(86 days)
Not Found
No
The summary describes a system for controlled fluid infusion using ultrasound and a catheter, with no mention of AI, ML, image processing, or data analysis that would typically indicate the presence of such technologies.
Yes
Justification: The device's intended use is for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, which directly implies a therapeutic purpose (e.g., dissolving blood clots with thrombolytics).
No.
The device is intended for the controlled and selective infusion of fluids and for controlled, regional infusion into selected vessels, not for identifying diseases or conditions.
No
The device description explicitly states the system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls energy, indicating hardware components are integral to the device's function.
Based on the provided information, the EKOS Micro-Infusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the infusion of fluids (including thrombolytics and contrast materials) directly into the patient's vasculature (peripheral and neurovasculature). This is an in vivo application, meaning it's used within the living body.
- Device Description: The device consists of a catheter and an instrument for energy delivery. This aligns with a device used for direct intervention within the body, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to test samples in vitro (outside the body) to diagnose conditions, monitor treatments, or screen for diseases.
Therefore, the EKOS Micro-Infusion System is a medical device used for therapeutic and diagnostic procedures performed directly on the patient, not an IVD.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Electrical safety and system testing confirmed the PT-2B operates as intended with the Micro-Infusion Catheters.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, with the letters "FDA" in a blue square. Next to the blue square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 7, 2022
EKOS Corporation Jocelyn Kersten Vice-President of Regulatory Affairs 11911 North Creek Pkwy. South Bothell, Washington 98011
Re: K062507
Trade/Device Name: 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 November 22, 2006. 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 S O'connell -S Date: 2022.01.07 13:50:17 -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
Public Health Service
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 stylized eagle with three overlapping wing segments, facing right. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2006
Jocelyn Kersten Vice-President of Regulatory Affairs EKOS Corporation 11911 North Creek Pkwy South Bothell, WA 98011
Re: K062507
Trade Name: EKOS Micro-Infusion System-Peripheral Indication Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA Dated: November 2, 2006 Received: November 6, 2006
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Kersten
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small 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/dsma/dsmamain.html
Sincerely yours,
Dinah R. Lochnes
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): 1