(16 days)
No
The description focuses on mechanical components and performance testing related to material properties and physical function, with no mention of AI/ML, image processing, or data-driven algorithms.
Yes.
The device is indicated for use "as therapy in patients with occlusive atherosclerotic disease in peripheral arteries" and "as a therapy in patients with occluded hemodialysis grafts," directly stating its therapeutic purpose.
No
Explanation: The device is described as a "percutaneous orbital atherectomy system" intended for therapy (removal of stenotic material), not for diagnosis.
No
The device description explicitly lists multiple hardware components, including an Orbital Atherectomy Device (OAD), Atherectomy Guide Wire, Saline Infusion Pump (SIP), and Atherectomy Lubricant.
Based on the provided information, the Diamondback 360 Peripheral Orbital Atherectomy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a therapeutic procedure performed directly on the patient's peripheral arteries and A-V grafts to remove stenotic material. This is an intervention, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device description details a system for physically removing material from within the body using an eccentrically rotating sanding surface. This is a mechanical intervention, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) outside of the body. The device's function is entirely focused on treating a condition within the patient's circulatory system.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Diamondback 360 system does not fit this description.
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 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)
Biocompatibility testing for the modified 1.25 Micro OAD (Diamondback 360 Peripheral Orbital Atherectomy System) has been completed. The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissue consistent with its intended use. The following biocompatibility tests were completed.
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Hemocompatibility
The modified 1.25 Micro OAD (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
- Stall Testing
- Introducer Compatibility Testing
- Contrast Injection Testing
- Temperature Testing
- Tensile Testing
- Flexibility Testing
- Delivered Torque Testing
- Orbit Testing
- Guide Wire Brake Testing
- Flow Testing
- Track Testing
- Packaging/Simulated Distribution Testing
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the modified 1.25 Micro OAD (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)
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).
0
NOV 22222013
Section. 6 510(k) Summary
| Company Name: | Cardiovascular Systems, Inc.
651 Campus Drive
Saint Paul, MN 55112 |
|----------------------------|--------------------------------------------------------------------------|
| Contact: | Blair Buth |
| Phone: | (651) 259-2032 |
| Fax: | (651) 305-7734 |
| Summary Date: | November 05, 2013 |
| 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 Device: | |
| 510(k) Number: | K110389, K122987, & K131092 |
|---|---|
| Manufacturer: | Cardiovascular Systems, Inc. |
| Trade Name: | Stealth 360 ° ® Orbital PAD System |
Description of Device 6.1
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)
6-1
1
K133389
6.2 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.
6.3 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 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) K131092, K122987, K110389 and Predator 360° (originally cleared as 3X) per K090521.
6.4 Performance Data
Biocompatibility testing for the modified 1.25 Micro OAD (Diamondback 360 Peripheral Orbital Atherectomy System) has been completed. The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissue consistent with its intended use. The following biocompatibility tests were completed.
- . Cytotoxicity
- Sensitization ●
- Irritation ●
- . Acute Systemic Toxicity
- . Pyrogenicity
- . Hemocompatibility
The modified 1.25 Micro OAD (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 .
- . Stall Testing
- . Introducer Compatibility Testing
- Contrast Injection Testing ●
- . Temperature Testing
- Tensile Testing ●
- Flexibility Testing .
2
6-3
- Delivered Torque Testing .
- Orbit Testing o
- Guide Wire Brake Testing .
- Flow Testing .
- Track Testing · .
- Packaging/Simulated Distribution Testing ●
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the modified 1.25 Micro OAD (Diamondback 360 Peripheral Orbital Atherectomy System) met the established specifications necessary for consistent performance during its intended use.
ર.ક Conclusions
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 device and does not raise any new safety or effectiveness questions.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol consisting of three curved lines, which are meant to represent the human form. The image is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2013
Cardiovascular Systems, Inc. Mr. Blair Buth Regulatory Affairs Manager 651 Campus Drive St. Paul, MN 55112
Re: K133399
Trade/Device Name: Diamondback 360 Peripheral Orbital Atherectorny System -Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: November 5, 2013 Received: November 6, 2013
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
4
Page 2 - Mr. Blair Buth
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 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.
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K133399
Indications for Use Statement Section. 5
510(k) Number: _K133399
Device Name: Diamondback 360° Peripheral Orbital Atherectomy System
Indications for Use:
The Diamondback 360 Peripheral Orbital Atherectomy System is a perculaneous 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 atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bram D. Zuckerman -S 2013.1