(21 days)
Not Found
No
The document describes a system for controlled fluid infusion using ultrasound and thermal sensing, with no mention of AI or ML technologies in the intended use, device description, or performance studies.
Yes
The device is described as an "EKOS Micro-Infusion System" that is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral and neurovasculature. Infusion of thrombolytics or other fluids into the body for treatment purposes classifies it as a therapeutic device.
No
The device is described as an "infusion system" intended for "controlled and selective infusion of physician-specified fluids," including thrombolytics and contrast materials, into the vasculature. Its function is to deliver substances rather than to diagnose medical conditions or analyze patient data to identify diseases.
No
The device description explicitly states the system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls energy, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the controlled and selective infusion of fluids (including thrombolytics and contrast materials) into the peripheral and neurovasculature. This is a therapeutic and diagnostic procedure performed directly on the patient's body, not on samples taken from the body.
- Device Description: The description details a catheter and an instrument for delivering energy and fluids directly into blood vessels. This aligns with an in-vivo (within the living body) application.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests on these types of samples.
Therefore, the EKOS Micro-Infusion System is an in-vivo medical device used for therapeutic and diagnostic procedures within the patient's circulatory system.
N/A
Intended Use / Indications for 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 and is not intended for use in the coronary vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEY, KRA
Device Description
The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed EKOS Micro- Infusion System is considered to be substantially equivalent to the currently marketed EKOS Micro- Infusion System based on a comparison of the intended uses and designs and results of the testing and evaluations performed.
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 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 Director, Regulatory Affairs 22030 20th Avenue SE, Suite 101 Bothell, Washington 98021
Re: K053432
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 December 30, 2005. 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 the name Gregory W. O'connell -S. It also shows that the image was digitally signed by Gregory W. O'connell -S on the date 2022.01.07. The time stamp is 13:37:47 -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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized representation of three human profiles facing right, arranged in a stacked formation. The profiles are depicted with simple, curved lines. Encircling the central emblem is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEC 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EKOS Corporation c/o Ms. Jocelyn Kersten Director, Regulatory Affairs 22030 20th Avenue SE, Suite 101 Bothell, WA 98021
Re: K053432
EKOS Micro-Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: December 6, 2005 Received: December 9, 2005
Dear Ms. Kersten:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained in substantially equivalent (for the indications for use stated in the enclosure) the devices marketed predicate devices marketed in interstate for use stated in the enclosure) to regally manced promoted Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prior to May 28, 1970, the chaeffired in accordance with the Federal Food, Drug, devices that have been reclassified in accordance was a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The You may, therefore, market the device, belyer is and in annual registration, listing of
general controls provisions of the Act include requirements for and successions and general controls provisions of the Fee merade copies against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) movements . Existing your device can
may be subject to such additional controls. Existing major regulations EDA may may be subject to such additional controls. Extrong mayor organisms be found in the Code of Pouchal Stegeral Stegeral Register.
2
Page 2 -- Ms. Jocelyn Kersten
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Icase of advised that I Dris issuantes vith other requirements of the requirements of the Act that I DA has made a dotenmancions administered by other Federal agencies. You must of any I cacal statutes and regainments, including, but not limited to: registration and listing (21 Comply with an the Fet 6 requirements, 01); good manufacturing practice requirements as set CFR Part 6077, abonnig (DF OFF Part 820); and if applicable, the electronic forth in the quant) bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation some of pro regin marketing your device as described in your Section 510(k) This letter will anow you to ough mailing of substantial equivalence of your device to a legally prematication: The PDF Intelling sification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dealer specific acrioliance at (240) 276-0120. Also, please note the regulation entitled, Connect the Office of County of Court (21CFR Part 807.97). You may obtain Mitsorancing of reference to presensibilities under the Act from the Division of Small other general micrinational 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.
Sincerely yours,
Blymmtma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SPECIAL 510(k) Notification EKOS Micro-Infusion System
Indications for Use
510(k) Number (if known): K053432
Device Name:
EKOS Micro-Infusion System
Indications for Use:
The EKOS Micro-Infusion System is intended for the controlled and selective infusion of The ENOS MICIO-Infusion Dystein is mombolytics, into the peripheral vasculature.
The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into The EKOS Micro- Infusion System is intended for regroincil Infusion System may be used for selected vessels in the neurovasculature. The EN CD SD SD Sot intended for use in the coronary vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
e.g.mee
of Cardiovascular Devices
KO 53432 510(k) Number
Page 1 of 1_
4
DEC 3 0 2005
| General Provisions | Submitter's Name and Address | EKOS Corporation
22030 20th Ave. SE
Suite 101
Bothell, WA 98021 |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| | Contact Person | Jocelyn Kersten
425-482-1108
425-482-1109 (fax)
jkersten@EKOSCORP.com |
| | Classification Name | Catheter, Continuous Flush (KRA) |
| | Common or Usual Name | Continuous Flush Catheter |
| | Proprietary Name | EKOS Micro- Infusion System |
| Name of Predicate
Device | Predicate Device
EKOS Peripheral Infusion System
EKOS Micro- Infusion System | 510(k) Reference Nos.
K050563
K051225 |
| Device Description | The system consists of a disposable infusion/ultrasound catheter and an instrument
that generates and controls the delivery of energy to the catheter. The catheter
contains a single ultrasound transducer, located at the distal tip, a thermal sensor
and a distal end hole for placement over a guide wire and fluid infusion. | |
| 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 and is not
intended for use in the coronary vasculature. | |
| Summary of
Technological
Characteristics | The proposed EKOS Micro- Infusion Catheter is similar in construction and
materials to the EKOS Micro-Infusion Catheter previously cleared under K051225
and K050563. | |
| Test Summary | The proposed EKOS Micro- Infusion System is considered to be substantially
equivalent to the currently marketed EKOS Micro- Infusion System based on a
comparison of the intended uses and designs and results of the testing and
evaluations performed. | |