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 (H6004 5Fr 3-Sphere) 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. 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

The provided text describes a medical device, the FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere), and its substantial equivalence determination by the FDA. However, the document does not contain the level of detail requested regarding acceptance criteria and the specifics of a study proving a device meets these criteria in the context of an AI/human-in-the-loop system.

The "study" mentioned in this document refers to performance testing for a mechanical medical device, specifically:

Dimensional Analysis Testing
Orbit Characterization Testing (effectiveness of sanding technology, lumen diameter vs. speed vs. time, plaque removal efficiency)
Simulated Life Test
Torque Stall and Loaded Start Test
Joint Tensile Test
Joint Torque Test
Particulate Analysis Comparison Test
Electric System Human Cadaver Pre-Clinical Test

There is no indication that this device incorporates AI or sophisticated software that would necessitate human-in-the-loop performance studies, expert ground truth adjudication, or metrics like sensitivity, specificity, or AUC, which are typically associated with AI-powered diagnostic or assistive devices.

Therefore, I cannot provide the requested information in the format of the questions because the document describes a mechanical atherectomy system, not a device whose performance is measured in the ways implied by the prompt's questions (e.g., AI assistance, expert readers, ground truth establishment for AI training/testing).

If the prompt intended for me to infer or create a hypothetical scenario for an AI-powered atherectomy system, I would need additional context or a different document. Based only on the provided text, the questions are not applicable to the described device and its testing.

Summary

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February 15, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Cardio Flow Inc. % Caitlyn Dzhafarov Regulatory Affairs Consultant Medical Devices Pathway, LLC. 14330 178th Lane NE Woodinville, Washington 98072

Re: K233483

Trade/Device Name: FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere) Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II Product Code: MCW Dated: January 18, 2024 Received: January 18, 2024

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 (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-shakoor -S Ariel G. Ash-shakoor -S Date: 2024.02.15 08:56:24 -05'00'

For

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K233483

Device Name

FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere)

Indications for Use (Describe)

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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K233483

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:	February 13th, 2024
Device Trade Name:	FreedomFlow™ Orbital Circumferential Atherectomy System (H60045Fr 3-Sphere)
Common Name:	Peripheral Atherectomy Device
Classification Name:	21 CFR 870.4875, Peripheral Atherectomy Catheter, Class IIProduct Code: MCW
Predicate Device:	K231538, FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow, Inc., Model H6001 5Fr 5-Sphere

Device Description

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K233483

Intended Use of the Device

The FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere) 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 modified FreedomFlow System (H6004 5Fr 3-Sphere) is the same as the predicate FreedomFlow System (H6001, 5Fr 5-Sphere cleared by K231538). 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 allowing for improved flexibility that is important in advancing through tortuous arterial anatomy. The configuration of the 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 and has a lumen that allows translation and rotation on a 0.014" atherectorny guidewire. The FreedomFlow proposed subject device (5 Fr 3-sphere configuration H6004) increases the spacing between spheres while maintaining a similar sphere treatment length by reducing the number of spheres from 5 to 3 to allow for more flexibility of the distal driveshaft as an option for user device selection while treating infrapopliteal vessels.

Table 1: Comparison to Predicate
Feature	FreedomFlow™ OrbitalCircumferentialAtherectomy System (H60045Fr 3-Sphere)(Subject Device)	FreedomFlow OrbitalCircumferentialAtherectomy System H6001(Predicate Device, K231538)	SubstantialEquivalenceComments
Product Code,Classification	MCW,21 CFR 870.4875 Intraluminalartery stripper, Class II	MCW,21 CFR 870.4875 Intraluminalartery stripper, Class II	Same
Intended Use	Peripheral atherectomy:Peripheral artery luminal gainby plaque removal.	Peripheral atherectomy:Peripheral artery luminal gainby plaque removal.	Same
Indications forUse	The FreedomFlow™ OrbitalCircumferential AtherectomySystem is indicated for use asa therapy in patients withocclusive atheroscleroticdisease in peripheral arteries.The therapy is intended for	The FreedomFlow™ OrbitalCircumferential AtherectomySystem is indicated for use asa therapy in patients withocclusive atheroscleroticdisease in peripheral arteries.The therapy is intended for	Same
Table 1: Comparison to Predicate
Feature	FreedomFlow™ OrbitalCircumferentialAtherectomy System (H60045Fr 3-Sphere)(Subject Device)	FreedomFlow OrbitalCircumferentialAtherectomy System H6001(Predicate Device, K231538)	SubstantialEquivalenceComments
	patients who are acceptablecandidates for percutaneoustransluminal atherectomy.	patients who are acceptablecandidates for percutaneoustransluminal atherectomy.
Prescription UseOnly	Yes	Yes	Same
Single patient use,disposable	Yes	Yes	Same
Target BodyLocation	Peripheral	Peripheral	Same
Mechanism ofOperation /Action (MOA)	Orbital AtherectomyThree (3) diamond coated,eccentrically mounted, rotatingsurfaces (Spheres) on anelectric motor driven rotatingdriveshaft at high speed toremove stenotic tissue. Adiamond coated distalhypotube is attached near thetip of the driveshaft to aiddriveshaft into tight lesions.	Orbital AtherectomyFive (5) diamond coated,eccentrically mounted, rotatingsurfaces (Spheres) on anelectric motor driven rotatingdriveshaft at high speed toremove stenotic tissue. Adiamond coated distalhypotube is attached near thetip of the driveshaft to aiddriveshaft into tight lesions.	Same
SystemComponents	Three (3):1. User Handle with internalsaline pump2. Tubing Set3. External Power supply	Three (3):1. User Handle with internalsaline pump2. Tubing Set3. External Power supply	Same
DriveshaftVariations	5 FrThree (3) diamond coated,eccentrically mounted, rotatingsurfaces (Spheres) on anelectric motor driven rotatingdriveshaft. A distal diamondcoated hypotube aids thedriveshaft into tight lesions.	5 FrFive (5) diamond coated,eccentrically mounted, rotatingsurfaces (Spheres) on anelectric motor driven rotatingdriveshaft. A distal diamondcoated hypotube aids thedriveshaft into tight lesions.	SimilarThe 5Fr, 3-sphereconfiguration (H6004)reduces the number ofspheres from 5 down to3 to allow for moreflexibility of the distaldriveshaft.Even with a reduction innumber of spheres, the5Fr 3-sphereconfiguration (H6004)has demonstrated asubstantially equivalentperformance to thepredicate device modelconfiguration (H6001).
DriveshaftWorking Length	150 cm working length for 5Fr User Handle	150 cm working length for 5Fr User Handle	Same
Rotational Speed	2 Speeds:	2 Speeds:	Same
Table 1: Comparison to Predicate
Feature	FreedomFlow™ OrbitalCircumferentialAtherectomy System (H60045Fr 3-Sphere)(Subject Device)	FreedomFlow OrbitalCircumferentialAtherectomy System H6001(Predicate Device, K231538)	SubstantialEquivalenceComments
	50 krpm and 76 krpm	50 krpm and 76 krpm
Display of speedin rpm on userhandle	No	No	Same
Saline flow rate	10 ml/minute minimum	10 ml/minute minimum	Same
Shelf life	2 Years	2 Years	Same
Provided sterileby EthyleneOxide Process	Yes	Yes	Same
SterilityAssurance Level(SAL)	SAL ≤ 10-6	SAL ≤ 10-6	Same
Non-Pyrogenic	Yes	Yes	Same
Sterile barrierpackage	YesTyvek lidded tray	YesTyvek lidded tray	Same
AtherectomyLubricant	None	None	Same
Driveshafttracked overcompatibleguidewire	YesCommercially available 0.014"compatible guidewire	YesCommercially available0.014" atherectomy guidewire	Same
Guidewire Clamp	Yes	Yes	Same
User Handletraverse distanceof driveshaft	12 cm	12 cm	Same
Software(Firmware)	Yes	Yes	Same
Control PowerSource	External Power Supply100 to 240 VAC input	External Power Supply100 to 240 VAC input	Same

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Summary of Testing to Support Substantial Equivalence

Table 2 below provides a summary of the testing performed to demonstrate substantial equivalence of the FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere) configuration to the predicate device, the 5 French 5-Sphere (H6001).

Performance Test	Description
Dimensional AnalysisTesting	The subject device utilizes a different distal-driveshaft dimension as compared tothe predicate. Dimensional analysis measurements assess diameters, lengths,angle orientation of the distal driveshaft dimensions.
Orbit CharacterizationTesting	Effectiveness of sanding technology as a measure of lumen diameter versusspeed versus time. Maintains speed range and tolerance within simulatedanatomy and characterization of orbit for subject device User Handle whichincludes plaque removal and removal efficiency.

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Performance Test	Description
Simulated Life Test	Simulated operating life test (up to 6 minutes) of FreedomFlow System at highestspeed in simulated peripheral anatomy model.
Torque Stall and LoadedStart Test	User Handle driveshaft assembly will not deform or be damaged during forcedsimulated torque-stalls.
Joint Tensile Test	Destructive Joint Tensile Testing.
Joint Torque Test	Destructive Joint Torque Testing.
Particulate AnalysisComparison Test	Particulate analysis testing to compare total particulate mean size and particulatecounts of the subject device (5Fr 3-Sphere) and the predicate device (5Fr 5-Sphere).
Electric System HumanCadaver Pre-Clinical Test	Formal prospective, single-center evaluation using a perfused human cadavermodel to compare the debulking effectiveness and incidence of adverse eventsfor the subject device (5Fr 3-Sphere) and predicate device (5Fr 5-Sphere).

Conclusion

With respect to the modified FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere) the subject device has the same intended use and similar technological characteristics as the legally marketed predicate device. The design control activities summarized provide valid scientific evidence to support the conclusion that there are no different questions of safety and effectiveness raised when compared to the 5 French 5-Sphere (H6001) predicate device. The modified FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere) is as safe and effective as the predicate, therefore, is substantially equivalent.

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).