EkoSonic Endovascular Device with Control Unit 4.0

K183361 · Btg International, Inc. · QEY · Apr 5, 2019 · Cardiovascular

Device Facts

• Record ID: K183361
• Device Name: EkoSonic Endovascular Device with Control Unit 4.0
• Applicant: Btg International, Inc.
• Product Code: QEY · Cardiovascular
• Decision Date: Apr 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EkoSonic Endovascular Device with Control Unit 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.

Device Story

Device consists of disposable infusion catheter with removable ultrasound core and Control Unit 4.0. Catheter features multiple side holes for fluid infusion and up to 30 ultrasound elements for energy delivery. Control Unit 4.0 generates/controls RF energy delivered to ultrasound core; monitors treatment zone temperature via thermal sensors. Used in clinical settings by physicians for ultrasound-facilitated thrombolytic therapy in pulmonary embolism and peripheral vasculature. Ultrasound energy facilitates delivery of thrombolytic agents into blood clots; temperature feedback system limits surface temperature to 43°C to ensure safety. System provides controlled, selective infusion, potentially improving clot dissolution and patient outcomes.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including hardware verification (electrical safety, EMC/EMI, battery, reliability) and software verification (firmware, UI, RF control, system integration). All tests passed.

Technological Characteristics

System comprises disposable infusion catheter (5.4 Fr, 106/135 cm length) and Control Unit 4.0. Ultrasound core contains 6-30 elements; frequency 2.0-2.5 MHz. RF energy source converted to ultrasound. Temperature monitoring/feedback loop limits surface temperature to 43°C. Software-limited power output (~50W). Internal lithium-ion backup battery. Radiopaque markers on ultrasound elements. Sterile, single-use.

Indications for Use

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

• EKOS EkoSonic Endovascular Device with CU 4.0 (K162771)

Submission Summary (Full Text)

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November 22, 2021

BTG International, Inc. Benjamin Hornsey Regulatory Affairs Manager 11911 N Creek Pkwy S Bothell, Washington 98011

Re: K183361

Trade/Device Name: EkoSonic Endovascular Device with Control Unit 4.0 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA

Dear Benjamin Hornsey:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 5, 2019. Specifically. FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, [phone], Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Gregory W - Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2021.11.22

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

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April 5, 2019

BTG International, Inc. Benjamin Hornsey Regulatory Affairs Manager 11911 N Creek Pkwy S Bothell, Washington 98011

Re: K183361

Trade/Device Name: EkoSonic Endovascular Device with Control Unit 4.0 Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: March 5, 2019 Received: March 6, 2019

Dear Mr. Hornsey:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Digitally signed by Haiira F. Hajira F. Ahmad -S Date: 2019.04.05 Ahmad -S 14:01:06 -04'00'

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K183361

Device Name

EkoSonic Endovascular Device with Control Unit 4.0

Indications for Use (Describe)

The EkoSonic Endovascular Device with Control Unit 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> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### l. Submitter

EKOS Corporation, Inc. 11911 North Creek Parkway S Bothell, WA 98011

Phone: [phone] Fax: [phone]

Contact Person: Benjamin Hornsey Date Prepared: December 3, 2018

### II. Device

| Proprietary Name: | EkoSonic™ Endovascular Device with Control Unit 4.0 |
|-----------------------|-----------------------------------------------------|
| Common or Usual Name: | Continuous Flush Catheter |
| Classification Name: | Catheter, Continuous Flush (21 CFR §870.1210) |
| Product Code: | KRA |

Continuous Flush Catheters have been classified by the FDA Cardiovascular Panel as Class II.

#### lll. Predicate Devices

The EkoSonic Endovascular Device with CU 4.0 (CU 4.0) is substantially equivalent to another legally marketed device. This predicate device is the EKOS EkoSonic Endovascular Device with CU 4.0 (K162771).

No reference devices were used in this submission.

### IV. Device Description

The EkoSonic Endovascular Device with CU 4.0 consists of an EkoSonic Endovascular Device and the Control System 4.0 (Control Unit 4.0 and Connector Interface Cables). The EkoSonic Endovascular Device consists of a 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 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System 4.0 generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.

It is the modifications to the Control System 4.0 that are the subject of this submission.

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## V. Intended Use/Indications for use

The EkoSonic Endovascular Device with Control Unit 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.

| | EkoSonic Endovascular Device with | EkoSonic Endovascular Device with |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | CU 4.0 | CU 4.0 |
| | (Subject Device) | (Predicate Device) |
| 510(k) Number | K183361 | K162771 |
| Product Code | KRA | KRA |
| Indications for<br>Use | The EkoSonic Endovascular Device with CU 4.0<br>is indicated for the:<br>• Ultrasound facilitated, controlled and<br>selective infusion of physician-specified<br>fluids, including thrombolytics, into the<br>vasculature for the treatment of pulmonary<br>embolism.<br>• Infusion of solutions into the pulmonary<br>arteries.<br>• Controlled and selective infusion of<br>physician-specified fluids, including<br>thrombolytics, into the peripheral<br>vasculature. | The EkoSonic Endovascular Device with CU 4.0<br>is indicated for the:<br>• Ultrasound facilitated, controlled and<br>selective infusion of physician-specified<br>fluids, including thrombolytics, into the<br>vasculature for the treatment of pulmonary<br>embolism.<br>• Infusion of solutions into the pulmonary<br>arteries.<br>• Controlled and selective infusion of<br>physician-specified fluids, including<br>thrombolytics, into the peripheral<br>vasculature. |
| Principle of<br>Operation | The EkoSonic Endovascular Device with CU 4.0<br>employs ultrasound to facilitate the delivery of<br>thrombolytic agents into vascular blood clots. | The EkoSonic Endovascular Device with CU 4.0<br>employs ultrasound to facilitate the delivery of<br>thrombolytic agents into vascular blood clots. |
| Software Version | 01.02.02 | 01.00.05 |
| Battery Version | 8742-003 | 6841-002 |
| Infusion Hole<br>Pattern | Multiple side-holes | Multiple side-holes |
| Catheter Working<br>Length | 106 cm or 135 cm | 106 cm or 135 cm |
| Treatment Zone<br>Length | 6 cm - 50 cm | 6 cm - 50 cm |
| | EkoSonic Endovascular Device with<br>CU 4.0<br>(Subject Device) | EkoSonic Endovascular Device with<br>CU 4.0<br>(Predicate Device) |
| Compatible<br>Guide Wire | 0.035" | 0.035" |
| Outer Diameter | 5.4 Fr | 5.4 Fr |
| Placement Mode | Percutaneous/endovascular | Percutaneous/endovascular |
| Packaged Sterile | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Single-Use<br>Disposable | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Materials<br>Biocompatible | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Radiopaque<br>Markers | Yes on IDDC<br>MSD ultrasound elements are radiopaque | Yes on IDDC<br>MSD ultrasound elements are radiopaque |
| Mechanism of<br>Action | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CU 4.0 converted to<br>ultrasound | R/F electrical from CU 4.0 converted to<br>ultrasound |
| Ultrasound<br>Transducer(s) in<br>Catheter | 6 to 30 | 6 to 30 |
| Acoustic<br>Characteristics | Frequency = 2.0 - 2.5 MHz | Frequency = 2.0 - 2.5 MHz |
| Battery Backup | Internal, lithium-ion backup battery | Internal, lithium-ion backup battery |
| Maximum<br>Output Power<br>Limit | Power is available for ~100W Pulses. The<br>power output is limited by software to ~50W. | Power is available for ~100W Pulses. The<br>power output is limited by software to ~50W. |
| Maximum<br>EkoSonic Device<br>Temperature | Temperature monitoring, feedback and control<br>system limits the surface temperature of the<br>IDDC to 43°C during operation. | Temperature monitoring, feedback and control<br>system limits the surface temperature of the<br>IDDC to 43°C during operation. |

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

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The device modifications described in the submission do not affect the intended use,

indications for use or the technological characteristics for the EkoSonic Endovascular System.

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## VII. Performance Data

Testing has confirmed that the EkoSonic Endovascular Device with CU 4.0 functions as intended and is substantially equivalent to the predicate device.

| Hardware Testing Performed | |
|--------------------------------------|------|
| Secondary Cell Battery Tests | Pass |
| Reliability Prediction | Pass |
| Battery Hardware Design Verification | Pass |
| Electrical Safety | Pass |
| Hardware Inspection | Pass |
| EMC/EMI | Pass |
| RF Board Hardware Tests | Pass |
| System Integration | Pass |
| CIC Hardware Tests | Pass |
| Shipping Package Tests | Pass |
| Design Verification Hardware Tests | Pass |
| UI Board Hardware Tests | Pass |
| Environmental Tests | Pass |
| Power Management Module Tests | Pass |
| Short Circuit Response | Pass |
| Patched Fastener Design Verification | Pass |
| EkoSonic Device Reliability | Pass |

| Software Testing Performed | |
|----------------------------|------|
| Periodic Self-Test | Pass |
| User Interface | Pass |
| Firmware Upgrade | Pass |
| Event Logging | Pass |
| System Connect Validation | Pass |
| Single Channel RF | Pass |
| Graphing | Pass |
| Device Compatibility | Pass |
| Dual Channel RF | Pass |
| Therapy Support | Pass |
| System Startup | Pass |
| Processor Communication | Pass |
| Constant Parameter | Pass |
| Source Code Inspection | Pass |
| AC and Battery Power | Pass |

Performance standards have not been promulgated for Continuous Flush Catheters.

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## VIII. Conclusions

The EkoSonic Endovascular Device with CU 4.0 is substantially equivalent to the predicate device. The modifications to the Control System 4.0 do not affect the intended use or the technological characteristics for the system and do not raise new questions of safety or effectiveness.