(41 days)
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.
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.
This looks like a 510(k) summary for a medical device called the "FreedomFlow™ Orbital Circumferential Atherectomy System". This document focuses on demonstrating substantial equivalence of a modified device to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the way one might for a novel AI/software device.
The premise of a 510(k) is that if a new device is shown to be substantially equivalent to a legally marketed predicate device, it does not require a new Pre-Market Approval (PMA) application. Substantial equivalence is often established by demonstrating that the device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
Therefore, the requested information about acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC, standalone performance, training set details), which are common for AI/software device submissions, are largely not applicable in the context of this specific 510(k) submission.
Here's a breakdown of why this information is largely absent and what is provided:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria/Performance: This document does not provide a table of acceptance criteria and reported device performance in the form typically expected for AI/software evaluations (e.g., sensitivity, specificity, AUC). Instead, it establishes "substantial equivalence" to predicate devices. The "performance" being evaluated here relates to the manufacturing process change (soldering to welding) and a pump head change. The document states: "There are no performances differences incurred as a result of this change." and "Testing verifies all pump related specifications."
- Table of Comparison (from the document): The document includes a large table on pages 6-7 comparing the subject devices (H6001 & H6004 with changes) to predicate devices (H6001 [K231538] & H6004 [K233483]). This table highlights that all key characteristics, including Product Code, Classification, Intended Use, Indications for Use, Mechanism of Operation, System Components, Driveshaft Variations, Rotational Speed, Saline flow rate, Shelf life, Sterility, etc., are "Same." The core acceptance criterion for this 510(k) is demonstrating that these characteristics remain equivalent despite the manufacturing changes.
2. Sample size used for the test set and the data provenance:
- Not Applicable in this context: The document does not describe a "test set" in the sense of a clinical or image dataset for an AI algorithm. The evaluations conducted are likely engineering bench tests, biocompatibility tests, and potentially functional tests related to the manufacturing processes. Details on sample sizes for these types of tests are not typically included in the 510(k) summary provided to the public.
- Data Provenance: Not applicable as there isn't a "data set" originating from specific countries or clinical studies as would be for an AI device. The data provenance would be internal engineering and manufacturing quality control data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: There is no "ground truth" established by experts in this context. The evaluation is against engineering specifications and the established performance of the predicate device.
4. Adjudication method for the test set:
- Not Applicable: There is no "adjudication method" as this is not a subjective diagnostic or interpretative task.
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:
- Not Applicable: This device is a physical medical device (atherectomy system) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is completely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable: This is a physical atherectomy system; it is not an algorithm.
7. The type of ground truth used:
- Ground Truth: In the context of this 510(k), the "ground truth" for the device's performance is its adherence to engineering specifications, functional requirements, and safety standards, which are themselves benchmarked against the predicate device. For example, biocompatibility testing would be compared against ISO standards, and functional tests (like rotational speed, saline flow) would be compared against their defined operational parameters.
8. The sample size for the training set:
- Not Applicable: There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable: There is no "training set."
In summary:
This 510(k) pertains to a manufacturing process change and a component change for a physical medical device (Atherectomy System). The regulatory submission demonstrates substantial equivalence to existing predicate devices by showing that these changes do not alter the intended use, indications for use, or fundamental technological characteristics, and do not raise new questions of safety or effectiveness. The detailed study parameters typically associated with AI/software device evaluation are not relevant to this type of submission.
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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.
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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
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assistance/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,
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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: | 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 IIProduct Code: MCW |
| Predicate Device: | K231538, FreedomFlow™ Orbital Circumferential AtherectomySystem Cardio Flow, Inc.&K233483, FreedomFlow Orbital Circumferential Atherectomy System(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.
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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 | |||||
|---|---|---|---|---|---|
| ModelNumber | Description | Introducer SheathSize (Fr) | Vessel SizeRange | WorkingLength | Affected by Changesin this 510(k) |
| H6001 | User Handle 5 Fr 5-Sphere 150cm Length | 5 French | 2.0 - 4.0 mm | 150 cm | Yes |
| H6002 | User Handle 6 Fr 5-Sphere 135cm Length | 6 French | 4.0 - 8.0 mm | 135 cm | No |
| H6004 | User Handle 5 Fr 3-Sphere 150cm 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
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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 OrbitalCircumferential AtherectomySystem (Subject Devices, H6001and H6004) | FreedomFlow OrbitalCircumferential AtherectomySystem (Predicate Devices H6001[K231538] & H6004 [K233483]) | Substantial EquivalenceComments |
|---|---|---|---|
| Product Code,Classification | MCW,21 CFR 870.4875 Intraluminalartery stripper, Class II(H6001 & H6004) | MCW,21 CFR 870.4875 Intraluminalartery stripper, Class II(H6001 & H6004) | Same |
| Intended Use | Peripheral atherectomy:Peripheral artery luminal gain byplaque removal.(H6001 & H6004) | Peripheral atherectomy: Peripheralartery luminal gain by plaqueremoval.(H6001 & H6004) | Same |
| Indications for Use | The FreedomFlow™ OrbitalCircumferential AtherectomySystem is indicated for use as atherapy in patients with occlusiveatherosclerotic disease inperipheral arteries. The therapy isintended for patients who areacceptable candidates forpercutaneous transluminalatherectomy.(H6001 & H6004) | The FreedomFlow™ OrbitalCircumferential AtherectomySystem is indicated for use as atherapy in patients with occlusiveatherosclerotic disease inperipheral arteries. The therapy isintended for patients who areacceptable candidates forpercutaneous transluminalatherectomy.(H6001 & H6004) | Same |
| Prescription UseOnly | Yes(H6001 & H6004) | Yes(H6001 & H6004) | Same |
| Single patient use,disposable | Yes(H6001 & H6004) | Yes(H6001 & H6004) | Same |
| Target BodyLocation | Peripheral(H6001 & H6004) | Peripheral(H6001 & H6004) | Same |
| Mechanism ofOperation / Action | Orbital Atherectomy(H6001 & H6004) | Orbital Atherectomy(H6001 & H6004) | Same |
| Five (5) diamond coated,eccentrically mounted, rotatingsurfaces (Spheres) on an electricmotor driven rotating driveshaft athigh speed to remove stenotictissue. (H6001)Three (3) diamond coated,eccentrically mounted, rotatingsurfaces (Spheres) on an electric | Five (5) diamond coated,eccentrically mounted, rotatingsurfaces (Spheres) on an electricmotor driven rotating driveshaft athigh speed to remove stenotictissue. (H6001 [K231538])Three (3) diamond coated,eccentrically mounted, rotatingsurfaces (Spheres) on an electric | Same | |
| high speed to remove stenotictissue. (H6004) | high speed to remove stenotictissue (H6004 [K233483]) | ||
| System Components | Three (3):1. User Handle with internal saline pump2. Tubing Set3. External Power supply(H6001 & H6004) | Three (3):1. User Handle with internal saline pump2. Tubing Set3. External Power supply(H6001 & H6004) | Same. |
| DriveshaftVariations | 5 Fr(H6001 & H6004) | 5 Fr(H6001 & H6004) | Same*Note, the H6002 6Fr deviceconfiguration included underK231538 is not consideredfor this comparison. |
| Driveshaft WorkingLength | 150 cm working length for 5 FrUser Handle(H6001 & H6004) | 150 cm working length for 5 FrUser Handle(H6001 & H6004) | Same*Note, the H6002 6Fr deviceconfiguration included underK231538 is not consideredfor this comparison. |
| Rotational Speed | 2 Speeds:50 krpm and 76 krpm(H6001 & H6004) | 2 Speeds:50 krpm and 76 krpm(H6001 & H6004) | Same |
| Display of speed inrpm on user handle | No(H6001 & H6004) | No(H6001 & H6004) | Same |
| Saline flow rate | 10 ml/minute minimum(H6001 & H6004) | 10 ml/minute minimum(H6001 & H6004) | Same |
| Shelf life | 2 Years(H6001 & H6004) | 2 Years(H6001 & H6004) | Same |
| Provided sterile byEthylene OxideProcess | Yes(H6001 & H6004) | Yes(H6001 & H6004) | Same |
| Sterility AssuranceLevel (SAL) | SAL $<$ 10-6 | SAL $≤$ 10-6 | Same |
| Non-Pyrogenic | Yes(H6001 & H6004) | Yes(H6001 & H6004) | Same |
| Sterile barrierpackage | YesTyvek lidded tray(H6001 & H6004) | YesTyvek pouched tray(H6001 & H6004) | Same |
| AtherectomyLubricant | None(H6001 & H6004) | None(H6001 & H6004) | Same |
| Driveshaft trackedover compatibleguidewire | YesCommercially available 0.014"compatible guidewire(H6001 & H6004) | YesCommercially available 0.014"atherectomy guidewire(H6001 & H6004) | Same |
| Guidewire Clamp | Yes(H6001 & H6004) | Yes(H6001 & H6004) | Same |
| User Handle traversedistance of driveshaft | 12 cm(H6001 & H6004) | 12 cm(H6001 & H6004) | Same |
| Software (Firmware) | Yes(H6001 & H6004) | Yes(H6001 & H6004) | Same |
| Control PowerSource | External Power Supply100 to 240 VAC input(H6001 & H6004) | External Power Supply100 to 240 VAC input(H6001 & H6004) | Same |
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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.
§ 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).