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

K233483 · Cardio Flow Inc., · MCW · Feb 15, 2024 · Cardiovascular

Device Facts

• Record ID: K233483
• Device Name: FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
• Applicant: Cardio Flow Inc.,
• Product Code: MCW · Cardiovascular
• Decision Date: Feb 15, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

FreedomFlow™ Orbital Circumferential Atherectomy System is a flexible over-the-wire rotational device for ablating atherosclerotic plaque in peripheral arteries. System components include a sterile, single-use User Handle with integrated driveshaft, a Tubing Set for saline delivery, and a reusable AC-powered external Power Supply. The driveshaft features three eccentrically mounted, diamond-coated spheres in a spiral configuration. During operation, centrifugal force causes the rotating spheres to contact and modify plaque within the vessel wall. The operator controls rotation speed (50 krpm or 76 krpm) and translation via the handle. The device tracks over a 0.014" guidewire. Used in clinical settings by physicians, the device facilitates luminal gain by removing stenotic tissue. The reduction from five to three spheres increases distal driveshaft flexibility for treating tortuous infrapopliteal anatomy.

Clinical Evidence

No human clinical trials were conducted. Evidence consists of bench testing (dimensional analysis, orbit characterization, simulated life, torque stall, joint tensile/torque, particulate analysis) and a formal prospective, single-center pre-clinical evaluation using a perfused human cadaver model to compare debulking effectiveness and adverse event incidence against the predicate.

Technological Characteristics

Orbital atherectomy system; 5Fr diameter; 3 diamond-coated spheres; 150 cm working length; 0.014" guidewire compatible; 50/76 krpm rotational speeds; saline-cooled; external AC/DC power supply; firmware-controlled handle; sterile (Ethylene Oxide, SAL ≤ 10^-6); single-use disposable handle/tubing.

Indications for Use

Indicated for patients with occlusive atherosclerotic disease in peripheral arteries who are candidates for percutaneous transluminal atherectomy.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• FreedomFlow™ Orbital Circumferential Atherectomy System, Model H6001 5Fr 5-Sphere (K231538)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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.<br>3530 88th Ave NE<br>Blaine, MN 55014 |
|------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael J. Kallok, Ph.D., FACC, FAHA; Chief Executive Officer,<br>Director, Cardio Flow, Inc. |
| Contact Phone: | [phone] |
| Date Summary Prepared: | February 13th, 2024 |
| Device Trade Name: | FreedomFlow™ Orbital Circumferential Atherectomy System (H6004<br>5Fr 3-Sphere) |
| Common Name: | Peripheral Atherectomy Device |
| Classification Name: | 21 CFR 870.4875, Peripheral Atherectomy Catheter, Class II<br>Product Code: MCW |
| Predicate Device: | K231538, FreedomFlow™ Orbital Circumferential Atherectomy System<br>Cardio Flow, Inc., Model H6001 5Fr 5-Sphere |

#### 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.

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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™ Orbital<br>Circumferential<br>Atherectomy System (H6004<br>5Fr 3-Sphere)<br>(Subject Device) | FreedomFlow Orbital<br>Circumferential<br>Atherectomy System H6001<br>(Predicate Device, K231538) | Substantial<br>Equivalence<br>Comments |
| Product Code,<br>Classification | MCW,<br>21 CFR 870.4875 Intraluminal<br>artery stripper, Class II | MCW,<br>21 CFR 870.4875 Intraluminal<br>artery stripper, Class II | Same |
| Intended Use | Peripheral atherectomy:<br>Peripheral artery luminal gain<br>by plaque removal. | Peripheral atherectomy:<br>Peripheral artery luminal gain<br>by plaque removal. | Same |
| Indications for<br>Use | The FreedomFlow™ Orbital<br>Circumferential Atherectomy<br>System is indicated for use as<br>a therapy in patients with<br>occlusive atherosclerotic<br>disease in peripheral arteries.<br>The therapy is intended for | The FreedomFlow™ Orbital<br>Circumferential Atherectomy<br>System is indicated for use as<br>a therapy in patients with<br>occlusive atherosclerotic<br>disease in peripheral arteries.<br>The therapy is intended for | Same |
| Table 1: Comparison to Predicate | | | |
| Feature | FreedomFlow™ Orbital<br>Circumferential<br>Atherectomy System (H6004<br>5Fr 3-Sphere)<br>(Subject Device) | FreedomFlow Orbital<br>Circumferential<br>Atherectomy System H6001<br>(Predicate Device, K231538) | Substantial<br>Equivalence<br>Comments |
| | patients who are acceptable<br>candidates for percutaneous<br>transluminal atherectomy. | patients who are acceptable<br>candidates for percutaneous<br>transluminal atherectomy. | |
| Prescription Use<br>Only | Yes | Yes | Same |
| Single patient use,<br>disposable | Yes | Yes | Same |
| Target Body<br>Location | Peripheral | Peripheral | Same |
| Mechanism of<br>Operation /<br>Action (MOA) | Orbital Atherectomy<br>Three (3) diamond coated,<br>eccentrically mounted, rotating<br>surfaces (Spheres) on an<br>electric motor driven rotating<br>driveshaft at high speed to<br>remove stenotic tissue. A<br>diamond coated distal<br>hypotube is attached near the<br>tip of the driveshaft to aid<br>driveshaft into tight lesions. | Orbital Atherectomy<br>Five (5) diamond coated,<br>eccentrically mounted, rotating<br>surfaces (Spheres) on an<br>electric motor driven rotating<br>driveshaft at high speed to<br>remove stenotic tissue. A<br>diamond coated distal<br>hypotube is attached near the<br>tip of the driveshaft to aid<br>driveshaft into tight lesions. | Same |
| System<br>Components | Three (3):<br>1. User Handle with internal<br>saline pump<br>2. Tubing Set<br>3. External Power supply | Three (3):<br>1. User Handle with internal<br>saline pump<br>2. Tubing Set<br>3. External Power supply | Same |
| Driveshaft<br>Variations | 5 Fr<br>Three (3) diamond coated,<br>eccentrically mounted, rotating<br>surfaces (Spheres) on an<br>electric motor driven rotating<br>driveshaft. A distal diamond<br>coated hypotube aids the<br>driveshaft into tight lesions. | 5 Fr<br>Five (5) diamond coated,<br>eccentrically mounted, rotating<br>surfaces (Spheres) on an<br>electric motor driven rotating<br>driveshaft. A distal diamond<br>coated hypotube aids the<br>driveshaft into tight lesions. | Similar<br>The 5Fr, 3-sphere<br>configuration (H6004)<br>reduces the number of<br>spheres from 5 down to<br>3 to allow for more<br>flexibility of the distal<br>driveshaft.<br>Even with a reduction in<br>number of spheres, the<br>5Fr 3-sphere<br>configuration (H6004)<br>has demonstrated a<br>substantially equivalent<br>performance to the<br>predicate device model<br>configuration (H6001). |
| Driveshaft<br>Working Length | 150 cm working length for 5<br>Fr User Handle | 150 cm working length for 5<br>Fr User Handle | Same |
| Rotational Speed | 2 Speeds: | 2 Speeds: | Same |
| Table 1: Comparison to Predicate | | | |
| Feature | FreedomFlow™ Orbital<br>Circumferential<br>Atherectomy System (H6004<br>5Fr 3-Sphere)<br>(Subject Device) | FreedomFlow Orbital<br>Circumferential<br>Atherectomy System H6001<br>(Predicate Device, K231538) | Substantial<br>Equivalence<br>Comments |
| | 50 krpm and 76 krpm | 50 krpm and 76 krpm | |
| Display of speed<br>in rpm on user<br>handle | No | No | Same |
| Saline flow rate | 10 ml/minute minimum | 10 ml/minute minimum | Same |
| Shelf life | 2 Years | 2 Years | Same |
| Provided sterile<br>by Ethylene<br>Oxide Process | Yes | Yes | Same |
| Sterility<br>Assurance Level<br>(SAL) | SAL ≤ 10-6 | SAL ≤ 10-6 | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Sterile barrier<br>package | Yes<br>Tyvek lidded tray | Yes<br>Tyvek lidded tray | Same |
| Atherectomy<br>Lubricant | None | None | Same |
| Driveshaft<br>tracked over<br>compatible<br>guidewire | Yes<br>Commercially available 0.014"<br>compatible guidewire | Yes<br>Commercially available<br>0.014" atherectomy guidewire | Same |
| Guidewire Clamp | Yes | Yes | Same |
| User Handle<br>traverse distance<br>of driveshaft | 12 cm | 12 cm | Same |
| Software<br>(Firmware) | Yes | Yes | Same |
| Control Power<br>Source | External Power Supply<br>100 to 240 VAC input | External Power Supply<br>100 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 Analysis<br>Testing | The subject device utilizes a different distal-driveshaft dimension as compared to<br>the predicate. Dimensional analysis measurements assess diameters, lengths,<br>angle orientation of the distal driveshaft dimensions. |
| Orbit Characterization<br>Testing | Effectiveness of sanding technology as a measure of lumen diameter versus<br>speed versus time. Maintains speed range and tolerance within simulated<br>anatomy and characterization of orbit for subject device User Handle which<br>includes 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 highest<br>speed in simulated peripheral anatomy model. |
| Torque Stall and Loaded<br>Start Test | User Handle driveshaft assembly will not deform or be damaged during forced<br>simulated torque-stalls. |
| Joint Tensile Test | Destructive Joint Tensile Testing. |
| Joint Torque Test | Destructive Joint Torque Testing. |
| Particulate Analysis<br>Comparison Test | Particulate analysis testing to compare total particulate mean size and particulate<br>counts of the subject device (5Fr 3-Sphere) and the predicate device (5Fr 5-<br>Sphere). |
| Electric System Human<br>Cadaver Pre-Clinical Test | Formal prospective, single-center evaluation using a perfused human cadaver<br>model to compare the debulking effectiveness and incidence of adverse events<br>for 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.