EkoSonic Endovascular Device

K211080 · Boston Scientific · QEY · Nov 19, 2021 · Cardiovascular

Device Facts

• Record ID: K211080
• Device Name: EkoSonic Endovascular Device
• Applicant: Boston Scientific
• Product Code: QEY · Cardiovascular
• Decision Date: Nov 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EkoSonic 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

EkoSonic Endovascular System facilitates thrombolytic delivery into vascular blood clots; consists of single-use infusion catheter with removable ultrasound core and EKOS Control Unit. Catheter features multiple side-holes for fluid infusion and up to 30 ultrasound elements; thermal sensors monitor treatment zone temperature. Control unit delivers radiofrequency energy to ultrasound core; converts to ultrasound energy to enhance thrombolytic penetration. Used in clinical settings by physicians; percutaneous/endovascular placement. System monitors and limits surface temperature to 43°C. Output allows physician-controlled infusion; benefits patient by improving thrombolytic efficacy in treating pulmonary embolism and peripheral vascular conditions.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including physical integrity (tensile strength, leak, burst pressure), biocompatibility (ISO 10993-1), and sterility/microbial assessments.

Technological Characteristics

Single-use infusion catheter; removable ultrasound core with 6-30 elements. Frequency 2.05-2.35 MHz. Luer: Cyrolite polymer, ISO 80369-7 compliant. Energy: RF electrical converted to ultrasound. Max power ~50W (software limited). Thermal sensors for 43°C surface limit. 5.4 Fr diameter; 106/135 cm length. Radiopaque markers on catheter and core. Sterile.

Indications for Use

Indicated for patients requiring ultrasound-facilitated, controlled, and selective infusion of physician-specified 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

• EkoSonic Endovascular Device (K191119)

Submission Summary (Full Text)

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November 19, 2021

Boston Scientific Mr. Daniel Root Senior Regulatory Affairs Specialist Two Scimed Place Maple Grove, Minnesota 55311

Re: K211080

Trade/Device Name: EkoSonic Endovascular Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEY, KRA Dated: October 18, 2021 Received: October 20, 2021

Dear Mr. Root:

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

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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 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 (OS) 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,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K211080

Device Name EkoSonic Endovascular Device

The EkoSonic 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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b>Prescription Use</b></span> (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"><b>Over-The-Counter Use</b></span> (21 CFR 801 Subpart C) |
| <div style="display:inline-block"><svg height="16" width="16"><path d="M2 2 L14 14 M2 14 L14 2" fill="none" stroke="black"></path></svg></div> | <div style="display:inline-block"></div> |

||X| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 [phone]

www.bostonscientific.com

| Sponsor | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, Massachusetts 01752<br>USA |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and<br>Information | Daniel Root<br>Three Scimed Place<br>Maple Grove, MN 55311-1566<br>Phone: [phone]<br>Email: [e-mail] |
| Proprietary Name | EkoSonic™ Endovascular Device |
| Common Name | Continuous Flush Catheter |
| Product Code<br>(Primary/Secondary) | QEY, KRA |
| Classification<br>(Primary/Secondary) | Mechanical Thrombolysis Catheter (21 CFR §870.5150)<br>Catheter, Continuous Flush (21 CFR §870.1210) |
| Predicate Device | The EkoSonic Endovascular Device is substantially equivalent to<br>another legally marketed device. This predicate device is the EkoSonic<br>Endovascular Device (K191119). |
| Device Description | The EkoSonic Endovascular System consists of an EkoSonic<br>Endovascular Device and EKOS Control Unit (Control Unit 4.0 or PT-<br>3B and Connector Interface Cables). The EkoSonic Endovascular<br>Device consists of a single-use, disposable infusion catheter with<br>removable ultrasound core. The infusion catheter contains multiple side<br>holes distributed over the length of the treatment zone. The ultrasound<br>core contains up to 30 ultrasound elements, evenly spaced over the<br>treatment zone. Thermal sensors in the treatment zone monitor<br>catheter temperature. The Control System generates and controls the<br>delivery of radiofrequency energy to the ultrasound core while<br>monitoring and controlling the temperature of the treatment zone. |
| Indications for Use/<br>Intended Use | The EkoSonic Endovascular System is indicated for the:<br>Ultrasound facilitated, controlled and selective infusion of<br>physician-specified fluids, including thrombolytics, into the<br>vasculature for the treatment of pulmonary embolism. Infusion of solutions into the pulmonary arteries. Controlled and selective infusion of physician-specified fluids,<br>including thrombolytics, into the peripheral vasculature. |
| Device Technology<br>Characteristics and<br>Comparison to<br>Predicate Device | The EkoSonic Endovascular Device incorporates the following changes<br>from the predicate EkoSonic Endovascular Device (K191119): an<br>updated luer design that is ISO 80369-7 compliant; luer material<br>change to a Cyrolite® Polymer; and updated packaging and labeling<br>appropriate to be consistent with legal manufacturer branding. |

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| Characteristic | EkoSonic Endovascular Device<br>(Subject Device) | EkoSonic Endovascular Device<br>(Predicate Device) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K211080 | K191119 |
| Product Code | QEY, KRA | QEY, KRA |
| Indications for<br>Use | The EkoSonic Endovascular System<br>[with Control Unit] is indicated for the:<br>• Ultrasound facilitated, controlled<br>and selective infusion of physician-<br>specified fluids, including<br>thrombolytics, into the vasculature<br>for the treatment of pulmonary<br>embolism.<br>• Infusion of solutions into the<br>pulmonary arteries.<br>• Controlled and selective infusion of<br>physician-specified fluids, including<br>thrombolytics, into the peripheral<br>vasculature. | The EkoSonic Endovascular System<br>[with Control Unit] is indicated for the:<br>· Ultrasound facilitated, controlled<br>and selective infusion of physician-<br>specified fluids, including<br>thrombolytics, into the vasculature<br>for the treatment of pulmonary<br>embolism.<br>• Infusion of solutions into the<br>pulmonary 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 System<br>[EkoSonic Endovascular Device with<br>Control Unit] employs ultrasound to<br>facilitate the delivery of thrombolytic<br>agents into vascular blood clots. | The EkoSonic Endovascular System<br>[EkoSonic Endovascular Device with<br>Control Unit] employs ultrasound to<br>facilitate the delivery of thrombolytic<br>agents into vascular blood clots. |
| 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 |
| 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 Endovascular Device | Yes - EkoSonic Endovascular Device |
| Single-Use<br>Disposable | Yes - EkoSonic Endovascular Device | Yes - EkoSonic Endovascular Device |
| Materials<br>Biocompatible | Yes - EkoSonic Endovascular Device | Yes - EkoSonic Endovascular Device |
| | EkoSonic Endovascular Device | EkoSonic Endovascular Device |
| Characteristic | (Subject Device) | (Predicate Device) |
| Radiopaque<br>Markers | Markerbands on the Infusion Catheter<br>(IC) are radiopaque<br>The Ultrasonic Core (USCO ultrasound<br>elements are also radiopaque | Markerbands on the IC are radiopaque<br>The USC ultrasound elements are also<br>radiopaque |
| Mechanism of<br>Action | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CU converted to<br>ultrasound | R/F electrical from CU converted to<br>ultrasound |
| Ultrasound<br>Transducer(s) in<br>Catheter | 6 to 30 | 6 to 30 |
| Acoustic<br>Characteristics | Frequency = 2.05 - 2.35 MHz | Frequency = 2.05 - 2.35 MHz |
| Maximum Output<br>Power Limit | Power is available for ~100W Pulses.<br>The power output is limited by<br>software to ~50W. | Power is available for ~100W Pulses.<br>The power output is limited by<br>software to ~50W. |
| Maximum<br>EkoSonic Device<br>Temperature | Temperature monitoring, feedback<br>and control system limits the surface<br>temperature of the IC to 43°C during<br>operation. | Temperature monitoring, feedback<br>and control system limits the surface<br>temperature of the IC to 43°C during<br>operation. |
| Luer Design | ISO 80369-7 Compliant | ISO 594 Compliant |
| Luer Material | Cyrolite® Polymer (acrylic copolymer) | Polycarbonate |

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| Non-Clinical<br>Performance<br>Data | Determination of substantial equivalence is based on an assessment<br>of non-clinical performance bench testing, including bench-top<br>performance evaluations and biological safety. |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Bench Testing:<br>Bench testing was performed to evaluate physical integrity,<br>functionality, and performance of the catheter. Performance criteria<br>includes: catheter tensile strengths, freedom from leak, and burst<br>pressure. |
| | Biological Safety Testing:<br>Biocompatibility testing in accordance with ISO 10993-1, microbial<br>assessments including bioburden and endotoxin, and pyrogenicity and<br>sterility assurance testing show the device has acceptable biological<br>safety for its intended use. |
| Clinical Testing | Performance testing from clinical studies is not required to<br>demonstrate substantial equivalence of EkoSonic Endovascular<br>Device. |
| Conclusion | Based on the indications for use, technological characteristics, and<br>performance testing, EkoSonic Endovascular Device has been shown<br>to be appropriate for its intended use and is considered to be<br>substantially equivalent to EkoSonic Endovascular Device. K191119. |