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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Primary Safety Endpoint: Freedom from Major Adverse Events (MAE) at 30 days. Performance Goal: > 85%	Achieved. Rate of freedom from MAE was 92.9% with a lower 95% confidence interval of 86.4%.
Primary Effectiveness Endpoint (Original): Technical success defined as the ability to achieve residual diameter stenosis less than 50% without adjunctive therapy. Performance Goal: 86%	Not met. The technical success rate was 67.4% with a lower 95% confidence interval of 58.7%, missing the performance goal of 86%.
Primary Effectiveness Endpoint (Supplemental): Mean Post Atherectomy Stenosis (PAS) statistically non-inferior to a PVI Registry Cohort, using an alpha of 0.025 and a non-inferiority margin of 7.0%.	Achieved. The observed PAS was 41.1% ± 19.2% for the FAST II cohort, and 46.2% ± 17.1% for the PVI Registry Cohort. FAST II PAS was demonstrated to be statistically non-inferior to the registry PAS.
Non-Clinical Performance Tests: (Dimensional Verification, 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, Usability Validation, Biocompatibility, Software, Electrical, Sterility, Sterile Barrier Integrity, Shelf life)	All non-clinical tests passed, demonstrating compliance with performance requirements and relevant standards (e.g., FDA guidance for Peripheral Vascular Atherectomy Devices, IEC 60601-1-6, ANSI/AAMI HE75, ISO 10993-1, IEC 62304, IEC 60601-1, IEC 60601-1-2, ANSI/AAMI/ISO 11135, ASTM D4169-16, ASTM F2096-11, ASTM F88). Animal and cadaveric model evaluations also supported pre-clinical safety and effectiveness, including in-vivo thrombogenicity.

Study Details

2. Sample sizes used for the test set and the data provenance

FAST II Study (Primary Clinical Study):
- The exact sample size isn't explicitly stated for this part, but it refers to "patients with symptomatic peripheral arterial disease (PAD) of the lower extremities."
- Provenance: Prospective, multi-center, single-arm, open-label clinical study. No specific country of origin is mentioned, but "multi-center" implies multiple locations.
Supplemental Analysis (Matched Comparison):
- FAST II Cohort: The same patient cohort from the FAST II study.
- PVI Registry Cohort: Real-world evidence obtained from the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry. This cohort was refined using propensity scoring to identify a control group with well-balanced baseline covariates.
- Provenance: This involves data from a prospective clinical study (FAST II) and retrospective registry data (VQI PVI). The "real-world evidence" suggests a broader, likely multi-national or U.S.-based, data source.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For the "raw data (i.e., arteriographic images) from the cohort registry and the FAST II study," an independent angiographic core-laboratory was used for blinded analysis.
The number and specific qualifications of experts within this core-laboratory are not explicitly detailed in the provided text.

4. Adjudication method for the test set

For the supplemental effectiveness analysis, the "raw data (i.e., arteriographic images)" were "randomized for blinded analysis by an independent angiographic core-laboratory." This implies a blinded, independent review process. The specific number of readers or a 2+1, 3+1 method is not stated, but the "core-laboratory" typically suggests a robust, structured review process.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned or performed. This submission is for an atherectomy system (a physical medical device) and its associated firmware, not a diagnostic AI system designed to assist human readers in interpreting images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this is not applicable. The FreedomFlow Orbital Circumferential Atherectomy System is a physical medical device. While it includes firmware (software), the studies described evaluate the device's clinical and non-clinical performance, not the standalone performance of an algorithm that generates an interpretation or diagnosis without human interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Clinical Outcomes Data: The primary safety endpoint (freedom from MAE) and primary effectiveness endpoints (technical success, Post Atherectomy Stenosis) are based on direct clinical outcomes measured in patients.
Expert Adjudication: For the effectiveness endpoint, residual diameter stenosis was determined by an "independent angiographic core-laboratory," which implies expert consensus based on angiographic images.

8. The sample size for the training set

Not applicable/Not provided. This information pertains to machine learning models. The studies described are evaluating a physical medical device, not training a machine learning model for diagnostic or predictive purposes where a distinct training set would be required for the evaluation itself. The "propensity scoring" used in the supplemental analysis to "refine" and "identify a control cohort" from the PVI registry is a statistical matching technique, not a machine learning training process in the sense of an algorithm.

9. How the ground truth for the training set was established

Not applicable/Not provided. As there is no described training set for a machine learning model in this context, the method for establishing its ground truth is not relevant here.

Summary

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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"

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(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

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OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K231538

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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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 NEBlaine, 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 IIProduct Code: MCW
Predicate Device:	K110389, Stealth 360™ Orbital PAD System [Diamondback 360°]Cardiovascular Systems, Inc.
Reference DeviceSupporting ClinicalEffectiveness:	K191419, Revolution Peripheral Atherectomy SystemRex Medical, L.P.

Device Description

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Intended Use of the Device

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 CircumferentialAtherectomy System(Subject Device)	Stealth 360™ / Diamondback 360° Orbital PADSystem(Predicate Device: K110389)
Product Code,Classification	MCW,21 CFR 870.4875 Intraluminal arterystripper, Class II	MCW,21 CFR 870.4875 Intraluminal artery stripper, Class II
Intended Use	Peripheral atherectomy: Peripheral arteryluminal gain by plaque removal.	Peripheral atherectomy: Peripheral artery luminal gainby plaque removal.
Indications forUse	The FreedomFlow™ Orbital CircumferentialAtherectomy System is indicated for use as atherapy in patients with occlusiveatherosclerotic disease in peripheral arteries.The therapy is intended for patients who areacceptable candidates for percutaneoustransluminal atherectomy.	The Stealth 360° Orbital PAD System is a percutaneousorbital atherectomy system indicated for use as therapyin patients with occlusive atherosclerotic disease inperipheral arteries and who are acceptable candidates forpercutaneous transluminal atherectomy.The OAS supports removal of stenotic material fromartificial arteriovenous dialysis fistulae (AV shunt). TheOAS is a percutaneous orbital atherectomy systemindicated as a therapy in patients with occludedhemodialysis grafts who are acceptable candidates forpercutaneous transluminal angioplasty.
Substantial Equivalence Technical Characteristics
Feature	FreedomFlow Orbital CircumferentialAtherectomy System(Subject Device)	Stealth 360TM / Diamondback 360° Orbital PADSystem(Predicate Device: K110389)
Prescription UseOnly	Yes	Yes
Single patientuse, disposable	Yes	Yes
Target BodyLocation	Peripheral	Peripheral
	Orbital Atherectomy	Orbital Atherectomy
Mechanism ofOperation	Five (5) diamond coated, eccentricallymounted, rotating surfaces (Spheres) on anelectric motor driven rotating driveshaft toremove stenotic tissue.	One (1) diamond coated, eccentrically rotating surface(Crown) on an electric motor driven, rotating driveshaftto remove stenotic tissue.
SystemComponents	Three (3):1. User Handle with internal saline pump2. Tubing Set3. External Power supply	Three (3):1. User Handle2. Tubing Set3. External saline pump with power supply
DriveshaftVariations	5 Fr and 6 Fr	4 Fr, 5 Fr, 6 Fr, 7 Fr
DriveshaftWorking Length	135 cm working length for 6 Fr User Handle150 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 sterileby EthyleneOxide Process	Yes	Yes
Non-Pyrogenic	Yes	Yes
Sterile barrier	Yes	Yes
package	Tyvek lidded tray	Tyvek pouched tray
Atherectomylubricant	None	Yes
Driveshafttracked overcompatibleguidewire	Yes0.014" atherectomy guidewire	Yes0.014" atherectomy guidewire
Software(Firmware)	Yes	Yes
Control Power	External Power Supply100 to 240 VAC input	External Power Supply100 to 240 VAC input

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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
UsabilityValidation	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 toMedical 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 - Part1: Evaluation and testing within a risk management process and FDA RecognizedConsensus Standards for: Cytotoxicity MEM Elution, (indirect material User Handle);Cytotoxicity MEM Elution; Neural Red Uptake Cytotoxicity Assay; Acute SystemicToxicity Test; ASTM Direct Contact Hemolysis; Material Mediated Pyrogenicity Test;Intracutaneous Reactivity Test; Guinea Pig Maximization Test; Complement Activation ofDirect Blood Contacting Components, SC5b-9; Partial Thromboplastin Time of DirectBlood Contacting Components; Platelet/Leukocyte Count of Direct Blood ContactingComponents		Pass
Software	Software validation, verification and applicable documentation were provided in conformance tothe FDA guidance documents: "Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices" and "FDA guidance, "Content of PremarketSubmissions for Management of Cybersecurity in Medical Devices" and IEC 62304:2015Medical 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 andEssential Performance) and EMC/EMI Compliance (IEC 60601-1-2:2014, Medical ElectricalEquipment -- 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 minimumsterility assurance level (SAL) of 10-6.		Pass
Sterile barrierintegrity	The sterile barrier package is a Tyvek lidded tray. The methods applied to evaluate the sterilebarrier package integrity included post terminal sterilization simulated distribution (ASTMD4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems), sealpeel and bubble emission testing (ASTM F2096-11 Standard Test Method for Detecting GrossLeaks in Packaging by Internal Pressurization).		Pass
Shelf life	Confirmation of device functional performance and sterile barrier integrity (seal peel per ASTMF88 and bubble leak per ASTM F2096) with accelerated aging and simulated distribution(ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers andSystems) and bubble leak (ASTM F2096-11 Standard Test Method for Detecting Gross Leaks inPackaging by Internal Pressurization))		Pass

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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

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compared to the predicate device. The combination of data demonstrate the FreedomFlow Orbital Atherectomy System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).