(29 days)
No
The description focuses on the mechanical action of the device (electrically driven shaft, diamond coated surface) and does not mention any computational or learning capabilities.
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." This explicitly states its therapeutic intent.
No
The device is described as an atherectomy system that removes stenotic material, indicating a therapeutic rather than a diagnostic function.
No
The device description explicitly lists multiple hardware components, including an orbital atherectomy device, guide wire, saline pump, and lubricant. It is a physical system for removing stenotic material.
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 therapeutic procedure performed on the patient (percutaneous orbital atherectomy) to treat occlusive atherosclerotic disease and stenotic material in peripheral arteries and A-V grafts. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a system for physically removing material from within the body using mechanical means (orbital atherectomy). This is a therapeutic intervention, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Stealth 360° Orbital PAD System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stealth 360° Orbital PAD 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 atherectorny 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 Stealth 360° Orbital PAD System 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 Stealth 360° uses an electrically driven shaft to apply 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 Stealth 360° Orbital PAD System consists of the following components:
-
- Orbital atherectomy device (OAD)
-
- Atherectomy guide wire
-
- Externally operated saline 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 and A-V graft (shunt), 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 modified Stealth 360° Orbital PAD System was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.
- Life/Stall Testing .
- Orbit Testing .
Testing results demonstrate that the modified Stealth 360° Orbital PAD System is as safe and effective as the predicate device.
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.
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.
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
510(k) Summary Section. 6
OCT 2 5 2012 Company Name: Cardiovascular Systems, Inc. 651 Campus Drive Saint Paul, MN 55112 Contact: Maureen McDonnell Phone: (651) 259-1644 Fax: (651) 305-7734 September 25, 2012 Summary Date: Trade Name: Stealth 360°® Orbital PAD System Common Name: Peripheral Atherectomy Device Classification Name: Peripheral Atherectomy Catheter (21 CFR 870.4875; Product Code: MCW) Predicate Device:
510(k) Number: K110389 Manufacturer: Cardiovascular Systems, Inc. Trade Name: Stealth 360º® Orbital PAD System
6.1 Description of Device
The Stealth 360° Orbital PAD System 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 Stealth 360° uses an electrically driven shaft to apply 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 Stealth 360° Orbital PAD System consists of the following components:
-
- Orbital atherectomy device (OAD)
-
- Atherectomy guide wire
-
- Externally operated saline pump
-
- Atherectomy Lubricant (e.g. ViperSlide)
1
Intended Use 6.2
The Stealth 360° Orbital PAD 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 Stealth 360° Orbital PAD System provides a method of removing occlusive atherosclerotic or stenotic material. The OAS applies a diamond coated, eccentrically rotating sanding surface to ablate stenotic tissue. The stenotic particles that are removed are small enough to be absorbed by the body. This same technology was cleared to market for use in 510(k) K110389, 510(k) K071350, and Predator 360° (originally cleared as 3X) per K090521.
The device crowns are comprised of blanks that are plated and diamond coated. The primary difference between the device that is the subject of this submission and the predicate device is that the current solid crown blanks are machined and the crown blanks for the modified device will be molded. Molding blanks is intended to be another method for producing a crown of the same material composition as the current blank. The plating and diamond coating processes will be exactly the same for both blanks.
6.4 Performance Data
The modified Stealth 360° Orbital PAD System was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.
- Life/Stall Testing .
- Orbit Testing .
6.5 Conclusions
The Stealth 360° Orbital PAD System with the molded crown is substantially equivalent to the predicate device. Design verification testing was performed to support the safety profile of the modified Stealth 360° Orbital PAD System. Testing results demonstrate that the modified Stealth 360° Orbital PAD System is as safe and effective as the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
2 5 2012
Cardiovascular Systems, Inc. c/o Maureen McDonnell Senior Regulatory Affairs Specialist 651 Campus Drive St. Paul, MN 55112
Re: K122987
Trade/Device Name: Stealth 360° Orbital PAD System Regulation Number: 21 CFR 870.4875 Regulation Name: Peripheral Atherectomy Catheter Regulatory Class: Class II Product Code: MCW Dated: September 25, 2012 Received: September 26, 2012
Dear Ms. McDonnell:
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. However, we remind you 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
3
Page 2 - Ms. Maureen McDonnell
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 devicerelated 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 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 Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and Radiological Health
4
Indications for Use Statement Section. 5
K122987 510(k) Number:
Device Name: Stealth 360°@ Orbital PAD System
Indications for Use:
The Stealth 360° Orbital PAD 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 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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Numb