(244 days)
Not Found
No
The summary describes a mechanical infusion system with ultrasound energy delivery and does not mention any AI/ML components or capabilities.
Yes
The device is described as "designed to deliver fluids through the catheter end-hole while simultaneously delivering ultrasound energy via a transducer element at the distal catheter tip" and one of the warnings notes that the ultrasound energy delivered is "intended to be therapeutic". This indicates a therapeutic intent beyond just diagnostic.
No
The device is described as an "infusion catheter system designed to deliver fluids" and "simultaneously delivering ultrasound energy via a transducer element". Its intended use is for "regional infusion of contrast materials" and to "deliver physician specified fluids", including thrombolytics, for therapeutic purposes. There is no mention of it being used to diagnose conditions or process diagnostic images.
No
The device description explicitly states it is an "infusion catheter system designed to deliver fluids through the catheter end-hole while simultaneously delivering ultrasound energy via a transducer element at the distal catheter tip," indicating it includes hardware components (catheter, transducer).
Based on the provided information, the EKOS Micro-Infusion System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the regional infusion of fluids (contrast materials, physician-specified fluids, thrombolytics) directly into selected vessels within the body (neurovasculature, coronary vasculature, peripheral vasculature). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description confirms it's an infusion catheter system designed to deliver fluids and ultrasound energy within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The provided information does not mention any analysis of biological samples or diagnostic testing.
Therefore, the EKOS Micro-Infusion System is a therapeutic and/or diagnostic device used in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels.
The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature.
WARNING: The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS Micro-Infusion system is intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established.
Product codes (comma separated list FDA assigned to the subject device)
QEY, KRA
Device Description
The EKOS Micro-Infusion System is an infusion catheter system designed to deliver fluids through the catheter end-hole while simultaneously delivering ultrasound energy via a transducer element at the distal catheter tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neurovasculature, coronary vasculature, 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)
EKOS has conducted preclinical bench and animal studies with the Micro-Infusion System. These studies demonstrate that the performance of the Micro-Infusion System meets its design specifications and is safe and effective for its intended use.
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.
EKOS Micro-Infusion System, (EKOS Corporation, K053437, K053432, K062507, K062508), Endeavor Infusion Catheter, (Cordis Corporation, K972110), PV 0.018 F/X, (JoMed, K944004), Renegade Hi-Flo Microcatheter, (Boston Scientific Corporation, K000177), TurboTracker 18 Infusion Catheter, (Boston Scientific Corporation, K960806), FasTracker 10 Infusion Catheter, (Boston Scientific Corporation, K926243)
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 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" in blue, and "ADMINISTRATION" in a smaller font below.
January 7, 2022
EKOS Corporation Jocelyn Kersten Vice President, Regulatory & Clinical Affairs 11911 N Creek Parkway South Bothell, Washington 98011
Re: K063620
Trade/Device Name: EKOS Micro-Infusion 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 6, 2007. 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: 2022.01.07 13:51:23 -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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.
AUG 6 2007
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EKOS Corporation c/o Ms. Jocelyn Kersten Vice President, Regulatory and Clinical Affairs 11911 North Creek Parkway South Bothell, WA 98011
Re: K063620
Trade/Device Name: EKOS Micro Infusion System Regulation Number: 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: II Product Code: KRA Dated: April 24, 2007 Received: April 25, 2007
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS micro-infusion system is not intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established.
2
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as prooced in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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 (1 Mr.), N. May 6 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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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): K063620
EKOS Micro-Infusion System Device Name:
Indications for Use:
The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels.
The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature.
WARNING: The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS Micro-Infusion system is intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use |
Division Sign-OffCONFIDENTIAL
4
8.0 510(k) Summary
| Applicant Name: | EKOS Corporation | AUG - 6 2007 |
|---|---|---|
| Address: | 11911 North Creek Parkway South | |
| Bothell, WA 98011 | ||
| Contact Person: | Jocelyn Kersten | |
| Director, Regulatory Affairs | ||
| Telephone: | (425) 415-3132 | |
| Fax: | (425) 415-3102 | |
| Device: | EKOS Micro-Infusion System | |
| Classification: | CFR 870.1210 - Continuous Flush Catheter | |
| Panel: | Cardiovascular | |
| Product Code: | KRA | |
| Intended Use: |
The EKOS Micro-Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels.
The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature.
| Device Description: | The EKOS Micro-Infusion System is an infusion catheter system
designed to deliver fluids through the catheter end-hole while
simultaneously delivering ultrasound energy via a transducer
element at the distal catheter tip. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Basis: | The EKOS Micro-Infusion System is substantially equivalent to
other legally marketed devices. These devices include:
EKOS Micro-Infusion System, (EKOS Corporation, K053437,
K053432, K062507, K062508)
Endeavor Infusion Catheter, (Cordis Corporation, K972110) |
CONFIDENTIAL
5
:
| PV 0.018 F/X, (JoMed, K944004) | |
|---|---|
| Renegade Hi-Flo Microcatheter, (Boston Scientific | |
| Corporation, K000177) | |
| TurboTracker 18 Infusion Catheter, (Boston Scientific | |
| Corporation, K960806) | |
| FasTracker 10 Infusion Catheter, (Boston Scientific | |
| Corporation, K926243) | |
| Performance: | EKOS has conducted preclinical bench and animal studies with the |
| Micro-Infusion System. These studies demonstrate that the | |
| performance of the Micro-Infusion System meets its design | |
| specifications and is safe and effective for its intended use. |
: