(122 days)
No reference devices were used in this submission.
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware and control system modifications without mentioning AI/ML functionalities.
Yes
The device is indicated for the treatment of pulmonary embolism, which is a therapeutic purpose.
No
Explanation: The device is indicated for therapy (infusion of fluids and thrombolytics) and not for diagnosing a condition.
No
The device description explicitly details hardware components like a disposable infusion catheter, ultrasound core with elements, thermal sensors, and a Control System 4.0 that generates and controls radiofrequency energy. The submission also mentions hardware testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EkoSonic Endovascular Device with Control Unit 4.0 is an invasive device that is inserted into the vasculature. Its function is to facilitate the infusion of fluids (like thrombolytics) directly into the blood vessels using ultrasound energy.
- Lack of Sample Analysis: The description does not mention any analysis of samples taken from the body. The device acts directly within the patient's circulatory system.
Therefore, the device's intended use and mechanism of action clearly place it outside the scope of in vitro diagnostics. It is an in vivo device used for therapeutic purposes.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
QEY, KRA
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.
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
Prescription Use
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 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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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. 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
1
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
2
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
3
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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4
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.
5
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 for | ||
| Use | The EkoSonic Endovascular Device with CU 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 | |
| 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. | ||
| Principle of | ||
| Operation | The EkoSonic Endovascular Device with CU 4.0 | |
| employs ultrasound to facilitate the delivery of | ||
| thrombolytic agents into vascular blood clots. | The EkoSonic Endovascular Device with CU 4.0 | |
| employs ultrasound to facilitate the delivery of | ||
| thrombolytic agents into vascular blood clots. | ||
| Software Version | 01.02.02 | 01.00.05 |
| Battery Version | 8742-003 | 6841-002 |
| Infusion Hole | ||
| Pattern | Multiple side-holes | Multiple side-holes |
| Catheter Working | ||
| Length | 106 cm or 135 cm | 106 cm or 135 cm |
| Treatment Zone | ||
| Length | 6 cm - 50 cm | 6 cm - 50 cm |
| EkoSonic Endovascular Device with | ||
| CU 4.0 | ||
| (Subject Device) | EkoSonic Endovascular Device with | |
| CU 4.0 | ||
| (Predicate Device) | ||
| Compatible | ||
| Guide 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-Use | ||
| Disposable | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Materials | ||
| Biocompatible | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Radiopaque | ||
| Markers | Yes on IDDC | |
| MSD ultrasound elements are radiopaque | Yes on IDDC | |
| MSD ultrasound elements are radiopaque | ||
| Mechanism of | ||
| Action | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CU 4.0 converted to | |
| ultrasound | R/F electrical from CU 4.0 converted to | |
| ultrasound | ||
| Ultrasound | ||
| Transducer(s) in | ||
| Catheter | 6 to 30 | 6 to 30 |
| Acoustic | ||
| Characteristics | Frequency = 2.0 - 2.5 MHz | Frequency = 2.0 - 2.5 MHz |
| Battery Backup | Internal, lithium-ion backup battery | Internal, lithium-ion backup battery |
| Maximum | ||
| Output Power | ||
| Limit | Power is available for ~100W Pulses. The | |
| power output is limited by software to ~50W. | Power is available for ~100W Pulses. The | |
| power output is limited by software to ~50W. | ||
| 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. |
VI. Comparison of Technological Characteristics with the Predicate Device
6
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.
7
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.
8
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.