
7
6.5 Performance Data
The Diamondback 360 Peripheral Orbital Atherectomy System was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.
- System Life Testing including guide wire ●
- . Stall Testing
- Introducer Compatibility Testing .
- . Switch Logic Testing
- Dimensional Analysis .
- Tactile Feedback ●
- Temperature Testing .
- Tensile Testing ●
- Flexibility Testing .
- Delivered Torque Testing .
- Orbit Testing .
- Guide Wire Brake Testing .
- Saline Flow Testing ●
- Track Testing ●
- Packaging/Simulated Distribution Testing for Guide Wire ●
8
- Guide Wire Tip Flexibility
- Guide Wire Trackability
- Guide Wire Torque Transfer
- Guide Wire Torque Strength .
- . Particulate Inspection
- Effluent Particulate Analysis .
All test results demonstrate that the materials, manufacturing process, and design utilized for the Diamondback 360 Peripheral Orbital Atherectomy System met the established specifications necessary for consistent performance during its intended use.
Conclusions 6.6
The Diamondback 360 Peripheral Orbital Atherectomy 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 Diamondback 360 Peripheral Orbital Atherectomy System is substantially equivalent to the legally marketed predicate devices and does not raise any new safety or effectiveness questions.