(47 days)
The EkoSonic Endovascular System is intended for the infusion of solutions into the pulmonary arteries.
The EkoSonic Endovascular System is an infusion Device designed to deliver fluids via a multi sidehole catheter. The fluid is dispersed via multiple ultrasound transducers distributed linearly along the length of an MicroSonic Device which is placed into the center lumen of the catheter. This device is intended to deliver physician-specified agents or fluids into the peripheral vasculature.
The provided documents are FDA 510(k) letters related to the EKOS EkoSonic Endovascular System. These documents confirm the regulatory classification and substantial equivalence of the device but do not contain information about specific acceptance criteria or the study data proving the device meets those criteria, especially not in the context of an AI/ML-driven device or study.
The description you've requested (acceptance criteria, test set details, expert qualifications, adjudication, MRMC study, standalone performance, ground truth, training set details) is typically found in detailed clinical study reports or 510(k) summaries for AI/ML devices, which this document is not. This document is a regulatory approval letter for a medical device (a catheter system), not an AI algorithm.
Therefore, I cannot fulfill your request using only the provided text. The information is not present in these FDA 510(k) general correspondence letters.
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November 22, 2021
EKOS Corporation Jocelyn Kersten VP. Quality Assurance, Clinical Regulatory Affairs 11911 North Creek Parkway South Bothell, Washington 98011
Re: K111705
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 August 3, 2011. 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,
Image /page/0/Picture/9 description: The image shows a digital signature. The signature is from Gregory W. O'connell -S. The date of the signature is 2021.11.22, and the time is 13:39:32 -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
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MI) 20993-0002
EKOS Corporation c/o Jocclyn Kersten 11911 North Creek Parkway South Bothell, WA 9801 1
AUG - 3 2011
Re: K111705
Trade/Device Name: EkoSonic Endovascular System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: June 17, 2011 Received: June 17, 2011
Dear Ms. Kersten:
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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Please be advised that I'DA'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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
/
Bram D. Zuckerm
- Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1.10 Indications for Use Statement
EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011
Indications for Use Statement
510(k) Number (if known):
Device Name: EkoSonic Endovascular System
Indications for Use:
The EkoSonic Endovascular System is intended for the infusion of solutions into the pulmonary arteries.
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| OR | |
| Over-The-Counter Use |
| Division Sign-Off |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K111705 |
|---|---|
| --------------- | --------- |
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AUG - 3 2011
510(k) Summary 8.0
",
| Applicant Name: | EKOS Corporation | |
|---|---|---|
| Address: | 11911 North Creek Parkway SouthBothell, WA 98011 | |
| Contact Person: | Jocelyn KerstenVice President, Quality Assurance, Regulatory and Clinical Affairs | |
| Telephone: | (425) 415-3132 | |
| Fax: | (425) 415-3102 | |
| Device: | EkoSonic Endovascular System | |
| Classification: | CFR 870.1210 - Continuous Flush Catheter | |
| Panel: | Cardiovascular | |
| Product Code: | KRA | |
| Intended Use: | The EkoSonic Endovascular System is intended for the infusion ofsolutions into the pulmonary arteries. | |
| Device Description: | The EkoSonic Endovascular System is an infusion Device designed todeliver fluids via a multi sidehole catheter. The fluid is dispersed viamultiple ultrasound transducers distributed linearly along the length of anMicroSonic Device which is placed into the center lumen of the catheter.This device is intended to deliver physician-specified agents or fluidsinto the peripheral vasculature. | |
| Predicate Basis: | The EkoSonic Endovascular System is substantially equivalent toanother legally marketed device. These devices includeEKOS EkoSonic Endovascular System (EKOS Corporation,K081467) | |
| Performance: | EKOS has conducted preclinical bench and animal studies with theEkoSonic Endovascular System. These studies demonstrate that theperformance of the EkoSonic Endovascular System meets its designspecifications and is safe and effective for its intended use. |
§ 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).