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§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Boston
Scientific
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752 (508) 683-4000
510(k) Summary
| Sponsor | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752 | |
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| Contact Name and
Information | Daniel Root
Three Scimed Place
Maple Grove, MN 55311-1566
Phone: 425-395-5820
Email: 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. | |
| Boston Scientific Corporation . | | |
| Boston Scientific Corporation
EKOS+ Endovascular Device | | |
| | EKOS+ Endovascular Device | EKOS+ Endovascular Device |
| Characteristic | (Subject 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 | |
| | EKOS+ Endovascular Device | EKOS+ Endovascular Device |
| Characteristic | (Subject 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 594 Compliant | ISO 80369-7 Compliant |
| Luer Material | Polycarbonate | Cyrolite® Polymer (acrylic copolymer) |
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| 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. |