(144 days)
No reference devices were used in this submission.
No
The summary describes a system for delivering fluids using ultrasound and temperature control, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the infusion of physician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism and other vascular conditions, which are therapeutic interventions.
No
The device is described as an "Endovascular System" used for the "infusion of physician-specified fluids" for treatment, indicating a therapeutic function rather than a diagnostic one.
No
The device description explicitly states that the system consists of both a disposable infusion catheter with a removable ultrasound core (hardware) and a Control Unit 4.0 (CU 4.0) which generates and controls energy (hardware). While software is mentioned in the performance studies, the core of the device is clearly hardware-based.
Based on the provided information, the EkoSonic® Endovascular System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a system for delivering fluids (including thrombolytics) directly into the patient's vasculature to treat conditions like pulmonary embolism. This is an in vivo application, meaning it's used within the living body.
- Device Description: The device components (catheter, ultrasound core, control unit) are designed for direct interaction with the patient's blood vessels.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The EkoSonic system does not perform this function. It's a therapeutic device used to deliver treatment directly to the patient.
Therefore, the EkoSonic® Endovascular System is a therapeutic medical device, not an IVD.
N/A
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, into the peripheral vasculature.
Product codes
KRA
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 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.
The EkoSonic Endovascular System employs ultrasound to facilitate the delivery of thrombolytic agents into vascular blood clots.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vasculature, pulmonary arteries, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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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3
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
4
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 predicate | ||
| device) | ||
| 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. | 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. | ||
| (These are equivalent to the predicate | ||
| device) | ||
| Principle of | ||
| Operation | The EkoSonic Endovascular System | |
| employs ultrasound to facilitate the delivery | ||
| of thrombolytic agents into vascular blood | ||
| clots. | The EkoSonic Endovascular System | |
| employs ultrasound to facilitate the delivery | ||
| of thrombolytic agents into vascular blood | ||
| clots. | ||
| (This is equivalent to the predicate | ||
| device) |
VI. Comparison of Technological Characteristics with the Predicate Devices
5
| Predicate Devices | Proposed Device | |
|---|---|---|
| Energy Source | The EkoSonic Control Unit (PT-3B) provides | |
| the power and user interface for operator | ||
| control. | The upgraded EkoSonic Control Unit (CU | |
| 4.0) provides the power and user interface | ||
| for operator control. | ||
| (This is equivalent to the predicate | ||
| device) | ||
| Battery Backup | No internal battery backup | Internal, lithium-ion backup battery |
| Maximum Output | ||
| Power Limit | Power limited to ~50 W Pulses | Power is available for ~100W Pulses. The |
| power output is limited by software to ~50W, | ||
| which is identical to the predicate device. | ||
| Maximum EkoSonic | ||
| Device Temperature | Temperature monitoring, feedback and | |
| control system limits the surface | ||
| temperature of the IDDC to 43°C during | ||
| operation. | Temperature monitoring, feedback and | |
| control system limits the surface temperature | ||
| of the IDDC to 43°C during operation. | ||
| (This is equivalent to the predicate | ||
| device) | ||
| Accessories | The predicate control unit is designed to | |
| provide electrical energy to drive the | ||
| ultrasound transducers in EKOS Corporation | ||
| catheters. | The Control Unit 4.0 is designed to provide | |
| electrical energy to drive the ultrasound | ||
| transducers in EKOS Corporation catheters. | ||
| (This is equivalent to the predicate | ||
| device) | ||
| Materials | Chassis and Front Panel: Die Cast and | |
| sheet Aluminum, Painted | Chassis - Sheet aluminum, powder coated | |
| or clear anodized | ||
| Front Panel - Black Powder-coated | ||
| Aluminum |
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 |
6
| 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.