Pure EP

K180805 · Biosig Technologies · DQK · Aug 8, 2018 · Cardiovascular

Device Facts

• Record ID: K180805
• Device Name: Pure EP
• Applicant: Biosig Technologies
• Product Code: DQK · Cardiovascular
• Decision Date: Aug 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

PURE EP™ is a computerized system intended for acquiring, digitizing, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.

Device Story

PURE EP is a computerized system for electrophysiology (EP) labs; acquires, digitizes, filters, measures, and records electrocardiographic (ECG) and intracardiac (IC) signals. System comprises an amplifier and a personal computer (PC) connected via high-speed fiber optic cable. Patient connects to amplifier via ECG cables and standard IC catheters. Amplifier includes hardware and embedded software for signal acquisition (12-lead ECG and 56 IC signals). PC runs PURE-EP software for real-time visualization and review. Healthcare practitioners use the system to interpret cardiac signals during EP procedures. Output aids in clinical decision-making by providing processed, filtered, and measured cardiac data. Benefits include enhanced signal visualization and data management for diagnostic EP procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software, electrical, and mechanical verification against industry standards (IEC 60601-1, IEC 62304, etc.).

Technological Characteristics

System consists of an amplifier and PC connected via fiber optic cable. Features 24-bit A/D converter, 2000 samples/sec sampling rate, and up to 64 channels. Software-programmable high-pass and low-pass filters for ECG and IC signals. PC hardware: Intel i7 quad-core, 16 GB RAM, 1 TB storage, Windows 7 OS. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 62304 standards.

Indications for Use

Indicated for patients undergoing electrophysiology (EP) procedures in an EP laboratory. Intended for use under the supervision of licensed healthcare practitioners.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• GE Healthcare; CardioLab (K130626)

Submission Summary (Full Text)

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August 8, 2018

BioSig Technologies Tiffini Wittwer Regulatory 12424 Wilshire Blvd. Suite 745 Los Angeles, California 90025

Re: K180805

Trade/Device Name: Pure EP Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: June 13, 2018 Received: June 21, 2018

Dear Tiffini Wittwer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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,

for

M.A. Wilhelm

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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#### Indications for Use

510(k) Number (if known) K180805

Device Name PURE EPTM

Indications for Use (Describe)

PURE EP™ is a computerized system intended for acquiring, digitizing, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☑</span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 16px;">☐</span> |

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### 510(k) Summary K180805

### Table 1: 510(k) Summary

| Submitter: | Biosig Technologies, Inc.<br>12424 Wilshire Blvd, Suite 745<br>Los Angeles, CA 90025 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiffini Diage<br>Regulatory Affairs Consultant<br>Phone: [phone]<br>E-mail: [e-mail] |
| Date Of Submission: | March 26, 2018 |
| Trade Name: | PURE EP™ |
| Common Name: | Programmable diagnostic computer / electrophysiology system |
| Classification: | Class II, per 21 CFR 870.1425 |
| Product Code: | DQK |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>• K130626 GE Healthcare; CardioLab (other systems included in cleared 510(k) application) |
| Device Description: | PURE EP™ is a system consists of two main parts: the amplifier, and the personal computer (PC), which are connected over a high-speed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens. |
| Indication for Use: | PURE EP™ is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. |

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| Item | Predicate Device GE CardioLab | Subject Device PURE EPTM |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K130626 | K180805 |
| Class | II | II |
| Product Code | DQK | DQK |
| Intended Use and<br>Indications for Use (IFU) | CardioLab System is intended for the<br>acquiring, filtering, digitizing, simplifying,<br>measuring and calculating, displaying,<br>recording and monitoring of clinical data<br>from adult and pediatric patients.<br>CardioLab System is configurable. Clinical<br>data includes: ECG waveforms,<br>intracardiac signals, stimulus data, ablation<br>data, pulse oximetry (SpO2), respiration<br>rate, CO2 (EtCO2),<br>temperature, and invasive and noninvasive<br>blood pressure. Physiological parameters<br>such as diastolic, systolic, mean pressure,<br>heart rate, and cycle length are derived<br>form the signal data, displayed, and<br>recorded. The data is entered manually or<br>acquired via interfaced devices and/or<br>information systems and may be used for<br>report<br>generation. | PURE EP is a computerized system<br>intended for acquiring, digitizing,<br>amplifying, filtering, measuring and<br>calculating, displaying, recording and<br>storing of electrocardiographic and<br>intracardiac signals for patients<br>undergoing electrophysiology (EP)<br>procedures in an EP laboratory under the<br>supervision of licensed healthcare<br>practitioners who are responsible for<br>interpreting the data. |
| Target Population | Clinical data from adult and pediatric<br>patients. | Patients undergoing EP studies in an EP<br>lab. |
| Anatomical Site | Multiple, including cardiac signals | Cardiac signals |
| Where used | Multiple hospital and clinical settings<br>including EP labs | EP labs |
| Energy<br>Used/Delivered | No energy delivered to patient | No energy delivered to patient |
| Processor/Data<br>Storage | Intel Pentium IV Xeon or greater<br>processor<br>512 MB of Ram<br>2 x 40 GB hard drives<br>OS: Windows XP Professional | Intel i7 quad-core CPU<br>16 GB of Ram<br>1 TB<br>OS: Windows 7 |
| Item | Predicate Device GE CardioLab | Subject Device PURE EPTM |
| Number of Channels | 32/64<br>96/128 | Up to 64 |
| Sampling Rate | 2000 samples per second | 2000 samples per second |
| Analog to Digital<br>Converter | 12 bit | 24 bit |
| Outputs | 12 lead ECG | Same |
| RF Filtering | All inputs | Same |
| Bandwidth | 0.05-1000 Hz | Same |
| ECG high pass<br>filter | 0.05 Hz, 0.5 Hz, 5.0 Hz | Software programmable at: 0.05 Hz, 0.5<br>Hz, 1.0<br>Hz, 5.0 Hz, 20 Hz, 30 Hz,<br>50 Hz, 200 Hz |
| ECG low pass filter | 100 Hz | Software programmable at: 30 Hz, 40<br>Hz, 50 Hz,<br>100 Hz, 150 Hz, 300 Hz,<br>500 Hz; |
| IC high pass filter | 0.05 Hz, 0.5 Hz, 5.0 Hz, 30<br>Hz, 100 Hz | Software programmable 0.05 Hz, 0.5 Hz,<br>1.0 Hz,<br>5.0 Hz, 20 Hz, 30 Hz, 50<br>Hz, 200 Hz |
| IC low pass filter | 150 Hz, 500 Hz, 1000 Hz; | Software programmable at: 30 Hz, 40<br>Hz, 50 Hz,<br>100 Hz, 150 Hz, 300 Hz,<br>500 Hz; |
| Notch Filter | 50/60 Hz | 60 Hz |
| Band Pass Filter | Not available | User selected combination of High Pass,<br>Low Pass and Notch Filter |
| Type CF | 0 -.5 Amps Class I | 0 -.8 Amps Class I |
| Operating Temp<br>range | 0 to 35° C (32/64 channel;) | 10-40° C |
| Temp<br>storage/transport | -15 to 50 C non- condensing | 20-65° C per ISTA 2A<br>2008 |
| Humidity<br>Operating | 95% at 35 C non- condensing | 30-75% non-condensing |
| Humidity<br>Transport/Storage | 95% at 35 C non- condensing | 20-85% per ISTA 2A<br>2008 |
| Patient Source | <10 uA | <10 uA |
| Item | Predicate Device GE CardioLab | Subject Device PURE EPTM |
| Patient Sink | <10 uA | <10 uA |
| Patient Sink (measured<br>at patient leads under<br>single fault<br>condition) | <50 uA | <50 uA |
| Chassis Leakage | <100uA | <100uA |
| Size | Height = 9.5 inches Depth = 13 inches<br>Width = 13 inches (32/64 channel<br>version) | Height = 16 inches Depth = 14.7<br>inches Width = 13 inches |
| Weight | 25 lbs<br>(32/64 channel version) | 38 lbs |

#### Substantial Equivalence Comparison

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#### Performance Testing / Safety and Effectiveness:

To verify that device design meets its functional and performance requirements, representative samples of the device underwent software, electrical, and mechanical testing in accordance with the following industry standards.

- ANSI/AAMI/IEC 62366-1:2015; Medical Devices Part 1: Application of Usability ● Engineering to Medical Devices.
- AAMI/ANSI/ISO 14971:2007/(R)2010 Medical devices -- Application of risk management to medical devices.
- IEC 60601-1-6: 2013, Medical Electrical Equipment Part 1-6: General Requirements ● For Basic Safety And Essential Performance - Collateral Standard: Usability
- AAMI/ANSI HE75: 2013, Human Factors Engineering - Design of Medical Devices..
- IEC 62304: 2015, Medical Device Software - Software Life Cycle Processes
- AAMI/ANSI ES60601-1: 2012 Medical Electrical Equipment Part 1: General ● Requirements For Basic Safety And Essential Performance
- AAMI/ANSI IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General ● Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
- Guidance for Industry and FDA Staff: ●
- Guidance for the Content of Premarket Submissions for Software Contained in o Medical Devices (Issued 5/11/2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical o Devices (Issued 10/2/2014)

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Summary of Clinical Tests:

Similar to the predicate, the subject of this premarket submission, PURE EPIM, did not require clinical studies to support substantial equivalence.

Conclusion:

PURE EPTM intended use, indication for use, anatomical sites, and fundamental technology is equivalent to those of the predicate device. Both devices acquire ECG and IC signals via instrument amplification. Both devices use A/D converters and send data to a host PC. Software, electrical safety, system performance testing and user validation demonstrates that the differences between the subject device and the predicate do not introduce any new questions of safety and effectiveness. The information demonstrates that the subject device is substantially equivalent to the predicate devices.