(120 days)
No
The description focuses on mechanical and electrical components and their functions, with no mention of AI or ML. The firmware mentioned is likely for basic control functions, not complex learning algorithms.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is indicated for use "as therapy" in patients with occlusive atherosclerotic disease.
No
Explanation: The device is described as an "atherectomy system" intended for "therapy in patients with occlusive atherosclerotic disease," and its description details a "flexible over-the-wire rotational device used to ablate atherosclerotic plaque." These functions relate to treatment rather than diagnosis.
No
The device description explicitly states that the system consists of three components: a User Handle with integrated driveshaft, a Tubing Set, and a Power Supply. It also mentions that the User Handle utilizes firmware and hardware to perform its functions. This indicates the presence of physical hardware components beyond just software.
Based on the provided information, the FreedomFlow™ Orbital Circumferential Atherectomy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for therapy in patients with occlusive atherosclerotic disease in peripheral arteries. This is a therapeutic intervention performed within the body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The device is described as a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from blood vessels. This is a mechanical device for treatment, not for analyzing biological samples.
- No mention of testing biological samples: The description focuses on the mechanical action of the device and its components for removing plaque. There is no mention of analyzing blood, tissue, or any other biological sample.
IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. The FreedomFlow™ System does not perform this function.
N/A
Intended Use / Indications for Use
The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.
Product codes
MCW
Device Description
The FreedomFlow™ Orbital Circumferential Atherectomy System is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply.
The User Handle with the integrated driveshaft is sterile, single use, and disposable. Both 5 Fr and 6 Fr variations of the User Handle are available. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral arteries
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
Raw data (i.e., arteriographic images) from the cohort registry and the FAST II study were randomized for blinded analysis by an independent angiographic core-laboratory.
Summary of Performance Studies
A prospective, multi-center, single arm, open-label Clinical Study (FAST II study, NCT03635190) was conducted to evaluate the safety and effectiveness of the FreedomFlow™ System in patients with symptomatic peripheral arterial disease (PAD) of the lower extremities. The FAST II study met the predefined primary safety endpoint (Freedom from MAE at 30 days). The rate of freedom from major adverse events was 92.9% with a lower 95% confidence interval of 86.4%, meeting the performance goal of 85%. The study did not meet the pre-defined primary effectiveness endpoint (technical success defined as ability to achieve residual diameter stenosis less than 50% without adjunctive therapy, utilizing the core lab adjudicated data). The rate of technical success rate was 67.4% with a lower 95% confidence interval of 58.7%, missing the performance goal of 86%.
To provide a supplemental analysis of the FAST II effectiveness performance, Cardio Flow conducted a matched comparison of the FAST II FreedomFlow debulking effectiveness, as measured by post atherectomy stenosis, to real world evidence obtained from the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry of rotational and orbital atherectomy cases. Specifically, registry candidate patients were refined using propensity scoring to identify a control cohort of patients with well-balanced baseline covariates that included parameters relevant to atherectomy debulking. Raw data (i.e., arteriographic images) from the cohort registry and the FAST II study were randomized for blinded analysis by an independent angiographic core-laboratory. The primary study endpoint was mean Post Atherectomy Stenosis (PAS), defined as the mean residual diameter stenosis after treatment with atherectomy without adjunctive therapy. The observed PAS was 41.1% ± 19.2% for the FAST II cohort and 46.2%± 17.1% for the PVI Registry Cohort. The FAST II PAS was demonstrated to be statistically non-inferior to the registry PAS using an alpha of 0.025 and a non-inferiority margin of 7.0% thus meeting the primary effectiveness endpoint. Therefore, the FreedomFlow Atherectomy device can be considered equivalent in performance as compared to similar, commercially-available products.
Key Metrics
Freedom from major adverse events was 92.9% with a lower 95% confidence interval of 86.4%.
Rate of technical success was 67.4% with a lower 95% confidence interval of 58.7%.
Observed PAS was 41.1% ± 19.2% for the FAST II cohort and 46.2% ± 17.1% for the PVI Registry Cohort.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
September 27, 2023
Cardio Flow, Inc. % Caitlyn Dzhafarov Sr. Regulatory Consultant Medical Devices Pathway, LLC. 19420 12th Ave NW Shoreline, Washington 98177
Re: K231538
Trade/Device Name: FreedomFlow Orbital Circumferential Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: Mav 27, 2023 Received: May 30, 2023
Dear Caitlyn Dzhafarov:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Ariel G. Ash- Ariel G. Ash-shakoor shakoor -S Date: 2023.09.27 09:53:51 -04'00'
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices
2
OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name
FreedomFlow™ Orbital Circumferential Atherectomy System
Indications for Use (Describe)
The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intends who are acceptable candidates for percutaneous transluminal atherectomy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
5.0 510(k) Summary
This 510(k) summary was prepared to provide an explanation of the basis for the determination of substantial equivalence in accordance with the requirements 21 CFR 807.92.
| Submitters Name: | Cardio Flow, Inc.
3530 88th Ave NE
Blaine, MN 55014 |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Contact Person: | Michael J. Kallok, Ph.D., FACC, FAHA; Chief Executive Officer,
Director, Cardio Flow, Inc. |
| Contact Phone: | (800) 294-5517 |
| Date Summary Prepared: | August 22nd, 2023 |
| Device Trade Name: | FreedomFlow™ Orbital Circumferential Atherectomy System |
| Common Name: | Peripheral Atherectomy Device |
| Classification Name: | 21 CFR 870.4875, Peripheral Atherectomy Catheter, Class II
Product Code: MCW |
| Predicate Device: | K110389, Stealth 360™ Orbital PAD System [Diamondback 360°]
Cardiovascular Systems, Inc. |
| Reference Device
Supporting Clinical
Effectiveness: | K191419, Revolution Peripheral Atherectomy System
Rex Medical, L.P. |
Device Description
The FreedomFlow™ Orbital Circumferential Atherectomy System is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply.
The User Handle with the integrated driveshaft is sterile, single use, and disposable. Both 5 Fr and 6 Fr variations of the User Handle are available. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.
5
Intended Use of the Device
The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.
Summary of Technological Characteristics
The mechanism of operation of the FreedomFlow System is similar to other high speed rotational devices utilizing Orbital Atherectomy principles. The Atherectomy System includes multiple abrasive spheres on a rotating driveshaft. The abrasive spheres are eccentrically mounted onto the driveshaft so that when the driveshaft is rotated, the spheres move outward due to centrifugal force. These abrasive spheres are spaced along the driveshaft in a spiral configuration to optimize plaque modification through inertial forces within a vessel while still maintaining flexibility that is important in advancing through tortuous arterial anatomy. The configuration of the multiple spheres and spiral orientation are designed to optimize inertial forces at low (50 krpm) and high (76 krpm) speeds with multiple points of contact with the vessel wall during rotation, which is designed to modify plaque within the intimal luminal area and medial wall layers.
The 5 Fr variation driveshaft is compatible with a 5 Fr size introducer, the 6 Fr variation is compatible with a 6 Fr size introducer. The driveshaft of both variations has a lumen that allows translation and rotation on a 0.014" atherectomy guidewire.
| Substantial Equivalence Technical Characteristics | ||
|---|---|---|
| Feature | FreedomFlow Orbital Circumferential | |
| Atherectomy System | ||
| (Subject Device) | Stealth 360™ / Diamondback 360° Orbital PAD | |
| System | ||
| (Predicate Device: K110389) | ||
| Product Code, | ||
| Classification | MCW, | |
| 21 CFR 870.4875 Intraluminal artery | ||
| stripper, Class II | MCW, | |
| 21 CFR 870.4875 Intraluminal artery stripper, Class II | ||
| Intended Use | Peripheral atherectomy: Peripheral artery | |
| luminal gain by plaque removal. | Peripheral atherectomy: Peripheral artery luminal gain | |
| by plaque removal. | ||
| Indications for | ||
| Use | The FreedomFlow™ Orbital Circumferential | |
| Atherectomy System is indicated for use as a | ||
| therapy in patients with occlusive | ||
| atherosclerotic disease in peripheral arteries. | ||
| The therapy is intended for patients who are | ||
| acceptable candidates for percutaneous | ||
| transluminal atherectomy. | 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. | ||
| Substantial Equivalence Technical Characteristics | ||
| Feature | FreedomFlow Orbital Circumferential | |
| Atherectomy System | ||
| (Subject Device) | Stealth 360TM / Diamondback 360° Orbital PAD | |
| System | ||
| (Predicate Device: K110389) | ||
| Prescription Use | ||
| Only | Yes | Yes |
| Single patient | ||
| use, disposable | Yes | Yes |
| Target Body | ||
| Location | Peripheral | Peripheral |
| Orbital Atherectomy | Orbital Atherectomy | |
| Mechanism of | ||
| Operation | Five (5) diamond coated, eccentrically | |
| mounted, rotating surfaces (Spheres) on an | ||
| electric motor driven rotating driveshaft to | ||
| remove stenotic tissue. | One (1) diamond coated, eccentrically rotating surface | |
| (Crown) on an electric motor driven, rotating driveshaft | ||
| to remove stenotic tissue. | ||
| System | ||
| Components | Three (3): |
- User Handle with internal saline pump
- Tubing Set
- External Power supply | Three (3):
- User Handle
- Tubing Set
- External saline pump with power supply |
| Driveshaft
Variations | 5 Fr and 6 Fr | 4 Fr, 5 Fr, 6 Fr, 7 Fr |
| Driveshaft
Working Length | 135 cm working length for 6 Fr User Handle
150 cm working length for 5 Fr User Handle | 145 cm working length |
| Rotational Speed | 2 Speeds:
50 krpm and 76 krpm | 3 Speeds:
60 krpm, 90 krpm, and 120 krpm |
| Saline flow rate | 10 ml/minute minimum | 5 ml/min to 30 ml/min |
| Shelf life | 2 Years | 2 Years |
| Provided sterile
by Ethylene
Oxide Process | Yes | Yes |
| Non-Pyrogenic | Yes | Yes |
| Sterile barrier | Yes | Yes |
| package | Tyvek lidded tray | Tyvek pouched tray |
| Atherectomy
lubricant | None | Yes |
| Driveshaft
tracked over
compatible
guidewire | Yes
0.014" atherectomy guidewire | Yes
0.014" atherectomy guidewire |
| Software
(Firmware) | Yes | Yes |
| Control Power | External Power Supply
100 to 240 VAC input | External Power Supply
100 to 240 VAC input |
6
7
Non-Clinical Performance Tests to Demonstrate Substantial Equivalency
To establish the technical equivalence of the FreedomFlow System, bench evaluations were conducted to confirm compliance with performance requirements.
| Test | Test Method Summary | Result | ||
|---|---|---|---|---|
| The following Test and Test methods were applied to the same or equivalent methods described in the FDA Guidance: | ||||
| Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions, May 20, 2021: | ||||
| Dimensional Verification Simulated-Use Testing Kink Resistance Corrosion Resistance Heat Generation | Torsional Strength Tensile Strength Rotational Speed Plaque Removal Efficiency Particulate Evaluation | Infusion Flow Rate Embolization Analysis Life Cycle/Fatigue Orbit Testing Coating Integrity | Pass | |
| Usability | ||||
| Validation | Tested in accordance with IEC 60601-1-6:2013 Medical electrical equipment - Part 1-6: | |||
| General requirements for basic safety and essential performance - Collateral standard: | ||||
| Usability and FDA Guidance (2016): Applying Human Factors and Usability Engineering to | ||||
| Medical Devices and ANSI/AAMI HE75:2009 (R2018), Human Factors Engineering - | ||||
| Design Of Medical Devices | Pass | |||
| Biocompatibility | Evaluated and Tested to ISO 10993-1:2018 Biological evaluation of medical devices - Part | |||
| 1: Evaluation and testing within a risk management process and FDA Recognized | ||||
| Consensus Standards for: Cytotoxicity MEM Elution, (indirect material User Handle); | ||||
| Cytotoxicity MEM Elution; Neural Red Uptake Cytotoxicity Assay; Acute Systemic | ||||
| Toxicity Test; ASTM Direct Contact Hemolysis; Material Mediated Pyrogenicity Test; | ||||
| Intracutaneous Reactivity Test; Guinea Pig Maximization Test; Complement Activation of | ||||
| Direct Blood Contacting Components, SC5b-9; Partial Thromboplastin Time of Direct | ||||
| Blood Contacting Components; Platelet/Leukocyte Count of Direct Blood Contacting | ||||
| Components | Pass | |||
| Software | Software validation, verification and applicable documentation were provided in conformance to | |||
| the FDA guidance documents: "Guidance for the Content of Premarket Submissions for | ||||
| Software Contained in Medical Devices" and "FDA guidance, "Content of Premarket | ||||
| Submissions for Management of Cybersecurity in Medical Devices" and IEC 62304:2015 | ||||
| Medical Device Software - Software Life Cycle Processes | Pass | |||
| Electrical | Tested to 60601-1 Electrical Safety (IEC 60601-1:2005, COR1:2006, COR2:2007, | |||
| AMD1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and | ||||
| Essential Performance) and EMC/EMI Compliance (IEC 60601-1-2:2014, Medical Electrical | ||||
| Equipment -- Part 1- 2: General Requirements for Basic Safety and Essential Performance -- | ||||
| Collateral Standard: Electromagnetic Disturbances - Requirements and Tests) | Pass | |||
| Sterility | Sterilization of the subject device was validated according to ANSI/AAMI/ISO 11135:2014, | |||
| Sterilization of healthcare products – Ethylene oxide - Requirements for development, | ||||
| validation and routine control of a sterilization process for medical devices, with a minimum | ||||
| sterility assurance level (SAL) of 10-6. | Pass | |||
| Sterile barrier | ||||
| integrity | The sterile barrier package is a Tyvek lidded tray. The methods applied to evaluate the sterile | |||
| barrier package integrity included post terminal sterilization simulated distribution (ASTM | ||||
| D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems), seal | ||||
| peel and bubble emission testing (ASTM F2096-11 Standard Test Method for Detecting Gross | ||||
| Leaks in Packaging by Internal Pressurization). | Pass | |||
| Shelf life | Confirmation of device functional performance and sterile barrier integrity (seal peel per ASTM | |||
| F88 and bubble leak per ASTM F2096) with accelerated aging and simulated distribution | ||||
| (ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and | ||||
| Systems) and bubble leak (ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in | ||||
| Packaging by Internal Pressurization)) | Pass |
8
Animal and cadaveric model evaluations were applied to support pre-clinical safety and effectiveness and testing included in-vivo thrombogenicity.
Clinical Performance Tests to Demonstrate Substantial Equivalencv
A prospective, multi-center, single arm, open-label Clinical Study (FAST II study, NCT03635190) was conducted to evaluate the safety and effectiveness of the FreedomFlow™ System in patients with symptomatic peripheral arterial disease (PAD) of the lower extremities. The FAST II study met the predefined primary safety endpoint (Freedom from MAE at 30 days). The rate of freedom from major adverse events was 92.9% with a lower 95% confidence interval of 86.4%, meeting the performance goal of 85%. The study did not meet the pre-defined primary effectiveness endpoint (technical success defined as ability to achieve residual diameter stenosis less than 50% without adjunctive therapy, utilizing the core lab adjudicated data). The rate of technical success rate was 67.4% with a lower 95% confidence interval of 58.7%, missing the performance goal of 86%.
To provide a supplemental analysis of the FAST II effectiveness performance, Cardio Flow conducted a matched comparison of the FAST II FreedomFlow debulking effectiveness, as measured by post atherectomy stenosis, to real world evidence obtained from the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry of rotational and orbital atherectomy cases. Specifically, registry candidate patients were refined using propensity scoring to identify a control cohort of patients with well-balanced baseline covariates that included parameters relevant to atherectomy debulking. Raw data (i.e., arteriographic images) from the cohort registry and the FAST II study were randomized for blinded analysis by an independent angiographic core-laboratory. The primary study endpoint was mean Post Atherectomy Stenosis (PAS), defined as the mean residual diameter stenosis after treatment with atherectomy without adjunctive therapy. The observed PAS was 41.1% ± 19.2% for the FAST II cohort and 46.2%± 17.1% for the PVI Registry Cohort. The FAST II PAS was demonstrated to be statistically non-inferior to the registry PAS using an alpha of 0.025 and a non-inferiority margin of 7.0% thus meeting the primary effectiveness endpoint. Therefore, the FreedomFlow Atherectomy device can be considered equivalent in performance as compared to similar, commercially-available products.
Conclusion
With respect to the subject FreedomFlow Orbital Atherectomy System, comparison to a predicate device, Diamondback 360°, the Freedom Flow has the same intended use, the same technological characteristics, similar clinical and scientific data supporting substantially equivalent safety and performance outcomes as the legally marketed predicate device. The non-clinical and clinical data provide valid scientific evidence to support the conclusion that there are no different questions of safety and effectiveness raised when
9
compared to the predicate device. The combination of data demonstrate the FreedomFlow Orbital Atherectomy System is substantially equivalent to the predicate device.