(221 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components and control systems without mentioning AI/ML functionalities.
Yes
The device is indicated for the treatment of pulmonary embolism and infusion of solutions into the vasculature, which are therapeutic interventions.
No
The device is used to infuse fluids into the vasculature for treatment, primarily of pulmonary embolism, not to diagnose a condition.
No
The device description clearly outlines hardware components including a disposable infusion catheter, ultrasound core with elements and thermal sensors, and a Control Unit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for delivering fluids (including thrombolytics) into the vasculature for treatment. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a catheter-based system with an ultrasound core designed for infusion and potentially enhancing the effect of the infused fluid. This is a medical device used for treatment, not for analyzing samples from the body to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to deliver substances into the body for therapeutic purposes.
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 (comma separated list FDA assigned to the subject device)
QEY, KRA
Device Description
The EkoSonic Endovascular System consists of an EkoSonic Endovascular Device and EKOS Control Unit (Control Unit 4.0 or PT-3B 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature for the treatment of pulmonary embolism
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)
Non-Clinical Performance Data: Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing, including bench-top performance evaluations and biological safety.
Bench Testing: Bench testing was performed to evaluate physical integrity, functionality, and performance of the catheter. Performance criteria includes: catheter tensile strengths, freedom from leak, and burst pressure.
Biological Safety Testing: Biocompatibility testing in accordance with ISO 10993-1, microbial assessments including bioburden and endotoxin, and pyrogenicity and sterility assurance testing show the device has acceptable biological safety for its intended use.
Clinical Testing: Performance testing from clinical studies is not required to demonstrate substantial equivalence of EkoSonic Endovascular Device.
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.
Not Found
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 19, 2021
Boston Scientific Mr. Daniel Root Senior Regulatory Affairs Specialist Two Scimed Place Maple Grove, Minnesota 55311
Re: K211080
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: October 18, 2021 Received: October 20, 2021
Dear Mr. Root:
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
1
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 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 (OS) 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,
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
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Indications for Use
510(k) Number (if known) K211080
Device Name EkoSonic Endovascular Device
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) |
||X| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 (508) 683-4000
| Sponsor | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Daniel Root
Three Scimed Place
Maple Grove, MN 55311-1566
Phone: 425-395-5820
Email: Daniel.Root@bsci.com |
| Proprietary Name | EkoSonic™ Endovascular Device |
| Common Name | Continuous Flush Catheter |
| Product Code
(Primary/Secondary) | QEY, KRA |
| Classification
(Primary/Secondary) | Mechanical Thrombolysis Catheter (21 CFR §870.5150)
Catheter, Continuous Flush (21 CFR §870.1210) |
| Predicate Device | The EkoSonic Endovascular Device is substantially equivalent to
another legally marketed device. This predicate device is the EkoSonic
Endovascular Device (K191119). |
| Device Description | The EkoSonic Endovascular System consists of an EkoSonic
Endovascular Device and EKOS Control Unit (Control Unit 4.0 or PT-
3B 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. |
| Indications for Use/
Intended 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. |
| Device Technology
Characteristics and
Comparison to
Predicate Device | The EkoSonic Endovascular Device incorporates the following changes
from the predicate EkoSonic Endovascular Device (K191119): an
updated luer design that is ISO 80369-7 compliant; luer material
change to a Cyrolite® Polymer; and updated packaging and labeling
appropriate to be consistent with legal manufacturer branding. |
4
| Characteristic | EkoSonic Endovascular Device
(Subject Device) | EkoSonic Endovascular Device
(Predicate Device) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K211080 | K191119 |
| Product Code | QEY, KRA | QEY, KRA |
| Indications for
Use | The EkoSonic Endovascular System
[with Control Unit] 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
[with Control Unit] 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
[EkoSonic Endovascular Device with
Control Unit] employs ultrasound to
facilitate the delivery of thrombolytic
agents into vascular blood clots. | The EkoSonic Endovascular System
[EkoSonic Endovascular Device with
Control Unit] employs ultrasound to
facilitate the delivery of thrombolytic
agents into vascular blood clots. |
| 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 |
| 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 Endovascular Device | Yes - EkoSonic Endovascular Device |
| Single-Use
Disposable | Yes - EkoSonic Endovascular Device | Yes - EkoSonic Endovascular Device |
| Materials
Biocompatible | Yes - EkoSonic Endovascular Device | Yes - EkoSonic Endovascular Device |
| | EkoSonic Endovascular Device | EkoSonic Endovascular Device |
| Characteristic | (Subject Device) | (Predicate Device) |
| Radiopaque
Markers | Markerbands on the Infusion Catheter
(IC) are radiopaque
The Ultrasonic Core (USCO ultrasound
elements are also radiopaque | Markerbands on the IC are radiopaque
The USC ultrasound elements are also
radiopaque |
| Mechanism of
Action | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CU converted to
ultrasound | R/F electrical from CU converted to
ultrasound |
| Ultrasound
Transducer(s) in
Catheter | 6 to 30 | 6 to 30 |
| Acoustic
Characteristics | Frequency = 2.05 - 2.35 MHz | Frequency = 2.05 - 2.35 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. |
| Maximum
EkoSonic Device
Temperature | Temperature monitoring, feedback
and control system limits the surface
temperature of the IC to 43°C during
operation. | Temperature monitoring, feedback
and control system limits the surface
temperature of the IC to 43°C during
operation. |
| Luer Design | ISO 80369-7 Compliant | ISO 594 Compliant |
| Luer Material | Cyrolite® Polymer (acrylic copolymer) | Polycarbonate |
5
| Non-Clinical
Performance
Data | Determination of substantial equivalence is based on an assessment
of non-clinical performance bench testing, including bench-top
performance evaluations and biological safety. |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Bench Testing:
Bench testing was performed to evaluate physical integrity,
functionality, and performance of the catheter. Performance criteria
includes: catheter tensile strengths, freedom from leak, and burst
pressure. |
| | Biological Safety Testing:
Biocompatibility testing in accordance with ISO 10993-1, microbial
assessments including bioburden and endotoxin, and pyrogenicity and
sterility assurance testing show the device has acceptable biological
safety for its intended use. |
| Clinical Testing | Performance testing from clinical studies is not required to
demonstrate substantial equivalence of EkoSonic Endovascular
Device. |
| Conclusion | Based on the indications for use, technological characteristics, and
performance testing, EkoSonic Endovascular Device has been shown
to be appropriate for its intended use and is considered to be
substantially equivalent to EkoSonic Endovascular Device. K191119. |