(98 days)
The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures.
The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.
The EP-TRACER is comprised of these major components:
EP-TRACER hardware – Amplifier/stimulator
EP-TRACER Software – Software pre-installed
This document describes the EP-TRACER System V2.2, an electrophysiology measurement system. The FDA 510(k) clearance (K183266) states its substantial equivalence to the predicate device, EP-TRACER System V2.0 (K161245). This submission primarily focuses on software modifications affecting the user interface, with no changes to the hardware.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a quantitative, measurable format like sensitivity/specificity thresholds for a diagnostic device. Instead, the "acceptance criteria" for this submission are implicitly defined by demonstrating that the modifications to the device (V2.2 compared to V2.0) do not adversely affect safety and effectiveness and that the device conforms to relevant harmonized standards.
The "device performance" is therefore described by showing that the new device (V2.2) maintains the same fundamental technological characteristics and meets all applicable standards as the predicate device (V2.0).
| Characteristic / Acceptance Criteria Type | Predicate Device EP-TRACER V2.0 Performance (Implicit Acceptance Baseline) | New Device EP-TRACER V2.2 Performance (Reported) | Met? |
|---|---|---|---|
| Hardware Components | Same as listed in "Technological Characteristics" table | Same | Yes |
| Amplifier Dimensions | 38 channels: 28x27x7 cm; 70/102 channels: 28x27x12 cm | Same | Yes |
| Environmental Specs (Temp, Humidity) | Operating: +10°C to +30°C, 20-80% rH; Storage: -29°C to +66°C, <95% rH | Same | Yes |
| Power Specs (Input, Requirements) | 100-240 V AC, 50-60 Hz; specific V/A for channels | Same | Yes |
| Design (Sampling Rate, CMRR, Impedance, Leakage, Filters, Gain, Dynamic Range, Baseline Correct.) | 1 kHz, >100 dB, 20 MΩ, <10 μA patient, <100 μA chassis, various filters, etc. | Same | Yes |
| Stimulator Specs (Pulse Amplitude/Duration, ISI, etc.) | Specific ranges and accuracies as listed in table | Same | Yes |
| Pacing Channels (Isolated, Isolation) | 2 isolated channels, IEC 60601-1 compliant | Same | Yes |
| Computer Controlled Stimulus Pulses | Ranges and accuracies for current, pulse duration, load impedance, etc. | Same | Yes |
| Programmed Protocols | BASIC 1, 2, 3; ACUTE, Multi-Sx, Pace, etc. | Same | Yes |
| Programmed Protocol Key | 10 | Same | Yes |
| Number of Extra-Stimuli | 5 (S2 - S6) | Same | Yes |
| Sensing (ECG Sync) | Internal from surface/intracardiac, trigger lockup, ECG delay | Same | Yes |
| Backup Stimulation | Use external backup stimulator | Same | Yes |
| Compliance with Standards | EN ISO 13485:2012, EN ISO 14971:2012, EN 60601-x series, EN 10993-1, etc. | Conformance demonstrated | Yes |
| Software User Interface (New) | |||
| Pressure mode display | Full-screen only | Full-screen and "minimized" display | N/A |
| Calipers | Horizontal only | Horizontal and vertical | N/A |
| Eport Generation | Limited format transfer | Customizable, preconfigured template transfer | N/A |
| Clock | Real-time clock | Real-time clock + procedure clock | N/A |
| New Icons | No (keystrokes for these functions) | Yes (for split-screens, pressure mode, stimulator settings, add comment/mark, screenshot, toggle stimulator windows) | N/A |
| Software Compatibility | Windows 7 (32 bit) | Windows 7 (64 bit) and (32 bit) | N/A |
| Overall Safety and Effectiveness | No adverse effects from modifications due to V&V activities. | Yes | Yes |
N/A for "Met?" column for new software features as they are additions/improvements, not criteria to be met against a baseline.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a clinical study with patients or data from a test set in the traditional sense of evaluating diagnostic accuracy. This submission is for an electrophysiology measurement system, with the current iteration (V2.2) involving only software modifications to the user interface. The performance testing primarily focused on demonstrating conformity to harmonized standards and verifying that the software changes did not negatively impact the device's safety and effectiveness.
Therefore, there is no specific mention of a "test set" sample size or data provenance (country of origin, retrospective/prospective) related to patient data or clinical outcomes. The evaluation is based on engineering verification and validation activities against the pre-existing design specifications and regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
Given that this is a modification to an electrophysiology measurement system focusing on user interface changes and compliance with standards, there is no indication of "experts" being used to establish ground truth for a test set in a diagnostic or clinical performance context. The "ground truth" here would relate to the correct functioning of the system's electrical measurements and stimulation based on engineering specifications and adherence to standards, likely assessed by qualified engineers and domain experts internal to the manufacturer.
4. Adjudication Method for the Test Set
As there is no described "test set" involving human interpretation or clinical data requiring ground truth establishment, there is no mention of an adjudication method.
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
No MRMC comparative effectiveness study was mentioned or performed. This device is an electrophysiology measurement system, not an AI-assisted diagnostic tool for image interpretation or similar. The "user interface convenience features" are productivity enhancements rather than AI-driven diagnostic assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The EP-TRACER System is an electrophysiology measurement system used by human operators (clinicians) for acquiring, displaying, and recording signals and performing diagnostic cardiac stimulation. It is not an algorithm designed to perform a standalone diagnostic task without human intervention. The software updates are improvements to the human-machine interface.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this submission, the "ground truth" essentially refers to:
- The engineering specifications of the device (e.g., accuracy of pulse amplitude, sampling rate, filter characteristics).
- Compliance with harmonized standards (e.g., electrical safety, EMC, usability).
- The predicate device (EP-TRACER V2.0) as a baseline for safety and effectiveness of the core functionality.
The performance testing (verification and validation) demonstrated that the updated software met predetermined design and performance specifications and that modifications did not adversely affect the safety and effectiveness compared to the predicate.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of machine learning or AI, as this submission doesn't describe an AI/ML algorithm being developed or deployed. The software modifications are user interface improvements.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm mentioned.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 1, 2019
Schwarzer CardioTek GmbH % Melissa Walker President and Chief Technology Officer Graematter, Inc. 1324 Clarkson Clayton Ctr., #332 Ballwin, Missouri 63011
Re: K183266
Trade/Device Name: EP-TRACER System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: February 4, 2019 Received: February 4, 2019
Dear Melissa Walker:
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,
Mude Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K183266
Device Name EP-TRACER System
Indications for Use (Describe)
The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures.
The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
EP TRACER Summary
| Submitter'sinformation | Contact: Tatjana NuberSchwarzer CardioTek GmbHIm Zukunftspark 374076 Heilbronn / Germany | Contact: Melissa WalkerGraematter, Inc.1324 Clarkson Clayton Ctr #332Ballwin, MO 63011Phone: 636-405-7498Date: 28 Feb 2019 |
|---|---|---|
| Device/classificationname | Device Name:The EP-TRACER is a Class 2 device (product code DQK). | |
| Classification/Common name:• Programmable diagnostic computer, 21 CFR §870.1425. | ||
| The marketed device(s) to which substantial equivalence is claimed:• EP-TRACER System, K161245. | ||
| Devicedescription | The EP-TRACER system is a computerized electrophysiology measurementsystem designed for both regular and experimental EP studies.The EP-TRACER is comprised of these major components:EP-TRACER hardware – Amplifier/stimulator EP-TRACER Software – Software pre-installed | |
| Indications foruse | "The EP-TRACER System is an electrophysiology measurement system used toacquire, filter, digitize, amplify, display, and record signals obtained duringelectrophysiological studies and related procedures."The system allows the user to monitor, display and record the signals. Thesystem incorporates a stimulator intended to be used for diagnostic cardiacstimulation during electrophysiological testing of the heart". | |
| Continued on next page |
{4}------------------------------------------------
510(k) Summary per 21CFR §807.92, Continued
Technological The table below lists the technological characteristics for both the new and characteristics predicate devices. Modifications to the EP TRACER for V2.2 are limited to user interface modifications.
| Device Characteristic | Predicate Device EP-TRACER V2.0 | New Device EP-TRACER V2.2 |
|---|---|---|
| Amplifier Dimensions (withintegrated stimulator) WxDxH | 38 channels: 28x27x7 in cm70/102 channels: 28x27x12 in cm | Same |
| Environmental Specifications | ||
| Temperature Operating | +10°C to +30°C | Same |
| Temperature Transport/Storage | -29°C to +66°C | Same |
| Humidity Operating | 20 - 80 % rH (non-condensing) | Same |
| Humidity Transport/Storage | < 95 % rH (non-condensing) | Same |
| Power Specifications | ||
| Power Requirements | 100 - 240 V AC,50 - 60 Hz | Same |
| Power Input | 38 channels:+5 V, 0.3 A & +12 V, 0.9 A | Same |
| 70 channels:+5 V, 0.3 A & +12 V, 1.5 A | ||
| 102 channels:+5 V, 0.3 A & +12 V, 2 A | ||
| Design | ||
| Sampling and Hold | Each channel sampled prior theacquisition | Same |
| Sampling Rate | 1 kHz | Same |
| CMRR | > 100 dB | Same |
| Input Impedance | Typical 20 ΜΩ | Same |
| Leakage Current | ||
| Patient Source | < 10 μΑ | Same |
| Patient Sink | < 10 μΑ | Same |
| Patient Sink (measured at patientleads under single faultconditions) | < 50 μΑ | Same |
| Chassis Leakage | < 100 μΑ | Same |
| ECG Input | ||
| Outputs | 12 lead ECG produced | Same |
| High Pass Filter | 0.05 Hz, 0.2 Hz | Same |
| Low Pass Filter | 150 Hz | Same |
| RF Filtering | All inputs | Same |
| Gain | Between 0 and 255 mm/mV -continuous | Same |
| Saturation Recovery | < 1 sec (manual reset) | Same |
| Notch Filter | Power line (50/60 Hz) | Same |
| Device Characteristic | Predicate Device EP-TRACER V2.0 | New Device EP-TRACER V2.2 |
| Dynamic Range | ±5 mV | Same |
| Baseline Correction | ±300 mV | Same |
| Input/ Output | ||
| Inputs 32/38 channels | 20 intracardiac channels, 6 auxiliarychannels, 12 ECG channels | Same |
| Inputs 64/70 channels | 52 intracardiac channels, 6 auxiliarychannels, 12 ECG channels | Same |
| Inputs 102 channels | 84 intracardiac channels, 6 auxiliary(pressure) channels, 12 ECG channels | Same |
| Outputs | No outputs | Same |
| Switching | Each channel can be either bipolar orunipolar with manual switching | Same |
| High Pass Filter | 0.05 Hz, 0.2 Hz, 40 Hz, 80 Hz | Same |
| Low Pass Filter | 350 Hz | Same |
| RF Filtering | All inputs | Same |
| Gain | Between 0 and 255 mm/mV -continuous | Same |
| Saturation Recovery | < 1 s (manual reset) | Same |
| Notch Filter | Power line (50/60 Hz) | Same |
| Dynamic Range | ±5 mV | Same |
| Baseline Correction | ±300 mV | Same |
| Stimulator (integrated into device) | ||
| Isolated Stimulus Channels | 2 | Same |
| Pulse Amplitude | ||
| Range | 0 - 25.5 mA into 1000 Ω load | Same |
| Increment | 0.1 ms | Same |
| Accuracy | ±0.15 ms | Same |
| Pulse Duration | ||
| Range | 0.1 - 9.9 ms | Same |
| Increment | 0.1 ms | Same |
| Accuracy | ±0.15 ms | Same |
| Inter-Stimulus Interval (ISI) | ||
| Range | 10 - 9999 ms | Same |
| Range (Burst) | 10 - 9999 ms | Same |
| Increment | 10 ms | Same |
| Sequential Delay (AV) | ||
| Range | 11 - 250 ms | Same |
| Increment | 1 ms | Same |
| Programmed Protocols | Preprogrammed protocols:BASIC 1 (induction)BASIC 2 (termination)BASIC 3 (backup)ACUTEMulti-Sx | Same |
| Device Characteristic | Predicate Device EP-TRACER V2.0 | New Device EP-TRACER V2.2 |
| Programmed Protocols | PaceAutomatic modeWenkebach modeUser defined protocols | Same |
| Programmable Protocol Key | 10 | Same |
| Number of Extra-Stimuli | 5 (S2 - S6) | Same |
| Sensing (ECG Synchronization) | ||
| Automatic or Manual TriggerSetting - Sensitivity | Internal from any surface or intra-cardiac channel | Same |
| Automatic or Manual TriggerSetting - Trigger lockup(refractory time) | 5 - 5000 ms | Same |
| Automatic or Manual TriggerSetting - ECG Delay | 5 - 5000 ms | Same |
| Additional Outputs | No | Same |
| Power Source | Integrated with amplifier38 channels:+5 V, 0.3 A & +12 V, 0.9 A70 channels:+5 V, 0.3 A & +12 V, 1.5 A102 channels:+5 V, 0.3 A & +12 V, 2 A | Same |
| Pacing Channels | ||
| Isolated Channels | (i) atrial and(ii) ventricular and(iii) emergency fixed pace output toatrium and ventricle | Same |
| Circuit Isolation | Compliant with IEC 60601-1, Type CF,5 kV, common & differential mode | Same |
| Computer Controlled Stimulus Pulses | ||
| Current | 0 - 25.5 mA into 1000 Ω load | Same |
| Current Steps | 0.1 mA | Same |
| Accuracy | ±0.1 mA | Same |
| Pulse duration | Pulse width 0.1 - 9.9 ms, steps of 0.1ms | Same |
| Accuracy | ±0.1 mA | Same |
| Load Impedance | 1000 Ω | Same |
| Max. Output Voltage | 25 V | Same |
| Inter-Stimulus Intervals | ||
| S1 Range | 10 - 9999 ms | Same |
| Stability | Quartz computer clock, ±30 parts permillion at +25°C | Same |
| Extra-Stimuli | 5 (S2 - S6) | Same |
| Coupling Interval | 30 - 9990 ms | Same |
| Accuracy | ±10 ms | Same |
| Protocol Automation | ||
| Auto decrement/increment | Yes | Same |
| Device Characteristic | Predicate Device EP-TRACER V2.0 | New Device EP-TRACER V2.2 |
| Backup Manually ControlledStimulation | Use external backup stimulator | Same |
| Emergency Backup Pacing | Use external backup stimulator | Same |
| Compliance with Standards | ||
| Standards | EN 60601-1EN 60601-1-2 | Same |
| Device Directive | European Union Medical DeviceDirective (CE Marked) | Same |
| Environmental/ Electrical Specifications | ||
| Operating Temperature | +10°C to +30°C | Same |
| Storage Temperature | -29°C to +66°C | Same |
| Operating Humidity | 20 - 80 % rH (non-condensing) | Same |
| Storage Humidity | < 95 % rH (non-condensing) | Same |
| Max. Current Draw | 15 A/115 V, 7 A/230 V | Same |
| Chassis Leakage Current | < 100 μΑ | Same |
| Advanced Features | ||
| Display Ablation Parameters | Connection to RF ablationgenerator(s) | Same |
| Certification | ||
| MDD Device Class | Class IIb | Same |
| IEC 60601-1 | Certified | Same |
| EMC Compliance | Certified | Same |
| CE Marking | Certified CE 0197 | Same |
| US Regulations | K161245 | Current submission |
| System Dimensions | ||
| W x D x H | Customer OptionMobile Cart: 100x80x170 cmMobile Desk: 125x80x150 cmControl Desk: customer definedLaptop: customer defined | Same |
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
Continued on next page
{8}------------------------------------------------
510(k) Summary per 21CFR §807.92, Continued
Software – user The EP TRACER V2.2 included software modifications affecting the user interface interface including improvements in the display and organization of the convenience system's outputs. There were no modifications to the hardware of the new features added device.
The table below shows the software differences between the EP-TRACER V2.2 vs. the predicate device EP-TRACER V2.0.
| Device Characteristic | Predicate DeviceEP-TRACER V2.0 | New DeviceEP-TRACER V2.2 |
|---|---|---|
| User Interface Convenience Features | ||
| Pressure mode display | Pressure data is displayed in afull-screen window which isseparate from the main tracedisplay window. | In addition to the full-screenpressure mode available in V2.0,pressure channels can bedisplayed in a “minimized”pressure mode display withinthe main trace display window. |
| Calipers | Horizontal calipers can bedisplayed | Both horizontal and verticalcalipers can be displayed |
| One-click report generation | Enables transfer of proceduraldata in a limited format | Enables transfer of proceduraldata to a customizable,preconfigured template. |
| Clock | Real-time clock | Added a procedure clock,displaying procedure time. |
| New Icons | ||
| Split-screens | Executed with keystrokes | Icon added for existing feature |
| Pressure mode | Only one pressure mode display | Toggles between full-screen andminimized pressure modedisplay |
| Stimulator power settings | Executed with keystrokes | Icon added for existing feature |
| Add comment | Executed with keystrokes | Icon added for existing feature |
| Add mark | Executed with keystrokes | Icon added for existing feature |
| Take screenshot | Executed with keystrokes | Icon added for existing feature |
| Toggle stimulator protocol/parameters windows | Executed with keystrokes | Icon added for existing feature |
| Software compatibility | ||
| Operating system | Windows 7 (32 bit) | Windows 7 (64 bit) andWindows 7 (32 bit) |
Continued on next page
{9}------------------------------------------------
510(k) Summary per 21CFR §807.92, Continued
| Performancetesting | Completion of all verification and validation activities demonstrated that thesubject devices meet their predetermined design and performancespecifications. Verification activities performed confirmed that themodifications to the predicate device did not adversely affect the safety andeffectiveness of the modified device. |
|---|---|
| Testing for the EP-Tracer V 2.2 shows conformance to the followingharmonized standards:• EN ISO 13485:2012• EN ISO 14971:2012• EN 60601-1:2006+A1: 2013• EN 60601-1-2:2007+ AC: 2010• EN 60601-1-6:2010• EN 60601-2-27:2006• EN 60601-2-34:2011• EN 10993-1:2009• EN 980:2008• EN 1041:2008• EN 62366: 2008• EN 62304: 2006 | |
| Conclusion | Both the subject and predicate devices have the same intended use,indications for use, and operate using the same fundamental scientifictechnology. |
Based on the technical characteristics and the results of the performance testing, the EP TRACER V2.2 is substantially equivalent to V2.0.
§ 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).