(122 days)
The EkoSonic Endovascular Device with Control Unit 4.0 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 Device with CU 4.0 consists of an EkoSonic Endovascular Device and the Control System 4.0 (Control Unit 4.0 and Connector Interface Cables). The EkoSonic Endovascular Device consists of a 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 4.0 generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.
It is the modifications to the Control System 4.0 that are the subject of this submission.
The EkoSonic Endovascular Device with Control Unit 4.0 is indicated for ultrasound-facilitated infusion of fluids, including thrombolytics, into the vasculature for pulmonary embolism treatment, infusion into pulmonary arteries, and controlled infusion into the peripheral vasculature.
The device's substantial equivalence to its predicate (EKOS EkoSonic Endovascular Device with CU 4.0, K162771) was established based on performance data provided in the submission. The modifications in this submission specifically relate to the Control System 4.0.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it lists various hardware and software tests conducted, with the reported performance being "Pass" for all of them, indicating compliance with internal standards for the modifications made to the Control System 4.0.
| Test Category | Specific Test | Reported Performance |
|---|---|---|
| Hardware | Secondary Cell Battery Tests | Pass |
| Reliability Prediction | Pass | |
| Battery Hardware Design Verification | Pass | |
| Electrical Safety | Pass | |
| Hardware Inspection | Pass | |
| EMC/EMI | Pass | |
| RF Board Hardware Tests | Pass | |
| System Integration | Pass | |
| CIC Hardware Tests | Pass | |
| Shipping Package Tests | Pass | |
| Design Verification Hardware Tests | Pass | |
| UI Board Hardware Tests | Pass | |
| Environmental Tests | Pass | |
| Power Management Module Tests | Pass | |
| Short Circuit Response | Pass | |
| Patched Fastener Design Verification | Pass | |
| EkoSonic Device Reliability | Pass | |
| Software | Periodic Self-Test | Pass |
| User Interface | Pass | |
| Firmware Upgrade | Pass | |
| Event Logging | Pass | |
| System Connect Validation | Pass | |
| Single Channel RF | Pass | |
| Graphing | Pass | |
| Device Compatibility | Pass | |
| Dual Channel RF | Pass | |
| Therapy Support | Pass | |
| System Startup | Pass | |
| Processor Communication | Pass | |
| Constant Parameter | Pass | |
| Source Code Inspection | Pass | |
| AC and Battery Power | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the various hardware and software tests, nor does it provide details on data provenance (e.g., country of origin, retrospective/prospective). The tests were likely conducted internally by the manufacturer, EKOS Corporation, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish a "ground truth" for the test set in the context typically seen for diagnostic or AI-based devices. The performance data here pertains to engineering and software validation of device functionality, not clinical outcome or diagnostic accuracy. Therefore, the concept of expert-established ground truth as a comparison point is not applicable to the type of testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The reported tests are engineering and software verification and validation, not clinical studies requiring adjudications by experts for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an endovascular catheter system with a control unit, not an AI-assisted diagnostic or imaging device that would typically undergo MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a physical medical device (catheter and control unit) that requires physician involvement. The "standalone" performance in this context refers to the functionality of the device components as tested in isolation or in simulated environments, as reflected in the hardware and software tests. The document confirms that "Testing has confirmed that the EkoSonic Endovascular Device with CU 4.0 functions as intended."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" in the context of clinical outcomes or pathology is not directly applicable to the performance data presented. The "ground truth" for these engineering and software tests would be the established design specifications, functional requirements, and recognized industry standards for safety and performance of such medical devices. The predicate device (K162771) serves as the basis for demonstrating substantial equivalence based on technological characteristics and intended use.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense. The "training" for the device, if any, would be its design and manufacturing processes, which are verified through the listed tests.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/ML algorithm.
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November 22, 2021
BTG International, Inc. Benjamin Hornsey Regulatory Affairs Manager 11911 N Creek Pkwy S Bothell, Washington 98011
Re: K183361
Trade/Device Name: EkoSonic Endovascular Device with Control Unit 4.0 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA
Dear Benjamin Hornsey:
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 April 5, 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,
Gregory W - Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2021.11.22
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 5, 2019
BTG International, Inc. Benjamin Hornsey Regulatory Affairs Manager 11911 N Creek Pkwy S Bothell, Washington 98011
Re: K183361
Trade/Device Name: EkoSonic Endovascular Device with Control Unit 4.0 Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: March 5, 2019 Received: March 6, 2019
Dear Mr. Hornsey:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
Digitally signed by Haiira F. Hajira F. Ahmad -S Date: 2019.04.05 Ahmad -S 14:01:06 -04'00'
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183361
Device Name
EkoSonic Endovascular Device with Control Unit 4.0
Indications for Use (Describe)
The EkoSonic Endovascular Device with Control Unit 4.0 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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l. Submitter
EKOS Corporation, Inc. 11911 North Creek Parkway S Bothell, WA 98011
Phone: 425-415-3143 Fax: 425-415-3105
Contact Person: Benjamin Hornsey Date Prepared: December 3, 2018
II. Device
| Proprietary Name: | EkoSonic™ Endovascular Device with Control Unit 4.0 |
|---|---|
| Common or Usual Name: | Continuous Flush Catheter |
| Classification Name: | Catheter, Continuous Flush (21 CFR §870.1210) |
| Product Code: | KRA |
Continuous Flush Catheters have been classified by the FDA Cardiovascular Panel as Class II.
lll. Predicate Devices
The EkoSonic Endovascular Device with CU 4.0 (CU 4.0) is substantially equivalent to another legally marketed device. This predicate device is the EKOS EkoSonic Endovascular Device with CU 4.0 (K162771).
No reference devices were used in this submission.
IV. Device Description
The EkoSonic Endovascular Device with CU 4.0 consists of an EkoSonic Endovascular Device and the Control System 4.0 (Control Unit 4.0 and Connector Interface Cables). The EkoSonic Endovascular Device consists of a 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 4.0 generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.
It is the modifications to the Control System 4.0 that are the subject of this submission.
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V. Intended Use/Indications for use
The EkoSonic Endovascular Device with Control Unit 4.0 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.
| EkoSonic Endovascular Device with | EkoSonic Endovascular Device with | |
|---|---|---|
| CU 4.0 | CU 4.0 | |
| (Subject Device) | (Predicate Device) | |
| 510(k) Number | K183361 | K162771 |
| Product Code | KRA | KRA |
| Indications forUse | The EkoSonic Endovascular Device with CU 4.0is indicated for the:• Ultrasound facilitated, controlled andselective infusion of physician-specifiedfluids, including thrombolytics, into thevasculature for the treatment of pulmonaryembolism.• Infusion of solutions into the pulmonaryarteries.• Controlled and selective infusion ofphysician-specified fluids, includingthrombolytics, into the peripheralvasculature. | The EkoSonic Endovascular Device with CU 4.0is indicated for the:• Ultrasound facilitated, controlled andselective infusion of physician-specifiedfluids, including thrombolytics, into thevasculature for the treatment of pulmonaryembolism.• Infusion of solutions into the pulmonaryarteries.• Controlled and selective infusion ofphysician-specified fluids, includingthrombolytics, into the peripheralvasculature. |
| Principle ofOperation | The EkoSonic Endovascular Device with CU 4.0employs ultrasound to facilitate the delivery ofthrombolytic agents into vascular blood clots. | The EkoSonic Endovascular Device with CU 4.0employs ultrasound to facilitate the delivery ofthrombolytic agents into vascular blood clots. |
| Software Version | 01.02.02 | 01.00.05 |
| Battery Version | 8742-003 | 6841-002 |
| Infusion HolePattern | Multiple side-holes | Multiple side-holes |
| Catheter WorkingLength | 106 cm or 135 cm | 106 cm or 135 cm |
| Treatment ZoneLength | 6 cm - 50 cm | 6 cm - 50 cm |
| EkoSonic Endovascular Device withCU 4.0(Subject Device) | EkoSonic Endovascular Device withCU 4.0(Predicate Device) | |
| CompatibleGuide Wire | 0.035" | 0.035" |
| Outer Diameter | 5.4 Fr | 5.4 Fr |
| Placement Mode | Percutaneous/endovascular | Percutaneous/endovascular |
| Packaged Sterile | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Single-UseDisposable | Yes - EkoSonic Device | Yes - EkoSonic Device |
| MaterialsBiocompatible | Yes - EkoSonic Device | Yes - EkoSonic Device |
| RadiopaqueMarkers | Yes on IDDCMSD ultrasound elements are radiopaque | Yes on IDDCMSD ultrasound elements are radiopaque |
| Mechanism ofAction | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CU 4.0 converted toultrasound | R/F electrical from CU 4.0 converted toultrasound |
| UltrasoundTransducer(s) inCatheter | 6 to 30 | 6 to 30 |
| AcousticCharacteristics | Frequency = 2.0 - 2.5 MHz | Frequency = 2.0 - 2.5 MHz |
| Battery Backup | Internal, lithium-ion backup battery | Internal, lithium-ion backup battery |
| MaximumOutput PowerLimit | Power is available for ~100W Pulses. Thepower output is limited by software to ~50W. | Power is available for ~100W Pulses. Thepower output is limited by software to ~50W. |
| MaximumEkoSonic DeviceTemperature | Temperature monitoring, feedback and controlsystem limits the surface temperature of theIDDC to 43°C during operation. | Temperature monitoring, feedback and controlsystem limits the surface temperature of theIDDC to 43°C during operation. |
VI. Comparison of Technological Characteristics with the Predicate Device
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The device modifications described in the submission do not affect the intended use,
indications for use or the technological characteristics for the EkoSonic Endovascular System.
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VII. Performance Data
Testing has confirmed that the EkoSonic Endovascular Device with CU 4.0 functions as intended and is substantially equivalent to the predicate device.
| Hardware Testing Performed | |
|---|---|
| Secondary Cell Battery Tests | Pass |
| Reliability Prediction | Pass |
| Battery Hardware Design Verification | Pass |
| Electrical Safety | Pass |
| Hardware Inspection | Pass |
| EMC/EMI | Pass |
| RF Board Hardware Tests | Pass |
| System Integration | Pass |
| CIC Hardware Tests | Pass |
| Shipping Package Tests | Pass |
| Design Verification Hardware Tests | Pass |
| UI Board Hardware Tests | Pass |
| Environmental Tests | Pass |
| Power Management Module Tests | Pass |
| Short Circuit Response | Pass |
| Patched Fastener Design Verification | Pass |
| EkoSonic Device Reliability | Pass |
| Software Testing Performed | |
|---|---|
| Periodic Self-Test | Pass |
| User Interface | Pass |
| Firmware Upgrade | Pass |
| Event Logging | Pass |
| System Connect Validation | Pass |
| Single Channel RF | Pass |
| Graphing | Pass |
| Device Compatibility | Pass |
| Dual Channel RF | Pass |
| Therapy Support | Pass |
| System Startup | Pass |
| Processor Communication | Pass |
| Constant Parameter | Pass |
| Source Code Inspection | Pass |
| AC and Battery Power | Pass |
Performance standards have not been promulgated for Continuous Flush Catheters.
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VIII. Conclusions
The EkoSonic Endovascular Device with CU 4.0 is substantially equivalent to the predicate device. The modifications to the Control System 4.0 do not affect the intended use or the technological characteristics for the system and do not raise new questions of safety or effectiveness.
§ 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).