(26 days)
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.
The EKOS+ Endovascular System consists of an EKOS+ Endovascular Device and EKOS Control Unit (Control Unit 4.0 and Connector Interface Cables). The EkoSonic 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.
N/A
FDA 510(k) Clearance Letter - EKOS+ Endovascular Device
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.04.32
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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K220866 - Daniel Root
Page 2
801); medical device reporting (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-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-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,
Digitally signed by Julie B. Mackel -S
Date: 2022.04.20 12:41:46 -04'00'
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
Page 3
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
Indications for Use
See PRA Statement below.
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)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (6/20)
Page 1 of 1
Page 4
Boston Scientific Corporation
EKOS+ Endovascular Device
Page 1 of 3
K220866
510(k) Summary
| Sponsor | Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752 |
|---|---|
| Contact Name and Information | Daniel RootThree Scimed PlaceMaple Grove, MN 55311-1566Phone: 425-395-5820Email: Daniel.Root@bsci.com |
| Date Prepared | April 18, 2022 |
| Proprietary Name | EKOS+ Endovascular Device |
| Common Name | Continuous Flush Catheter |
| Product Code (Primary/Secondary) | QEY, KRA |
| Classification (Primary/Secondary) | Mechanical Thrombolysis Catheter (21 CFR §870.5150)Catheter, Continuous Flush (21 CFR §870.1210) |
| Predicate Device | The EKOS+ Endovascular Device is substantially equivalent to another legally marketed device. This predicate device is the EKOS+ Endovascular Device (K213422). |
| Device Description | The EKOS+ Endovascular System consists of an EKOS+ Endovascular Device and EKOS Control Unit (Control Unit 4.0 and Connector Interface Cables). The EkoSonic 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. |
| Indications for Use/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 Technology Characteristics and Comparison to Predicate Device | The EKOS+ Endovascular Device incorporates the following changes from the predicate EKOS+ Endovascular Device (K213422): an updated luer design that is ISO 80369-7 compliant; luer material change to a Cyrolite® Polymer; and an updated distal catheter tip design and material. |
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Boston Scientific Corporation
EKOS+ Endovascular Device
Page 2 of 3
K220866
| Characteristic | EKOS+ Endovascular Device (Subject Device) | EKOS+ Endovascular Device (Predicate Device) |
|---|---|---|
| 510(k) Number | K220866 | K213422 |
| Product Code | QEY, KRA | QEY, KRA |
| Indications for 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. | 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. |
| Principle of Operation | The EKOS+ Endovascular System [EKOS+ Endovascular Device with Control Unit] employs ultrasound to facilitate the delivery of thrombolytic agents into vascular blood clots. | The EKOS+ Endovascular System [EKOS+ Endovascular Device with Control Unit] employs ultrasound to facilitate the delivery of thrombolytic agents into vascular blood clots. |
| Infusion Hole Pattern | Multiple side-holes | Multiple side-holes |
| Catheter Working Length | 106 cm or 135 cm | 106 cm or 135 cm |
| Treatment Zone Length | 8 cm — 20 cm | 8 cm — 20 cm |
| Compatible Guide Wire | 0.035" | 0.035" |
| Labeled Outer Diameter | 7.8 Fr | 7.7 Fr |
| Sterilization Method | Ethylene Oxide Sterilization | Ethylene Oxide Sterilization |
| SAL | 10⁻⁶ | 10⁻⁶ |
| Infusion Hole Pattern | Multiple side-holes | Multiple side-holes |
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Boston Scientific Corporation
EKOS+ Endovascular Device
Page 3 of 3
K220866
| Characteristic | EKOS+ Endovascular Device (Subject Device) | EKOS+ Endovascular Device (Predicate Device) |
|---|---|---|
| Radiopaque Markers | One tungsten-loaded Pebax tip and one platinum iridium marker band on the IC.USC ultrasound elements are radiopaque | One tungsten-loaded Pebax tip and one platinum iridium marker band on the IC.USC ultrasound elements are radiopaque |
| Single-Use | Yes | Yes |
| Biocompatibility | Meets all the requirements in accordance with ISO 10993-1 | Meets all the requirements in accordance with ISO 10993-1 |
| Infusion Catheter Tip Material | Pebax Tungsten Blend | Pebax Tungsten Blend |
| Luer and Manifold Design | ISO 80369-7 Compliant | ISO 594 Compliant |
| Luer Material | Cyrolite® Polymer (acrylic copolymer) | Polycarbonate |
| Non-Clinical Performance Data | Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing, including bench-top performance evaluations and biological safety.Bench Testing:Bench testing was performed to evaluate physical integrity, functionality, and performance of the catheter. Performance criteria includes: guidewire/sheath compatibility, tip pressure, luer lock/connector performance.Biological Safety Testing:Biocompatibility testing in accordance with ISO 10993-1, microbial assessments including bioburden and endotoxin, and pyrogenicity and sterility assurance testing show the device has acceptable biological safety for its intended use. |
|---|---|
| Clinical Testing | Performance testing from clinical studies is not required to demonstrate substantial equivalence of EKOS+ Endovascular Device. |
| Conclusion | Based on the indications for use, technological characteristics, and performance testing, EKOS+ Endovascular Device has been shown to be appropriate for its intended use and is considered to be substantially equivalent to EKOS+ Endovascular Device, K213422. |
§ 870.5150 Embolectomy catheter.
(a)
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.(b)
Classification. Class II (performance standards).