(86 days)
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.
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.
The provided text is a 510(k) summary for the EKOS Micro-Infusion System and does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and a study proving their fulfillment. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance study results against specific acceptance criteria.
However, I can extract the available information and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the device modification is for the PT-2B Control Unit, a second-generation version of the PT-2. The "acceptance criteria" presented are functional ("operates as intended") rather than quantitative performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| PT-2B operates as intended with Micro-Infusion Catheters. | "Electrical safety and system testing confirmed the PT-2B operates as intended with the Micro-Infusion Catheters." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text mentions "electrical safety and system testing" but does not specify the sample size, the type of test set (e.g., in vitro, in vivo), or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The "testing" mentioned appears to be engineering/functional testing, not a clinical study involving experts establishing ground truth for a diagnostic or treatment outcome.
4. Adjudication Method for the Test Set
This information is not provided in the document. As there's no mention of expert review or clinical trial for establishing ground truth, adjudication methods are not applicable here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not provided in the document. The document describes a "SPECIAL 510(k) Notification" for a device modification, which typically relies on demonstrating equivalence rather than conducting a full-scale MRMC comparative effectiveness study to show improvement over human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not provided in the document. The device is a "Micro-Infusion System," an electro-mechanical device for delivering fluids. The concept of "algorithm only" or "human-in-the-loop performance" as applied to software or AI is not relevant to this type of medical device in the context presented.
7. The Type of Ground Truth Used
The "ground truth" for the testing performed appears to be functional verification that the PT-2B unit correctly interfaces and operates with the Micro-Infusion Catheters, demonstrated through "electrical safety and system testing." It's not a clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
This information is not provided in the document. The device is not described as involving machine learning or AI that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document, as there is no mention of a "training set" or AI/machine learning components.
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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
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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
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Indications for Use
510(k) Number (if known): 1<06 2 50 7
Device Name: Micro-Infusion System
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.
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)
Donna E. Barnes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K067507
Page 1 of 1
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SPECIAL 510(k) Notification Micro-Infusion System
NOV 2 2 2006
Section 4. 510(k) Summary
General Provisions
| Submitter's Name and Address: | EKOS Corporation11911 North Creek Pkwy SouthBothell, WA 98011 |
|---|---|
| Contact Person: | Jocelyn Kersten425-415-3132425-415-3101 (fax)jkersten@EKOSCORP.com |
| Classification Name: | Catheter, Continuous Flush (KRA) |
| Common or Usual Name: | Continuous Flush Catheter |
| Proprietary Name: | Micro-Infusion System |
| Name of Predicate Device: | Micro-Infusion System |
| 510(k) Reference No.: | K060084K053437K053432 |
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 device modifications described in this notification do not affect the technological characteristics for the Micro-Infusion System.
Test Summary
Electrical safety and system testing confirmed the PT-2B operates as intended with the Micro-Infusion Catheters.
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Section 5. General Information
Trade and Common Names
Trade Name: Micro-Infusion System Common Name: Continuous Flush Catheter
Establishment Registration
3001627457
Manufacturing Facility
EKOS Corporation 11911 North Creck Pkwy South Bothell, WA 98011
Device Classification
Continuous flush catheters have been classified by the FDA Cardiovascular Panel as Class II (KRA).
Purpose of Notification
The purpose of this SPECIAL 510(k) notification is to seek clearance for a device modification that will implement a 2nd generation of the PT-2 Control Unit, the PT-2B.
Predicate Device
The Micro-Infusion System is similar in design and composition and identical in function and intended use to the previously cleared Micro-Infusion System (K053437, K053432 and K060084).
Performance Standards
Performance standards have not been promulgated for continuous flush catheters.
§ 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).