(24 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML, image processing, or data-driven decision making.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use as therapy" in patients with occlusive atherosclerotic disease and occluded hemodialysis grafts. It also describes the system as providing a "method of removing stenotic material," which constitutes a therapeutic intervention.
No
Explanation: The device is described as a "peripheral orbital atherectomy system" intended for "removing stenotic material" from arteries and grafts, indicating a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components, including an Orbital Atherectomy Device, Guide Wire, Saline Infusion Pump, and Atherectomy Lubricant. The performance studies also focus on hardware-related testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the Diamondback 360 Peripheral Orbital Atherectomy System as a device used within the body (percutaneous) to physically remove stenotic material from peripheral arteries and A-V grafts. It is a therapeutic device, not a diagnostic one.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is mechanical removal of blockages.
Therefore, based on the provided information, the Diamondback 360 Peripheral Orbital Atherectomy System is a therapeutic medical device, not an In Vitro Diagnostic device.
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 (comma separated list FDA assigned to the subject device)
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 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.
The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:
-
- Orbital Atherectomy Device (OAD)
-
- Atherectomy Guide Wire (e.g., ViperWire Advance)
-
- Saline Infusion Pump (SIP)
-
- 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
- Temperature Testing
- Tensile Testing
- Flexibility Testing
- Delivered Torque Testing
- Orbit Testing
- Guide Wire Brake Testing
- Saline Flow Testing
- Track Testing
- Packaging/Simulated Distribution Testing
- Biocompatibility
- Cytotoxicity per ISO 10993-5
- Sensitization per ISO 10993-10
- Irritation per ISO 10993-10
- Acute Systemic Toxicity per ISO 10993-11
- Pyrogenicity per ISO 10993-11
- Hemocompatibility per ISO 10993-4
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Diamondback 360 Peripheral Orbital Atherectomy System met the established specifications necessary for consistent performance during its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K110389, K122987, K131092, K133399
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are connected to form a single, flowing shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2015
Cardiovascular Systems, Inc. c/o Mr. Blair Buth Regulatory Affairs Manager 1225 Old Highway 8 NW Saint Paul, MN 55112
Re: K150732
Trade/Device Name: 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: March 19, 2015 Received: March 20, 2015
Dear Mr. Buth:
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
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/ResourcesforYou/Industry/default.htm.
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) K150732
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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Section. 6 510(k) Summary
| Company Name: | Cardiovascular Systems, Inc.
1225 Old Highway 8
Saint Paul, MN 55112 | | |
|----------------------------|----------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Blair Buth | | |
| Phone: | (651) 259-2032 | | |
| Fax: | (651) 305-7734 | | |
| Summary Date: | March 19, 2015 | | |
| 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) Numbers:
Manufacturer:
Trade Name: | | K110389, K122987, & K131092
Cardiovascular Systems, Inc.
Stealth 360°® Orbital PAD System, Model
PRD-SC30-125 |
| | 510(k) Number:
Manufacturer:
Trade Name: | | K133399
Cardiovascular Systems, Inc.
Diamondback 360® Peripheral Orbital
Atherectomy System, Model DBP-
125MICRO145 |
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 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.
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 Infusion Pump (SIP)
-
- Atherectomy Lubricant (e.g., ViperSlide)
6.2 Description of Change
The 1.25 Solid Peripheral Orbital Atherectomy Device was modified to reduce the diameter of the shaft (drive shaft, drive shaft tip bushing, and saline sheath) including modification of the crown for compatibility with the smaller diameter drive shaft. In addition, the saline sheath material and design for the 1.25 Solid and 1.25 Micro OAD configurations was changed and an updated glue plug component was added to accomadate the new saline sheath design.
6.3 Intended 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.
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 surface to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body. This is the same technology that was cleared to market for use in the peripheral arteries for Stealth 360° in 510(k) K110389. K122987. K131092 and for Diamondback 360° Peripheral per K133399, and K133999.
5
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
- o Introducer Compatibility Testing
- Temperature Testing ●
- Tensile Testing
- o Flexibility Testing
- o Delivered Torque Testing
- Orbit Testing ●
- Guide Wire Brake Testing
- Saline Flow Testing ●
- Track Testing
- Packaging/Simulated Distribution Testing ●
- . Biocompatibility
- Cytotoxicity per ISO 10993-5 o
- Sensitization per ISO 10993-10 o
- Irritation per ISO 10993-10 o
- Acute Systemic Toxicity per ISO 10993-11 o
- Pyrogenicity per ISO 10993-11 o
- Hemocompatibility per ISO 10993-4 o
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Diamondback 360 Peripheral Orbital Atherectomy System met the established specifications necessary for consistent performance during its intended use.
6.6 Conclusions
Diamondback 360 Peripheral Orbital Atherectomy System met all The 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.