(144 days)
Not Found
No
The summary describes a mechanical infusion system using ultrasound energy, with no mention of AI or ML terms, image processing, or data sets typically associated with AI/ML development.
Yes
The device is intended for the infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, and is designed to deliver ultrasound energy. The "Intended Use / Indications for Use" explicitly states its purpose for controlled and selective infusion of therapeutic agents.
No
Explanation: The device is described as an "infusion catheter system" intended for "controlled and selective infusion of physician-specified fluids," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly 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, the EKOS Peripheral Infusion System 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EKOS Peripheral Infusion System is described as an "infusion catheter system designed to deliver ultrasound energy... and physician-specified agents or fluids into the peripheral vasculature." This is an in vivo procedure, meaning it is performed within the living body.
- Intended Use: The intended use is for "controlled and selective infusion of physician-specified fluids... into the peripheral vasculature." This is a therapeutic or interventional procedure, not a diagnostic test performed on a sample outside the body.
Therefore, the EKOS Peripheral Infusion System falls under the category of a therapeutic or interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EKOS Peripheral Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Product codes
QEY, KRA
Device Description
The EKOS Peripheral 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 physician-specified agents or fluids into the peripheral vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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 Peripheral Infusion System. These studies demonstrate that the performance of the Peripheral Infusion System meets its design specifications and is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
K000177, K960806, K926243, K023514, K950907, K944004
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency responsible for regulating food and drugs in the United States.
January 7, 2022
EKOS Corporation Jocelyn Kersten Regulatory Affairs Manager 22030 20th Avenue SE, Suite 101 Bothell, Washington 98021
Re: K030637
Trade/Device Name: EKOS Peripheral 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 July 22, 2003. 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 13:28:57 -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
Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract design featuring three stylized lines that resemble an eagle or a bird in flight, with a wavy line underneath.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2003
EKOS Corp. c/o Ms. Jocelyn Kersten 22030 2011 Ave SE, Suite 101 Bothell, WA 98021
Re: K030637
EKOS Peripheral Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II (two) Product Code: KRA Dated: June 20, 2003 Received: June 23, 2003
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. Jocelyn 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 (OS) 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
I. Deletti
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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510(k) Notification
1.10 Indications for Use Statement
EKOS Corporation 22030 20th Ave. SE, Suite 101 Bothell, WA 98021
Indications for Use Statement
510(k) Number (if known):
EKOS Peripheral Infusion System Device Name:
Indications for Use:
The EKOS Peripheral Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
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 | K030637 |
|---|---|
| --------------- | --------- |
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EKOS Peripheral Infusion System
16030637 510(k) Notification
JUL 2 2 2 2003
9.0 510(k) Summary
| Applicant Name: | EKOS Corporation |
|---|---|
| Address: | 22030 20th Ave. SE, Suite 101 |
| Bothell, WA 98021 | |
| Contact Person: | Jocelyn Kersten |
| Regulatory Affairs Manager | |
| Telephone: | (425) 482-1108 X 287 |
| Fax: | (425) 482-1109 |
| Device: | EKOS Peripheral Infusion System |
| Classification: | CFR 870.1210 - Continuous Flush Catheter |
| Panel: | Cardiovascular |
| Product Code: | KRA |
| Intended Use: | The Peripheral Infusion System is intended for the controlled and |
| selective infusion of physician-specified fluids, including | |
| thrombolytics, into the peripheral vasculature. | |
| Device Description: | The EKOS Peripheral 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 | |
| physician-specified agents or fluids into the peripheral vasculature. | |
| Predicate Basis: | The EKOS Peripheral Infusion System is substantially equivalent |
| to other legally marketed devices. These devices include | |
| Boston Scientific Corporation: Renegade Hi-Flo Microcatheter (K000177)Boston Scientific Corporation: TurboTracker 18 Infusion Catheter (K960806)Boston Scientific Corporation: FasTracker Infusion Catheter (K926243)Bacchus Vascular, Inc.: Trellis Infusion System (K023514)AngioDynamics: Pulse Spray Infusion System PRO Infusion Catheter (K950907)JoMed: PV 0.018 F/X (K944004) | |
| Performance: | EKOS has conducted preclinical bench and animal studies with the |
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Peripheral Infusion System. These studies demonstrate that the performance of the Peripheral Infusion System meets its design specifications and is safe and effective for its intended use.