(133 days)
K130626 GE Healthcare; CardioLab
Not Found
No
The summary describes a system for acquiring, displaying, and processing physiological signals with standard filtering options. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is described as a computerized system for acquiring, digitizing, filtering, measuring, calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for diagnostic purposes, not for providing direct therapy.
Yes
The device is intended for "acquiring, digitizing, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures," and "healthcare practitioners who are responsible for interpreting the data." This process of collecting and processing physiological data for interpretation to understand a patient's condition falls under the definition of a diagnostic device.
No
The device description explicitly states that the system consists of two main parts: an amplifier (hardware with embedded software) and a personal computer (PC) with preinstalled software. The amplifier is a physical component that acquires signals from the patient.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
- PURE EP™ Function: The PURE EP™ system acquires and processes electrical signals directly from the patient's heart (both externally via ECG and internally via intracardiac catheters). This is a form of in vivo (within the living body) measurement, not in vitro testing of specimens.
The description clearly states it acquires "electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures." This is a direct measurement of physiological activity within the patient's body.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DOK, DQK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiac signals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed healthcare practitioners who are responsible for interpreting the data.
EP laboratory
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)
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 Medical Devices (Issued 5/11/2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Issued 10/2/2014)
Similar to the predicate, the subject of this premarket submission, PURE EP™, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K130626 GE Healthcare; CardioLab
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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510(k) Summary K180805
Table 1: 510(k) Summary
| Submitter: | Biosig Technologies, Inc.
12424 Wilshire Blvd, Suite 745
Los Angeles, CA 90025 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiffini Diage
Regulatory Affairs Consultant
Phone: 707.799.6732
E-mail: tdiage@raechelon.com |
| 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:
• 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 | ||
| Indications for Use (IFU) | CardioLab System is intended for the | |
| acquiring, filtering, digitizing, simplifying, | ||
| measuring and calculating, displaying, | ||
| recording and monitoring of clinical data | ||
| from adult and pediatric patients. | ||
| CardioLab System is configurable. Clinical | ||
| data includes: ECG waveforms, | ||
| intracardiac signals, stimulus data, ablation | ||
| data, pulse oximetry (SpO2), respiration | ||
| rate, CO2 (EtCO2), | ||
| temperature, and invasive and noninvasive | ||
| blood pressure. Physiological parameters | ||
| such as diastolic, systolic, mean pressure, | ||
| heart rate, and cycle length are derived | ||
| form the signal data, displayed, and | ||
| recorded. The data is entered manually or | ||
| acquired via interfaced devices and/or | ||
| information systems and may be used for | ||
| report | ||
| generation. | 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. | ||
| Target Population | Clinical data from adult and pediatric | |
| patients. | Patients undergoing EP studies in an EP | |
| lab. | ||
| Anatomical Site | Multiple, including cardiac signals | Cardiac signals |
| Where used | Multiple hospital and clinical settings | |
| including EP labs | EP labs | |
| Energy | ||
| Used/Delivered | No energy delivered to patient | No energy delivered to patient |
| Processor/Data | ||
| Storage | Intel Pentium IV Xeon or greater | |
| processor | ||
| 512 MB of Ram | ||
| 2 x 40 GB hard drives | ||
| OS: Windows XP Professional | Intel i7 quad-core CPU | |
| 16 GB of Ram | ||
| 1 TB | ||
| OS: Windows 7 | ||
| Item | Predicate Device GE CardioLab | Subject Device PURE EPTM |
| Number of Channels | 32/64 | |
| 96/128 | Up to 64 | |
| Sampling Rate | 2000 samples per second | 2000 samples per second |
| Analog to Digital | ||
| Converter | 12 bit | 24 bit |
| Outputs | 12 lead ECG | Same |
| RF Filtering | All inputs | Same |
| Bandwidth | 0.05-1000 Hz | Same |
| ECG high pass | ||
| filter | 0.05 Hz, 0.5 Hz, 5.0 Hz | Software programmable at: 0.05 Hz, 0.5 |
| Hz, 1.0 | ||
| Hz, 5.0 Hz, 20 Hz, 30 Hz, | ||
| 50 Hz, 200 Hz | ||
| ECG low pass filter | 100 Hz | Software programmable at: 30 Hz, 40 |
| Hz, 50 Hz, | ||
| 100 Hz, 150 Hz, 300 Hz, | ||
| 500 Hz; | ||
| IC high pass filter | 0.05 Hz, 0.5 Hz, 5.0 Hz, 30 | |
| Hz, 100 Hz | Software programmable 0.05 Hz, 0.5 Hz, | |
| 1.0 Hz, | ||
| 5.0 Hz, 20 Hz, 30 Hz, 50 | ||
| Hz, 200 Hz | ||
| IC low pass filter | 150 Hz, 500 Hz, 1000 Hz; | Software programmable at: 30 Hz, 40 |
| Hz, 50 Hz, | ||
| 100 Hz, 150 Hz, 300 Hz, | ||
| 500 Hz; | ||
| Notch Filter | 50/60 Hz | 60 Hz |
| Band Pass Filter | Not available | User selected combination of High Pass, |
| Low Pass and Notch Filter | ||
| Type CF | 0 -.5 Amps Class I | 0 -.8 Amps Class I |
| Operating Temp | ||
| range | 0 to 35° C (32/64 channel;) | 10-40° C |
| Temp | ||
| storage/transport | -15 to 50 C non- condensing | 20-65° C per ISTA 2A |
| 2008 | ||
| Humidity | ||
| Operating | 95% at 35 C non- condensing | 30-75% non-condensing |
| Humidity | ||
| Transport/Storage | 95% at 35 C non- condensing | 20-85% per ISTA 2A |
| 2008 | ||
| Patient Source |