EKOS PE Endovascular Device with Control System 4.0 (CS4.0)

K200648 · Ekos Corporation · QEY · Aug 17, 2020 · Cardiovascular

Device Facts

• Record ID: K200648
• Device Name: EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
• Applicant: Ekos Corporation
• Product Code: QEY · Cardiovascular
• Decision Date: Aug 17, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EKOS PE Endovascular System is indicated for the: - Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism. - Infusion of solutions into the pulmonary arteries. - Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Device Story

The EKOS PE Endovascular System consists of a single-use infusion catheter with a removable ultrasound core and a Control Unit (CU4.0). The catheter features multiple side holes for fluid delivery and integrated thermal sensors. The CU4.0 generates radiofrequency energy, which the ultrasound core converts into ultrasound waves to facilitate the delivery of thrombolytic agents into vascular blood clots. The device is used in a clinical setting by a physician to treat pulmonary embolism or peripheral vascular conditions. The physician monitors the procedure via the control unit, which provides feedback and regulates the treatment zone temperature to a maximum of 43°C. The ultrasound energy enhances the penetration of the thrombolytic agent into the clot, potentially improving treatment efficacy and patient outcomes.

Clinical Evidence

Bench testing only. Performance verification included physical dimensions, tip shape (ISO 10555-1), kink resistance, tensile strength, electrical safety (IEC 60601-1, IEC 60601-1-2), acoustic characteristics, radiopacity, pressure resistance, temperature sensing, functional life, biocompatibility (ISO 10993-1), sterilization (ISO 11135), and shelf life (3 years). All tests passed.

Technological Characteristics

Single-use infusion catheter with removable ultrasound core; 7.7 Fr outer diameter; 8-20 ultrasound transducers; 1.58-2.00 MHz frequency; R/F energy source; thermal sensors for temperature feedback/control (max 43°C); biocompatible materials; radiopaque markers; sterile; 106 cm or 135 cm working length; software-limited power output (~50W).

Indications for Use

Indicated for patients requiring ultrasound-facilitated, controlled, and selective infusion of physician-specified fluids (including thrombolytics) into the pulmonary arteries for pulmonary embolism treatment, or into the peripheral vasculature.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• EkoSonic Endovascular Device with CU4.0 (K183361)

Submission Summary (Full Text)

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August 17, 2020

EKOS Corporation Mr. Joshua Kim Sr. Regulatory Affairs Specialist 11911 North Creek Parkway S Bothell, Washington 98011

Re: K200648

Trade/Device Name: EKOS PE Endovascular Device with Control System 4.0 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEY, KRA Dated: July 17, 2020 Received: July 20, 2020

Dear Mr. Kim:

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

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) K200648

Device Name

EKOS PE Endovascular Device with Control Unit 4.0

Indications for Use (Describe)

The EKOS PE Endovascular Device with CU 4.0 is indicated for the:

- · Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- · Infusion of solutions into the pulmonary arteries.
- · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------|--|
| <span style="text-decoration: line-through;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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# Premarket Notification 510(k) Summary for K200648

#### l. Submitter

EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011

Phone: [phone] Fax: [phone]

Contact Person: Joshua Kim Date Prepared: August 17, 2020

#### ll. Device

| Proprietary Name: | EKOS™ PE Endovascular Device with CU4.0 | | EKOS PE Endovascular Device<br>with CU4.0<br>(Subject Device) | EkoSonic Endovascular Device<br>with CU4.0<br>(Predicate Device) |
|--------------------------------|-----------------------------------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Continuous Flush Catheter | 510(k) Number | K200648 | K183361 |
| Primary Classification Name: | Mechanical Thrombolysis Catheter (21 CFR §870.5150) | Product Code | QEY, KRA | KRA |
| Primary Product Code: | QEY | Indications for<br>Use | The EKOS PE Endovascular<br>System [with CU4.0] is indicated<br>for the:<br>• Ultrasound facilitated,<br>controlled and selective<br>infusion of physician-specified<br>fluids, including<br>thrombolytics, into the<br>vasculature for the treatment<br>of pulmonary embolism.<br>• Infusion of solutions into the<br>pulmonary arteries.<br>• Controlled and selective<br>infusion of physician-specified<br>fluids, including<br>thrombolytics, into the<br>peripheral vasculature. | The EkoSonic Endovascular<br>Device with CU4.0 is indicated<br>for the:<br>• Ultrasound facilitated,<br>controlled and selective<br>infusion of physician-specified<br>fluids, including thrombolytics,<br>into the vasculature for the<br>treatment of pulmonary<br>embolism.<br>• Infusion of solutions into the<br>pulmonary arteries.<br>• Controlled and selective<br>infusion of physician-specified<br>fluids, including thrombolytics,<br>into the peripheral<br>vasculature. |
| FDA Panel/Device Class: | Cardiovascular; Class II | Principle of<br>Operation | The EKOS PE Endovascular<br>System [EKOS PE Endovascular<br>Device with CU4.0] employs<br>ultrasound to facilitate the<br>delivery of thrombolytic agents<br>into vascular blood clots. | The EkoSonic Endovascular<br>System employs ultrasound to<br>facilitate the delivery of<br>thrombolytic agents into<br>vascular blood clots. |
| Secondary Classification Name: | Catheter, Continuous Flush (21 CFR §870.1210) | Infusion Hole<br>Pattern | Multiple side-holes | Multiple side-holes |
| Secondary Product Code: | KRA | Catheter<br>Working Length | 106 cm or 135 cm | 106 cm or 135 cm |
| FDA Panel/Device Class: | Cardiovascular; Class II | Treatment<br>Zone Length | 8 cm - 20 cm | 6 cm - 50 cm |

#### lll. Predicate Devices

The EKOS PE Endovascular Device with CU4.0 is substantially equivalent to another legally marketed device. This predicate device is the EkoSonic Endovascular Device with CU4.0 (K183361).

No reference devices were used in this notification.

#### IV. Device Description

The EKOS PE Endovascular System consists of an EKOS PE Endovascular Device and CU4.0 (Control Unit 4.0 and Connector Interface Cables). The EKOS PE Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 20 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.

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#### V. Intended Use/Indications for use

The EKOS PE Endovascular System is indicated for the:

- Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, . including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- . Infusion of solutions into the pulmonary arteries.
- . Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

#### VI. Comparison of Technological Characteristics with the Predicate Device

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# E K.O)S)

| | EKOS PE Endovascular Device<br>with CU4.0<br>(Subject Device) | EkoSonic Endovascular Device<br>with CU4.0<br>(Predicate Device) |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Compatible<br>Guide Wire | 0.035" | 0.035" |
| Outer Diameter | 7.7 Fr | 5.4 Fr |
| Placement<br>Mode | Percutaneous/endovascular | Percutaneous/endovascular |
| Packaged<br>Sterile | Yes - EKOS PE Endovascular<br>Device | Yes - EkoSonic Endovascular<br>Device |
| Single-Use<br>Disposable | Yes - EKOS PE Endovascular<br>Device | Yes - EkoSonic Endovascular<br>Device |
| Materials<br>Biocompatible | Yes – EKOS PE Endovascular<br>Device | Yes - EkoSonic Endovsacular<br>Device |
| Radiopaque<br>Markers | Yes on IDDC<br>MSD ultrasound elements are<br>radiopaque | Yes on IDDC<br>MSD ultrasound elements are<br>radiopaque |
| Mechanism of<br>Action | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CU converted<br>to ultrasound | R/F electrical from CU converted<br>to ultrasound |
| Ultrasound<br>Transducer(s)<br>in Catheter | 8 to 20 | 6 to 30 |
| Acoustic<br>Characteristics | Frequency = 1.58-2.00 MHz | Frequency = 2.05 - 2.35 MHz |
| Maximum<br>Output Power<br>Limit | Power is available for ~100W<br>Pulses. The power output is<br>limited by software to ~50W. | Power is available for ~100W<br>Pulses. The power output is<br>limited by software to ~50W. |
| Maximum<br>EkoSonic<br>Device<br>Temperature | Temperature monitoring,<br>feedback and control system<br>limits the surface temperature of<br>the IDDC to 43°C during<br>operation | Temperature monitoring,<br>feedback and control system<br>limits the surface temperature of<br>the IDDC to 43°C during<br>operation |

The device modifications described in the notification do not affect the intended use, indications for use, or the technological characteristics for the EKOS PE Endovascular System (EKOS PE Endovascular Device with CU4.0).

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#### VII. Performance Data

Testing has confirmed that the EKOS PE Endovascular Device functions as intended and is substantially equivalent to the predicate device.

| Product<br>Specification | Purpose | EKOS PE Endovascular Device<br>(Subject Device) | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------|
| | | T = 0 | Accelerated Aged<br>(T=3 Years) |
| Physical<br>Dimensions | Verified dimensional compatibility and stability<br>with the MSD and DDC. | Pass | Pass |
| Tip Shape | Verified tip conformity to ISO 10555-1<br>requirements. | Pass | Pass |
| Kink Resistance | Verified device can be used within the target<br>vasculature. | Pass | Pass |
| Tensile Strength | Verified device conformity to ISO 10555-1<br>requirements. | Pass | Pass |
| Electrical Safety | Verified device conformity IEC 60601-1 and IEC<br>60601-1-2 requirements. | Pass | Pass |
| Acoustic<br>Characteristics | Verified device met specified acoustic design<br>requirements. | Pass | Pass |
| Radiopacity | Verified device can be viewed under standard<br>imaging techniques. | Pass | Pass |
| Pressure<br>Resistance | Verified device lumens conformity to ISO 10555-<br>1. | Pass | Pass |
| Temperature<br>Sensing | Verified the device temperature sensors met<br>specified design and functional requirements. | Pass | Pass |
| Functional Life | Verified device met specified functional life<br>requirements. | Pass | Pass |
| Biocompatibility | Verified the device met biocompatibility<br>requirements per ISO 10993-1. | Pass | Pass |
| Sterilization | Verified the device met sterilization<br>requirements per ISO 11135. | Pass | Pass |
| Shelf Life | Verified the device met functional requirements<br>after a 3-year shelf life. | N/A. | Pass |
| System<br>Integration with<br>CU4.0 | Verified the device integrates with the control<br>unit, specifically, its acoustic protocol and<br>enabled temperature safety features | Pass | N/A. |

Table 1: Testing Overview Supporting the EKOS PE Endovascular System

Performance standards have not been promulgated for Mechanical Thrombolysis or Continuous Flush Catheters.

#### VIII. Conclusions

The EKOS PE Endovascular Device with CU4.0 is substantially equivalent to the predicate devices. The modifications to the EkoSonic Endovascular Device with CU4.0 do not affect the intended use or the technological characteristics for the system.