(67 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 data-driven components indicative of AI/ML. The performance studies listed are standard bench tests for mechanical and electrical safety, not AI/ML validation.
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 "orbital atherectomy system" intended to remove stenotic material as a therapy, not to diagnose conditions.
No
The device description explicitly lists multiple hardware components (Orbital Atherectomy Device, Guide Wire, Saline Infusion Pump, Lubricant) and the performance studies include hardware-specific testing (Life/Stall, Orbit, Electrical Safety, EMC).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Stealth 360° Orbital PAD System is a percutaneous orbital atherectomy system. Its intended use is to physically remove stenotic material from peripheral arteries and A-V grafts. This is a therapeutic procedure performed directly on the patient's body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes based on laboratory testing.
Therefore, the Stealth 360° Orbital PAD System is a therapeutic medical 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 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 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
-
- 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 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 Testint
- Orbit Testing
- Switch Logic/End of Life Testing
- Distribution Testing
- Shelf Life Testing
- ISO MEM Elution Assay
- ISO Intracutaneous Reactivity Test
- Electrical Safety Testing
- Electromagnetic Compatibility (EMC) Testing
- Firmware testing: Modular, Integration, Functional
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Stealth 360° Orbital PAD 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.
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.
K122987, K110389, K071350, K090521
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
2013
| Section. 5 | 510(k) Summary | JUN 2 | |
|---|---|---|---|
| Company Name: | Cardiovascular Systems, Inc. | ||
| 651 Campus Drive | |||
| Saint Paul, MN 55112 | |||
| Contact: | Maureen McDonnell | ||
| Phone: | (651) 259-1644 | ||
| Fax: | (651) 305-7734 | ||
| Summary Date: | April 17, 2013 | ||
| Trade Name: | Stealth 360°® Orbital PAD System | ||
| Product Code: | MCW—Catheter, Peripheral, Atherectomy | ||
| Classification: | 21 CFR 870.4875—Intraluminal Artery Stripper | ||
| Predicate Device: | 510(k) Number: | ||
| Manufacturer: | |||
| Trade Name: | K110389 & K122987 | ||
| Cardiovascular Systems, Inc. | |||
| Stealth 360°® Orbital PAD System |
5.1 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
-
- Saline Infusion Pump (SIP)
-
- Atherectomy Lubricant (e.g. ViperSlide)
1
5.2 Intended 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 atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
5.3 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) K122987, K110389, K071350, and Predator 3600 (originally cleared as 3X) per K090521.
The current printed circuit board assembly (PCBA) used in the OAD is developed and purchased externally. A CSI developed board was created that will allow for additional Input/Output (I/O) points to enable future expandability options. The modified device will use one of the additional I/O points to add a saline prime button to the device handle that functions in the same way as the existing prime button on the saline infusion pump. The instructions for use were updated to include information about use of the prime button on the OAD.
5.4 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 Testint ●
- Orbit Testing .
- Switch Logic/End of Life Testing ●
- . Distribution Testing
- Shelf Life Testing .
- ISO MEM Elution Assay
- . ISO Intracutaneous Reactivity Test
- Electrical Safety Testing .
- Electromagnetic Compatibility (EMC) Testing .
- 0 Firmware testing: Modular, Integration, Functional
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Stealth 360° Orbital PAD System met the established specifications necessary for consistent performance during its intended use.
2
5.5 Conclusions
The Stealth 360° Orbital PAD System with the CSI developed PCBA 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 Stealth 360° Orbital PAD System with the CSI developed PCBA is substantially equivalent to the legally marketed predicate device and does not raise any new safety or effectiveness questions.
Stealth 360°® Orbital PAD System
5-3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2013
Cardiovascular Systems. Inc. c/o Ms. Maureen McDonnell Sr. Regulatory Affairs Specialist 651 Campus Drive St. Paul, MN 55112
Re: K131092
Trade/Device Name: Stealth 360° Orbital PAD System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: June 3, 2013 Received: June 4, 2013
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 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
4
Page 2 - Ms. Maureen McDonnell
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/Resourcesfor You/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
Section. 4 Indications for Use Statement
510(k) Number: K131092
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 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)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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