(90 days)
The Cambridge Heart Hi-Res TM ECG Electrode is intended for short term use to measure electrocardiogram signals at rest and during ECG stress testing with the CH 2000 Stress Test System and successor systems. This device is supplied non-sterile and is intended for one time use only.
The Cambridge Heart Hi-Res TM ECG Electrode is a pregelled, single use, multisegment Ag/AgCl electrode used in measuring electrocardiogram signals. It was designed specifically for use with the Cambridge Heart, Inc. CH 2000 Stress Test System and successor systems. The electrode comprises four closely spaced electrode segments, consisting of three equal sized segments equidistant around a center segment, each capable of receiving ECG signals. By itself, the center segment functions as a standard Ag/AgCl ECG electrode. The three ring segments are used to receive additional ECG signals and are used, along with the center segment, to obtain real time measures of electrode surface-to-skin impedance and trans-thoracic (respiratory) impedance. These additional ECG signals and impedance measurements are used by the noise reduction algorithms on the CH 2000 to reduce baseline wander and movement artifact from the ECG.
The provided text describes the Cambridge Heart Hi-Res™ ECG Electrode and its substantial equivalence to predicate devices, primarily focusing on regulatory aspects and comparisons based on design and adherence to standards. However, it does not include a study specifically designed to establish acceptance criteria with reported device performance in the format requested.
Here's an analysis of what information can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Hi-Res™ ECG Electrode "met the performance requirements of ANSI/AAMI EC12-1991 and the biocompatibility requirements of ISO 10993-5." While these are the acceptance criteria (i.e., compliance with these standards), the document does not provide a table with specific performance metrics and their measured values from a study. It only states that the device "met" these requirements.
Similarly, it mentions that the CH 2000 Stress Test System's respiratory impedance measurement method "meets the AAMI Standard For Safe Current Limits for Electromedical Apparatus ES1, Section 3.5." Again, this indicates the acceptance criterion but does not report specific performance data.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "testing" for performance and biocompatibility but does not specify the sample size used for these tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts and Their Qualifications for Ground Truth
The document does not describe a process for establishing ground truth using experts in the context of device performance testing. The evaluation of adherence to standards would typically involve laboratory testing and verification against the standard's specifications, rather than expert-derived ground truth.
4. Adjudication Method
As there is no mention of expert-established ground truth, an adjudication method is not applicable and therefore not mentioned.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
The document does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study. The focus is on the substantial equivalence of the device itself, not on how human readers perform with or without AI assistance from the device. The "noise reduction algorithms" mentioned are part of the device's function, not a human-in-the-loop AI assistance system in the context of MRMC studies.
6. Standalone (Algorithm Only) Performance
The document describes the performance of the "Hi-Res™ ECG Electrode" and the "CH 2000 Stress Test System" which includes "noise reduction algorithms." This implies a standalone performance of the system as a whole against the standards. However, it does not provide specific metrics for the algorithm's performance in isolation (e.g., sensitivity, specificity for noise reduction, or specific error rates). It simply states the system "reduces baseline wander, movement artifact and muscle artifact from the ECG" and that the algorithm "creates an ECG signal that can then be processed by the CH 2000 like a standard ECG signal."
7. Type of Ground Truth Used
The ground truth used for assessing the device's performance is compliance with established voluntary industry standards: ANSI/AAMI EC12-1991 for electrode performance, ISO 10993-5 for biocompatibility, and AAMI Standard For Safe Current Limits for Electromedical Apparatus ES1, Section 3.5 for respiratory impedance measurement. These standards provide objective criteria and test methods. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these evaluations.
8. Sample Size for the Training Set
The document does not describe any training set or machine learning model development. The device is an ECG electrode with associated signal processing, and the evaluation focuses on its physical and electrical characteristics and adherence to existing medical device standards.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set, the establishment of its ground truth is not applicable.
In summary, the provided text is primarily a 510(k) summary aimed at demonstrating substantial equivalence. It confirms that the device meets relevant performance and biocompatibility standards but does not offer the detailed performance data, study design specifics, or expert-based ground truth information typically found in a clinical study report for an AI/ML powered device.
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AUG 29 1998
SIO SECTION 2.0 549(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
As required under Section 12, part (a)(i)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information regarding safety and effectiveness follows:
2.1 General Information
Name and Address of Submitter:
Cambridge Heart, Inc. One Oak Park Bedford, MA 01730
Contact:
Robert T. Miragliuolo V.P. of Regulatory and Clinical Affairs
Date of Summary:
May 15, 1996
Name of Device:
Cambridge Heart Hi-ResTM ECG Electrode
Common/Usual Name of Device:
ECG Electrode
Device Classification:
Electrocardiograph Electrode
Predicate Devices:
Smart™ Bi-Lectrode (K791006) Quinton Quik-Prep Electrode(K782079) 3M Red Dot Electrode (K821438) HP M1176A Cardiac Monitor (K882609)
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Device Description and Intended Use 2.2
The Cambridge Heart Hi-Res TM ECG Electrode is a pregelled, single use, multisegment Ag/AgCl electrode used in measuring electrocardiogram signals. It was designed specifically for use with the Cambridge Heart, Inc. CH 2000 Stress Test System and successor systems.
The Cambridge Heart Hi-Res™ ECG Electrode is intended for short term use to measure electrocardiogram signals at rest and during ECG stress testing with the CH 2000 Stress Test System and successor systems. This device is supplied non-sterile and is intended for one time use only.
The Hi-Res™ ECG Electrode is constructed of a polyester basepad, four silversilver chloride ink electrode segments, an adhesive coated die cut foam, a conductive gel, and a silicone coated polystyrene carrier (release liner).
The electrode comprises four closely spaced electrode segments, consisting of three equal sized segments equidistant around a center segment, each capable of receiving ECG signals. By itself, the center segment functions as a standard Ag/AgCl ECG electrode. It is non-polarizing should defibrillation be required when the electrode is in place. The ECG signal received by the center segment is the primary source of the ECG reported on the display screen and on printouts of the CH 2000 Stress Test System.
The three ring segments are used to receive additional ECG signals and are used, along with the center segment, to obtain real time measures of electrode surface-to-skin impedance and trans-thoracic (respiratory) impedance. These additional ECG signals and impedance measurements are used by the noise reduction algorithms on the CH 2000 to reduce baseline wander and movement artifact from the ECG.
The Cambridge Heart Hi-Res™ ECG Electrode can be used to measure electrocardiogram signals at rest and during stress testing with the CH 2000 Stress Test System and successor systems.
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The HI-Res™ ECG Electrode reduces baseline wander, movement artifact and muscle artifact from the ECG, when used with the CH 2000 Stress Test system or successor systems.
The center segment of the electrode is non-polarizing should defibrillation be required while the electrode is in place.
The electrode is flexible, has a low profile, is capable of adhering to the skin under the variety of conditions particular to exercise stress testing, and is pregelled as required for lowering skin-electrode impedance.
The Hi-Res™ ECG Electrode was designed to specifications, confirmed by testing, that meet or exceed the following voluntary guidelines and standards as they apply to disposable ECG electrodes used for exercise testing: ISO 10933-5 and ANSI/AAMI EC12-1991.
The Hi-Res™ ECG Electrode is used at LL, V2, V4, V5, V6, I and H. It interfaces with a high resolution patient lead cable supplied by Cambridge Heart, Inc., for use with the CH 2000 Stress Test System. This high resolution patient lead cable is similar to the standard 14 electrode patient lead cable included in the 510(k), K950018, for the CH 2000 Stress Test System with the exception that the leadwires and electrode connectors have been changed so as to be used with the Hi-Res TM ECG Electrode. Testing has confirmed that the high resolution patient cable meets the AAMI EC-53 standard.
A noise reduction algorithm has been added to the CH 2000 specifically for recognizing and processing the additional ECG and impedance signals from the Hi-Res TM ECG Electrode. This algorithm creates a weighted average of the ECG signals from the segments of the each electrode to reduce noise through adaptive cancellation of artifact in the ECG. In creating the average, the algorithm also uses the impedance signals to cancel baseline noise artifact. This noise reduction process creates an ECG signal that can then be processed by the CH 2000 like a standard ECG signal from a conventional single segment electrode.
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The CH 2000 Stress Test System and the HP M1176A device, K882609, measure respiratory impedance in a similar manner. Both devices inject a low level high-frequency current through the torso, using existing electrodes, and measure the resulting voltage drop across the body.
The Hi-Res ™ ECG Electrode is substantially equivalent to the Smart™ Bi-Lectrode (K791006), the Quinton Quik-Prep Electrode (K782079), and the 3M Red Dot Electrode (K821438). Refer to Exhibit 2.1 for a summary of similarities and differences.
2.3 Summary of Similarities and Differences
The table below shows the frequency and current used by the CH 2000 and the predicate device for the purpose of measuring respiratory impedance. The CH 2000 current is significantly lower than the maximum of 280 uA allowed by AAMI standard ES1, Section 3.5 for a frequency of 28 kHz.
| CH 2000 | HP M1176A | |
|---|---|---|
| Frequency | 28 kHz | 39 kHz |
| Maximum RMScurrent | 100 $ \mu $ A | 68 $ \mu $ A |
Please refer to the exhibit 2.1 on the following page for a summary of the similarities and differences.
{4}------------------------------------------------
SUMMARY OF SIMILARITIES AND DIFFERENCE
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{5}------------------------------------------------
XHIBIT 2.1 (continued
SUMMARY OF SIMILARITIES AND DIFFERENCE
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| ,のな50לייני אוניברסיטע אין דער מידע אין דער מערכת אין דער מערכת אין דער מענט אין דער מענט אין דער מענט אין דער מענט אין דער מענט אין דער מענט אין דער מענט אין דער מענט אין דער מענ0.0的8.7.20发1988ﻟﻠﻘﻀﺎﺀ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤు ర2203. 2017 12:00 | · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · | 11:28:21్లోക്ഷേത്രം ഗ്രാമസഭയും സ്വീതിക്കുന്നു ഗ്രാമത്തിലെ | ::: |
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2.4 Substantial Equivalence Decision Tree
The 510(k) "Substantial Equivalence" Decision Making Process in ODE Guidance Memo #K86-3. was used in making the determination of substantial equivalence. The answer to these questions lead to a determination of substantial equivalence.
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- Does New Device Have the Same Indication Statements?
Yes. The Hi-Res™ ECG Electrode and the predicate electrode devices are all indicated for the same basic purpose of conducting the ECG signal from the surface of the skin to the electrocardiograph. The Hi-Res™ ECG Electrode is indicated for short time use, at rest and during stress testing; the predicate devices are intended for the same use and also for long term monitoring. The HP M1176A is a cardiac device for obtaining ECG and respiratory measurements. The CH 2000 Stress Test System is intended for the recording of ECGs and vector cardiograms by a physician, or under the direction of a physician , at rest and during ECG stress testing.
- Does New Device Have the Same Indication Statements?
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- Does the New Device Have the Same Technology Characteristics, e.g., Design, Materials, Etc. ?
Yes. The Hi-Res™ ECG Electrode functions in the same manner as the predicate devices in that it is a transducer of the electrical signals emanating from the heart by converting an ionic signal in tissue to a metal conductive electrical signal. It has a similar conductive system consisting of silver-silver chloride elements to increase the rate of depolarization; a conductive gel to enhance skin contact and conductivity; and an adhesive on a flexible material, made from a relatively inert polymer, to hold the electrode on to the skin. The multi-segment design of the Hi-Res™ ECG is an extension of the bi-segment design of the Smart™ Bi-Lectrode.
- Does the New Device Have the Same Technology Characteristics, e.g., Design, Materials, Etc. ?
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The CH 2000 Stress Test System and the HP M1176A device. K882609, measure respiratory impedance in a similar manner. Both devices inject a low level high-frequency current through the torso, using existing electrodes, and measure the resulting voltage drop across the body.
- Are the Descriptive Characteristics Precise Enough to Ensure Equivalence? గా
NO. The descriptive characteristics are not precise enough to ensure safety of effectiveness equivalence.
Are Performance Data Available to Assess Equivalence র্ব .
The Hi-Res™ ECG Electrode was tested and met the performance requirements of ANSI/AAMI EC12-1991 and the biocompatibility requirements of ISO 10993-5. In their respective premarket applications, the Quik Prep Electrode and the 3M Red Dot Electrode were tested to demonstrate compliance with certain voluntary standards as they applied to ECG electrodes. The requirements of these standards are similar to the requirements of ANSI/AAMI EC12-1991 and ISO10933-5 for performance and biocompatibility. The CH 2000 Stress Test System's method of measuring respiratory impedance meets the AAMI Standard For Safe Current Limits for Electromedical Apparatus ES1, Section 3.5.
Performance Data Demonstrates Equivalence ? ട്.
Yes. The results of biocompatibility testing on the Hi-Res ™ ECG Electrode and on the predicate devices were substantially equivalent. The results of the performance testing on the Hi-Res™ ECG Electrode and the predicate devices were substantially equivalent. The results of the testing demonstrate
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that the manner in which CH 2000 Stress Test System measures respiratory impedance is substantially equivalent to the predicate device.
Based on the FDA's decision tree, the Hi-Res™ ECG Electrode is substantially equivalent to the Smart™ Bi-Lectrode, the Quinton Quik-Prep Electrode, and the 3M Red Dot Electrode, and the HP M1176A and CH 2000 Stress Test System are substantially equivalent.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.