(231 days)
Intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician.
A conductive wet gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated ABS cyelet, nickel plated brass stud, an adhesive foam substrate, vinyl label and polystyrene release liner. Electrodes are packaged either as 100 per pouch (Medi-Trace® 200) or 30 per pouch (Medi-Trace® 200-30); pouches are heat sealed. Unit of sale for each packaging is a case of either 600 or 1000 electrodes.
This document describes a 510(k) summary for ECG electrodes, which are hardware devices and do not involve AI or algorithms. Therefore, much of the requested information (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) is not applicable.
However, I can extract the acceptance criteria and performance summary related to the physical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| AAMI EC12-1991 (Electrical Performance) | Meets or exceeds performance specifications |
| AAMI EC12-1991 (Labeling) | Meets AAMI standard |
| AAMI EC12-1991 (Shelf Life) | Meets AAMI standard |
| AAMI EC12-1991 (Packaging) | Meets AAMI standard |
| AAMI EC12-1991 (Safety) | Meets AAMI standard |
| Graphic Controls' Internal Specifications (Trace Performance) | Meets internal specifications |
| ISO 10993 Part 1 (Biocompatibility - Irritation) | Non-irritating |
| ISO 10993 Part 1 (Biocompatibility - Cytotoxicity) | Non-cytotoxic |
| ISO 10993 Part 1 (Biocompatibility - Sensitization) | Non-sensitizing |
| Real-time shelf life studies | Substantiates claimed shelf life |
2. Sample size used for the test set and the data provenance:
- This information is not explicitly provided in the document. The tests performed are for device performance as per AAMI standards.
- Data provenance is not specified, but the testing would have been conducted by or for Graphic Controls Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a hardware device. Device performance is measured against established industry standards (AAMI EC12-1991) and internal specifications, not expert-established ground truth in a diagnostic sense.
4. Adjudication method for the test set:
- Not applicable. Performance is measured against objective standards, not through expert adjudication.
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:
- Not applicable, as this is a hardware device (ECG electrode), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a hardware device (ECG electrode), not an AI algorithm.
7. The type of ground truth used:
- The "ground truth" here is the set of specifications and performance requirements outlined in the AAMI EC12-1991 standard for Disposable ECG Electrodes, as well as Graphic Controls' internal specifications and the biocompatibility standards of ISO 10993.
8. The sample size for the training set:
- Not applicable, as this is a hardware device (ECG electrode), not an AI algorithm.
9. How the ground truth for the training set was established:
- Not applicable, as this is a hardware device (ECG electrode), not an AI algorithm.
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Graphic Controls Corporation
189 Van Rensselaar Street PO Box 1274 Buffalo, New York 14240-1271 I ISA 716 853-7500
Customer Relations 900 609 1009 1 :1 : 300 347 : 11 : 1
OCT 28 1996
510(k) SUMMARY; K960968
Graphic Controls
Date: Manufacturer:
Manufacturing Location
Telephone:
Contact Person:
October 25, 1996
Graphic Controls Corporation 189 Van Rensselaer Street PO Box 1271 Buffalo, NY 14240 Registration Number 1317188
Graphic Controls, Canada, Ltd. 215 Herbert Steet Gananoque, Ontario Canada, K7G 2Y7
(716) 853-7500
Kathleen H. Selover Regulatory Affairs Specialist (716) 853-7500, Extension 7630 Fax Number: (716) 847-7531
Device Trade Name: Medi-Trace® 200 and Medi-Trace® 200-30 ECG Electrodes
Common Name: Disposable ECG Monitoring Electrode
Classification Name: Electrocardiograph Electrode
Regulatory Reference: 74 DRX
Predicate Device: Medi-Trace® 500 Electrodes
Image /page/0/Picture/24 description: The image shows a stylized letter 'S' inside a circle. The 'S' is designed with a flowing, almost flame-like appearance, and the circle provides a solid, dark background. A trademark symbol is located to the bottom right of the circle.
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A conductive wet gel electrode consisting of a conductive adhesive gel, a Description: silver/silver chloride plated ABS cyelet, nickel plated brass stud, an adhesive foam substrate, vinyl label and polystyrene release liner. Electrodes are packaged either as 100 per pouch (Medi-Trace® 200) or 30 per pouch (Medi-Trace® 200-30); pouches are heat sealed. Unit of sale for each packaging is a case of either 600 or 1000 electrodes. Intended for use in general electrocardiograph procedures where ECG Intended Use: monitoring is deemed necessary and is ordered by a physician.
Physical/Technical Comparison:
Medi-Trace® 200 is equivalent to the predicate device. Physical and technical characteristics, including materials used in contruction, size, intended use and conductive gel type of device and the predicate are comparable.
Performance Summary:
The device and the predicate were subjected to AAMI electrical performance tests as described in EC12-1991. Test results indicate that this device meet or exceeds the the performance specifications as established in EC12-1991 for Disposable ECG Electrodes. In addition, the device was found to meet EC12-1991 AAMI standard for labeling, shelf life, packaging and safety and Graphic Controls' internal specifications for trace performance.
Biocompatibility Testing:
The device was subjected to biocompatibility testing as recommended in the May 1, 1995 FDA memorandum entitled: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The device was found to be non-irritating, noncytotoxic and non-sensitizing.
Shelf Life:
Data obtained in real time shelf life studies was reviewed and found to substantiate our claimed shelf life.
§ 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.