(294 days)
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 EKOS Micro-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 angiographic contrast material into the neurovasculature.
The provided text describes the 510(k) summary for the EKOS Micro-Infusion System. It details the device's intended use and the studies conducted to support its substantial equivalence.
Here's an analysis of the provided information, framed by your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| For what purpose? To demonstrate the acceptable performance requirements to be met by the EKOS Micro-Infusion System. | How measured? Preclinical bench and animal studies. |
| Criterion 1: Meet design specifications. | The studies "demonstrate that the performance of the EKOS Micro-Infusion System meets its design specifications." |
| Criterion 2: Safe for its intended use. | The studies "demonstrate that the performance of the EKOS Micro-Infusion System... is safe and effective for its intended use." |
| Criterion 3: Effective for its intended use. | The studies "demonstrate that the performance of the EKOS Micro-Infusion System... is safe and effective for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The summary states that "EKOS has conducted preclinical bench and animal studies." It does not specify the sample sizes used for these studies (e.g., number of animals, number of bench tests). The data provenance is from preclinical bench and animal studies, implying a prospective and controlled experimental setup rather than retrospective human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As the studies were preclinical (bench and animal), the concept of "experts" in the context of human data ground truth (like radiologists) does not directly apply. The "ground truth" would have been established by the experimental design and measurements conducted by the study investigators.
4. Adjudication Method for the Test Set
This information is not provided. Given the preclinical nature of the studies, formal adjudication methods typically used for human clinical data (like 2+1 or 3+1 for discrepancies) would not be applicable in the same way. The results of the bench and animal studies would have been assessed against predetermined performance metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an infusion system, not an AI-powered diagnostic or interpretive device, so the comparison of human readers with and without AI assistance is irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the EKOS Micro-Infusion System is a physical medical device (catheter system for infusion), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the device's performance was established by direct experimental measurements and observations from preclinical bench and animal studies. This likely involved:
- Bench Test Results: Measuring parameters like flow rates, pressure resistance, structural integrity, and material compatibility under simulated conditions.
- Animal Study Observations: Assessing safety (e.g., tissue damage, adverse events) and effectiveness (e.g., successful infusion, distribution of contrast material) in a living system.
8. The Sample Size for the Training Set
This question is not applicable as the EKOS Micro-Infusion System is a physical device and not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
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041826
9.0 510(k) Summary
.
| Applicant Name: | EKOS Corporation | APR 27 2005 |
|---|---|---|
| Address: | 22030 20th Ave. SE, Suite 101Bothell, WA 98021 | |
| Contact Person: | Jocelyn KerstenDirector, Regulatory Affairs | |
| Telephone: | (425) 482-1108 X 287 | |
| Fax: | (425) 482-1109 | |
| Device: | EKOS Micro-Infusion System | |
| Classification: | CFR 870.1210 - Continuous Flush Catheter | |
| Panel: | Cardiovascular | |
| Product Code: | KRA | |
| Intended Use: | The EKOS Micro-Infusion System is intended for regionalinfusion of contrast materials into selected vessels in theneurovasculature. The EKOS Micro-Infusion System may be usedfor controlled, regional infusion into selected vessels and is notintended for use in the coronary vasculature. | |
| Device Description: | The EKOS Micro-Infusion System is an infusion catheter systemdesigned to deliver ultrasound energy through a transducer elementat the distal catheter tip. This device is intended to deliverangiographic contrast material into the neurovasculature. | |
| Predicate Basis: | The EKOS Micro-Infusion System is substantially equivalent toother legally marketed devices. These devices include | |
| EKOS Peripheral Infusion System (K030637) Boston Scientific Corporation: Magic Infusion Catheter (K923368 & K023351) Boston Scientific Corporation: Renegade Hi-Flo Microcatheter (K000177) Boston Scientific Corporation Turbo-Tracker Microcatheter (K960806) BioSphere Medical EmboCath Hydrophilic Infusion Catheter (K003105) Spencer Technologies TCD 100M Transcranial Doppler |
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(K002533)
EKOS has conducted preclinical bench and animal studies with the Performance: EKOS Micro-Infusion System. These studies demonstrate that the performance of the EKOS Micro-Infusion System meets its design specifications and is safe and effective for its intended use.
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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
APR 2 7 2005
Re: K041826
Trade Name: EKOS Micro-Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: NUI Dated: March 2, 2005 Received: March 3, 2005
Dear Ms. Kersten:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 9 ro(s) premaince is substantially equivalent (for the indications felerenced above and nave used.
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally management date of the Medical Device American Frank Food. Days commerce prior to May 28, 1970, the characted and of the Federal Food. Drug, devices that nave been reclassified in accessed in a market the device, subject to the general controls and Cosment Act (7tcl). "Tou may, thereflect below. The general controls provisions of the provisions of the Act and the minutions desorved over of devices, good manufacturing practice, Act fictuale requireritions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this avol u I he Office of Device Evaluation has decemblace in the proposed labeling and that such use device will be used for an michaed as the rasition 513(i)(1)(E) of the Act, the following could cause harm. Therefore, in accordance with became of ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( device's labeling:
"The safety and effectiveness of the EKOS Micro-Infusion System for thrombolytic therapy in " The safety and effectivelless of the EROS finners interest of endics are necessary to ensure the neurovasculature nave not been exadonsilou. The neurovasculature does not result in an that use of devices to defree 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. Please note that the above labore 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 I he I DA Iniding of substantial equive and permits your device to proceed to the uc vice results in a classification 101 Jour device as described in your Section market. "This letter will anon-you to evigation 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), if your device is classified too about of . Existing major regulations affecting your device can be it may be subject to adultions, 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 I least be advised that I Dris issuality that your device complies with other requirements of the Act that I DA has made a deceminations administered by other Federal agencies. You must or any I catal statures and regulaties, including, but not limited to: registration and listing (21 Comply with an the Act 810 cm Part 801); good manufacturing practice requirements as set CFR Part 807), adoling (21 CFR Part 820); and if applicable, the electronic ronth in the quany by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to your If you desire specific information actuact the Office of Compliance at (240) 276-0115. Also, de vice (21 CFR Part 001), priuse SMisbranding by reference to premarket notification' (21 prease note the regulation onears, "Atlocracion on your responsibilities under the Cl K ratt 607.27): "Pouring Joseph 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.
Sincercly yours.
Sincerely yours,
Dr. Rita Tillman, Ph.D.
Ilman, Ph.I Donna-Bea Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K041826
Device Name: EKOS Micro-Infusion System
Indications For Use:
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 into selected vessels in the near ordecantly of the selected vessels and is not intended for use in the coronary vasculature.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Evaluation (SDA)
§ 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).