(28 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 does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is primarily a 510(k) summary and an FDA clearance letter for the EKOS Micro-Infusion System. It details:
- Device Description and Intended Use: The system is for controlled and selective infusion of fluids into peripheral vasculature and regional infusion of contrast materials into selected neurovasculature vessels, not for coronary use.
- Predicate Device: The device is considered substantially equivalent to a previously cleared EKOS Micro-Infusion System (K051225 and K050563).
- Testing: It states that testing and evaluations were performed, and the results support substantial equivalence, but it does not specify what tests were done, what the acceptance criteria for those tests were, or what the reported performance outcomes were.
- FDA Clearance and Limitations: The FDA clearance includes a box warning that "The safety and effectiveness of the EKOS Micro-Infusion System for thrombolytic therapy in the neurovasculature have not been established. Further clinical studies are necessary to ensure that use of devices to deliver thrombolytic therapy into the neurovasculature does not result in an increased incidence of adverse events (e.g., intracranial hemorrhage)." This indicates that for this specific application (thrombolytic therapy in neurovasculature), the device's safety and effectiveness were not fully proven at the time of clearance, and further studies were required.
Therefore, I cannot populate the table or answer most of the questions you've asked because the provided text does not contain that level of detail about performance criteria or studies.
Here's what I can extract based on the limitations of the provided text:
Acceptance Criteria and Device Performance Study
The provided text does not explicitly state specific acceptance criteria or report detailed device performance against such criteria. It broadly mentions "results of the testing and evaluations performed" supporting substantial equivalence to a predicate device, but no quantitative or qualitative performance metrics are given.
The FDA letter, however, imposes a limitation for a specific use case, indicating that for "thrombolytic therapy in the neurovasculature," safety and effectiveness have not been established, and further clinical studies are necessary. This implies that for this particular application, the device did not meet implicit criteria for established safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | Not specified in the provided text for general use. |
| For thrombolytic therapy in the neurovasculature: Established safety and effectiveness (implicit criterion for market clearance without a warning). | For thrombolytic therapy in the neurovasculature: Safety and effectiveness "have not been established." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "testing and evaluations" but not the type or source of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified.
4. Adjudication method for the test set
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not mentioned. This document describes a medical device for infusion, not an AI or imaging diagnostic device where MRMC studies are typically performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not mentioned. This document describes a medical device for infusion, not an algorithm.
7. The type of ground truth used
- Not specified.
8. The sample size for the training set
- Not applicable/Not specified. This document is about a hardware device, not a machine learning algorithm with a training set.
9. How the ground truth for the training set was established
- Not applicable/Not specified.
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053437
Section 4. 510(k) Summary
:
| General Provisions | 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 | Ultrasound, Infusion, System (NUI) | |
| Common or Usual Name | Ultrasound Infusion Catheter | |
| Proprietary Name | EKOS Micro- Infusion System | |
| Name of PredicateDevice | Predicate DeviceEKOS Peripheral Infusion SystemEKOS Micro- Infusion System | 510(k) Reference Nos.K050563K051225 |
| Device Description | The system consists of a disposable infusion/ultrasound catheter and an instrumentthat generates and controls the delivery of energy to the catheter. The cathetercontains a single ultrasound transducer, located at the distal tip, a thermal sensorand 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 selectiveinfusion of physician-specified fluids, including thrombolytics, into the peripheralvasculature.The EKOS Micro- Infusion System is intended for regional infusion of contrastmaterials into selected vessels in the neurovasculature. The EKOS Micro- InfusionSystem may be used for controlled, regional infusion into selected vessels and is notintended for use in the coronary vasculature. | |
| Summary ofTechnologicalCharacteristics | The proposed EKOS Micro- Infusion Catheter is similar in construction andmaterials to the EKOS Micro-Infusion Catheter previously cleared under K051225and K050563. | |
| Test Summary | The proposed EKOS Micro- Infusion System is considered to be substantiallyequivalent to the currently marketed EKOS Micro- Infusion System based on acomparison of the intended uses and designs and results of the testing andevaluations performed. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
JAN - 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jocelyn Kersten Director, Regulatory Affairs EKOS Corporation 22030 20th Avenue SE, Suite 101 Bothell, Washington 98021
Re: K053437
Trade Name: EKOS Micro-Infusion Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: NUI 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 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear as a box warning, immediately following the indications for use, in the device's labeling:
"The safety and effectiveness of the EKOS Micro-Infusion System for thrombolytic therapy in the neurovasculature have not been established. Further clinical studies are necessary to ensure that use of devices to deliver thrombolytic therapy into the neurovasculature does not result in an increased incidence of adverse events (e.g., intracranial hemorrhage)."
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Page 2 - Ms. Jocelyn Kersten
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your be subject to 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.
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 that I Drilatel statutes and regulations administered by other Federal agencies. You must or any 1 vith 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 Crith in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty by of voyisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, de roo (21 OF Creat on the do "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the CI K Fat 601.77). You may 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/industry/support/index.html.
Sincerely yours,
Neeatlm
Donna Dee Tillman, Ph.D.
Donna-Bea 7 Iman Ph () Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
大 053437 510(k) Number (if known):
Device Name:
EKOS 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)
Barbara-Buchino for MXM
estorative. and Neu
Page I of
510(k) Number K053437
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).