(262 days)
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No
The summary provides no information suggesting the use of AI or ML. It describes a system for draining CSF, which is a mechanical function.
Yes
The device is intended to drain cerebrospinal fluid to reduce intracranial pressure and CSF volume, which are actions to treat a medical condition.
No
The device is described as draining cerebrospinal fluid to reduce intracranial pressure and CSF volume, which is a therapeutic intervention, not a diagnostic one.
No
The intended use describes a "System" that includes "dimensionally compatible devices for draining cerebrospinal fluid (CSF)". This strongly implies hardware components are involved in the draining process, making it a hardware-software system, not software-only.
Based on the provided information, the EKOS Ultrasound EVD System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to drain cerebrospinal fluid (CSF) to reduce intracranial pressure and CSF volume. This is a therapeutic procedure performed directly on a patient, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as analyzing samples, providing diagnostic information, or using reagents.
Therefore, the EKOS Ultrasound EVD System is a medical device used for a therapeutic intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EKOS Ultrasound EVD System is intended to be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) as a means of reducing intracranial pressure and CSF volume.
Product codes
HCA, JXG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.
March 24, 2018
BTG International, Inc. Jocelyn Kersten Vice President, Regulatory Affairs 11911 North Creek Parkway South Bothell, Washington 98011
Re: K172035
Trade/Device Name: EKOS Ultrasound EVD System Regulation Number: 21 CFR 882.4100 Regulation Name: Ventricular Catheter Regulatory Class: Class II Product Code: HCA, JXG Dated: February 20, 2018 Received: February 21, 2018
Dear Jocelyn 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Carlos L. Pena -S" in a simple, sans-serif font. The text is black against a white background, making it easily readable. The letter "S" is slightly offset and smaller than the rest of the name, which could indicate an initial or abbreviation.
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172035
Device Name EKOS Ultrasound EVD System
Indications for Use (Describe)
The EKOS Ultrasound EVD System is intended to be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) as a means of reducing intracranial pressure and CSF volume.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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