(301 days)
Not Found
No
The summary describes a passive electrode and mentions standard electrical and energy throughput testing, with no indication of AI/ML functionality.
Yes
The device is described as being "Intended for use in defibrillation procedures," which is a therapeutic intervention to treat cardiac arrhythmias.
No
The device is intended for defibrillation procedures and ECG monitoring, which is a physiological measurement, not for diagnosing a disease or condition.
No
The device description explicitly details physical components like electrodes, vinyl, metal foil, and hydrogel, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "defibrillation procedures" and "ECG monitoring." These are procedures performed directly on a patient's body to treat or monitor their physiological state.
- Device Description: The device is a "pre-gelled conductive electrode" designed to be attached to the body for electrical contact.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological or pathological state. This device does not involve the analysis of such specimens.
The device described is a medical device used for external electrical therapy and monitoring, not for in vitro diagnostic testing.
No
This clearance letter does not mention a Predetermined Change Control Plan (PCCP) or indicate that the device is authorized under such a plan. PCCPs are relatively new and specifically called out in clearance letters when applicable.
Intended Use / Indications for Use
Intended for use in defibrillation procedures. This device also allows for Intended Use: ECG monitoring. There are no population restrictions for the device except as noted in the directions for use.
Product codes
Not Found
Device Description
A pre-gelled conductive electrode consisting of a means of attaching the electrode to the cable, an insulating layer of vinyl, a layer of metal foil, a conductive adhesive hydrogel, a pressure sensitive adhesive ring and a release liner. Device is packaged in pairs in a heat sealed pouch, 10 pouches are packaged into one shelf-box/shipper.
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 was subjected to AAMI electrical tests as described in ANSI/AAMI DF39-1993 standard, part 3.3.19 and energy throughput testing. Test results indicated that this device meets or exceeds ANSI/AAMI specifications for electrical testing as established in DF39-1993, part 3.3.19and labeling requirements as established in part 3.1.2 for self adhesive electrodes for monitoring and defibrillation.
Key Metrics
Not Found
Predicate Device(s)
Laerdal Heartstart® Defibrillation Electrode
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
OCT 2 4 1996
510(k) SUMMARY; K955923
| Date: | October 18, 1996 |
|---|---|
| Manufacturer: | Graphic Controls Corporation |
| 189 Van Rensselaer Street | |
| PO Box 1271 | |
| Buffalo, NY 14240 | |
| Registration Number 1317188 | |
| 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® 1110L Combination Defibrillation and |
| ECG Electrode | |
| Common Name: | Self Adhesive Electrode for Monitoring and |
| Defibrillation | |
| Classification Name: | Accessory to an automatic or semiautomatic |
| defibrillator | |
| Regulatory Reference: | 74 MKJ |
| Predicate Device: | Laerdal Heartstart® Defibrillation Electrode |
1
| Description: | A pre-gelled conductive electrode consisting of a means of attaching the electrode to the cable, an insulating layer of vinyl, a layer of metal foil, a conductive adhesive hydrogel, a pressure sensitive adhesive ring and a release liner. Device is packaged in pairs in a heat sealed pouch, 10 pouches are packaged into one shelf-box/shipper. |
|---|---|
| -------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- Intended for use in defibrillation procedures. This device also allows for Intended Use: ECG monitoring. There are no population restrictions for the device except as noted in the directions for use.
Physical/Technical Comparison:
Medi-Trace® 1110L Electrode is replaceable with the Laerdal Heartstart® Defibrillation Electrode. Physical and technical characteristics, including materials used in construction, size, intended use and conductive gel type of these electrodes are comparable. Since formulation of conductive gel is considered proprietary, exact chemical comparisons could not be made.
Performance Summary:
The device was subjected to AAMI electrical tests as described in ANSI/AAMI DF39-1993 standard, part 3.3.19 and energy throughput testing. Test results indicated that this device meets or exceeds ANSI/AAMI specifications for electrical testing as established in DF39-1993, part 3.3.19and labeling requirements as established in part 3.1.2 for self adhesive electrodes for monitoring and defibrillation.
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 accelerated shelf life studies was reviewed and found to substantiate our claimed shelf life.