(231 days)
Medi-Trace® 500 Electrodes
Not Found
No
The device description and performance studies focus on the electrical and physical properties of a disposable ECG electrode, with no mention of AI or ML.
No
Explanation: The device is described as an ECG electrode used for monitoring, not for treating a condition. Its intended use is for "general electrocardiograph procedures where ECG monitoring is deemed necessary."
No
The device is used for ECG monitoring, which is a method of acquiring physiological signals, but it does not diagnose a condition. The collected data would then be interpreted by a physician to make a diagnosis.
No
The device description explicitly details physical components like conductive gel, eyelets, studs, foam substrate, and packaging, indicating it is a hardware device (ECG electrodes).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general electrocardiograph procedures where ECG monitoring is deemed necessary". This describes a procedure performed on a living patient to measure electrical activity of the heart.
- Device Description: The device is a "conductive wet gel electrode". This is a component used to acquire physiological signals from the body surface.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples in a laboratory or clinical setting to provide diagnostic information. This device is a component used in a procedure performed directly on a patient.
N/A
Intended Use / Indications for Use
Intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician.
Product codes
74 DRX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Medi-Trace® 500 Electrodes
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.