(119 days)
No reference devices were used in this notification.
No
The summary describes a device that uses ultrasound and radiofrequency energy for fluid infusion and temperature monitoring, with no mention of AI or ML in its description, intended use, or performance studies.
Yes
The device 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," which describes a therapeutic intervention.
No
The device is indicated for infusion of fluids, including thrombolytics, into the vasculature for treatment, not for diagnosis.
No
The device description clearly outlines physical components including a disposable infusion catheter, removable ultrasound core with ultrasound elements and thermal sensors, and a Control System with a Control Unit and Connector Interface Cables. This indicates a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The EkoSonic Endovascular System is used to deliver fluids (including thrombolytics) directly into the patient's vasculature using ultrasound facilitation. It is an interventional device used within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly describes a therapeutic intervention (infusion of fluids into the vasculature) for treating conditions like pulmonary embolism. This is not a diagnostic process involving analyzing patient specimens.
- Device Description: The description details a catheter and a control system that work together to deliver energy and fluids within the body. There is no mention of collecting or analyzing biological samples.
Therefore, the EkoSonic Endovascular System falls under the category of therapeutic or interventional medical devices, not In Vitro Diagnostics.
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, including thrombolytics, into the peripheral vasculature.
Product codes
QEY, KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary arteries, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician (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
Device Level Testing: Tensile Strength, Catheter Interlock, Impedance, Resonant Frequency, Luers, Electrical Isolation, Sterilization, Shipping, Storage, Shelf Life, Burst Strength, Fluid Immersion, Bending Force. All passed at T=0 and Artificially Aged (T=3 Years), where applicable.
System Level Testing: System Integration with PT-3B and CU4.0. Both passed at T=0. Samples were not aged for system integration validation testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this notification.
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).
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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
1
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
2
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
3
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 Device
with Control Unit 4.0
(Predicate Device) | EkoSonic Endovascular Device
with 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 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
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. |
| 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. | The EkoSonic Endovascular
System [EkoSonic Endovascular
Device with EKOS Control Unit]
employs ultrasound to facilitate
the delivery of thrombolytic
agents into vascular blood clots. |
| Infusion Hole
Pattern | Multiple side-holes | Multiple side-holes | Multiple side-holes |
| Catheter
Working Length | 106 cm or 135 cm | 106 cm or 135 cm | 106 cm or 135 cm |
| Treatment
Zone Length | 6 cm - 50 cm | 6 cm - 50 cm | 6 cm - 50 cm |
| | EkoSonic Endovascular Device
with Control Unit 4.0
(Predicate Device) | EkoSonic Endovascular Device
with Control Unit PT-3B
(Predicate Device) | EkoSonic Endovascular Device
(Subject Device) |
| Compatible
Guide Wire | 0.035" | 0.035" | 0.035" |
| Outer Diameter | 5.4 Fr | 5.4 Fr | 5.4 Fr |
| Placement
Mode | Percutaneous/endovascular | Percutaneous/endovascular | Percutaneous/endovascular |
| Packaged
Sterile | Yes - EkoSonic Device | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Single-Use
Disposable | Yes - EkoSonic Device | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Materials
Biocompatible | Yes - EkoSonic Device | Yes - EkoSonic Device | Yes - EkoSonic Device |
| Radiopaque
Markers | Yes on IDDC
MSD ultrasound elements are
radiopaque | Yes on IDDC
MSD ultrasound elements are
radiopaque | Yes on IDDC
MSD ultrasound elements are
radiopaque |
| Mechanism of
Action | Ultrasound | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CU 4.0
converted to ultrasound | R/F electrical from PT-3B
converted to ultrasound | R/F electrical from CU converted
to ultrasound |
| Ultrasound
Transducer(s)
in Catheter | 6 to 30 | 6 to 30 | 6 to 30 |
| Acoustic
Characteristics | Frequency = 2.0 - 2.5 MHz | Frequency = 2.0 - 2.5 MHz | Frequency = 2.0 - 2.5 MHz |
| 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. | 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. | Temperature monitoring,
feedback and control system
limits the surface temperature of
the IDDC to 43°C during
operation. |
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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.
| Product
Specification | 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 |
| Catheter
Interlock | 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 |
| Resonant
Frequency | 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 |
| Electrical
Isolation | 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 |
| Product
Specification | Purpose | EkoSonic Endovascular Device
(Subject Device) | |
| | | T = 0 | Artificially Aged
(T=3 Years) |
| System Level Testing | | | |
| System
Integration with
PT-3B | The proposed MSD hub changes affect the
connection between the MSD and the Control
System. | Pass | N/A. Samples
were not aged for
system integration
validation testing. |
| System
Integration with
CU4.0 | The proposed MSD hub changes affect the
connection between the MSD and the Control
System. | 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.