← Product Code [DRX](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX) · K960968 # MEDI-TRACE 200, MEDI-TRACE 200-30 (K960968) _Graphic Controls Corp. · DRX · Oct 28, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K960968 ## Device Facts - **Applicant:** Graphic Controls Corp. - **Product Code:** [DRX](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX.md) - **Decision Date:** Oct 28, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2360 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use Intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician. ## Device Story Disposable ECG monitoring electrode; conductive wet gel interface; silver/silver chloride plated ABS eyelet; nickel plated brass stud; adhesive foam substrate; vinyl label; polystyrene release liner. Used in clinical settings for ECG monitoring; applied to patient skin by healthcare personnel to acquire electrical signals for diagnostic/monitoring equipment. Benefits include reliable signal acquisition for cardiac monitoring. ## Clinical Evidence Bench testing only. Device tested per AAMI EC12-1991 standards for electrical performance, labeling, shelf life, packaging, and safety. Biocompatibility testing performed per ISO-10993; results confirmed non-irritating, non-cytotoxic, and non-sensitizing. Real-time shelf life studies substantiated. ## Technological Characteristics Conductive wet gel electrode. Materials: silver/silver chloride plated ABS eyelet, nickel plated brass stud, adhesive foam substrate, vinyl label, polystyrene release liner. Complies with AAMI EC12-1991 standards. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Medi-Trace® 500 Electrodes ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 10/25/1996 14:58 7168477531 GRAPHIC CONTROLS PAGE 04 Graphic Controls Corporation 189 Van Rensselaer Street PO Box 1274 Buffalo, New York 14240-1274 USA 716 853-7500 Customer Relations: 900 609 1009 Fax: 800 347-2421 K960968 OCT 28 1996 ![img-0.jpeg](img-0.jpeg) ## 510(k) SUMMARY; K960968 ## Graphic Controls Date: October 25, 1996 Manufacturer: Graphic Controls Corporation 189 Van Rensselaer Street PO Box 1271 Buffalo, NY 14240 Registration Number 1317188 Manufacturing Location: Graphic Controls, Canada, Ltd. 215 Herbert Street Gananoque, Ontario Canada, K7G 2Y7 Telephone: (716) 853-7500 Contact Person: 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 {1} 10/25/1996 14:58 7168477531 GRAPHIC CONTROLS PAGE 05 ## Description: A conductive wet gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated ABS eyelet, 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 Use: Intended for use in general electrocardiograph procedures where ECG 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 construction, 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 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, non-cytotoxic and non-sensitizing. ## Shelf Life: Data obtained in real time shelf life studies was reviewed and found to substantiate our claimed shelf life. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K960968](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K960968) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com