(165 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on the mechanical and ultrasound-based fluid delivery system.
No
The 'Intended Use' section explicitly states that the ultrasound energy delivered by the device is "not intended to be therapeutic". The device's primary function is for infusion of solutions.
No
The device is an infusion system designed to deliver fluids, not to diagnose a condition.
No
The device description clearly outlines hardware components including a catheter, ultrasound core, and ultrasound transducers, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "infusion of solutions into the pulmonary arteries." This describes a procedure performed within the body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The device is described as an "infusion catheter system" designed to "deliver fluids via a multi sidehole catheter." This is consistent with a device used for direct delivery of substances into the body.
- Lack of IVD Characteristics: There is no mention of analyzing 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 into the body, which is not the purpose of an IVD.
N/A
Intended Use / Indications for Use
The EndoWaveTM Infusion System is intended for the infusion of solutions into the pulmonary arteries.
The safety and effectiveness of the EKOS EndoWaveTM Infusion system 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
KRA
Device Description
The EndoWaveTM Infusion System is an infusion catheter system designed to deliver fluids via a multi sidehole catheter. The fluid is dispersed via multiple ultrasound transducers distributed linearly along the length of an ultrasound core which is placed into the center lumen of the catheter. This device is intended to deliver physician-specified agents or fluids into the peripheral vasculature.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
EKOS has conducted preclinical bench and animal studies with the EndoWave™ Infusion System. These studies demonstrate that the performance of the EndoWave™ Infusion System meets its design specifications for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K071933, K072507, K062508, K063620, K014054, K003052, K011557, K030589
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
510(k) Summary
| Applicant Name: | EKOS Corporation | APR 22 2008 |
|---|---|---|
| Address: | 11911 North Creek Parkway South | |
| Bothell, WA 98011 | ||
| Contact Person: | Jocelyn Kersten | |
| Vice President, Quality Assurance, Regulatory and Clinical Affairs | ||
| Telephone: | (425) 415-3132 | |
| Fax: | (425) 415-3102 | |
| Device: | EndoWaveTM Infusion System | |
| Classification: | CFR 870.1210 - Continuous Flush Catheter | |
| Panel: | Cardiovascular | |
| Product Code: | KRA | |
| Intended Use: | The EndoWaveTM Infusion System is intended for the infusion of | |
| solutions into the pulmonary arteries. | ||
| The safety and effectiveness of the EKOS EndoWaveTM Infusion | ||
| system 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. | ||
| Device Description: | The EndoWaveTM Infusion System is an infusion catheter system | |
| designed to deliver fluids via a multi sidehole catheter. The fluid is | ||
| dispersed via multiple ultrasound transducers distributed linearly along | ||
| the length of an ultrasound core which is placed into the center lumen of | ||
| the catheter. This device is intended to deliver physician-specified | ||
| agents or fluids into the peripheral vasculature. | ||
| Predicate Basis: | The EndoWaveTM Infusion System is substantially equivalent to other | |
| legally marketed devices. These devices include |
- EKOS EndoWave Infusion System ( EKOS Corporation , K071933,
K072507) - EKOS NeuroWave Infusion System ( EKOS Corporation , K062508,
K063620) - Edwards Swan-Ganz Standard Thermodilution Pulmonary Artery
Catheter, ( Edwards Lifesciences , K014054) - Z-Med 11-X, ( NuMED, Inc. , K003052,K011557, K030589) | |
| Performance: | EKOS has conducted preclinical bench and animal studies with the | |
1
EndoWave™ Infusion System. These studies demonstrate that the
performance of the EndoWave™ Infusion System meets its design
specifications for its intended use.
、
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2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human figures connected at the shoulders, with flowing lines representing movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2008
EKOS Corporation c/o Ms. Jocelyn Kersten 11911 North Creek Parkway South Bothell, WA 98011
Re: K073166
EKOS EndoWave Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: II (two) Product Code: KRA Dated: January 18, 2008 Received: January 22, 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). 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 immediately following the indication for use in the device's labeling:
The safety and effectiveness of the EKOS EndoWave™ Infusion system 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.
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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 vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may 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 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.
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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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,
Donna Rae Tillman, Ph.D., M.B.A.
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1.10 Indications for Use Statement
EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011
Indications for Use Statement
510(k) Number (if known): K073166
EndoWave™ Infusion System Device Name:
Indications for Use:
The EndoWave™ Infusion System is intended for the infusion of solutions into the pulmonary arteries.
The safety and effectiveness of the EKOS EndoWave™ Infusion system 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 Counter
Concurrence of CDRH, Office of Device Evaluation (ODE)
surver 2 (Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_Ko73166