(55 days)
The EkoSonicTM 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, 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.
The sterile, single-use EkoSonic Endovascular Device consists of an Infusion Catheter (IC) and an Ultrasonic Core (USC). The USC fits within the central lumen of the IC. Together, they are used to deliver physician-specified fluids and ultrasound energy to the treatment zone.
The sterile, single-use EKQS+ Endovascular Device consists of an Infusion Catheter (IC),and an Ultrasonic Core (USC). The USC fits within the central lumen of the IC. Together, they are used to deliver physician-specified fluids and ultrasound energy to the treatment zone.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance metrics. Instead, it is a 510(k) premarket notification for the EkoSonic Endovascular Device and EKOS+ Endovascular Device, which are medical devices for intravascular infusion, not AI/ML software.
The document discusses expanding the Indications for Use to include Deep Vein Thrombosis (DVT), stating that this change does not impact the technological characteristics of the device. It references a systematic literature review, including data from the ACCESS-PTS trial and CAVA studies, to support the inclusion of DVT in the indications for use.
Therefore, I cannot extract the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as these are not relevant to the content of this document.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2021
Boston Scientific Corporation Ambreen Athar Regulatory Affairs, Principal Specialist Three Scimed Place Maple Grove, Minnesota 55311
Re: K213422
Trade/Device Name: EkoSonic Endovascular Device, EKOS+ 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 Ambreen Athar:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213422
Device Name EkoSonic Endovascular Device EKOS+ Endovascular Device
Indications for Use (Describe)
The EkoSonicTM 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, 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Premarket Notification 510(k) Summary for K213422
l. Submitter
Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311
Phone: 763.995.8171
Contact Person: Ambreen Athar Alternate Contact Person: Brent Hathcock
Date Prepared: December 13, 2021
II. Devices
| Proprietary Name: | EkoSonic Endovascular Device |
|---|---|
| Common or Usual Name: | Continuous Flush Catheter |
| Primary Classification Name: | Mechanical Thrombolysis Catheter (21 CFR §870.5150) |
| Primary Product Code: | QEY |
| FDA Panel/Device Class: | Cardiovascular; Class II |
| Secondary Classification Name: | Catheter, Continuous Flush (21 CFR §870.1210) |
| Secondary Product Code: | KRA |
| FDA Panel/Device Class: | Cardiovascular; Class II |
| Proprietary Name: | EKOS+ Endovascular Device |
| Common or Usual Name: | Continuous Flush Catheter |
| Primary Classification Name: | Mechanical Thrombolysis Catheter (21 CFR §870.5150) |
| Primary Product Code: | QEY |
| FDA Panel/Device Class: | Cardiovascular; Class II |
| Secondary Classification Name: | Catheter, Continuous Flush (21 CFR §870.1210) |
| Secondary Product Code: | KRA |
| FDA Panel/Device Class: | Cardiovascular; Class II |
lll. Predicate Devices
The proposed modification is to the Indications For Use for both the EkoSonic Endovascular Device (K191119) and EKOS PE Endovascular Device (K200648). The modification to the indications is to include Deep Vein Thrombosis (DVT). A systematic literature review is presented to support the appropriateness of the change. There is no change to the design or manufacture of the device as a result of this change, therefore, the predicate devices are the current versions of the legally marketed devices. The predicate devices will be EkoSonic Endovascular Device (K191119) and the EKOS PE Endovascular Device (K200648).
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No reference devices were used in this notification.
IV. Device Description
EkoSonic Endovascular Device -
The sterile, single-use EkoSonic Endovascular Device consists of an Infusion Catheter (IC) and an Ultrasonic Core (USC). The USC fits within the central lumen of the IC. Together, they are used to deliver physician-specified fluids and ultrasound energy to the treatment zone.
EKOS+ Endovascular Device -
The sterile, single-use EKQS+ Endovascular Device consists of an Infusion Catheter (IC),and an Ultrasonic Core (USC). The USC fits within the central lumen of the IC. Together, they are used to deliver physician-specified fluids and ultrasound energy to the treatment zone.
V. Proposed Intended Use/Indications for use
The EkoSonic™ 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.
| PREDICATE DEVICES | SUBJECT DEVICES | |||
|---|---|---|---|---|
| EkoSonic EndovascularDevice(Predicate Device) | EKOS PE EndovascularDevice with CU4.0(Predicate Device) | EkoSonic EndovascularDevice(Subject Device) | EKOS+ EndovascularDevice(Subject Device) | |
| 510(k) Number | K191119 | K200648 | To be assigned | To be assigned |
| Product Code | QEY, KRA | QEY, KRA | QEY, KRA | QEY, KRA |
| Product Name | EkoSonic EndovascularDevice | EKOS PE EndovascularDevice | EkoSonic EndovascularDevice | EKOS+ EndovascularDevice |
| PREDICATE DEVICES | SUBJECT DEVICES | |||
| EkoSonic Endovascular | EKOS PE Endovascular | EkoSonic Endovascular | EKOS+ Endovascular | |
| Device | Device with CU4.0 | Device | Device | |
| (Predicate Device) | (Predicate Device) | (Subject Device) | (Subject Device) | |
| Indications forUse | The EkoSonicEndovascular Device withCU4.0 is indicated for the:· Ultrasound facilitated,controlled and selectiveinfusion of physician-specified fluids, includingthrombolytics, into thevasculature for thetreatment of pulmonaryembolism.· Infusion of solutions intothe pulmonary arteries.· Controlled and selectiveinfusion of physician-specified fluids, includingthrombolytics, into theperipheral vasculature. | The EKOS PEEndovascular System [withCU4.0] is indicated for the:· Ultrasound facilitated,controlled and selectiveinfusion of physician-specified fluids,including thrombolytics,into the vasculature forthe treatment ofpulmonary embolism.• Infusion of solutions intothe pulmonary arteries.· Controlled and selectiveinfusion of physician-specified fluids,including thrombolytics,into the peripheralvasculature. | The EkoSonic™Endovascular System isindicated for the:Ultrasound facilitated,controlled andselective intravascularinfusion of physician-specified fluids,includinathrombolytics, for thetreatment ofpulmonary embolismand/or deep veinthrombosisControlled andselective infusion ofphysician-specifiedfluids, includingthrombolytics, into thepulmonary arteriesand/or peripheralvasculature. | The EKOS+ EndovascularSystem is indicated for the:Ultrasound facilitated,controlled andselective intravascularinfusion of physician-specified fluids,includingthrombolytics, for thetreatment ofpulmonary embolismand/or deep veinthrombosisControlled andselective infusion ofphysician-specifiedfluids, includingthrombolytics, into thepulmonary arteriesand/or peripheralvasculature. |
| Principle ofOperation | The EkoSonicEndovascular Systememploys ultrasound tofacilitate the delivery ofthrombolytic agents intovascular blood clots. | The EKOS PEEndovascular System[EKOS PE EndovascularDevice with CU4.0]employs ultrasound tofacilitate the delivery ofthrombolytic agents intovascular blood clots. | The EkoSonicEndovascular Systememploys ultrasound tofacilitate the delivery ofthrombolytic agents intovascular blood clots. | The EKOS+ EndovascularSystem employs ultrasoundto facilitate the delivery ofthrombolytic agents intovascular blood clots. |
| Infusion HolePattern | Multiple side-holes | Multiple side-holes | Multiple side-holes | Multiple side-holes |
| CatheterWorkingLength | 106 cm or 135 cm | 106 cm or 135 cm | 106 cm or 135 cm | 106 cm or 135 cm |
| TreatmentZone Length | 6 cm - 50 cm | 8 cm - 20 cm | 6 cm - 50 cm | 8 cm - 20 cm |
| CompatibleGuide Wire | 0.035" | 0.035" | 0.035" | 0.035" |
| Outer Diameter | 5.4 Fr | 7.7 Fr | 5.4 Fr | 7.7 Fr |
| PlacementMode | Percutaneous/endovascular | Percutaneous/endovascular | Percutaneous/endovascular | Percutaneous/endovascular |
| PackagedSterile | Yes - EkoSonicEndovascular Device | Yes - EKOS PEEndovascular Device | Yes - EkoSonicEndovascular Device | Yes - EKOS+Endovascular Device |
| PREDICATE DEVICES | SUBJECT DEVICES | |||
| EkoSonic EndovascularDevice(Predicate Device) | EKOS PE EndovascularDevice with CU4.0(Predicate Device) | EkoSonic EndovascularDevice(Subject Device) | EKOS+ EndovascularDevice(Subject Device) | |
| Single-UseDisposable | Yes - EkoSonicEndovascular Device | Yes - EKOS PEEndovascular Device | Yes - EkoSonicEndovascular Device | Yes - EKOS+Endovascular Device |
| MaterialsBiocompatible | Yes - EkoSonicEndovascular Device | Yes - EKOS PEEndovascular Device | Yes - EkoSonicEndovascular Device | Yes - EKOS+Endovascular Device |
| RadiopaqueMarkers | Yes on ICUSC ultrasound elementsare radiopaque | Yes on ICUSC ultrasound elementsare radiopaque | Yes on ICUSC ultrasound elementsare radiopaque | Yes on ICUSC ultrasound elementsare radiopaque |
| Mechanism ofAction | Ultrasound | Ultrasound | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CUconverted to ultrasound | R/F electrical from CUconverted to ultrasound | R/F electrical from CUconverted to ultrasound | R/F electrical from CUconverted to ultrasound |
| UltrasoundTransducer(s)in Catheter | 6 to 30 | 8 to 20 | 6 to 30 | 8 to 20 |
| AcousticCharacteristics | Frequency = 2.05 - 2.5MHz | Frequency = 1.58-2.00MHz | Frequency = 2.05 - 2.5MHz | Frequency = 1.58-2.00MHz |
| MaximumOutput PowerLimit | Power is available for~100W Pulses. The poweroutput is limited by softwareto ~50W. | Power is available for~100W Pulses. The poweroutput is limited by softwareto ~50W. | Power is available for~100W Pulses. The poweroutput is limited by softwareto ~50W. | Power is available for~100W Pulses. The poweroutput is limited by softwareto ~50W. |
| MaximumEkoSonicDeviceTemperature | Temperature monitoring,feedback and controlsystem limits the surfacetemperature of the IC to43°C during operation. | Temperature monitoring,feedback and controlsystem limits the surfacetemperature of the IC to43°C during operation. | Temperature monitoring,feedback and controlsystem limits the surfacetemperature of the IC to43°C during operation. | Temperature monitoring,feedback and controlsystem limits the surfacetemperature of the IC to43°C during operation. |
VI. Comparison of Technological Characteristics with the Predicate Devices
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There are no device modifications (individually or cumulatively) to the subject devices that impact the technological characteristics of the devices since the last 510(k) submission including:
- Product specification requirements
- Raw material composition or constituents .
- . Product chemical composition or the physical and chemical properties
- Device packaging (with the exception of BSC branding on the labels) ●
The only change is to the indications for use to include the DVT as a treatment and a change to the trade name of EKOS PE to EKOS+.
VII. Performance Data
Device testing was not required to support the change to the indications for use changes. There are no changes to the device technological characteristics. The devices are, therefore, substantially equivalent to the predicate device.
VIII. Clinical Data
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A systematic literature review, including data from the ACCESS-PTS trial and CAVA studies, were used to support the inclusion of DVT to the indications for use with both the EkoSonic Endovascular and EKOS+ Endovascular devices.
IX. Conclusions
The EkoSonic Endovascular Device and the EKOS+ Endovascular Device are substantially equivalent to the predicate devices. The expansion to the indications for use and the change to the trade name do not impact the technological characteristics for the system.
§ 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).