(133 days)
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 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.
The provided text describes the PURE EP™ system, a computerized system for acquiring, digitizing, filtering, measuring, calculating, displaying, recording, and storing electrocardiographic and intracardiac signals during electrophysiology (EP) procedures. The document does not contain specific acceptance criteria for device performance, nor does it detail a clinical study proving the device meets such criteria in terms of diagnostic accuracy or equivalent clinical outcomes.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (GE Healthcare's CardioLab) through engineering and safety testing, rather than a statistical study against a specific performance benchmark.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy). The "Performance Testing" section lists compliance with a variety of industry standards for software, electrical, and mechanical testing, which implies that the device achieved performance within the specified limits of those standards. However, these are general safety and engineering standards, not specific performance criteria for signal interpretation accuracy.
| Performance Aspect | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Functional/Performance Requirements | Device design meets its functional and performance requirements as verified through software, electrical, and mechanical testing in accordance with industry standards. | Representative samples underwent software, electrical, and mechanical testing in accordance with listed industry standards (e.g., ANSI/AAMI/IEC 62366-1, AAMI/ANSI/ISO 14971, IEC 60601-1-6, AAMI/ANSI HE75, IEC 62304, AAMI/ANSI ES60601-1, AAMI/ANSI IEC 60601-1-2). User validation was also performed. |
| Electrical Safety | Compliance with AAMI/ANSI ES60601-1: 2012. Patient Source: <10 uA; Patient Sink: <10 uA; Patient Sink (single fault): <50 uA; Chassis Leakage: <100 uA. | The device meets these electrical safety standards (listed with values identical to the predicate). |
| Electromagnetic Compatibility (EMC) | Compliance with AAMI/ANSI IEC 60601-1-2:2014. | Device underwent testing to ensure electromagnetic compatibility. |
| Usability | Compliance with ANSI/AAMI/IEC 62366-1:2015 and IEC 60601-1-6: 2013 and AAMI/ANSI HE75: 2013. | Device underwent usability engineering and human factors testing. |
| Software Life Cycle | Compliance with IEC 62304: 2015. | Software development followed life cycle processes specified by the standard. |
| Risk Management | Compliance with AAMI/ANSI/ISO 14971:2007/(R)2010. | Risk management principles were applied during development. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Similar to the predicate, the subject of this premarket submission, PURE EPIM, did not require clinical studies to support substantial equivalence." This indicates no clinical test set was used for a study proving device performance on patient data against specific performance criteria. The testing was focused on engineering, safety, and functional parameters.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical studies were performed to establish performance on patient data, no experts were used to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set was used, there was no adjudication method applied.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, as the device's function is for acquiring, digitizing, filtering, measuring, calculating, displaying, recording, and storing signals, not for providing interpretative AI assistance to human readers. It's a data acquisition and processing system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is fundamentally a data acquisition and display system. It's not an "algorithm" in the sense of providing automated diagnostic insights independently. Its function is to present data to healthcare practitioners for their interpretation. Therefore, a "standalone algorithm only" performance study in a diagnostic context is not applicable to this device as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the engineering and safety performance tests, the "ground truth" would be the expected output or behavior as defined by the engineering specifications and industry standards. For example, signal amplification accuracy would be judged against a known input signal and the device's specified gain. However, for a clinical diagnostic "ground truth," none was used as no clinical-diagnostic performance study was conducted.
8. The sample size for the training set
Since no clinical studies for diagnostic performance were conducted, and the device functions as a data acquisition and processing system rather than an AI-driven diagnostic algorithm, there is no concept of a "training set" in the context of diagnostic accuracy. Training here would refer to the development and internal testing of the system by the manufacturer to ensure it meets its engineering specifications.
9. How the ground truth for the training set was established
As there was no clinical "training set" for diagnostic performance, this question is not applicable. The "ground truth" during the device's development (analogous to a training phase) would have been established through design specifications, simulated signals, and controlled laboratory testing to ensure the electrical and software components performed as designed.
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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 (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 745Los Angeles, CA 90025 |
|---|---|
| Contact Person: | Tiffini DiageRegulatory Affairs ConsultantPhone: 707.799.6732E-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 andIndications for Use (IFU) | CardioLab System is intended for theacquiring, filtering, digitizing, simplifying,measuring and calculating, displaying,recording and monitoring of clinical datafrom adult and pediatric patients.CardioLab System is configurable. Clinicaldata includes: ECG waveforms,intracardiac signals, stimulus data, ablationdata, pulse oximetry (SpO2), respirationrate, CO2 (EtCO2),temperature, and invasive and noninvasiveblood pressure. Physiological parameterssuch as diastolic, systolic, mean pressure,heart rate, and cycle length are derivedform the signal data, displayed, andrecorded. The data is entered manually oracquired via interfaced devices and/orinformation systems and may be used forreportgeneration. | PURE EP is a computerized systemintended for acquiring, digitizing,amplifying, filtering, measuring andcalculating, displaying, recording andstoring of electrocardiographic andintracardiac signals for patientsundergoing electrophysiology (EP)procedures in an EP laboratory under thesupervision of licensed healthcarepractitioners who are responsible forinterpreting the data. |
| Target Population | Clinical data from adult and pediatricpatients. | Patients undergoing EP studies in an EPlab. |
| Anatomical Site | Multiple, including cardiac signals | Cardiac signals |
| Where used | Multiple hospital and clinical settingsincluding EP labs | EP labs |
| EnergyUsed/Delivered | No energy delivered to patient | No energy delivered to patient |
| Processor/DataStorage | Intel Pentium IV Xeon or greaterprocessor512 MB of Ram2 x 40 GB hard drivesOS: Windows XP Professional | Intel i7 quad-core CPU16 GB of Ram1 TBOS: Windows 7 |
| Item | Predicate Device GE CardioLab | Subject Device PURE EPTM |
| Number of Channels | 32/6496/128 | Up to 64 |
| Sampling Rate | 2000 samples per second | 2000 samples per second |
| Analog to DigitalConverter | 12 bit | 24 bit |
| Outputs | 12 lead ECG | Same |
| RF Filtering | All inputs | Same |
| Bandwidth | 0.05-1000 Hz | Same |
| ECG high passfilter | 0.05 Hz, 0.5 Hz, 5.0 Hz | Software programmable at: 0.05 Hz, 0.5Hz, 1.0Hz, 5.0 Hz, 20 Hz, 30 Hz,50 Hz, 200 Hz |
| ECG low pass filter | 100 Hz | Software programmable at: 30 Hz, 40Hz, 50 Hz,100 Hz, 150 Hz, 300 Hz,500 Hz; |
| IC high pass filter | 0.05 Hz, 0.5 Hz, 5.0 Hz, 30Hz, 100 Hz | Software programmable 0.05 Hz, 0.5 Hz,1.0 Hz,5.0 Hz, 20 Hz, 30 Hz, 50Hz, 200 Hz |
| IC low pass filter | 150 Hz, 500 Hz, 1000 Hz; | Software programmable at: 30 Hz, 40Hz, 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 Temprange | 0 to 35° C (32/64 channel;) | 10-40° C |
| Tempstorage/transport | -15 to 50 C non- condensing | 20-65° C per ISTA 2A2008 |
| HumidityOperating | 95% at 35 C non- condensing | 30-75% non-condensing |
| HumidityTransport/Storage | 95% at 35 C non- condensing | 20-85% per ISTA 2A2008 |
| Patient Source | <10 uA | <10 uA |
| Item | Predicate Device GE CardioLab | Subject Device PURE EPTM |
| Patient Sink | <10 uA | <10 uA |
| Patient Sink (measuredat patient leads undersingle faultcondition) | <50 uA | <50 uA |
| Chassis Leakage | <100uA | <100uA |
| Size | Height = 9.5 inches Depth = 13 inchesWidth = 13 inches (32/64 channelversion) | Height = 16 inches Depth = 14.7inches Width = 13 inches |
| Weight | 25 lbs(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.
§ 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).