(30 days)
EndoWave Infusion System K080392
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components and energy delivery, with no mention of AI/ML capabilities.
No
The device explicitly states that "the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic". Its primary function is infusing solutions.
No
The device is described as an "infusion system" intended for "infusion of solutions" and "infusion of physician-specified fluids." Its function is therapeutic (delivering substances) rather than diagnostic (detecting or identifying a condition).
No
The device description explicitly states the system consists of a disposable infusion catheter with a removable ultrasound core and an instrument that generates and controls energy delivery, indicating significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "infusion of solutions into the pulmonary arteries" and "controlled and selective infusion of physician-specified fluids... into the peripheral vasculature." This describes a therapeutic or interventional procedure performed within the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a catheter and an instrument for delivering energy and fluids into the vasculature. This aligns with an interventional device, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver substances directly into the patient's circulatory system.
N/A
Intended Use / Indications for Use
The EkoSonic™ Endovascular System with Rapid Pulse Modulation is intended for the infusion of solutions into the pulmonary arteries.
The safety and effectiveness of the EKOS EkoSonic™ Endovascular System with Rapid Pulse Modulation for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.
Product codes
QEY, KRA
Device Description
The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pulmonary arteries, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Electrical safety testing, electrical circuit qualification testing, software validation testing and system integration testing confirmed the modified EkoSonic System is substantially equivalent to the predicate EndoWave System.
Key Metrics
Not Found
Predicate Device(s)
EndoWave Infusion System K080392
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
November 22, 2021
EKOS Corporation Jocelyn Kersten Vice President 11911 N Creek Parkway South Bothell, Washington 98011
Re: K081467
Trade/Device Name: EkoSonic Endovascular System With Rapid Pulse Modulation 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 June 26, 2008. 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: 2021.11.22 13:37:13 -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
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2008
EKOS Corporation c/o Ms. Jocclyn Kersten Vice President, Quality Assurance, Regulatory and Clinical Affairs 11911 N Creek Pkwy S Bothell, WA 98011
Re: K081467
Trade/Device Name: EkoSonic™ Endovascular System with Rapid Pulse Modulation Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II (two) Product Code: KRA Dated: May 22, 2008 Received: May 27, 2008
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.
2
Page 2 - Ms. Jocelyn 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R. Vochner
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 EkoSonic™ Endovascular System
EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011
Indications for Use Statement
510(k) Number (if known): K081467
EkoSonic™ Endovascular System with Rapid Pulse Modulation Device Name:
Indications for Use:
The EkoSonic™ Endovascular System with Rapid Pulse Modulation is intended for the infusion of solutions into the pulmonary arteries.
The safety and effectiveness of the EKOS EkoSonic™ Endovascular System with Rapid Pulse Modulation for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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K081467 page lot 2
SPECIAL 510(k) Notification EkoSonic™ Endovascular System
JUN 2 6 2008
Section 4. 510(k) Summary
General Provisions
| Submitter's Name and Address: | EKOS Corporation
11911 North Creek Parkway South
Bothell, WA 98011 |
|-------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Jocelyn Kersten
425-415-3132
425-415-3102 (fax)
jkersten@EKOSCORP.com |
| Classification Name: | Catheter, Continuous Flush (KRA) |
| Regulation Number: | 21 CFR §870.1210 |
| Common or Usual Name: | Continuous Flush Catheter |
| Proprietary Name: | EkoSonic™ Endovascular System with Rapid Pulse
Modulation |
| Name of Predicate Device: | EndoWave Infusion System |
| 510(k) Reference No.: | K080392, K073166 |
Device Description
The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature.
Intended Use
The EkoSonic System is intended for the controlled and selective infusion of physicianspecified fluids, including thrombolytics, into the peripheral vasculature.
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KCE1167 page 2 of 2
SPECIAL 510(k) Notification EkoSonic™ Endovascular System
The EkoSonic ™ Endovascular System with Rapid Pulse Modulation is intended for the infusion of solutions into the pulmonary arteries.
The safety and effectiveness of the EKOS EkoSonic™ Endovascular System with Rapid Pulse Modulation for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.
Summary of Technological Characteristics
The device modification described in this notification does not affect the technological characteristics for the EkoSonic System.
Test Summary
Electrical safety testing, electrical circuit qualification testing, software validation testing and system integration testing confirmed the modified EkoSonic System is substantially equivalent to the predicate EndoWave System.