EKOS+ Endovascular Device

K220866 · Boston Scientific · QEY · Apr 20, 2022 · Cardiovascular

Device Facts

• Record ID: K220866
• Device Name: EKOS+ Endovascular Device
• Applicant: Boston Scientific
• Product Code: QEY · Cardiovascular
• Decision Date: Apr 20, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EKOS+ Endovascular System is indicated for the: · Ultrasound facilitated, controlled and selective intravascular infusion of physician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis. · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries and/ or peripheral vasculature.

Device Story

The EKOS+ Endovascular System is a single-use, disposable infusion catheter with a removable ultrasound core, used in clinical settings by physicians. The catheter features multiple side holes for fluid delivery and an ultrasound core containing up to 20 elements. The system includes a control unit that generates and delivers radiofrequency energy to the ultrasound core while monitoring treatment zone temperature via integrated sensors. The ultrasound facilitates the delivery of physician-specified fluids (e.g., thrombolytics) into vascular blood clots. The device is used for the treatment of pulmonary embolism and deep vein thrombosis, as well as infusion into pulmonary arteries and peripheral vasculature. The healthcare provider uses the system to perform controlled, selective infusion, which aids in the treatment of thrombi. The device benefits patients by providing ultrasound-facilitated thrombolysis.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including physical integrity, functionality, and performance evaluations (guidewire/sheath compatibility, tip pressure, luer lock/connector performance), and biological safety testing in accordance with ISO 10993-1.

Technological Characteristics

Single-use infusion catheter with removable ultrasound core (up to 20 elements). Materials include Pebax tungsten blend for the tip and Cyrolite® polymer for the luer. Features multiple side holes for infusion. Connectivity includes a control unit for RF energy delivery and temperature monitoring. Sterilization method not specified. Compliant with ISO 80369-7 for luer design.

Indications for Use

Indicated for ultrasound-facilitated, controlled, selective intravascular infusion of physician-specified fluids (including thrombolytics) to treat pulmonary embolism and/or deep vein thrombosis, and for controlled, selective infusion of such fluids into pulmonary arteries and/or 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+ Endovascular Device (K213422)

Submission Summary (Full Text)

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April 20, 2022

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

## Re: K220866

Trade/Device Name: EKOS+ Endovascular Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEY, KRA Dated: March 23, 2022 Received: March 25, 2022

## Dear Daniel 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 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 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-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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K220866

Device Name EKOS+ Endovascular Device

Indications for Use (Describe)

The EKOS+ Endovascular System is indicated for the:

· Ultrasound facilitated, controlled and selective intravascular infusion of physician-specified fluids, including

thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis.

· Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries and/ or peripheral vasculature.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Boston
Scientific

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

www.bostonscientific.com

# 510(k) Summary

| Sponsor | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, Massachusetts 01752 | |
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