(301 days)
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Not Found
No
The device description and performance studies focus on the electrical and physical properties of the electrodes, with no mention of AI or ML algorithms for analysis or decision-making.
Yes
The device is used for defibrillation, cardioversion, and pacing, all of which are therapeutic procedures aimed at treating cardiac conditions.
No
The "Intended Use / Indications for Use" section states the device is for defibrillation, cardioversion, and pacing, which are therapeutic procedures, not diagnostic ones. The "Device Description" describes an electrode, which is a component used in these therapeutic applications.
No
The device description clearly outlines physical components like electrodes, insulating layers, metal foil, and adhesive 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, cardioversion and pacing." These are all procedures performed on the patient's body to treat a medical condition.
- Device Description: The device is a "pre-gelled conductive electrode" designed to be attached to the patient's skin for electrical contact.
- 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.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is clearly designed for in vivo (within the body) use.
N/A
Intended Use / Indications for Use
This device is intended for use on adults. Not for use on children or infants.
Product codes
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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. Intended for use in defibrillation procedures, cardioversion and pacing.
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
adults.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The device and the predicate were subjected to AAMI electrical tests as described in DF-39, 3.3.19 and energy throughput testing. Test results for both the device and the predicate met the specifications as established in DF-39 for self adhesive electrodes for monitoring, and defibrillation and pacing. In addition, the device was subjected to simulated used testing consisted of multiple defibrillation shocks and maximum current pacing. Test results for the device met the specifications as established in DF-39 for self adhesive electrodes for monitoring, and defibrillation and pacing.
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.
Key Metrics
Not Found
Predicate Device(s)
Hewlett® Packard M1749A Multifunction Adult 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
ート | アートレー | | アイトレー | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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OCT 2 4 1996
510(k) SUMMARY; K955882
| Date: | October 24, 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® 1210H Combination Defibrillation, |
| Pacing and ECG Electrode | |
| Common Name: | Self Adhesive Electrode for Monitoring and |
| Defibrillation, optional Pacing | |
| Classification Name: | Multi-Purpose Electrocardiograph Electrode |
| Regulatory Reference: | 74 MLN |
| Predicate Device: | Hewlett® Packard M1749A Multifunction Adult |
| Electrode |
1
A pre-gelled conductive electrode consisting of a means of attaching the Description: 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, cardioversion and pacing. Intended Use: This device is intended for use on adults. Not for use on children or
Physical/Technical Comparison:
infants.
Medi-Trace® 1210H Electrode is replaceable with the Hewlett® Packard M1749A Multifunction Adult 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 and the predicate were subjected to AAMI electrical tests as described in DF-39, 3.3.19 and energy throughput testing. Test results for both the device and the predicate met the specifications as established in DF-39 for self adhesive electrodes for monitoring, and defibrillation and pacing.
In addition, the device was subjected to simulated used testing consisted of multiple defibrillation shocks and maximum current pacing. Test results for the device met the specifications as established in DF-39 for self adhesive electrodes for monitoring, and defibrillation and pacing.
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.