(29 days)
The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems 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.
The atherectomy guide wire is a component that is part of the Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy System. The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System (OAS) are 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 and the Diamondback 360 use 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.
In addition to the atherectomy guide wire, the Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components: Orbital Atherectomy Device (OAD), Saline Infusion Pump, and Atherectomy Lubricant (e.g., ViperSlide).
The ViperWire Advance Flex Tip Guide Wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft.
This document is a 510(k) premarket notification for a medical device called the "Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy System," specifically addressing a modification to a component: the ViperWire Advance Flex Tip Peripheral Guide Wire.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical table of acceptance criteria with specific numerical targets and matching device performance values. Instead, it lists the types of performance bench tests conducted and states that "All test results demonstrate that the materials chosen, the manufacturing processes, and the design utilized for the ViperWire Advance Flex Tip Guide Wire met the established specifications necessary for consistent performance during its intended use." And "The ViperWire Advance Flex Tip Guide Wire met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs."
Here's a summarized table based on the provided text, indicating the types of tests performed:
| Test Category | Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|---|
| Mechanical/Physical Tests | Established specifications necessary for consistent performance during its intended use. | Met established specifications and predetermined acceptance criteria. Performs as well or better than the predicate device. |
| Corrosion Testing | (Implied: No unacceptable corrosion) | Met established specifications and predetermined acceptance criteria. |
| Life Testing | (Implied: Device maintains integrity and function for intended duration) | Met established specifications and predetermined acceptance criteria. |
| Tensile Strength | (Implied: Meets required strength for intended use) | Met established specifications and predetermined acceptance criteria. |
| Tip Flexibility | (Implied: Demonstrates appropriate flexibility) | Met established specifications and predetermined acceptance criteria. |
| Trackability | (Implied: Device tracks smoothly through血管) | Met established specifications and predetermined acceptance criteria. |
| Orbit Testing | (Implied: Crown maintains proper orbital function) | Met established specifications and predetermined acceptance criteria. |
| Torque Transfer | (Implied: Efficient transfer of torque for device operation) | Met established specifications and predetermined acceptance criteria. |
| Combined Load Testing | (Implied: Device integrity under various loads) | Met established specifications and predetermined acceptance criteria. |
| Packaging/Simulated Distribution Testing | (Implied: Packaging protects device during distribution) | Met established specifications and predetermined acceptance criteria. |
| Biocompatibility Tests | As per ISO 10993 standards (5, 10, 11, 4) | Met established specifications and predetermined acceptance criteria. |
| Cytotoxicity (ISO 10993-5) | (Implied: Non-cytotoxic) | Met established specifications and predetermined acceptance criteria. |
| Systemic Toxicity (ISO 10993-11) | (Implied: No unacceptable systemic toxicity) | Met established specifications and predetermined acceptance criteria. |
| Sensitization (ISO 10993-10) | (Implied: Non-sensitizing) | Met established specifications and predetermined acceptance criteria. |
| Irritation (ISO 10993-10) | (Implied: Non-irritating) | Met established specifications and predetermined acceptance criteria. |
| Pyrogenicity (ISO 10993-11) | (Implied: Non-pyrogenic) | Met established specifications and predetermined acceptance criteria. |
| Hemocompatibility (ISO 10993-4) | (Implied: Compatible with blood, minimal undesirable interactions) | Met established specifications and predetermined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "performance bench testing" and "design verification and validation testing," using phrases like "All test results demonstrate..." which implies that a test set was used. However, specific sample sizes for any of these tests are not provided.
The data provenance is not explicitly stated as country of origin, but these are bench tests conducted by the manufacturer, Cardiovascular Systems, Inc., which is based in Saint Paul, MN, USA. The tests are described as retrospective in the sense that they are laboratory evaluations of the modified device, not clinical trials on patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the document. The study described is bench testing of a device component's physical and biocompatibility properties, not a study involving human diagnosis or interpretation where expert ground truth would be established. The "ground truth" for these tests would be the established engineering specifications and ISO standard requirements.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation studies to resolve discrepancies among multiple expert readers. This document describes bench testing, not a reader study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document describes bench testing of a guide wire component, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable as the device is a physical medical device (atherectomy system component), not an AI algorithm. Therefore, "algorithm only" or "human-in-the-loop" performance are not relevant concepts for this type of device submission. The performance described is purely device-only (standalone physical device component) performance.
7. The Type of Ground Truth Used:
For the bench testing described, the "ground truth" is defined by:
- Established engineering specifications: Performance requirements set by the manufacturer for the guide wire (e.g., tensile strength, flexibility).
- Applicable standards: Specifically, ISO 10993 series for biocompatibility (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and irritation, ISO 10993-11 for systemic toxicity and pyrogenicity, ISO 10993-4 for hemocompatibility).
- Test protocols: Documented procedures detailing how each test was to be performed and what constituted a successful outcome.
- Customer inputs: (Implied: requirements derived from user needs and clinical application).
8. The Sample Size for the Training Set:
This information is not applicable. The document describes a 510(k) submission for a physical medical device component, which involves bench testing and comparison to a predicate device. It does not involve machine learning or AI, and therefore there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above (no training set for an AI algorithm).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10,2015
Cardiovascular Systems, Inc. c/o Ms. Kim Wallner Senior Regulatory Affairs Specialist 1228 Old Highway 8 NW Saint Paul, MN 55112
Re: K151260
Trade/Device Name: Stealth 360 Orbital PAD System and 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: May 11, 2015 Received: May 12, 2015
Dear Ms. Wallner:
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
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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
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.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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
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Indications for Use
510(k) Number (if known) K151260
Device Name
Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy System
Indications for Use (Describe)
The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems 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 NWSaint Paul, MN 55112 | ||
|---|---|---|---|
| Contact: | Kim Wallner | ||
| Phone: | (651) 202-4917 | ||
| Fax: | (651) 305-7734 | ||
| Summary Date: | May 11, 2015 | ||
| Trade Name: | ViperWire Advance Flex Tip Peripheral Guide Wire(OAS component that is part of the: Stealth 360 Orbital PAD Systemand 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: | K110389, K122987, K131092 | ||
| Manufacturer: | Cardiovascular Systems, Inc. | ||
| Trade Name: | Stealth 360 Orbital PAD System | ||
| 510(k) Number: | K133399, K150732 | ||
| Manufacturer: | Cardiovascular Systems, Inc. | ||
| Trade Name: | Diamondback 360 Peripheral Orbital AtherectomySystem |
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6.1 Description of Device
The atherectomy guide wire is a component that is part of the Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy System. The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System (OAS) are 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 and the Diamondback 360 use 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.
In addition to the atherectomy guide wire, the Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components: Orbital Atherectomy Device (OAD), Saline Infusion Pump, and Atherectomy Lubricant (e.g., ViperSlide).
6.2 Description of Change
The guide wire was modified to update the distal spring tip, coil material, and core wire diameter.
6.3 Intended Use
The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems 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 Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System provide 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.
The ViperWire Advance Flex Tip Guide Wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper
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positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft.
This is the same technology that was cleared to market for use in the peripheral arteries for Stealth 360 Orbital PAD in 510(k) K110389, K122987, K131092 and for Diamondback 360 Peripheral OAS per K133399 and K150732.
6.5 Performance Data
The ViperWire Advance Flex Tip Guide Wire was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.
- Corrosion Testing ●
- Life Testing
- Tensile Strength
- Tip Flexibility ●
- Trackability ●
- Orbit Testing ●
- . Torque Transfer
- Combined Load Testing ●
- . Packaging/Simulated Distribution Testing
- Biocompatibility .
- o Cytotoxicity per ISO 10993-5
- Systemic Toxicity per ISO 10993-11 O
- Sensitization per ISO 10993-10 O
- Irritation per ISO 10993-10 o
- Pyrogenicity per ISO 10993-11 о
- Hemocompatibility per ISO 10993-4 o
All test results demonstrate that the materials chosen, the manufacturing processes, and the design utilized for the ViperWire Advance Flex Tip Guide Wire met the established specifications necessary for consistent performance during its intended use.
Conclusion 6.6
The ViperWire Advance Flex Tip Guide Wire 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 ViperWire AdvanceFlex Tip Guide Wire used with the Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy System is substantially equivalent to the legally marketed predicate device, does not raise any new safety or effectiveness questions, and performs as well or better than the predicate device.
§ 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).