(100 days)
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 are who are acceptable candidates for percutaneous transluminal atherectomy.
The Diamondback 360° Orbital System (OAS) is intended for use in the treatment of peripheral artery stenosis also referred to as Peripheral Artery Disease (PAD). PAD is the result of a stenosis of peripheral arteries, typically in the legs. The OAS provides a method of removing stenotic material from peripheral arteries. The OAS applies a diamond coated, eccentrally rotating cutting surface to ablate stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body. The Diamondback 360° Orbital Atherectomy System consists of the following three significant components: 1) Orbital Atherectomy Device, 2) Guide Wire, and 3) Controller.
The provided document is a 510(k) summary for the Diamondback 360° Orbital Atherectomy System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and studies in the same way a PMA (Pre-Market Approval) submission for a novel device would.
Therefore, much of the requested information regarding acceptance criteria, study methodologies, sample sizes, and expert adjudication for an algorithm's performance is not present in this document because the device in question is a physical medical device (an atherectomy system), not an AI/ML algorithm or a diagnostic tool that would typically have such performance metrics.
However, I can extract the information that is present and indicate where the requested information is not applicable or not provided.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or a "reported device performance" in terms of specific numerical thresholds for a device's diagnostic or predictive accuracy. Instead, the "performance" shown is that the device was deemed "substantially equivalent" to predicate devices based on safety and effectiveness.
| Acceptance Criteria (Not explicitly stated as such for a performance algorithm) | Reported Device Performance (Summary of Conclusion) |
|---|---|
| Safety: Device comparable to predicates in terms of potential risks and complications. | "Laboratory animal and clinical data were provided to support the safety of the Diamondback 360° Orbital Atherectomy System." The FDA concluded, "No new questions of safety... are raised." |
| Effectiveness: Device achieves intended therapeutic purpose comparably to predicates. | "Laboratory animal and clinical data were provided to support the... effectiveness of the Diamondback 360° Orbital Atherectomy System." The FDA concluded, "No new questions of... effectiveness are raised." The device was found "substantially equivalent" to predicate atherectomy devices for treating peripheral artery stenosis. |
| Technological Characteristics: Similarities in design, materials, and operational principles to predicates. | The device uses a "diamond coated, eccentrically rotating cutting surface to ablate stenotic material," which is stated to be the same technology as a previously cleared device (CSI A-V Graft System, K041630) but with modified indication for use and disposable device variations. It's composed of an orbital atherectomy device, guide wire, and controller, similar in concept to predicate atherectomy systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Laboratory animal and clinical data" were provided but does not specify the sample size for the clinical study or the test set (if referring to a dataset for an algorithm, which is not the case here).
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: "Laboratory animal and clinical data." No mention of specific countries of origin or whether the clinical data was retrospective or prospective is present.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this 510(k) submission as it concerns a physical medical device, not a diagnostic algorithm that requires "ground truth" derived from expert consensus on images or data. Clinical studies for devices like this typically involve assessment of patient outcomes by physicians, but this is different from establishing a diagnostic ground truth for an AI system.
- Number of Experts: Not applicable/not specified for an AI ground truth.
- Qualifications of Experts: Not applicable/not specified for an AI ground truth.
4. Adjudication Method for the Test Set
This is not applicable for a physical atherectomy device. Adjudication methods like 2+1 or 3+1 refer to how multiple expert opinions are combined to establish a ground truth for an AI algorithm's test set.
- Adjudication Method: Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is an atherectomy system, not a diagnostic AI tool that would assist human readers in interpreting medical images or data.
- MRMC Study: Not applicable.
- Effect Size of AI Assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device, not an algorithm.
- Standalone Performance Study: Not applicable.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically discussed for AI algorithms (expert consensus, pathology, outcome data for diagnosis) does not directly apply to the performance evaluation of an atherectomy device in the same way. The studies focused on "safety" and "effectiveness," which would involve clinical endpoints like reduction in stenosis, complication rates (e.g., vessel dissection, distal embolization), and patient outcomes, rather than a diagnostic "ground truth."
- Type of Ground Truth: Clinical endpoints related to safety (e.g., adverse events, complications) and effectiveness (e.g., patency rates, reduction of stenosis), rather than a diagnostic "ground truth."
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set."
- Sample Size for Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set" or "ground truth" in the context of an AI algorithm for this physical device.
- Ground Truth for Training Set: Not applicable.
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K07135⁰
510(k) Summary
AUG 2 2 2007
Company Name: Cardiovascular Systems, Inc. 651 Campus Drive St. Paul, MN 55112
Contact: Michael Kallok PhD, FACC, Chief Scientific Officer
Phone: (651) 259-1610
Fax: (651) 259-1696
Summary Date: May 9, 2007
Trade Name: Diamondback 360° Orbital Atherectomy System
Common Name: Peripheral Atherectomy Device
Classification Name: 21 CFR 870.4875, Peripheral Atherectomy Catheter
Predicate Device:
| 510(k) Number: | K901206 |
|---|---|
| Manufacture: | Heart Technologies (Acquired by Boston Scientific |
| Trade Name: | Rotablator Peripheral Atherectomy Device |
| 510(k) Number: | K043553 |
| Manufacture: | Fox Hollow, Inc. |
| Trade Name: | Silver Hawk Peripheral Plaque Excision System |
| 510(k) Number: | K041630 |
| Manufacture: | Cardiovascular Systems, Inc. |
| Trade Name: | CSI A-V Graft System |
1.0 Description of Device
The Diamondback 360° Orbital System (OAS) is intended for use in the treatment of peripheral artery stenosis also referred to as Peripheral Artery Disease (PAD). PAD is the result of a stenosis of peripheral arteries, typically in the legs.
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The OAS provides a method of removing stenotic material from peripheral arteries. The OAS applies a diamond coated, eccentrically rotating cutting surface to ablate stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body.
The technology of applying a rotating abrasive surface to remove a peripheral stenotic material has a technology predicate. The Cardiovascular Systems, Inc. (CSI) rotational atherectomy system, commercial name CSI A-V Graft System, was reviewed and cleared to market for use in A-V Grafts by 510(k) K041630. This same device, with modifications to the indication for use and additions of disposable device variations is applied for use in atherectomy of peripheral arteries.
The Diamondback 360° Orbital Atherectomy System consists of the following three significant components:
-
- Orbital Atherectomy Device,
-
- Guide Wire, and
-
- Controller.
2.0 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 are who are acceptable candidates for percutaneous transluminal atherectomy.
3.0 Technology
The Diamondback 360° Orbital Atherectomy System (OAS) provides a method of removing occlusive neointimal tissue. The OAS applies a diamond coated, eccentrically rotating cutting surface to ablate neointimal tissue. The resulting particles of removed neointimal tissue are very small and can be absorbed by the body. This same technology was cleared to market for use in A-V Grafts, reference K041630.
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4.0 Conclusions
The OAS is substantially equivalent to the predicate devices. Laboratory animal and clinical data were provided to support the safety of the Diamondback 360° Orbital Atherectomy System. No new questions of safety or effectiveness are raised.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2007
Cardiovascular Systems, Inc. c/o Michael J. Kallok, Ph.D. Chief Scientific Officer 651 Campus Drive St. Paul, MN 55112-3495
Re: K071350
Diamondback 360°™ Orbital Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II (Two) Product Code: MCW Dated: July 27, 2007 Received: July 30, 2007
Dear Dr. Kallok:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 – Michael J. Kallok, Ph.D.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. lochner
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): K()71,55
Device Name: Diamondback 360° Orbital Atherectomy System
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 are who are acceptable candidates for percutaneous transluminal atherectomy.
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 THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dune R. Whitney
Sign-Off
Cardiovascular Devices
STU(K) Number_K071350
Page 1 of 1
§ 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).