VARIA-NCI

K141462 · Neurochaos Solutions, Inc. · IYN · Nov 19, 2014 · Radiology

Device Facts

• Record ID: K141462
• Device Name: VARIA-NCI
• Applicant: Neurochaos Solutions, Inc.
• Product Code: IYN · Radiology
• Decision Date: Nov 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Varia-NCI is a stand-alone software accessory to a Transcranial Doppler Ultrasound device (TCD) that retrieves, analyzes, and displays Cerebral Blood Flow velocity (CBFv) data from a Transcranial Doppler Ultrasound device. Varia-NCI uses CBFv data to measure the variability of a patient's cerebral blood flow velocity. Varia-NCI is to be used by clinicians managing head trauma in the ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine Settings.

Device Story

Varia-NCI is a stand-alone software accessory for Transcranial Doppler (TCD) ultrasound systems; it retrieves, analyzes, and displays Cerebral Blood Flow velocity (CBFv) data. The software processes CBFv data to calculate and display variability metrics as both numeric values and charts. Used by clinicians in ICU, surgical, emergency, and sports medicine settings to manage head trauma patients. The software facilitates data storage, retrieval, and export in CSV format. It assists clinicians in monitoring cerebral hemodynamics, potentially aiding in the clinical management of head trauma. The device does not perform primary ultrasound imaging but acts as a post-processing and visualization tool for data generated by TCD hardware.

Clinical Evidence

No clinical data. Bench testing only. Software verification and validation testing confirmed system integration, timing, memory allocation, user interface functionality, calculation accuracy, and data export capabilities.

Technological Characteristics

Stand-alone software application; developed using Delphi XE2 environment. Integrates with Compumedics QL 3.0 TCD software. Features include data retrieval, variability calculation, numeric/chart display, and CSV export. No hardware, sterilization, or biocompatibility requirements.

Indications for Use

Indicated for clinicians managing head trauma in ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine settings to measure cerebral blood flow velocity (CBFv) variability using data from a Transcranial Doppler Ultrasound device.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Compumedics Germany – Doppler-Box X (K051085)

Reference Devices

• Spencer Technologies; TCD 100M, PWD13 TRANSDUCER (K002533)
• CompumedicsDWL Elektronische Systeme GmbH; Multi-Dop X (K931801)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that overlap and create a sense of movement.

November 19, 2014

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

NeuroChaos Solutions, Inc. % Ms. Elisa Maldonado-Holmertz Consultant Obelix Consulting, LLC 12416 Fairfax Ridge Place AUSTIN TX 78738

Re: K141462 Trade/Device Name: Varia-NCI Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN Dated: October 16, 2014 Received: October 21, 2014

Dear Ms. Maldonado-Holmertz:

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) k141462

Device Name

Varia-NCI

Indications for Use (Describe)

Varia-NCI is a stand-alone software accessory to a Transcranial Doppler Ultrasound device (TCD) that retrieves, analyzes, and displays Cerebral Blood Flow velocity (CBFv) data from a Transcranial Doppler Ultrasound device. Varia-NCI uses CBFv data to measure the variability of a patient's cerebral blood flow velocity.

Varia-NCI is to be used by clinicians managing head trauma in the ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine Settings.

Type of Use (Select one or both, as applicable)

XPrescription Use (Part 21 CFR 801 Subpart D)

□Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for NeuroChaos Solutions. The logo features a stylized, abstract graphic to the left of the company name. The text "NeuroChaos" is in a bold, sans-serif font, with the word "SOLUTIONS" appearing in smaller letters below it.

# Section 5 – 510(k) Cover Letter

# 510(k) Summary

# Varia-NCI

# 1. Submission Sponsor

NeuroChaos Solutions, Inc. 2645 Creeks Edge Parkway Austin, TX 78733 USA Contact: Patrick Kothe, CEO Phone: [phone] Email: [e-mail]

## 2. Submission Correspondent

Obelix Consulting, LLC 12416 Fairfax Ridge Place Austin, TX 78738 USA Contact: Elisa Maldonado-Holmertz, Consultant Phone: [phone] Email: [e-mail]

#### 3. Date Prepared

30 May 2014

# 4. Device Identification

| Trade/Proprietary Name: | NeuroChaos Solutions, System 1.0 |
|----------------------------|------------------------------------------|
| Common/Usual Name: | Accessory to Transcranial Doppler |
| Classification Name: | Ultrasonic pulsed Doppler imaging system |
| Classification Regulation: | CRF 892.1550 |
| Product Code: | IYN |
| Device Class: | Class II |
| Classification Panel: | Radiology |

# 5. Legally Marketed Predicate Device(s)

Compumedics Germany – Doppler-Box X (K051085)

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Image /page/4/Picture/0 description: The image shows the logo for NeuroChaos Solutions. The logo consists of a stylized, abstract symbol to the left of the text "NeuroChaos" in a bold, sans-serif font. Below "NeuroChaos" is the word "SOLUTIONS" in a smaller, lighter font. The overall design is clean and professional.

#### 6. Device Description

Varia-NCI accesses data from Compumedics Germany QL 3.0 software. QL 3.0 is a trade mark of PC-based software supplied by Compumedics Germany, GmbH and included with their digital Transcranial Doppler (TCD) Ultrasound device.

#### 7. Indication for Use Statement

Varia-NCI is an accessory to a Transcranial Doppler Ultrasound device (TCD) that collects, analyzes, stores, and displays Cerebral Blood Flow velocity (CBFv) data. Varia-NCl uses CBFv data to measure the variability of a patient's cerebral blood flow velocity.

Varia-NCI is to be used by clinicians managing head trauma in the ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine Settings.

#### 8. Substantial Equivalence Discussion

The following table compares the Varia-NCI to the predicate device with respect to indications for use, intended use, and principles of operation for the determination of substantial equivalence.

| Manufacturer | NeuroChaos Solutions, Inc. | Compumedics Germany, GmbH |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Varia-NCI | Doppler-Box X |
| 510(k) Number | -- | K051085 |
| Product Code | IYN | IYN and ITX |
| Regulation Number | 892.1550 | 892.1550<br>892.1570 |
| Regulation Name | Ultrasonic pulsed Doppler imaging system | Ultrasonic pulsed Doppler imaging system |
| Indications for Use | Varia-NCI is a stand-alone software accessory to a<br>Transcranial Doppler Ultrasound device (TCD) that retrieves, analyzes, stores, and displays<br>Cerebral Blood Flow velocity (CBFv) data from a Transcranial<br>Doppler Ultrasound device.<br>Varia-NCI uses CBFv data to measure the variability of a<br>patient's cerebral blood flow velocity.<br><br>Vari-NCI is to be used by<br>clinicians managing head trauma | The Doppler-Box is a medical<br>ultrasound device for measuring<br>the blood flow velocities in arteries<br>and veins mainly subcutaneously.<br>The 16MHz probe can also be used<br>intraoperative. |

#### Table 5A - Comparison of Characteristics

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| Manufacturer | NeuroChaos Solutions, Inc.<br>in the ICU, Surgical Unit,<br>Emergency Department, and<br>Clinical and Sports Medicine<br>Settings. | Compumedics Germany, GmbH |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate | Compumedics Germany GmbH<br>Doppler-Box X | Spencer Technologies; TCD 100M,<br>PWD13 TRANSDUCER K002533<br>CompumedicsDWL Elektronische<br>Systeme GmbH; Multi-Dop X<br>K931801 |
| Significant<br>Differences | Stand-alone software accessory<br>to a Transcranial Doppler | Digital Doppler sonography system.<br>HD resolution in Doppler M-Mode<br>permits more precise insonation.<br>The innovative hardware design<br>with no integrated computer, but<br>with the possibility to connect to all<br>standard Windows©-based<br>computer systems |

## 9. Non-Clinical Performance Data

A test report was generated consisting of Test Description, Test Date, Tester Name, Test Criteria, Test Setup, Pass Fail Criteria, and Test Data Files. The report indicates that the software passed the test.

The following software testing has been performed to support substantial equivalence:

- System Integration Multiprocessing testing : Test Passed ●
- . System Integration - Timing and Memory Allocation : Test Passed
- User Interface Module : Test Passed ●
- Single Patient Module Patient information needs to be displayed. O
- O User interface needs to display CBFv variability values and chart
- The system needs to export results in csv format O
- Patient Data testing o
- CBFv exp files were entered into the database
- Patient name was entered into the database
- . Patient was recalled and verified that the data was the correct file
- Calculation Testing and Display results : Test Passed
- The variability of CBFv was calculated and displayed as o numeric value and as a chart
- Save results Testing : Test Passed
- Test results were successfully saved using Save button O

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Image /page/6/Picture/0 description: The image contains the logo for NeuroChaos Solutions. The logo features a stylized graphic to the left of the company name. The text "NeuroChaos" is in a bold, sans-serif font, with the word "SOLUTIONS" appearing in a smaller font size below it.

- System Verification/Validation Performance Testing : Test Passed ●
- Labeling - User Manual Verification/Validation : Test Passed
- Manufacturing : Test Passed
- o Verify that all manufacturing documentation is released
- o All software files checked into VNS Software repository
- o Ran through the software build process and built the package on a clean machine with Delphi XE2 installed.
- l Installed libraries as directed in Build Process
- . Installed
- -ExpressQuantumGrid
- -ExpressBars
- -ExpressNavBar
- -DBSAM
- Installed application software
- . Run Delphi and Install supplied
- application libraries Hyperclass,

HyperDSP, ECG, and Miracle:

- Open Menu: File/Open... Name of the libraryD7.dpk
- Compiled Software
- Reviewed BOM and Software Package

Varia-NCI is not required to conduct sterilization, biocompatibility, or electrical testing as a standalone software accessory.

As part of demonstrating safety and effectiveness, Varia-NCI shows substantial equivalence as an accessory to the predicate device that is subject to this 510(k) submission. Varia-NCI complies with the applicable Software standards.

# 10. Clinical Performance Data

No clinical testing is required because the device's indication for use does not substantiate the need for clinical data to support equivalency to the predicate device. The predicate device has been on the market for nearly 10 years with proven safety and effectiveness. The non-clinical testing detailed in this submission confirms the safety and effectiveness of the Varia-NCI.

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Image /page/7/Picture/0 description: The image shows the logo for NeuroChaos Solutions. The logo features a stylized, abstract graphic to the left of the text. The text "NeuroChaos" is in a bold, sans-serif font, with the word "SOLUTIONS" in a smaller font size underneath. The colors used in the logo are shades of blue.

### 11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same operational characteristics as the previously cleared predicate device, or the device has the same intended use and different operational characteristics in which substantial equivalency can be demonstrated in the device in comparison to the predicate device. Additionally, the new device does not raise new questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between Varia-NCI and the predicate device does not raise any questions regarding its safety and effectiveness. Varia-NCI, as designed and produced, is determined to be substantially equivalent as an accessory to the referenced predicate device.