(70 days)
Not Found
No
The summary describes a mechanical atherectomy system and does not mention any AI or ML components or functionalities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as therapy in patients with occlusive atherosclerotic disease" and "indicated as a therapy in patients with occluded hemodialysis grafts." The "Device Description" also mentions its use "in the treatment of peripheral arteries and A-V graft (shunt) stenosis" and its method of "removing stenotic material," which directly describes a therapeutic action.
No
The Diamondback 360° Orbital Atherectomy System is described as a "therapy" and a "method of removing stenotic material" to treat occlusive atherosclerotic disease. It is an atherectomy system designed for active intervention (removing material), not for diagnosing conditions.
No
The device description explicitly lists multiple hardware components: Orbital atherectomy device, Atherectomy guide wire, Atherectomy saline pump or controller, and Atherectomy lubricant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for treating occlusive atherosclerotic disease in peripheral arteries and occluded hemodialysis grafts. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device description details a system that physically removes stenotic material from blood vessels using a diamond-coated, eccentrically rotating surface. This is a mechanical process performed in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on biological samples to gain information about a person's health. This device is used inside the body to treat a condition.
N/A
Intended Use / Indications for Use
The Diamondback 360° 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° Orbital Atherectomy System with ViperSlide is an orbital atherectomy system (OAS) that 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 OAS applies a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.
The Diamondback 360° Orbital Atherectomy System consists of the following components:
-
- Orbital atherectomy device (OAD, air or electric powered)
-
- Atherectomy guide wire
-
- Atherectomy saline pump or controller
-
- Atherectomy lubricant
The Diamondback 360° Orbital Atherectorny System with ViperSlide provides a method of removing occlusive atherosclerotic or stenotic material. The OAS applies a diamond coated, eccentrically rotating surface to ablate stenotic tissue. The ViperSlide lubricant is a lipid emulsion with soybean oil, egg phospholipid, and glycerin prepared with water for injection. ViperSlide is mixed with saline prior to treatment and acts as a lubricant to cool the OAD during use.
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 Diamondback 360° Orbital Atherectomy System with ViperSlide was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.
- System Life Testing.
- Emulsion Admixture Stability
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Diamondback 360° Orbital Atherectomy System with ViperSlide met the established specifications necessary for consistent performance during its intended use.
Biocompatibility testing on the proposed Diamondback 360° Orbital Atherectomy System with ViperSlide has been completed. The biocompatibility test results show that the materials used in the design and manufacture of ViperSlide are biocompatible with the biological tissue consistent with its intended use. The following biocompatibility tests were completed.
- ISO MEM Elution Assay
- Hemolysis – Direct Contact Method
- In-vitro Hemocompatibility Assay
- ISO Acute Systemic Injection Test
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.
K071350, K071427, K082981, K090521, K110389
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/0 description: The image contains handwritten text. The text at the top appears to be "Kili.388". Below that, the text reads "P. 1 of" followed by an illegible symbol. The handwriting is somewhat messy, and the symbol at the end is difficult to decipher.
Section. 6 510(k) Summary
JUL 2 6 2011
| Company Name: | Cardiovascular Systems, Inc.
651 Campus Drive
Saint Paul, MN 55112 | |
|----------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Contact: | Megan M. Brandt | |
| Phone: | (651) 259-2805 | |
| Fax: | (651) 305-7734 | |
| Summary Date: | May 16, 2011 | |
| Trade Name: | Diamondback 360® Orbital Atherectomy System with ViperSlide®
Lubricant | |
| Common Name: | Peripheral Atherectomy Device | |
| Classification Name: | Peripheral Atherectomy Catheter (21 CFR 870.4875; Product Code:
MCW) | |
| Predicate Devices: | 510(k) Number: | K071350 |
| | Manufacture: | Cardiovascular Systems, Inc. |
| | Trade Name: | Diamondback 360® Orbital Atherectomy System |
| | 510(k) Number: | K071427 |
| | Manufacture: | Cardiovascular Systems, Inc. |
| | Trade Name: | Diamondback 360® Orbital Atherectomy System |
| | 510(k) Number: | K082981 |
| | Manufacture: | Cardiovascular Systems, Inc. |
| | Trade Name: | Diamondback 360® Orbital Atherectomy System
with ViperSlide Lubricant |
| | 510(k) Number: | K090521 |
| | Manufacture: | Cardiovascular Systems, Inc. |
| | Trade Name: | Diamondback Predator 360® Orbital Atherectomy
System |
| | 510(k) Number: | K110389 |
| | Manufacture: | Cardiovascular Systems, Inc. |
| | Trade Name: | Stealth 360® Orbital PAD System |
1
K111388
P. 2 of 3
6.1 Description of Device
The Diamondback 360° Orbital Atherectomy System with ViperSlide is an orbital atherectomy system (OAS) that 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 OAS applies a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.
The Diamondback 360° Orbital Atherectomy System consists of the following components:
-
- Orbital atherectomy device (OAD, air or electric powered)
-
- Atherectomy guide wire
-
- Atherectomy saline pump or controller
-
- Atherectomy lubricant
6.2 Intended Use
The Diamondback 360° 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° Orbital Atherectorny System with ViperSlide provides a method of removing occlusive atherosclerotic or stenotic material. The OAS applies a diamond coated, eccentrically rotating surface to ablate stenotic tissue. The ViperSlide lubricant is a lipid emulsion with soybean oil, egg phospholipid, and glycerin prepared with water for injection. ViperSlide is mixed with saline prior to treatment and acts as a lubricant to cool the OAD during use.
This 510(k) specifically addresses the addition of an alternate ViperSlide lubricant formulation for use with the Diamondback 360° Orbital Atherectomy System. The OAS technologies described in the previous submissions remain unchanged since the lubricants are interchangeable. The alternate ViperSlide formulation design and components are substantially equivalent to the predicate devices. The use of lubricant with the Diamondback 360° OAS was cleared to market for use in peripheral arteries in 510(k) K071350 and K082981, Predator 360° (originally cleared as 3X) per K090521, Stealth 360° per K110389, and for use in A-V grafts in 510(k) K071427.
2
Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The top line reads "K1113888", with the "K" being a capital letter and the rest being numbers. The bottom line reads "P-3 of 3", with "P" being a capital letter and the rest being numbers and words.
6.4 Performance Data
The Diamondback 360° Orbital Atherectomy System with ViperSlide was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.
- System Life Testing .
- . Emulsion Admixture Stability
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Diamondback 360° Orbital Atherectomy System with ViperSlide met the established specifications necessary for consistent performance during its intended use.
Biocompatibility testing on the proposed Diamondback 360° Orbital Atherectomy System with ViperSlide has been completed. The biocompatibility test results show that the materials used in the design and manufacture of ViperSlide are biocompatible with the biological tissue consistent with its intended use. The following biocompatibility tests were completed.
- ISO MEM Elution Assay .
- . Hemolysis – Direct Contact Method
- In-vitro Hemocompatibility Assay .
- ISO Acute Systemic Injection Test .
6.5 Conclusions
The Diamondback 360° Orbital Atherectomy System with ViperSlide 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° Orbital Atherectomy System with ViperSlide is substantially equivalent to the legally marketed predicate device and does not raise any new safety or effectiveness questions.
3
Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cardiovascular Systems, Inc. c/o Megan M. Brandt 651 Campus Dr. St. Paul, MN 55112
JUL 2 6 2011
Re: K111388
Trade/Device Name: Diamondback 360 Orbital Atherectomy System (OAS) with ViperSlide Regulation Number: 21 CFR 870.4875 Regulation Name: Peripheral Atherectomy Catheters Regulatory Class: Class II Product Code: MCW Dated: May 16, 2011 Received: May 17, 2011
Dear Ms. Brandt:
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 coneerning 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
4
Page 2 - Ms. Megan M. Brandt
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K111388
Device Name: Diamondback 360® Orbital Atherectomy System with ViperSlide® Lubricant
Indications For Use:
The Diamondback 360° 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1 .
vision of Cardiovascular Devices
510(k) Number K111388