(144 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, into the peripheral vasculature.
The EkoSonic Endovascular System consists of an EkoSonic Device and the Control Unit 4.0 (CU 4.0). The EkoSonic 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 CU 4.0 generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.
The provided text describes a 510(k) premarket notification for the EkoSonic® Endovascular System with Control Unit 4.0. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with clinical endpoints and detailed acceptance criteria for an AI/ML-driven medical device. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided text.
Based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied to be that the new Control Unit 4.0 (CU 4.0) functions as intended and is substantially equivalent to the predicate device, the EkoSonic Control Unit (PT-3B), without raising new questions of safety or effectiveness. The performance data presented consists of a series of hardware and software tests, all of which "Pass."
| Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Hardware Testing | System Tip Test | Pass | Pass |
| Secondary Cell Battery Test | Pass | Pass | |
| Reliability Prediction | Pass | Pass | |
| Battery Life Prediction | Pass | Pass | |
| Electrical Safety | Pass | Pass | |
| Hardware Inspection | Pass | Pass | |
| EMC/EMI | Pass | Pass | |
| RF Board Tests | Pass | Pass | |
| System Integration | Pass | Pass | |
| CIC Hardware Tests | Pass | Pass | |
| Shipping Package Tests | Pass | Pass | |
| Design Verification Hardware Tests | Pass | Pass | |
| UI Board Hardware Tests | Pass | Pass | |
| Environmental Tests | Pass | Pass | |
| Power Management Module Tests | Pass | Pass | |
| Software Testing | Periodic Self-Test | Pass | Pass |
| User Interface | Pass | Pass | |
| Firmware Upgrade | Pass | Pass | |
| Event Logging | Pass | Pass | |
| System Connect Validation | Pass | Pass | |
| Single Channel RF | Pass | Pass | |
| Graphing | Pass | Pass | |
| Device Compatibility | Pass | Pass | |
| Dual Channel RF | Pass | Pass | |
| Therapy Support | Pass | Pass | |
| Workflow | Pass | Pass | |
| System Startup | Pass | Pass | |
| Processor Communication | Pass | Pass | |
| Constant Parameter | Pass | Pass | |
| Source Code Inspection | Pass | Pass | |
| AC and Battery Power | Pass | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a typical AI/ML algorithm evaluation (e.g., a set of medical images or patient data). The evaluation appears to be based on engineering verification and validation testing of the hardware and software components of the device itself. Therefore, sample sizes for data (e.g., patient data) are not applicable or provided. The data provenance is internal testing performed 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
Not applicable. This submission is for a hardware/software device modification that does not involve diagnostic interpretation using AI/ML with a ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests performed are engineering-based, not clinical evaluations requiring adjudication of expert opinions.
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
No. An MRMC study is not mentioned as this device is a continuous flush catheter system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable. The device is a physical system (catheter, control unit) that performs a therapeutic function (ultrasound-facilitated infusion), not a standalone algorithm. The "performance" refers to the device's functional integrity as a system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the engineering tests performed would be the design specifications and expected functional behavior of the hardware and software components.
8. The sample size for the training set
Not applicable. This document describes a device modification, not the development or training of an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a "training set" in the context of AI/ML algorithm development.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures connected by flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2017
BTG International, Inc. Curtis Jensen Senior Regulatory Affairs Associate 11911 N Creek Pkwy S Bothell, Washington 98011
Re: K162771
Trade/Device Name: EkoSonic Endovascular System with Control Unit 4.0 Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: January 18, 2017 Received: January 23, 2017
Dear Curtis Jensen:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
for
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) K162771
Device Name
EkoSonic Endovascular System with Control Unit 4.0
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, 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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Section 5: 510(k) Summary
Submitter l.
EKOS Corporation, Inc. 11911 North Creek Parkway S Bothell, WA 98011
Phone: 425-415-3122 Fax: 425-415-3105
Contact Person: Curtis Jensen Date Prepared: September 30, 2016
ll. Device
EkoSonic® Endovascular System with Control Unit 4.0 Proprietary Name: Common or Usual Name: Continuous Flush Catheter Catheter, Continuous Flush (21 CFR §870.1210) Classification Name: Product Code: KRA
Continuous Flush Catheters have been classified by the FDA Cardiovascular Panel as Class II.
���. Predicate Devices
The EkoSonic Endovascular System with Control Unit 4.0 (CU 4.0) is substantially equivalent to another legally marketed device. This predicate device is the EKOS EkoSonic Endovascular System with the EkoSonic Control Unit (PT-3B) (K140151).
This predicate device has been subject to one design-related Class II recall. Recall Z-1752-2008 was determined to be Software Design related. The device design used as a predicate device for this submission represents the most current software and hardware design.
No reference devices were used in this submission.
IV. Device Description
The EkoSonic Endovascular System consists of an EkoSonic Device and the Control Unit 4.0 (CU 4.0). The EkoSonic 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
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30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The CU 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 unit that are the subject of this submission.
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.
| Predicate Devices | Proposed Device | |
|---|---|---|
| Device Name | EkoSonic Endovascular System with PT3-B | EkoSonic Endovascular System with CU 4.0 |
| 510(k) Number(s) | K140151 - Amendment 002 | To be assigned |
| Product Code | KRA | KRA(This is equivalent to the predicatedevice) |
| Indications for Use | The EkoSonic® Endovascular System isindicated for the:• Ultrasound facilitated, controlled andselective infusion of physician-specified fluids, includingthrombolytics, into the vasculature forthe treatment of pulmonary embolism.• Infusion of solutions into thepulmonary arteries.• Controlled and selective infusion ofphysician-specified fluids, includingthrombolytics, into the peripheralvasculature. | The EkoSonic® Endovascular System isindicated for the:• Ultrasound facilitated, controlled andselective infusion of physician-specified fluids, includingthrombolytics, into the vasculature forthe treatment of pulmonary embolism.• Infusion of solutions into thepulmonary arteries.• Controlled and selective infusion ofphysician-specified fluids, includingthrombolytics, into the peripheralvasculature.(These are equivalent to the predicatedevice) |
| Principle ofOperation | The EkoSonic Endovascular Systememploys ultrasound to facilitate the deliveryof thrombolytic agents into vascular bloodclots. | The EkoSonic Endovascular Systememploys ultrasound to facilitate the deliveryof thrombolytic agents into vascular bloodclots.(This is equivalent to the predicatedevice) |
VI. Comparison of Technological Characteristics with the Predicate Devices
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| Predicate Devices | Proposed Device | |
|---|---|---|
| Energy Source | The EkoSonic Control Unit (PT-3B) providesthe power and user interface for operatorcontrol. | The upgraded EkoSonic Control Unit (CU4.0) provides the power and user interfacefor operator control. |
| (This is equivalent to the predicatedevice) | ||
| Battery Backup | No internal battery backup | Internal, lithium-ion backup battery |
| Maximum OutputPower Limit | Power limited to ~50 W Pulses | Power is available for ~100W Pulses. Thepower output is limited by software to ~50W,which is identical to the predicate device. |
| Maximum EkoSonicDevice Temperature | Temperature monitoring, feedback andcontrol system limits the surfacetemperature of the IDDC to 43°C duringoperation. | Temperature monitoring, feedback andcontrol system limits the surface temperatureof the IDDC to 43°C during operation.(This is equivalent to the predicatedevice) |
| Accessories | The predicate control unit is designed toprovide electrical energy to drive theultrasound transducers in EKOS Corporationcatheters. | The Control Unit 4.0 is designed to provideelectrical energy to drive the ultrasoundtransducers in EKOS Corporation catheters.(This is equivalent to the predicatedevice) |
| Materials | Chassis and Front Panel: Die Cast andsheet Aluminum, Painted | Chassis - Sheet aluminum, powder coatedor clear anodizedFront Panel - Black Powder-coatedAluminum |
The device modifications described in the submission do not affect the intended use, indications for use or the technological characteristics for the EkoSonic System.
VII. Performance Data
Testing has confirmed that the EkoSonic Endovascular System with CU 4.0 functions as intended and is substantially equivalent to the predicate device.
| Hardware Testing Performed | |
|---|---|
| System Tip Test | Pass |
| Secondary Cell Battery Test | Pass |
| Reliability Prediction | Pass |
| Battery Life Prediction | Pass |
| Electrical Safety | Pass |
| Hardware Inspection | Pass |
| EMC/EMI | Pass |
| RF Board Tests | Pass |
| System Integration | Pass |
| CIC Hardware Tests | Pass |
| Shipping Package Tests | Pass |
| Design Verification Hardware Tests | Pass |
| UI Board Hardware Tests | Pass |
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| Hardware Testing Performed | |
|---|---|
| Environmental Tests | Pass |
| Power Management Module Tests | 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 |
| Workflow | 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.
VIII. Conclusions
The EkoSonic Endovascular System with Control Unit 4.0 is substantially equivalent to the predicate device. The modifications in the control unit do not affect the intended use or the technological characteristics for the system and do not raise different 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).