(448 days)
The Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect various arrhythmias and will measure ST elevation or depression. The system acts in both an automatic mode (tape analyzed without operator intervention) and in an interactive mode (operator can intervene and affect analysis).
The Pathfinder 700 Holter ECG analyzer is a high-speed Holter cassette analyzer capable of analyzing tapes recorded at 1.47 mm/second and 1.0 mm/second as well as solid-state recorders such as the Reynolds eRAM and the Braemar DL700. It is a successor to the Reynolds Pathfinder 3 analyzer, marketing of which has been approved by the FDA under 510 (k) number K871344. The unit features arrhythmia analysis, ST analysis, pacemaker beat deviation detection, and determination of beat types, in both an automatic and interactive mode. The system uses an icon-based, mousecontrolled, Graphical User Interface ("GUI"), visually similar to those found on the well-known Apple and Windows operating systems. Analysis is performed at 1000 times the recording speed, obtained by using parallel computations and a 188 megabyte random-access memory, in addition to a 1000 megabyte hard disk. Thus a 24 hours lible megabyte hard disk. Thus, a 24 hour Holter tape can be analyzed in approximately 1.5 minutes. A 486 motherboard is used to provide disk control and keyboard/mouse interfacing, while the analysis sections use parallel computing, based on the T400 and T425 transputers, a computer element which forms the basis of many parallel computing systems. Pathfinder system is mouse-controlled, and uses a cathoderay tube display and keyboard. The analysis is based on the Neilson principle or algorithm, which have been used on the previous Reynolds analyzers, and which have received in all approval. The backs and which have received 510(k) approval. The basic principles of the analysis are the same as those used previously by Reynolds; the new features of this system lie principally in its new electronic features, which have led to re-programming the equations and analysis principles.
The Reynolds Pathfinder 700 Holter Analyzer is a device designed to analyze ambulatory electrocardiograms (Holter tapes) for arrhythmias and ST segment deviations. The provided 510(k) summary focuses primarily on the device's technical specifications and comparison to predicate devices, rather than detailed performance metrics and a specific study design to prove acceptance criteria. Therefore, a comprehensive table of acceptance criteria and reported performance with exact numerical values is not explicitly available within this document.
However, based on the information provided, we can infer the general acceptance criteria and the type of evidence presented to support the device's performance.
1. Table of Acceptance Criteria and Reported Device Performance
Note: Specific numerical acceptance criteria and precise performance metrics are not explicitly stated in the 510(k) summary. The document describes the types of tests performed and the conclusion that the device meets safety and effectiveness standards comparable to predicate devices.
| Feature/Metric | Acceptance Criteria (Inferred) | Reported Device Performance (Inferred from Summary) |
|---|---|---|
| Safety | Compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards. | Meets requirements of IEC 950 1988 with amendments 1 and 2 and EN60590 1986 with amendments 1 and 2. Electromagnetic compatibility tests done to EN 55022 level B. Classified as office equipment. |
| Effectiveness | Arrhythmia Detection Accuracy: Comparable to, or better than, predicate devices (Pathfinder 3, DelMar 263, Zymed 1510) and performance on standardized test tapes (MIT and AHA). | Clinical tests compared Pathfinder 700 analysis with Pathfinder 3 and Marquette 8000 on standard AHA test tapes. The conclusion states the device "performs as well or better than the legally marketed devices." No specific accuracy percentages (e.g., sensitivity, specificity for various arrhythmias) are provided for the Pathfinder 700 or predicate devices in this summary. The analysis is based on the "Neilson principle or algorithm" which has received 510(k) approval in previous Reynolds analyzers. |
| ST Analysis Accuracy | Comparable to, or better than, predicate devices and performance on standardized test tapes. | Similar to arrhythmia detection, clinical tests implied comparison against predicate devices on standard AHA tapes. Conclusion: "performs as well or better than the legally marketed devices." |
| Speed/Efficiency | Faster analysis speed as an improvement over previous models. | Analyzes a 24-hour Holter tape in approximately 1.5 minutes (at 1000 times recording speed). This is a key improvement described. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions the use of "standard AHA test tapes" for clinical testing. It does not specify the number of AHA test tapes used.
- Data Provenance: The "standard AHA test tapes" are generally synthetic or well-characterized recordings used industry-wide for performance evaluation. Their specific country of origin or whether they represent retrospective or prospective patient data is not stated, but they are a standardized, known benchmark.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information on the number or qualifications of experts used to establish the ground truth for the "standard AHA test tapes." For standardized test tapes like AHA, the "ground truth" (i.e., known arrhythmias, ST changes) is inherent to the design and composition of the tape itself, often established through expert consensus at the time of their creation. It is unlikely that new experts were recruited specifically for this 510(k) submission to re-establish the ground truth of these pre-existing standard tapes.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1, none) is mentioned for the test set. Given that "standard AHA test tapes" were used, the ground truth is pre-defined within the tapes themselves, making re-adjudication by experts for each test typically unnecessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The study described compares the device's analysis (Pathfinder 700) to the analysis provided by predicate devices (Pathfinder 3, Marquette 8000) on standard test tapes. This is an algorithm-to-algorithm comparison, not a human reader comparison with or without AI assistance. Therefore, no effect size for human readers improving with AI vs. without AI assistance is reported.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The "clinical tests" described explicitly compare the "analysis of the Pathfinder 700" to the "analysis provided by a predicate device" and another system (Marquette 8000) using "standard AHA test tapes." This is a direct evaluation of the algorithm's performance without human intervention, specifically in its "automatic mode." The summary states the system can operate in both automatic (no operator intervention) and interactive modes, and the comparison with predicate devices on test tapes would primarily evaluate its automatic, standalone capabilities.
7. Type of Ground Truth Used
The ground truth used for the clinical tests was standardized test data (AHA test tapes). For these tapes, the presence, type, and timing of arrhythmias and ST changes are pre-defined and known, serving as the benchmark against which the device's analysis is compared.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set. It primarily discusses the device's hardware, software principles, and validation against predicate devices and standard tapes.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any training set was established. Given the age of the device (1995 submission), detailed information on machine learning model training (including training data specifics and ground truth establishment) might not have been a standard requirement or reported in the same way as for modern AI/ML submissions. The analysis is based on the "Neilson principle or algorithm" which was utilized in previous Reynolds analyzers, suggesting an established, possibly rule-based or empirically developed, analytical methodology rather than a purely data-driven machine learning approach that would necessitate a large, explicitly defined training set with ground truth.
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Reynolds Pathfinder 700 510(k) Summary Page Bl
Reynolds Medical Ltd. 510(k) Submission Pathfinder 700 Holter Analyzer
510 (k) Summary
JIL 1 5 1995
(a) Basic Data
(1) Submitter Information
Name: Reynolds Medical Ltd. Address: 1-2 Harforde Court, John Tate Road, Hertford, Herts, SG13 7NW, England Contact Person: Dr. George Myers, 201-438-2310 Date Prepared: April 1, 1995
(2) Names of Device
Proprietary Name: Pathfinder 700 Holter Analyzer Common/Usual Name: Holter analyzer Classification Name: Arrhythmia Detector and Alarm
(3) Predicate Devices:
The principal predicate device is the Reynolds Pathfinder 3, which received marketing permission from the FDA under K871344 on October 20, 1987.1 The principal modification of the Pathfinder 700 is the use of modern, high-speed, digital technology.
Other predicate devices are the DelMar 263 (a PC-based analyzer, and the Zymed 1510 (also a stand-alone analyzer). Comparisons of the Pathfinder to these devices are in the Comparison section.
(4) Description of the Device
I. Introduction
The Pathfinder 700 Holter ECG analyzer is a high-speed Holter cassette analyzer capable of analyzing tapes recorded at 1.47 mm/second and 1.0 mm/second as well as solid-state recorders such as the Reynolds eRAM and the Braemar DL700. It is a successor to the Reynolds Pathfinder 3 analyzer, marketing of which has been approved by the FDA under 510 (k) number K871344. The unit features arrhythmia analysis, ST analysis, pacemaker beat deviation detection, and determination of beat types, in both an automatic and interactive mode. The system uses an icon-based, mousecontrolled, Graphical User Interface ("GUI"), visually
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similar to those found on the well-known Apple and Windows operating systems. Analysis is performed at 1000 times the recording speed, obtained by using parallel computations and a 188 megabyte random-access memory, in addition to a 1000
megabyte hard disk. Thus a 24 hours lible megabyte hard disk. Thus, a 24 hour Holter tape can be analyzed in approximately 1.5 minutes. A 486 motherboard is used to provide disk control and keyboard/mouse interfacing, while the analysis sections use parallel computing, based on the T400 and T425 transputers, a computer element which forms the basis of many parallel computing systems. Pathfinder system is mouse-controlled, and uses a cathoderay tube display and keyboard. The analysis is based on the Neilson principle or algorithm, which have been used on the previous Reynolds analyzers, and which have received in all
approval. The backs and which have received 510(k) approval. The basic principles of the analysis are the same as those used previously by Reynolds; the new features of this system lie principally in its new electronic features, which have led to re-programming the equations and analysis principles.
II. Description of System
Physically, the analyzer computer is in a "tower" cabinet, to which are connected the keyboard, the mouse, the cathode-ray tube display, a laser printer. The tape reader is an integral part of the cabinet.
An optical disk accessory for archival storage is also offered. This option, which must be installed by Reynolds personnel, plays no role in the analysis or the operation of the program as is the solid state recorder interface.
The heart of the system, responsible for all Holter analysis, is the transputer data processing components. The transputer network communicates to peripherals by means of a 486 motherboard which gives it access to the hard disk and the keyboard. The tape reader, 188 megabyte RAM memory, video display, and laser printer communicate directly with the transputer components. The 486 motherboard boots the transputer network (including loading the individual RAMs with program) and then acts as a slave input/output processor for the keyboard, disk, mouse, and network It also monitors the "error" line from services. the transputer hardware and resets it if an error occurs. Network options are also available for archival storage.
The basic element of the parallel computer system is the transputer (derived from TRANSistor and comPUTER). The Pathfinder 700 uses mainly the 1400 and T425 transputers (27 ın all). Each of these devices have the basic capacity of
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Reynolds Pathfinder 700 510(k) Summary Page B3
two INTEL 80386 chips (20 MHz), and each has internal memory. Basically, the transputer is an independent computing element (with the power of a motherboard chip with memory) which has links to other transputers, each of which has its own memory for computation and programming. Thus, they can each carry on independent computations. In addition, the transputers have internal timing circuits.
While this overview cannot give a detailed description of how parallel computing works, the following presents the general idea for a Holter monitor. The tape or solid state reader transfers the electrocardiogram to RAM, and the data in RAM is immediately analyzed by the parallel system while the tape-reading process is going on. The criteria for the analysis are set by the user, as will be explained later. The ECG data is also displayed and (if desired) printed and stored on disk. The results of the analysis are also stored in results storage (RAM), displayed, and printed and/or stored on disk. The mode of display can be selected by the user. However, since the entire operation of (tape reading > analysis > storage) takes only 90 seconds, the user is in general unaware of this underlying process. If the user has selected the "Automatic" mode, the results display and print-out can proceed after the 90 seconds. If "Interactive" mode is desired, the screens start showing intermediate results very rapidly, but the user is basically unaware of the fact that the entire analysis has probably already been completed.
III. General Program Flow
This section will present a brief description of the general program flow as seen by the operator. Note that this section does not describe the actual internal workings of the analyzer.
When the power is turned on after a boot period, the operator first sees a "basic display screen."
The basic display screen has a menu bar at the top, a representation of the ECG section currently being analyzed in the center, and an expanded section of the ECG at the bottom. This expanded ECG is in a rectangle called the "Highlight Box," and is used for selecting segments of the ECG during interactive analysis. The analysis criteria, scale factors, etc., can be changed by the operator, as explained in the instruction manual. The section marked "mouse buttons" shows the functions of the buttons on the mouse, which may change during various parts of the analysis.
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Reynolds Pathfinder 700 510(k) Summary Page B4
The first menu to be selected would be "Start Analysis," which resets all adjustable parameters to "powerup" status and clears the memories, including patient details. The parameters can then be changed by means of "Control Analysis," which sets various values to be used in the analysis: for example, sensitivity, criteria for various tests, the number of channels on the tape, and whether automatic or interactive analysis is desired. This can only be set through "START ANALYSIS." Since parameters are rarely changed for different patients, the values of these parameters may be stored so that they become the "power-up" parameters. However, parameters can be changed after starting the tape and the initial analysis with only a slight loss in time, since the procedure is so rapid. In interactive analysis, the operator is presented with each event or complex (as selected by the operator) in the sequence indicated, accompanied by the diagnosis performed by the analysis. The operator then has the choice of accepting or changing these diagnoses. The operator can always enter interactive analysis at any time. If the criteria are not to be changed for succeeding tapes, the set-up can be saved to disk and it will be unnecessary to enter this menu for succeeding tapes.
The "Display Menu" controls the nature of the various displays as the analysis proceeds. For an automatic analysis, these displays are unnecessary, but for an interactive analysis, the operator can regulate the displays to facilitate the interactive process.
When "Start Analysis" is selected, menus appear to set up the particular analysis to be performed, including the type of recorder, the analysis type (automatic or interactive), options for printing the report, and the start time of the analysis. "Analyze" starts the analysis itself.
The analysis performed is the same for "automatic" and "interactive" modes, and, as noted above, the analysis is completed in about 90 seconds. In automatic mode, the report prints the first analysis "as is." In interactive mode, the operator can either change the classifications o I arrhythmias proposed by the analysis algorithm, or can define new morphologies to be identified by the system.
The "Recorder Type" menu lists a large number of the most common recorders, as well as "generic" recorders. The system will automatically adjust to the recording speed of the recorder selected (1.0 mm/sec., 1.47 mm./sec or others) from the menu, as well as special formats which may be used.
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Reynolds Pathfinder 700 510(k) Summary Page B5
After the analysis, the "Report" menu can be used to control whether the report is printed or stored, its language (English or other), its format, the sequence of the events in the report, and the sections to be included. Again, if all tapes are to have the same report choices, this section does not have to be changed for each analysis.
The overall flow is the following: After the initial selection of parameters and options, the system enters either automatic or interactive analysis. These analyses have an arrhythmia section, and an ST section. The ST section is optional, but the arrhythmia detection must always be selected. The unit then continues with the analyses, which are explained in more detail in the software section.
In operation, the tape reader supplies data to the Data Extraction unit, which also provides EMG (muscle noise) filtering. The data is then put into an ECG database. There are two identical channels for each channel of recorded data, plus a third channel to read the pacemaker channel. The data first goes through a "filter chain" to smooth the data, and then goes to a unit which determines the "trigger" position (where the unit "triggers" on a complex and a shape classification processor. The outputs are then combined and the arrhythmias are classified. The results go to the graphical interface for display. The Video Display Control is the path by which the user makes modifications in interactive analysis. The 486 motherboard is under the control of the DOS operating system. There is no "operating system" as such for the transputers.
(5) Intended Use
The Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect various arrhythmias and will measure ST elevation or depression. The system acts in both an automatic mode (tape analyzed without operator intervention) and in an interactive mode (operator can intervene and affect analysis).
(6) Comparison with Predicate Devices
The Pathfinder 700 is substantially equivalent to the Reynolds Pathfinder 3, the DelMar 263, and the Zymed 1510, as noted previously.
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Reynolds Pathfinder 700 510(k) Summary Page B6
(b) Performance Data
The Pathfinder 700 has been tested in comparison with the predicate devices, and also with standardized MIT and AHA tapes.
(1) Non-clinical tests
The Pathfinder 700 has been tested by independent laboratories, and it meets the requirements of IEC 950 1988 with amendments 1 and 2 and EN60590 1986 with amendments 1 and 2. Since the device is not patient connected, it is classed as office equipment. Electromagnetic compatibility tests have been done to EN 55022 level B.
These analyzers are now manufactured for sale in the United Kingdom and sold in more than ten countries around the world. The system has also received a French homologation.
The software has undergone extensive validation testing. The tests and results are in the Software section.
(2) Clinical Tests
The system has undergone a clinical test in which the analysis of the Pathfinder 700 has been compared to the analysis provided by a predicate device, the Pathfinder 3, and the Marquette 8000. In this test, the units under test analyzed standard AHA test tapes.
(3) Conclusion
The conclusions drawn from the non-clinical and clinical tests demonstrate that the device is as safe and effective, and performs as well or better than the legally marketed devices identified in paragraph (a) (3) .
§ 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).