(25 days)
The EKOS Peripheral Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
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.
I am sorry, but the provided text from the FDA 510(k) notification for the EKOS Peripheral Infusion System does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, as outlined in your request.
Specifically, the document is a substantial equivalence (SE) determination letter and a 510(k) summary. These types of documents focus on demonstrating that a new device is as safe and effective as a legally marketed predicate device. They do not typically include:
- Explicit acceptance criteria: The document states the device is "substantially equivalent" which is the overall regulatory acceptance, but it doesn't detail performance metrics or thresholds.
- Detailed study methodology: While it mentions "testing and evaluations performed" in the Test Summary, it does not provide specifics about:
- Sample sizes for test sets (or training sets)
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- Results of multi-reader multi-case (MRMC) studies
- Standalone algorithm performance
- Type of ground truth used or how it was established.
The 510(k) summary (page 4) lists general characteristics and intended use, and the "Test Summary" section simply states that the new device is "substantially equivalent" to the previously cleared device based on a comparison of uses, designs, and testing results. It does not elaborate on the specific tests, their criteria, or their results.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance.
- Number and qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth.
- Training set sample size.
- Ground truth establishment for the training set.
This information would typically be found in the full 510(k) submission, which is not provided in this excerpt.
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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: K050563
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 March 29, 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,
Digitally signed by Gregory W. Gregory W. O'connell -O'connell -S Date: 2022.01.07 13:34:51 -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 Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three overlapping shapes that resemble an eagle or bird in flight. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2005
EKOS Corporation c/o Ms. Jocelyn Kersten Director, Regulatory Affairs 22030 20th Avenue, SE, Suite 101 Bothell, WA 98021
Re: K050563
EKOS Peripheral Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II (Two) Product Code: KRA Dated: March 3, 2005 Received: March 4, 2005
Dear Ms. Kersten:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the chelosure) to regard) to regard case of the Medical Device American be of the d. Ford. commerce prof to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices mat have been recuired in accessfrou in accessful of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the 110 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 If your device is classified (500 a0070) mis. Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Pouchal Ingerning 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 r lease oc devised that I Drivision that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any i coclar sundles and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 8077; laceming (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction of to begin marketing your device as described in your Section 510(k) I ms letter with and w Jourse of substantial equivalence of your device to a legally premated notification: The 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) 594-4648. 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 other Echeral 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,
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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SPECIAL 510(k) Notification EKOS Peripheral Infusion System
Indications for Use
510(k) Number (if known):
Device Name:
EKOS Peripheral Infusion System
Indications for Use:
The EKOS Peripheral Infusion System is intended for the controlled and selective infusion of The DICOD Feripheral nuids, including thrombolytics, into the peripheral 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)
Dia Malli
Koso563 510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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| GeneralProvisions | Submitter's Name and Address | EKOS Corporation22030 20th Ave. SESuite 101Bothell, WA 98021 |
|---|---|---|
| Contact Person | Jocelyn Kersten425-482-1108425-482-1109 (fax)jkersten@EKOSCORP.com | |
| Classification Name | Catheter, Continuous Flush (KRA) | |
| Common or Usual Name | Continuous Flush Catheter | |
| Proprietary Name | EKOS Peripheral Infusion System | |
| Name ofPredicate Device | Predicate DeviceEKOS Peripheral Infusion System | 510(k) Reference Nos.K033214 |
| DeviceDescription | The system consists of a disposable infusion/ultrasound catheter and aninstrument that generates and controls the delivery of energy to thecatheter. The catheter contains a single ultrasound transducer, located atthe distal tip, a thermal sensor and a distal end hole for placement over aguide wire and fluid infusion. | |
| Intended Use | The EKOS Peripheral Infusion System is intended for the controlled andselective infusion of physician-specified fluids, including thrombolytics,into the peripheral vasculature. | |
| Summary ofTechnologicalCharacteristics | The proposed EKOS Peripheral Infusion System is similar in constructionand materials to the previously cleared EKOS Peripheral Infusion System. | |
| Test Summary | The proposed EKOS Peripheral Infusion System is considered to besubstantially equivalent to the currently marketed EKOS PeripheralInfusion System based on a comparison of the intended uses and designsand results of the testing and evaluations performed. |
MAR 2 9 2005
Section 4. 510(k) Summary
§ 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).