EKOS ultrasound EVD Device, EVD Control Unit

K172035 · Btg International, Inc. · JXG · Mar 24, 2018 · Neurology

Device Facts

• Record ID: K172035
• Device Name: EKOS ultrasound EVD Device, EVD Control Unit
• Applicant: Btg International, Inc.
• Product Code: JXG · Neurology
• Decision Date: Mar 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The EKOS Ultrasound EVD System is a medical device designed for the drainage of cerebrospinal fluid (CSF) to manage intracranial pressure. It functions by integrating with dimensionally compatible external ventricular drainage (EVD) devices. The system utilizes ultrasound technology to facilitate CSF drainage. It is intended for use in clinical settings by healthcare professionals. By enabling controlled drainage of CSF, the device assists in the reduction of intracranial pressure and CSF volume, potentially benefiting patients suffering from conditions associated with elevated intracranial pressure. The device operates as an adjunct to standard EVD catheters.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

The system utilizes ultrasound technology for the drainage of cerebrospinal fluid. It is designed to be used with dimensionally compatible EVD catheters. The device is classified as a ventricular catheter under 21 CFR 882.4100 (Product Codes HCA, JXG).

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) drainage to reduce intracranial pressure and CSF volume.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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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