(119 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the EkoSonic Endovascular Device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes several device-level and system-level tests performed to demonstrate substantial equivalence, particularly focusing on modifications to the MSD hub portion of the device. The reported performance for all tests is "Pass," indicating that the device met the established acceptance criteria for each test.
| Product Specification | Purpose | Acceptance Criteria (Implied) | Reported Device Performance (T=0) | Reported Device Performance (Artificially Aged (T=3 Years)) |
|---|---|---|---|---|
| Device Level Testing | ||||
| Tensile Strength | Redesign of shaft-to-cable and Luer-to-cover joints (replaces lap joint with soldered PCB, Luer-to-cover epoxy with snap-on cover). | Maintain structural integrity | Pass | Pass |
| Catheter Interlock | Redesigned catheter interlock, replacing watertight epoxy seal with copolyester overmold. | Maintain watertight seal | Pass | Pass |
| Impedance | Redesigns connection between shaft-to-cable, which is the RF energy path. | Maintain electrical conductivity | Pass | Pass |
| Resonant Frequency | (Associated with Impedance testing) | Maintain optimal frequency | Pass | Pass |
| Luers | Redesigned Luer barb to facilitate snap-on cover. | Maintain proper Luer function | Pass | Pass |
| Electrical Isolation | Redesigns leakage current pathway from connector to external fluid. | Maintain electrical safety | Pass | Pass |
| Sterilization | Device undergoes shipping, storage, sterilization, and shelf life simulation to provide representative test articles. | Maintain sterile barrier/integrity | Pass | Pass |
| Shipping | (Part of simulating representative test articles) | Withstand shipping stresses | Pass | Pass |
| Storage | (Part of simulating representative test articles) | Withstand storage conditions | Pass | Pass |
| Shelf Life | (Part of simulating representative test articles) | Maintain function over shelf life | Pass | Pass |
| Burst Strength | Redesigns Luer-to-cover interface, affecting resistance to high static pressure. | Maintain resistance to burst | Pass | Pass |
| Fluid Immersion | Redesigns and replaces primary seal with overmold; assessed continuity before and after fluid immersion. | Maintain fluid integrity/continuity | Pass | Pass |
| Bending Force | Replaces Luer and strain relief with new Luer barb and snap-on cover; assessed bending force of snap-on cover. | Maintain structural flexibility | Pass | Pass |
| System Level Testing | ||||
| System Integration with PT-3B | MSD hub changes affect connection between MSD and Control System. | Maintain system compatibility | Pass | N/A |
| System Integration with CU4.0 | MSD hub changes affect connection between MSD and Control System. | Maintain system compatibility | Pass | validation testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "Testing has confirmed that the EkoSonic Endovascular Device functions as intended and is substantially equivalent to the predicate device." However, it does not explicitly state the sample sizes used for each of the various tests (e.g., tensile strength, burst strength). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). The nature of the tests (physical and electrical performance) generally implies laboratory testing rather than clinical data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The study described is focused on the physical and electrical performance of the device components due to a modification. It is not a diagnostic device study that would typically involve establishing ground truth based on expert consensus of medical images or patient outcomes. Therefore, there is no mention of experts or their qualifications for establishing ground truth in the context of these engineering performance tests. The "ground truth" here is the expected physical and electrical performance as defined by engineering specifications and standards.
4. Adjudication Method for the Test Set:
Given that this is a technical performance study of device components, an "adjudication method" in the clinical sense (like 2+1 or 3+1 consensus for medical image interpretation) is not applicable and not mentioned. The results of these engineering tests ("Pass") would be determined by whether the device meets pre-defined quantitative or qualitative engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or performed. The device is an EkoSonic Endovascular Device used for ultrasound-facilitated, controlled, and selective infusion of fluids. It's a therapeutic device, not a diagnostic imaging device typically evaluated with MRMC studies comparing human readers with and without AI assistance.
6. Standalone Performance Study:
The study is inherently about the standalone performance of the modified device components and its integration with the control unit. The listed tests (tensile strength, impedance, electrical isolation, etc.) evaluate the device's intrinsic physical and electrical characteristics. There is no "algorithm only" aspect as it's a physical medical device. It's not an AI-driven diagnostic tool that would have a separate standalone algorithm performance.
7. Type of Ground Truth Used:
The ground truth for this type of performance study is based on engineering specifications, design requirements, and established industry standards for medical device safety and functionality. For example, burst strength would have a defined pressure threshold, and electrical isolation would have maximum leakage current limits. The "Pass" results indicate that the device met these predefined engineering criteria.
8. Sample Size for the Training Set:
This document describes a study for a physical medical device. It does not involve a "training set" in the context of machine learning or artificial intelligence. The performance data presented are for validation testing of the modified device.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this type of device performance study, this question is not applicable. The "ground truth" for evaluating the test items relates to engineering specifications as described in point 7.
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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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The text is stacked, with "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
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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Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 Devicewith Control Unit 4.0(Predicate Device) | EkoSonic Endovascular Devicewith Control Unit PT-3B(Predicate Device) | EkoSonic Endovascular Device(Subject Device) | |
|---|---|---|---|
| 510(k) Number | K183361 | K182324 | K191119 |
| Product Code | KRA | KRA | QEY/KRA(Primary/Secondary) |
| Indications forUse | The EkoSonic EndovascularDevice with CU 4.0 is indicatedfor the:• Ultrasound facilitated,controlled and selectiveinfusion of physician-specifiedfluids, including thrombolytics,into the vasculature for thetreatment of pulmonaryembolism.• Infusion of solutions into thepulmonary arteries.• Controlled and selectiveinfusion of physician-specifiedfluids, including thrombolytics,into the peripheralvasculature. | The EkoSonic EndovascularSystem is indicated for the:• Ultrasound facilitated,controlled and selectiveinfusion of physician-specifiedfluids, including thrombolytics,into the vasculature for thetreatment of pulmonaryembolism.• Infusion of solutions into thepulmonary arteries.• Controlled and selectiveinfusion of physician-specifiedfluids, including thrombolytics,into the peripheralvasculature. | The EkoSonic EndovascularSystem is indicated for the:· Ultrasound facilitated,controlled and selectiveinfusion of physician-specifiedfluids, includingthrombolytics, into thevasculature for the treatmentof pulmonary embolism.• Infusion of solutions into thepulmonary arteries.• Controlled and selectiveinfusion of physician-specifiedfluids, includingthrombolytics, into theperipheral vasculature. |
| Principle ofOperation | The EkoSonic EndovascularSystem employs ultrasound tofacilitate the delivery ofthrombolytic agents intovascular blood clots. | The EkoSonic EndovascularSystem employs ultrasound tofacilitate the delivery ofthrombolytic agents intovascular blood clots. | The EkoSonic EndovascularSystem [EkoSonic EndovascularDevice with EKOS Control Unit]employs ultrasound to facilitatethe delivery of thrombolyticagents into vascular blood clots. |
| Infusion HolePattern | Multiple side-holes | Multiple side-holes | Multiple side-holes |
| CatheterWorking Length | 106 cm or 135 cm | 106 cm or 135 cm | 106 cm or 135 cm |
| TreatmentZone Length | 6 cm - 50 cm | 6 cm - 50 cm | 6 cm - 50 cm |
| EkoSonic Endovascular Devicewith Control Unit 4.0(Predicate Device) | EkoSonic Endovascular Devicewith Control Unit PT-3B(Predicate Device) | EkoSonic Endovascular Device(Subject Device) | |
| CompatibleGuide Wire | 0.035" | 0.035" | 0.035" |
| Outer Diameter | 5.4 Fr | 5.4 Fr | 5.4 Fr |
| PlacementMode | Percutaneous/endovascular | Percutaneous/endovascular | Percutaneous/endovascular |
| PackagedSterile | Yes - EkoSonic Device | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Single-UseDisposable | Yes - EkoSonic Device | Yes - EkoSonic Device | Yes - EkoSonic Device |
| MaterialsBiocompatible | Yes - EkoSonic Device | Yes - EkoSonic Device | Yes - EkoSonic Device |
| RadiopaqueMarkers | Yes on IDDCMSD ultrasound elements areradiopaque | Yes on IDDCMSD ultrasound elements areradiopaque | Yes on IDDCMSD ultrasound elements areradiopaque |
| Mechanism ofAction | Ultrasound | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CU 4.0converted to ultrasound | R/F electrical from PT-3Bconverted to ultrasound | R/F electrical from CU convertedto ultrasound |
| UltrasoundTransducer(s)in Catheter | 6 to 30 | 6 to 30 | 6 to 30 |
| AcousticCharacteristics | Frequency = 2.0 - 2.5 MHz | Frequency = 2.0 - 2.5 MHz | Frequency = 2.0 - 2.5 MHz |
| MaximumOutput PowerLimit | Power is available for ~100WPulses. The power output islimited by software to ~50W. | Power is available for ~100WPulses. The power output islimited by software to ~50W. | Power is available for ~100WPulses. The power output islimited by software to ~50W. |
| MaximumEkoSonicDeviceTemperature | Temperature monitoring,feedback and control systemlimits the surface temperature ofthe IDDC to 43°C duringoperation. | Temperature monitoring,feedback and control systemlimits the surface temperature ofthe IDDC to 43°C duringoperation. | Temperature monitoring,feedback and control systemlimits the surface temperature ofthe IDDC to 43°C duringoperation. |
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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.
| ProductSpecification | Purpose | EkoSonic Endovascular Device(Subject Device) | |
|---|---|---|---|
| T = 0 | Artificially Aged(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 |
| CatheterInterlock | 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 |
| ResonantFrequency | 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 |
| ElectricalIsolation | 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 |
| ProductSpecification | Purpose | EkoSonic Endovascular Device(Subject Device) | |
| T = 0 | Artificially Aged(T=3 Years) | ||
| System Level Testing | |||
| SystemIntegration withPT-3B | The proposed MSD hub changes affect theconnection between the MSD and the ControlSystem. | Pass | N/A. Sampleswere not aged forsystem integrationvalidation testing. |
| SystemIntegration withCU4.0 | The proposed MSD hub changes affect theconnection between the MSD and the ControlSystem. | 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.
§ 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).