(119 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other terms typically associated with AI/ML technology in medical devices. The description focuses on the physical mechanism of ultrasound-facilitated fluid infusion.
Yes
The device is indicated for the treatment of pulmonary embolism, which is a therapeutic purpose.
No
The device is described as an "Endovascular System" indicated for the "infusion of physician-specified fluids... into the vasculature for the treatment of pulmonary embolism." This describes a therapeutic, not a diagnostic, function.
No
The device description is not available, but the intended use clearly describes a "System" that facilitates infusion of fluids into the vasculature using ultrasound. This strongly implies hardware components (ultrasound transducer, infusion pump, etc.) are part of the system, not just software.
Based on the provided information, the EkoSonice Endovascular System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system that is used in vivo (within the body) to facilitate the infusion of fluids into the vasculature for treating pulmonary embolism. This is a therapeutic intervention performed directly on the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples taken from the body (blood, urine, tissue, etc.).
- Providing diagnostic information based on the analysis of these samples.
- Using reagents or assays to detect specific substances.
IVDs are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or screening purposes. The EkoSonice system is a device used within the body for treatment.
N/A
Intended Use / Indications for Use
The EkoSonice 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.
Product codes
QEY, KRA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound facilitated
Anatomical Site
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full agency name on the right. The FDA part of the logo is in blue, with the acronym in a square and the agency name, "U.S. Food & Drug Administration," written out in full.
July 27, 2020
Btg International, Inc. Jocelyn Kersten VP, Clinical And Regulatory Affairs 11911 North Creek Parkway S Bothell, Washington 98011
Re: K140151
Trade/Device Name: EkoSonic Endovascular System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA
Dear Jocelyn Kersten:
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 May 21, 2014. Specifically, FDA is updating this SE Letter 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. O'connell -S -04'00
Digitally signed by Gregory W. O'connell -S Date: 2020.07.27 08:22:53
Gregory O'Connell Assistant Director Plaque Modification Devices Team 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2014
BTG International, Inc. Brit Baird Senior Regulatory Affairs Manager 11911 North Creek Parkway S Bothell, WA 98011
- Re: K140151
Trade/Device Name: EkoSonic MACH 4 Endovascular Device/EkoSonic Control Unit Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: May 16, 2014 Received: May 19, 2014
Dear Mr. Baird,
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.
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Page 2 - Brit Baird
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Kenneth J. Cavanaugh -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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· DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No: 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K140151
Device Name
EkoSonic Endovascular System
Indications for Use (Describe)
The EkoSonice Endovascular System is indicated for the ultrasound facilitated, controlled and selective infusion of physicianspecified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE STORE FOR STORES OF THE FOR FOR FOR FOR FOR FOR FOR STARTS CONTRACT AND THE SE
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)