EkoSonic Endovascular Device
Device Facts
| Record ID | K191119 |
|---|---|
| Device Name | EkoSonic Endovascular Device |
| Applicant | Btg International, Inc. |
| Product Code | QEY · Cardiovascular |
| Decision Date | Aug 23, 2019 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for 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 consists of a single-use, disposable infusion catheter with a removable ultrasound core and a control unit. The catheter features multiple side holes for fluid infusion and up to 30 ultrasound elements for clot treatment. The control unit delivers radiofrequency energy to the ultrasound core, converting it to ultrasound to facilitate thrombolytic agent delivery into vascular blood clots. Thermal sensors in the treatment zone monitor temperature, with the control system limiting surface temperature to 43°C. Used in clinical settings by physicians for endovascular procedures. The device provides ultrasound-facilitated infusion to improve thrombolytic efficacy in treating pulmonary embolism and peripheral vascular conditions.
Clinical Evidence
Bench testing only. No clinical data presented. Verification testing included tensile strength, catheter interlock, impedance, resonant frequency, electrical isolation, burst strength, fluid immersion, and bending force. System integration testing with Control Units PT-3B and CU4.0 was performed. All tests passed at T=0 and after 3-year artificial aging where applicable.
Technological Characteristics
Catheter-based system with ultrasound core (6-30 elements). Frequency: 2.0-2.5 MHz. Max output power: ~100W pulses (software-limited to ~50W). Surface temperature limit: 43°C. Compatible with 0.035" guide wires. 5.4 Fr outer diameter. Materials: Biocompatible. Sterilization: Sterile. Connectivity: RF electrical connection to external control unit. Software: Embedded control system for temperature feedback and power regulation.
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 of solutions into pulmonary arteries, or infusion into the 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
Submission Summary (Full Text)
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November 22, 2021
BTG International, Inc. Joshua Kim Sr. Regulatory Affairs Specialist 11911 North Creek Parkway S Bothell, Washington 98011
Re: K191119
Trade/Device Name: EkoSonic Endovascular Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA
Dear Joshua Kim:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 23, 2019. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -O'connell -S Date: 2021.11.22 13:41:54 -05'00'
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
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August 23, 2019
BTG International, Inc. Joshua Kim Sr. Regulatory Affairs Specialist 11911 North Creek Parkway S Bothell, Washington 98011
Re: K191119
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: April 24, 2019 Received: April 26, 2019
Dear Mr. Joshua Kim:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 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,
Image /page/2/Picture/5 description: The image shows the name "Gregory W. O'connell -S" in a large font. To the right of the name is a digital signature. The signature includes the name Gregory W. O'connell -S, and the date 2019.08.23 10:03:52 -04'00'.
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) K191119
Device Name EkoSonic® Endovascular Device
Indications for Use (Describe)
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) | |
|-------------------------------------------------|--|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
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Image /page/4/Picture/1 description: The image shows the logo for EKOS, a BTG International group company. The logo is in blue and features the company name in a stylized font. The letters 'K' and 'O' have curved elements within them. Below the company name is the text 'a BTG International group company' in a smaller font size.
# Premarket Notification 510(k) Summary K191119
#### l. Submitter
EKOS Corporation, Inc. 11911 North Creek Parkway S Bothell, WA 98011
Phone: 425-415-3114 Fax: 425-415-3105
Contact Person: Joshua Kim Date Prepared: August 22, 2019
#### II. Device
| 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 |
#### lll. Predicate Devices
The EkoSonic Endovascular Device is substantially equivalent to another legally marketed device. This predicate device is the EkoSonic MACH 4 Endovascular Device, cleared as part of the EkoSonic Endovascular System with the EKOS Control Unit (model PT-3B [K182324] and CU4.0 [K183361]).
No reference devices were used in this notification.
### IV. Device Description
The EkoSonic Endovascular System consists of an EkoSonic Endovascular Device and the Control System (Control Unit 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 30 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.
This notification is being made due to the modification of the MSD hub portion of the EkoSonic Endovascular Device.
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Image /page/5/Picture/1 description: The image shows the logo for EKOS, a BTG International group company. The logo is in blue and features the company name in a stylized font. The words "a BTG International group company" are written in a smaller font below the company name.
#### V. Intended Use/Indications for 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.
#### VI. Comparison of Technological Characteristics with the Predicate Device
| | EkoSonic Endovascular Device<br>with Control Unit 4.0<br>(Predicate Device) | EkoSonic Endovascular Device<br>with Control Unit PT-3B<br>(Predicate Device) | EkoSonic Endovascular Device<br>(Subject Device) |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K183361 | K182324 | K191119 |
| Product Code | KRA | KRA | QEY/KRA<br>(Primary/Secondary) |
| Indications for<br>Use | The EkoSonic Endovascular<br>Device with CU 4.0 is indicated<br>for the:<br>• Ultrasound facilitated,<br>controlled and selective<br>infusion of physician-specified<br>fluids, including thrombolytics,<br>into the vasculature for the<br>treatment of pulmonary<br>embolism.<br>• Infusion of solutions into the<br>pulmonary arteries.<br>• Controlled and selective<br>infusion of physician-specified<br>fluids, including thrombolytics,<br>into the peripheral<br>vasculature. | The EkoSonic Endovascular<br>System is indicated for the:<br>• Ultrasound facilitated,<br>controlled and selective<br>infusion of physician-specified<br>fluids, including thrombolytics,<br>into the vasculature for the<br>treatment of pulmonary<br>embolism.<br>• Infusion of solutions into the<br>pulmonary arteries.<br>• Controlled and selective<br>infusion of physician-specified<br>fluids, including thrombolytics,<br>into the peripheral<br>vasculature. | The EkoSonic Endovascular<br>System is indicated for the:<br>· Ultrasound facilitated,<br>controlled and selective<br>infusion of physician-specified<br>fluids, including<br>thrombolytics, into the<br>vasculature for the treatment<br>of pulmonary embolism.<br>• Infusion of solutions into the<br>pulmonary arteries.<br>• Controlled and selective<br>infusion of physician-specified<br>fluids, including<br>thrombolytics, into the<br>peripheral vasculature. |
| Principle of<br>Operation | The EkoSonic Endovascular<br>System employs ultrasound to<br>facilitate the delivery of<br>thrombolytic agents into<br>vascular blood clots. | The EkoSonic Endovascular<br>System employs ultrasound to<br>facilitate the delivery of<br>thrombolytic agents into<br>vascular blood clots. | The EkoSonic Endovascular<br>System [EkoSonic Endovascular<br>Device with EKOS Control Unit]<br>employs ultrasound to facilitate<br>the delivery of thrombolytic<br>agents into vascular blood clots. |
| Infusion Hole<br>Pattern | Multiple side-holes | Multiple side-holes | Multiple side-holes |
| Catheter<br>Working Length | 106 cm or 135 cm | 106 cm or 135 cm | 106 cm or 135 cm |
| Treatment<br>Zone Length | 6 cm - 50 cm | 6 cm - 50 cm | 6 cm - 50 cm |
| | EkoSonic Endovascular Device<br>with Control Unit 4.0<br>(Predicate Device) | EkoSonic Endovascular Device<br>with Control Unit PT-3B<br>(Predicate Device) | EkoSonic Endovascular Device<br>(Subject Device) |
| Compatible<br>Guide Wire | 0.035" | 0.035" | 0.035" |
| Outer Diameter | 5.4 Fr | 5.4 Fr | 5.4 Fr |
| Placement<br>Mode | Percutaneous/endovascular | Percutaneous/endovascular | Percutaneous/endovascular |
| Packaged<br>Sterile | Yes - EkoSonic Device | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Single-Use<br>Disposable | Yes - EkoSonic Device | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Materials<br>Biocompatible | Yes - EkoSonic Device | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Radiopaque<br>Markers | Yes on IDDC<br>MSD ultrasound elements are<br>radiopaque | Yes on IDDC<br>MSD ultrasound elements are<br>radiopaque | Yes on IDDC<br>MSD ultrasound elements are<br>radiopaque |
| Mechanism of<br>Action | Ultrasound | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CU 4.0<br>converted to ultrasound | R/F electrical from PT-3B<br>converted to ultrasound | R/F electrical from CU converted<br>to ultrasound |
| Ultrasound<br>Transducer(s)<br>in Catheter | 6 to 30 | 6 to 30 | 6 to 30 |
| Acoustic<br>Characteristics | Frequency = 2.0 - 2.5 MHz | Frequency = 2.0 - 2.5 MHz | Frequency = 2.0 - 2.5 MHz |
| Maximum<br>Output Power<br>Limit | Power is available for ~100W<br>Pulses. The power output is<br>limited by software to ~50W. | Power is available for ~100W<br>Pulses. The power output is<br>limited by software to ~50W. | Power is available for ~100W<br>Pulses. The power output is<br>limited by software to ~50W. |
| Maximum<br>EkoSonic<br>Device<br>Temperature | Temperature monitoring,<br>feedback and control system<br>limits the surface temperature of<br>the IDDC to 43°C during<br>operation. | Temperature monitoring,<br>feedback and control system<br>limits the surface temperature of<br>the IDDC to 43°C during<br>operation. | Temperature monitoring,<br>feedback and control system<br>limits the surface temperature of<br>the IDDC to 43°C during<br>operation. |
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Image /page/6/Picture/0 description: The image shows the logo for EKOS, a BTG International group company. The logo is in blue and features the company name in a stylized font. The letters 'K' and 'O' have curved elements within them. Below the company name, in a smaller font, is the text 'a BTG International group company'.
The device modifications described in the notification do not affect the intended use, indications for use or the technological characteristics for the EkoSonic Endovascular System (EkoSonic Endovascular Device with Control Unit).
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Image /page/7/Picture/1 description: The image shows the logo for EKOS, a BTG International group company. The logo features the company name in a stylized font, with the letters "E," "K," "O," and "S" clearly visible. Below the company name, in a smaller font, is the text "a BTG International group company," indicating EKOS's affiliation with BTG International.
### Performance Data VII.
Testing has confirmed that the EkoSonic Endovascular Device functions as intended and is substantially equivalent to the predicate device.
| Product<br>Specification | Purpose | EkoSonic Endovascular Device<br>(Subject Device) | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------|
| | | T = 0 | Artificially Aged<br>(T=3 Years) |
| Device Level Testing | | | |
| Tensile Strength | The proposed MSD hub change redesigns the shaft-to-cable and Luer-to-cover joints. It replaces the shaft-to-cable lap joint with a soldered PCB connection and the Luer-to-cover epoxy joint with a snap-on cover. | Pass | Pass |
| Catheter<br>Interlock | The proposed MSD hub change redesigns the catheter interlock by replacing the epoxy which served as the watertight seal with a copolyester overmold. The overmold fills the void between the Luer barb and the snap-on cover. | Pass | Pass |
| Impedance | The proposed MSD hub change redesigns the connection between the shaft-to-cable | Pass | Pass |
| Resonant<br>Frequency | connection which is the RF energy path from the CIC to the transducers. | Pass | Pass |
| Luers | The proposed MSD hub change redesigned the Luer barb to facilitate the use of the snap-on cover. The design change did not affect any other aspect aside from the cover interaction. | Pass | Pass |
| Electrical<br>Isolation | The proposed MSD hub change redesigns the leakage current pathway from the connector to external fluid. | Pass | Pass |
| Sterilization | The device undergoes shipping, storage, sterilization, and shelf life simulation to provide | Pass | Pass |
| Shipping | representative test articles for design verification testing. | Pass | Pass |
| Storage | | Pass | Pass |
| Shelf Life | | Pass | Pass |
| Burst Strength | The proposed MSD hub change redesigns the Luer-to-cover interface and affects resistance to high static pressure. | Pass | Pass |
| Fluid Immersion | The proposed MSD hub change replaces the primary seal with and overmold. As such, design verification testing assessed continuity before and after fluid immersion. | Pass | Pass |
| Bending Force | The proposed MSD hub change replaces the Luer and strain relief with a new Luer bard and snap-on cover. As such, EKOS assessed the bending force of snap-on cover. | Pass | Pass |
| Product<br>Specification | Purpose | EkoSonic Endovascular Device<br>(Subject Device) | |
| | | T = 0 | Artificially Aged<br>(T=3 Years) |
| System Level Testing | | | |
| System<br>Integration with<br>PT-3B | The proposed MSD hub changes affect the<br>connection between the MSD and the Control<br>System. | Pass | N/A. Samples<br>were not aged for<br>system integration<br>validation testing. |
| System<br>Integration with<br>CU4.0 | The proposed MSD hub changes affect the<br>connection between the MSD and the Control<br>System. | Pass | validation testing. |
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Image /page/8/Picture/1 description: The image shows the logo for EKOS, a BTG international group company. The logo is in blue and features the company name in a stylized font. The letters are bold and slightly curved, giving the logo a modern and professional look. Below the company name, the text "a BTG international group company" is written in a smaller, sans-serif font.
Performance standards have not been promulgated for Mechanical Thrombolysis or Continuous Flush Catheters.
#### VIII. Conclusions
The EkoSonic Endovascular Device is substantially equivalent to the predicate devices. The modifications to the EkoSonic Endovascular Device do not affect the intended use or the technological characteristics for the system.
