(294 days)
Not Found
No
The summary describes a mechanical infusion system with ultrasound energy delivery, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device delivers contrast material for imaging rather than treating a disease or condition. While the device does deliver ultrasound energy, its stated purpose is to deliver contrast material.
No
The device is described as an "infusion catheter system designed to deliver ultrasound energy... to deliver angiographic contrast material." Its intended use is for "regional infusion of contrast materials into selected vessels." This functionality relates to delivering substances for imaging or therapy, not to diagnosing a condition.
No
The device description clearly states it is an "infusion catheter system" designed to deliver ultrasound energy through a "transducer element at the distal catheter tip," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The EKOS Micro-Infusion System is a catheter system designed to infuse substances (contrast materials) directly into the neurovasculature. It is an invasive device used within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states "regional infusion of contrast materials into selected vessels in the neurovasculature." This is a therapeutic or diagnostic procedure performed directly on the patient, not an in vitro test.
Therefore, the EKOS Micro-Infusion System falls under the category of a medical device used for in-vivo procedures, not an In Vitro Diagnostic.
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 and is not intended for use in the coronary vasculature.
Product codes
KRA, NUI
Device Description
The EKOS Micro-Infusion System is an infusion catheter system designed to deliver ultrasound energy through a transducer element at the distal catheter tip. This device is intended to deliver angiographic contrast material into the neurovasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neurovasculature
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
EKOS has conducted preclinical bench and animal studies with the Performance: EKOS Micro-Infusion System. These studies demonstrate that the performance of the EKOS Micro-Infusion System meets its design specifications and is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
K030637, K923368, K023351, K000177, K960806, K003105, K002533
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
041826
9.0 510(k) Summary
.
| Applicant Name: | EKOS Corporation | APR 27 2005 |
|---|---|---|
| Address: | 22030 20th Ave. SE, Suite 101 | |
| Bothell, WA 98021 | ||
| Contact Person: | Jocelyn Kersten | |
| Director, Regulatory Affairs | ||
| Telephone: | (425) 482-1108 X 287 | |
| Fax: | (425) 482-1109 | |
| 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 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 and is not | ||
| intended for use in the coronary vasculature. | ||
| Device Description: | The EKOS Micro-Infusion System is an infusion catheter system | |
| designed to deliver ultrasound energy through a transducer element | ||
| at the distal catheter tip. This device is intended to deliver | ||
| angiographic contrast material into the neurovasculature. | ||
| Predicate Basis: | The EKOS Micro-Infusion System is substantially equivalent to | |
| other legally marketed devices. These devices include | ||
| EKOS Peripheral Infusion System (K030637) Boston Scientific Corporation: Magic Infusion Catheter (K923368 & K023351) Boston Scientific Corporation: Renegade Hi-Flo Microcatheter (K000177) Boston Scientific Corporation Turbo-Tracker Microcatheter (K960806) BioSphere Medical EmboCath Hydrophilic Infusion Catheter (K003105) Spencer Technologies TCD 100M Transcranial Doppler |
1
(K002533)
EKOS has conducted preclinical bench and animal studies with the Performance: EKOS Micro-Infusion System. These studies demonstrate that the performance of the EKOS Micro-Infusion System meets its design specifications and is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings or feathers. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jocelyn Kersten Director, Regulatory Affairs EKOS Corporation 22030 20th Avenue SE, Suite 101 Bothell, Washington 98021
APR 2 7 2005
Re: K041826
Trade Name: EKOS Micro-Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: NUI Dated: March 2, 2005 Received: March 3, 2005
Dear Ms. Kersten:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 9 ro(s) premaince is substantially equivalent (for the indications felerenced above and nave used.
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally management date of the Medical Device American Frank Food. Days commerce prior to May 28, 1970, the characted and of the Federal Food. Drug, devices that nave been reclassified in accessed in a market the device, subject to the general controls and Cosment Act (7tcl). "Tou may, thereflect below. The general controls provisions of the provisions of the Act and the minutions desorved over of devices, good manufacturing practice, Act fictuale requireritions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this avol u I he Office of Device Evaluation has decemblace in the proposed labeling and that such use device will be used for an michaed as the rasition 513(i)(1)(E) of the Act, the following could cause harm. Therefore, in accordance with became of ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( device's labeling:
"The safety and effectiveness of the EKOS Micro-Infusion System for thrombolytic therapy in " The safety and effectivelless of the EROS finners interest of endics are necessary to ensure the neurovasculature nave not been exadonsilou. The neurovasculature does not result in an that use of devices to defree events (e.g., intracranial hemorrhage)."
3
Page 2 - Ms. Jocelyn Kersten
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Please note that the above labore 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 I he I DA Iniding of substantial equive and permits your device to proceed to the uc vice results in a classification 101 Jour device as described in your Section market. "This letter will anon-you to evigation 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), if your device is classified too about of . Existing major regulations affecting your device can be it may be subject to adultions, 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 I least be advised that I Dris issuality that your device complies with other requirements of the Act that I DA has made a deceminations administered by other Federal agencies. You must or any I catal statures and regulaties, including, but not limited to: registration and listing (21 Comply with an the Act 810 cm Part 801); good manufacturing practice requirements as set CFR Part 807), adoling (21 CFR Part 820); and if applicable, the electronic ronth in the quany by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to your If you desire specific information actuact the Office of Compliance at (240) 276-0115. Also, de vice (21 CFR Part 001), priuse SMisbranding by reference to premarket notification' (21 prease note the regulation onears, "Atlocracion on your responsibilities under the Cl K ratt 607.27): "Pouring Joseph Manufacturers, International, and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours.
Sincerely yours,
Dr. Rita Tillman, Ph.D.
Ilman, Ph.I Donna-Bea Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K041826
Device Name: EKOS Micro-Infusion System
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 into selected vessels in the near ordecantly of the selected vessels and is not intended for use in the coronary vasculature.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Evaluation (SDA)