(21 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.
This document is a 510(k) premarket notification for the EKOS Micro-Infusion System, establishing its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, device performance, or a specific study proving it meets acceptance criteria in the way a clinical trial or performance study would for an AI/digital health device.
Here's why and what information can be extracted:
The document is a regulatory approval for a medical device (catheter system), not an AI/digital health software. Therefore, the questions related to AI device performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and ground truth types are not applicable in this context.
Substantial equivalence for this type of device typically relies on:
- Similar Indications for Use: The new device is intended for the same purpose as a legally marketed predicate device.
- Similar Technological Characteristics: The new device has similar design, materials, and operational principles as the predicate device.
- Performance Data: This usually involves non-clinical testing (e.g., bench testing, biocompatibility, sterilization, electrical safety, mechanical robustness) to demonstrate that any differences in technological characteristics do not raise new questions of safety or effectiveness.
Based on the provided text, here's what can be gleaned:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria or specific numerical performance metrics. Instead, it states that the device is "substantially equivalent" to predicate devices based on:
| Acceptance Criteria Category (Implied by 510(k)) | Statement in Document |
|---|---|
| Intended Use Equivalence | "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." |
| Technological Equivalence | "The proposed EKOS Micro- Infusion Catheter is similar in construction and materials to the EKOS Micro-Infusion Catheter previously cleared under K051225 and K050563." |
| Safety and Effectiveness | "The proposed EKOS Micro- Infusion System is considered to be substantially equivalent to the currently marketed EKOS Micro- Infusion System based on a comparison of the intended uses and designs and results of the testing and evaluations performed." (This implies the testing results met the necessary criteria for safety and effectiveness, but the specific criteria are not detailed here.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. For a device like a catheter, "test set" and "data provenance" as described for AI models are not directly applicable. Performance testing would involve bench or animal studies, not typically human data sets described in this manner in a 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable to this type of device and regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable to this type of device and regulatory submission.
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 applicable, as this is not an AI/imaging device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is a physical medical device (catheter system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" would relate to verification and validation endpoints, such as material properties meeting specifications, flow rates being within tolerance, or a device's ability to withstand pressure or fatigue. These are typically established through engineering and laboratory testing.
8. The sample size for the training set
Not applicable, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):
The document provides a "Test Summary" indicating that the proposed EKOS Micro-Infusion System demonstrated substantial equivalence to currently marketed predicate devices (EKOS Peripheral Infusion System K050563 and EKOS Micro-Infusion System K051225).
The "study" that proves this is described generally as "a comparison of the intended uses and designs and results of the testing and evaluations performed." While the specific types, protocols, and results of these tests and evaluations are not detailed within this 510(k) summary document, for a device like a catheter system, they would typically include:
- Bench Testing: Mechanical strength, fluid dynamics (infusion rates), material properties, durability, fatigue testing.
- Biocompatibility Testing: To ensure materials are safe for contact with the body.
- Sterilization Validation: To ensure the device can be effectively sterilized.
- Performance Testing: To confirm the device operates as intended under simulated use conditions.
The FDA's "substantial equivalence determination" implies that these tests were conducted, reviewed by the FDA, and found to be sufficient to demonstrate that the new device is as safe and effective as the predicate devices.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
January 7, 2022
EKOS Corporation Jocelyn Kersten Director, Regulatory Affairs 22030 20th Avenue SE, Suite 101 Bothell, Washington 98021
Re: K053432
Trade/Device Name: EKOS 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 December 30, 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,
Image /page/0/Picture/9 description: The image shows the name Gregory W. O'connell -S. It also shows that the image was digitally signed by Gregory W. O'connell -S on the date 2022.01.07. The time stamp is 13:37:47 -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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized representation of three human profiles facing right, arranged in a stacked formation. The profiles are depicted with simple, curved lines. Encircling the central emblem is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEC 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EKOS Corporation c/o Ms. Jocelyn Kersten Director, Regulatory Affairs 22030 20th Avenue SE, Suite 101 Bothell, WA 98021
Re: K053432
EKOS Micro-Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA 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 indication We have reviewed your Section 910(x) premained in substantially equivalent (for the indications for use stated in the enclosure) the devices marketed predicate devices marketed in interstate for use stated in the enclosure) to regally manced promoted Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prior to May 28, 1970, the chaeffired in accordance with the Federal Food, Drug, devices that have been reclassified in accordance was a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The You may, therefore, market the device, belyer is and in annual registration, listing of
general controls provisions of the Act include requirements for and successions and general controls provisions of the Fee merade copies 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 (Scc above) movements . Existing your device can
may be subject to such additional controls. Existing major regulations EDA may may be subject to such additional controls. Extrong mayor organisms be found in the Code of Pouchal Stegeral Stegeral 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 1 Icase of advised that I Dris issuantes vith other requirements of the requirements of the Act that I DA has made a dotenmancions administered by other Federal agencies. You must of any I cacal statutes and regainments, including, but not limited to: registration and listing (21 Comply with an the Fet 6 requirements, 01); good manufacturing practice requirements as set CFR Part 6077, abonnig (DF OFF Part 820); and if applicable, the electronic forth in the quant) bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation some of pro regin marketing your device as described in your Section 510(k) This letter will anow you to ough mailing of substantial equivalence of your device to a legally prematication: The PDF Intelling sification 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 If you dealer specific acrioliance at (240) 276-0120. Also, please note the regulation entitled, Connect the Office of County of Court (21CFR Part 807.97). You may obtain Mitsorancing of reference to presensibilities under the Act from the Division of Small other general micrinational 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,
Blymmtma for
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 Micro-Infusion System
Indications for Use
510(k) Number (if known): K053432
Device Name:
EKOS Micro-Infusion System
Indications for Use:
The EKOS Micro-Infusion System is intended for the controlled and selective infusion of The ENOS MICIO-Infusion Dystein is mombolytics, into the peripheral vasculature.
The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into The EKOS Micro- Infusion System is intended for regroincil Infusion System may be used for selected vessels in the neurovasculature. The EN CD SD SD Sot 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)
e.g.mee
of Cardiovascular Devices
KO 53432 510(k) Number
Page 1 of 1_
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DEC 3 0 2005
| 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 | Catheter, Continuous Flush (KRA) | |
| Common or Usual Name | Continuous Flush 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. |
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).