(111 days)
Not Found
No
The description focuses on mechanical and electrical components, firmware for control, and performance testing related to physical characteristics and function, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries."
No
This device is described as an atherectomy system used for therapy (ablation of atherosclerotic plaque), not for diagnosing conditions.
No
The device description explicitly states that the system consists of three hardware components: a User Handle with integrated driveshaft, a Tubing Set, and a Power Supply. It also mentions that the User Handle utilizes firmware and hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. This is a therapeutic intervention performed within the body (in vivo).
- Device Description: The description details a mechanical device used to ablate plaque from blood vessels. This is a physical treatment, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and therapeutic.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.
Product codes (comma separated list FDA assigned to the subject device)
MCW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Test: Dimensional Analysis Testing
Description: The subject device utilizes a different distal-driveshaft dimension as compared to the predicate. Dimensional analysis measurements assess diameters, lengths, angle orientation of the distal driveshaft dimensions.
Performance Test: Orbit Characterization Testing
Description: Effectiveness of sanding technology as a measure of lumen diameter versus speed versus time. Maintains speed range and tolerance within simulated anatomy and characterization of orbit for subject device User Handle which includes plaque removal and removal efficiency.
Performance Test: Simulated Life Test
Description: Simulated operating life test (up to 6 minutes) of FreedomFlow System at highest speed in simulated peripheral anatomy model.
Performance Test: Torque Stall and Loaded Start Test
Description: User Handle driveshaft assembly will not deform or be damaged during forced simulated torque-stalls.
Performance Test: Joint Tensile Test
Description: Destructive Joint Tensile Testing.
Performance Test: Joint Torque Test
Description: Destructive Joint Torque Testing.
Performance Test: Particulate Analysis Comparison Test
Description: Particulate analysis testing to compare total particulate mean size and particulate counts of the subject device (5Fr 3-Sphere) and the predicate device (5Fr 5-Sphere).
Performance Test: Electric System Human Cadaver Pre-Clinical Test
Description: Formal prospective, single-center evaluation using a perfused human cadaver model to compare the debulking effectiveness and incidence of adverse events for the subject device (5Fr 3-Sphere) and predicate device (5Fr 5-Sphere).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
0
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"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Digitally signed by Ariel G. Ash-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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
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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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.
3530 88th Ave NE
Blaine, MN 55014 |
|------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael J. Kallok, Ph.D., FACC, FAHA; Chief Executive Officer,
Director, Cardio Flow, Inc. |
| Contact Phone: | (800) 294-5517 |
| Date Summary Prepared: | February 13th, 2024 |
| Device Trade Name: | FreedomFlow™ Orbital Circumferential Atherectomy System (H6004
5Fr 3-Sphere) |
| Common Name: | Peripheral Atherectomy Device |
| Classification Name: | 21 CFR 870.4875, Peripheral Atherectomy Catheter, Class II
Product Code: MCW |
| Predicate Device: | K231538, FreedomFlow™ Orbital Circumferential Atherectomy System
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.
5
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 | ||
| Circumferential | |||
| Atherectomy System (H6004 | |||
| 5Fr 3-Sphere) | |||
| (Subject Device) | FreedomFlow Orbital | ||
| Circumferential | |||
| Atherectomy System H6001 | |||
| (Predicate Device, K231538) | Substantial | ||
| Equivalence | |||
| Comments | |||
| Product Code, | |||
| Classification | MCW, | ||
| 21 CFR 870.4875 Intraluminal | |||
| artery stripper, Class II | MCW, | ||
| 21 CFR 870.4875 Intraluminal | |||
| artery stripper, Class II | Same | ||
| Intended Use | Peripheral atherectomy: | ||
| Peripheral artery luminal gain | |||
| by plaque removal. | Peripheral atherectomy: | ||
| Peripheral artery luminal gain | |||
| by plaque removal. | Same | ||
| Indications for | |||
| Use | The FreedomFlow™ Orbital | ||
| Circumferential Atherectomy | |||
| System is indicated for use as | |||
| a therapy in patients with | |||
| occlusive atherosclerotic | |||
| disease in peripheral arteries. | |||
| The therapy is intended for | 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 | Same | ||
| Table 1: Comparison to Predicate | |||
| Feature | FreedomFlow™ Orbital | ||
| Circumferential | |||
| Atherectomy System (H6004 | |||
| 5Fr 3-Sphere) | |||
| (Subject Device) | FreedomFlow Orbital | ||
| Circumferential | |||
| Atherectomy System H6001 | |||
| (Predicate Device, K231538) | Substantial | ||
| Equivalence | |||
| Comments | |||
| patients who are acceptable | |||
| candidates for percutaneous | |||
| transluminal atherectomy. | patients who are acceptable | ||
| candidates for percutaneous | |||
| transluminal atherectomy. | |||
| Prescription Use | |||
| Only | Yes | Yes | Same |
| Single patient use, | |||
| disposable | Yes | Yes | Same |
| Target Body | |||
| Location | Peripheral | Peripheral | Same |
| Mechanism of | |||
| Operation / | |||
| Action (MOA) | Orbital Atherectomy | ||
| Three (3) diamond coated, | |||
| eccentrically mounted, rotating | |||
| surfaces (Spheres) on an | |||
| electric motor driven rotating | |||
| driveshaft at high speed to | |||
| remove stenotic tissue. A | |||
| diamond coated distal | |||
| hypotube is attached near the | |||
| tip of the driveshaft to aid | |||
| driveshaft into tight lesions. | Orbital Atherectomy | ||
| Five (5) diamond coated, | |||
| eccentrically mounted, rotating | |||
| surfaces (Spheres) on an | |||
| electric motor driven rotating | |||
| driveshaft at high speed to | |||
| remove stenotic tissue. A | |||
| diamond coated distal | |||
| hypotube is attached near the | |||
| tip of the driveshaft to aid | |||
| driveshaft into tight lesions. | Same | ||
| System | |||
| Components | Three (3): |
- User Handle with internal
saline pump - Tubing Set
- External Power supply | Three (3):
- User Handle with internal
saline pump - Tubing Set
- External Power supply | Same |
| Driveshaft
Variations | 5 Fr
Three (3) diamond coated,
eccentrically mounted, rotating
surfaces (Spheres) on an
electric motor driven rotating
driveshaft. A distal diamond
coated hypotube aids the
driveshaft into tight lesions. | 5 Fr
Five (5) diamond coated,
eccentrically mounted, rotating
surfaces (Spheres) on an
electric motor driven rotating
driveshaft. A distal diamond
coated hypotube aids the
driveshaft into tight lesions. | Similar
The 5Fr, 3-sphere
configuration (H6004)
reduces the number of
spheres from 5 down to
3 to allow for more
flexibility of the distal
driveshaft.
Even with a reduction in
number of spheres, the
5Fr 3-sphere
configuration (H6004)
has demonstrated a
substantially equivalent
performance to the
predicate device model
configuration (H6001). |
| Driveshaft
Working Length | 150 cm working length for 5
Fr User Handle | 150 cm working length for 5
Fr User Handle | Same |
| Rotational Speed | 2 Speeds: | 2 Speeds: | Same |
| Table 1: Comparison to Predicate | | | |
| Feature | FreedomFlow™ Orbital
Circumferential
Atherectomy System (H6004
5Fr 3-Sphere)
(Subject Device) | FreedomFlow Orbital
Circumferential
Atherectomy System H6001
(Predicate Device, K231538) | Substantial
Equivalence
Comments |
| | 50 krpm and 76 krpm | 50 krpm and 76 krpm | |
| Display of speed
in rpm on user
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
by Ethylene
Oxide Process | Yes | Yes | Same |
| Sterility
Assurance Level
(SAL) | SAL ≤ 10-6 | SAL ≤ 10-6 | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Sterile barrier
package | Yes
Tyvek lidded tray | Yes
Tyvek lidded tray | Same |
| Atherectomy
Lubricant | None | None | Same |
| Driveshaft
tracked over
compatible
guidewire | Yes
Commercially available 0.014"
compatible guidewire | Yes
Commercially available
0.014" atherectomy guidewire | Same |
| Guidewire Clamp | Yes | Yes | Same |
| User Handle
traverse distance
of driveshaft | 12 cm | 12 cm | Same |
| Software
(Firmware) | Yes | Yes | Same |
| Control Power
Source | External Power Supply
100 to 240 VAC input | External Power Supply
100 to 240 VAC input | Same |
6
7
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 | |
| Testing | The subject device utilizes a different distal-driveshaft dimension as compared to |
| the predicate. Dimensional analysis measurements assess diameters, lengths, | |
| angle orientation of the distal driveshaft dimensions. | |
| Orbit Characterization | |
| Testing | Effectiveness of sanding technology as a measure of lumen diameter versus |
| speed versus time. Maintains speed range and tolerance within simulated | |
| anatomy and characterization of orbit for subject device User Handle which | |
| includes plaque removal and removal efficiency. |
8
| Performance Test | Description |
|---|---|
| Simulated Life Test | Simulated operating life test (up to 6 minutes) of FreedomFlow System at highest |
| speed in simulated peripheral anatomy model. | |
| Torque Stall and Loaded | |
| Start Test | User Handle driveshaft assembly will not deform or be damaged during forced |
| simulated torque-stalls. | |
| Joint Tensile Test | Destructive Joint Tensile Testing. |
| Joint Torque Test | Destructive Joint Torque Testing. |
| Particulate Analysis | |
| Comparison Test | Particulate analysis testing to compare total particulate mean size and particulate |
| counts of the subject device (5Fr 3-Sphere) and the predicate device (5Fr 5- | |
| Sphere). | |
| Electric System Human | |
| Cadaver Pre-Clinical Test | Formal prospective, single-center evaluation using a perfused human cadaver |
| model to compare the debulking effectiveness and incidence of adverse events | |
| 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.