FreedomFlow™ Orbital Circumferential Atherectomy System

K242947 · Cardio Flow Inc., · MCW · Nov 5, 2024 · Cardiovascular

Device Facts

• Record ID: K242947
• Device Name: FreedomFlow™ Orbital Circumferential Atherectomy System
• Applicant: Cardio Flow Inc.,
• Product Code: MCW · Cardiovascular
• Decision Date: Nov 5, 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 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.

Device Story

FreedomFlow™ is a flexible over-the-wire rotational atherectomy device for ablating peripheral arterial plaque. System comprises a sterile, single-use user handle with integrated driveshaft, a tubing set for saline delivery, and a reusable AC-powered transformer. Operator uses the handle to control driveshaft rotation (50 or 76 krpm) and translation over a 0.014" guidewire. Eccentrically mounted diamond-coated spheres on the driveshaft utilize centrifugal force to modify plaque within the vessel. Device is used in clinical settings by physicians. Changes in this submission include a transition from soldered to welded driveshaft attachment and an interchangeable internal pump head. These modifications do not alter device function or performance. The device enables luminal gain by removing stenotic tissue, potentially improving blood flow in patients with peripheral artery disease.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility testing of the new welded driveshaft design and verification testing of the interchangeable pump head.

Technological Characteristics

Orbital atherectomy system; diamond-coated spheres on rotating driveshaft; 5 Fr configuration; 150 cm working length; 50/76 krpm rotational speeds; saline-cooled; ethylene oxide sterilized; Tyvek lidded tray; AC-powered transformer; firmware-controlled user handle; compatible with 0.014" guidewires.

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 (K231538)
• FreedomFlow Orbital Circumferential Atherectomy System (K233483)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

November 5, 2024

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

Re: K242947

Trade/Device Name: FreedomFlow™ Orbital Circumferential Atherectomy System (H6001 & H6004) Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: September 24, 2024 Received: September 25, 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 (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.

{1}------------------------------------------------

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" (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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

{2}------------------------------------------------

assistance/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,

Ariel G. Ash- Digitally signed by
Ariel G. Ash-shakoor -S
shakoor -S Date: 2024.11.05
13:31:27 -05'00'

For

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices 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) K242947

Device Name

FreedomFlow™ Orbital Circumferential Atherectomy System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 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: | October 26, 2024 |
| Device Trade Name: | FreedomFlow™ Orbital Circumferential Atherectomy System |
| 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<br>System Cardio Flow, Inc.<br>&<br>K233483, FreedomFlow Orbital Circumferential Atherectomy System<br>(H6004/5Fr 3-Sphere Configuration) |

### Device Description

(H6001 & H6004)

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. 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}------------------------------------------------

#### Description of Change

Cardio Flow, Inc. is proposing to change the process of soldering the driveshaft to a welded process. The band-welded driveshaft is a manufacturing process change for attachment of diamond coated components to the driveshaft coil. The design of the finished driveshaft assembly is unchanged from that of the soldered version. Biocompatibility testing of this change demonstrated the new design of each configuration of the FreedomFlow™ H6001 and H6004 devices are biocompatible. There are no performances differences incurred as a result of this change.

A second change introduced in this submission is the proposed change to an interchangeable internal pump head. The design and function of the new pump is equivalent to the pump cleared under the predicate devices; there is no functional or mechanical differences in the pump design. Testing verifies all pump related specifications.

Table 1 below outlines the configurations of the FreedomFlow™ devices which are affected, and those which are unaffected, by the changes described above.

| Table 1. FreedomFlow™ Device Configurations and Effect of Changes Described | | | | | |
|-----------------------------------------------------------------------------|--------------------------------------------|--------------------------------|----------------------|-------------------|---------------------------------------|
| Model<br>Number | Description | Introducer Sheath<br>Size (Fr) | Vessel Size<br>Range | Working<br>Length | Affected by Changes<br>in this 510(k) |
| H6001 | User Handle 5 Fr 5-Sphere 150<br>cm Length | 5 French | 2.0 - 4.0 mm | 150 cm | Yes |
| H6002 | User Handle 6 Fr 5-Sphere 135<br>cm Length | 6 French | 4.0 - 8.0 mm | 135 cm | No |
| H6004 | User Handle 5 Fr 3-Sphere 150<br>cm Length | 5 French | 2.0 - 4.0 mm | 150 cm | Yes |

### Intended Use of the Device

#### (H6001 & H6004)

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

### (H6001 & H6004)

The mechanism of operation is a type of Orbital Atherectomy. 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

{6}------------------------------------------------

modification through inertial forces within a vessel. 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 driveshafts are compatible with a 5 Fr size introducer and have a lumen that allows translation and rotation on a 0.014" atherectomy guidewire.

| Feature | FreedomFlow Orbital<br>Circumferential Atherectomy<br>System (Subject Devices, H6001<br>and H6004) | FreedomFlow Orbital<br>Circumferential Atherectomy<br>System (Predicate Devices H6001<br>[K231538] & H6004 [K233483]) | Substantial Equivalence<br>Comments |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Product Code,<br>Classification | MCW,<br>21 CFR 870.4875 Intraluminal<br>artery stripper, Class II<br>(H6001 & H6004) | MCW,<br>21 CFR 870.4875 Intraluminal<br>artery stripper, Class II<br>(H6001 & H6004) | Same |
| Intended Use | Peripheral atherectomy:<br>Peripheral artery luminal gain by<br>plaque removal.<br>(H6001 & H6004) | Peripheral atherectomy: Peripheral<br>artery luminal gain by plaque<br>removal.<br>(H6001 & H6004) | Same |
| Indications for Use | The FreedomFlow™ Orbital<br>Circumferential Atherectomy<br>System is indicated for use as a<br>therapy in patients with occlusive<br>atherosclerotic disease in<br>peripheral arteries. The therapy is<br>intended for patients who are<br>acceptable candidates for<br>percutaneous transluminal<br>atherectomy.<br>(H6001 & H6004) | The FreedomFlow™ Orbital<br>Circumferential Atherectomy<br>System is indicated for use as a<br>therapy in patients with occlusive<br>atherosclerotic disease in<br>peripheral arteries. The therapy is<br>intended for patients who are<br>acceptable candidates for<br>percutaneous transluminal<br>atherectomy.<br>(H6001 & H6004) | Same |
| Prescription Use<br>Only | Yes<br>(H6001 & H6004) | Yes<br>(H6001 & H6004) | Same |
| Single patient use,<br>disposable | Yes<br>(H6001 & H6004) | Yes<br>(H6001 & H6004) | Same |
| Target Body<br>Location | Peripheral<br>(H6001 & H6004) | Peripheral<br>(H6001 & H6004) | Same |
| Mechanism of<br>Operation / Action | Orbital Atherectomy<br>(H6001 & H6004) | Orbital Atherectomy<br>(H6001 & H6004) | Same |
| | Five (5) diamond coated,<br>eccentrically mounted, rotating<br>surfaces (Spheres) on an electric<br>motor driven rotating driveshaft at<br>high speed to remove stenotic<br>tissue. (H6001)<br>Three (3) diamond coated,<br>eccentrically mounted, rotating<br>surfaces (Spheres) on an electric | Five (5) diamond coated,<br>eccentrically mounted, rotating<br>surfaces (Spheres) on an electric<br>motor driven rotating driveshaft at<br>high speed to remove stenotic<br>tissue. (H6001 [K231538])<br>Three (3) diamond coated,<br>eccentrically mounted, rotating<br>surfaces (Spheres) on an electric | Same |
| | high speed to remove stenotic<br>tissue. (H6004) | high speed to remove stenotic<br>tissue (H6004 [K233483]) | |
| System Components | Three (3):<br>1. User Handle with internal saline pump<br>2. Tubing Set<br>3. External Power supply<br>(H6001 & H6004) | Three (3):<br>1. User Handle with internal saline pump<br>2. Tubing Set<br>3. External Power supply<br>(H6001 & H6004) | Same. |
| Driveshaft<br>Variations | 5 Fr<br>(H6001 & H6004) | 5 Fr<br>(H6001 & H6004) | Same<br>*Note, the H6002 6Fr device<br>configuration included under<br>K231538 is not considered<br>for this comparison. |
| Driveshaft Working<br>Length | 150 cm working length for 5 Fr<br>User Handle<br>(H6001 & H6004) | 150 cm working length for 5 Fr<br>User Handle<br>(H6001 & H6004) | Same<br>*Note, the H6002 6Fr device<br>configuration included under<br>K231538 is not considered<br>for this comparison. |
| Rotational Speed | 2 Speeds:<br>50 krpm and 76 krpm<br>(H6001 & H6004) | 2 Speeds:<br>50 krpm and 76 krpm<br>(H6001 & H6004) | Same |
| Display of speed in<br>rpm on user handle | No<br>(H6001 & H6004) | No<br>(H6001 & H6004) | Same |
| Saline flow rate | 10 ml/minute minimum<br>(H6001 & H6004) | 10 ml/minute minimum<br>(H6001 & H6004) | Same |
| Shelf life | 2 Years<br>(H6001 & H6004) | 2 Years<br>(H6001 & H6004) | Same |
| Provided sterile by<br>Ethylene Oxide<br>Process | Yes<br>(H6001 & H6004) | Yes<br>(H6001 & H6004) | Same |
| Sterility Assurance<br>Level (SAL) | SAL $<$ 10-6 | SAL $≤$ 10-6 | Same |
| Non-Pyrogenic | Yes<br>(H6001 & H6004) | Yes<br>(H6001 & H6004) | Same |
| Sterile barrier<br>package | Yes<br>Tyvek lidded tray<br>(H6001 & H6004) | Yes<br>Tyvek pouched tray<br>(H6001 & H6004) | Same |
| Atherectomy<br>Lubricant | None<br>(H6001 & H6004) | None<br>(H6001 & H6004) | Same |
| Driveshaft tracked<br>over compatible<br>guidewire | Yes<br>Commercially available 0.014"<br>compatible guidewire<br>(H6001 & H6004) | Yes<br>Commercially available 0.014"<br>atherectomy guidewire<br>(H6001 & H6004) | Same |
| Guidewire Clamp | Yes<br>(H6001 & H6004) | Yes<br>(H6001 & H6004) | Same |
| User Handle traverse<br>distance of driveshaft | 12 cm<br>(H6001 & H6004) | 12 cm<br>(H6001 & H6004) | Same |
| Software (Firmware) | Yes<br>(H6001 & H6004) | Yes<br>(H6001 & H6004) | Same |
| Control Power<br>Source | External Power Supply<br>100 to 240 VAC input<br>(H6001 & H6004) | External Power Supply<br>100 to 240 VAC input<br>(H6001 & H6004) | Same |

{7}------------------------------------------------

{8}------------------------------------------------

## Conclusion

As outlined, the intended use, indications for use, and features of the FreedomFlow™ System are substantially equivalent to the predicate devices. There are no differences in substantial equivalence as a result of these incurred process changes. Cardio Flow therefore concludes that the design basis and collective data and information provided within this 510(k) demonstrate the substantial equivalence of the FreedomFlow™ device to the predicate devices.