(48 days)
Not Found
Not Found
No
The device description and performance studies focus on the electrical and physical properties of a standard electrode, with no mention of AI or ML capabilities.
Yes
The device is described as a "defibrillation, monitoring and pacing electrode" and its intended uses include "defibrillation procedures, cardioversion, pacing and ECG monitoring on adults," which are all therapeutic or diagnostic medical interventions.
No
The device is an electrode used for defibrillation, cardioversion, pacing, and ECG monitoring, all of which are therapeutic or monitoring functions, not diagnostic ones.
No
The device description clearly outlines physical components like a vinyl substrate, metal foil, hydrogel, and PSA ring, indicating it is a hardware device.
Based on the provided information, the Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states procedures performed on adults (defibrillation, cardioversion, pacing, and ECG monitoring). These are procedures performed directly on the patient's body.
- Device Description: The description details an electrode that is applied to the skin for electrical contact. This is an external device used for physiological monitoring and intervention.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body), such as blood, urine, or tissue. IVDs are designed to examine these types of samples to provide diagnostic information.
Therefore, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"Intended for use in defibrillation procedures, cardioversion and pacing. This device is intended for use on adults."
The Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode is intended for use in defibrillation procedures, cardioversion, pacing and ECG monitoring on adults.
Product codes
74MLN
Device Description
A pre-gelled conductive electrode consisting of a pre-attached leadwire, and insulating layer of a vinyl substrate, a secondary vinyl piece covering the crimped wire connector, a layer of metal foil, a conductive adhesive hydrogel, a pressure sensitive adhesive (PSA) 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
Adults
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 subject to AAMI electrical tests as described in DF-39, 3.3.19 and energy through put testing. Test results for both the device and the predicate meet 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 use testing consisting of multiple defibrillation shocks, maximum current pacing and ECG monitoring. Test results for the device met the specifications as established in DF-39 for self adhesive electrodes for monitoring, defibrillation and pacing.
Key Metrics
Not Found
Predicate Device(s)
Cardiotronics Systems, Inc., a division of Ballard Medical Products,.R2® Pads™ Pacing/Defibrillation and ECG 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
5 1998 NOV
K98328
510(k) SUMMARY
المشاركة المستوى المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المن
| | Date: | Graphic Controls
September 16, 1998 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturing Facility: | Graphic Controls Corporation
189 Van Rensselaer Street
P.O. Box 1271
Buffalo, NY 14240
Registration Number 1317188 |
| | Telephone: | (716) 853-7500 |
| | Contact Person: | Kathleen Selover
Regulatory Affairs Specialist
(716) 853-7500, extension 7630
Fax: (716) 847-7531 |
| | Device Trade Name: | Medi-Trace® 1610C Combination Defibrillation,
Monitoring and Pacing Electrode |
| | Device Common Name: | Self Adhesive Defibrillation and Monitoring
Electrode |
| | Classification Name: | Electrode, Electrocardiograph, Multifunction |
| | Regulatory Reference: | 74MLN |
| | Predicate Device: | Cardiotronics Systems, Inc., a division of Ballard
Medical Products,.R2® Pads™ Pacing/Defibrillation
and ECG Electrode |
| | Description: | A pre-gelled conductive electrode consisting of a
pre-attached leadwire, and insulating layer of a vinyl
substrate, a secondary vinyl piece covering the
crimped wire connector, a layer of metal foil, a
conductive adhesive hydrogel, a pressure sensitive
adhesive (PSA) 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/Indications for Use: | Intended for use in defibrillation procedures,
cardioversion and pacing. This device is intended for
use on adults. | |
| Physical/Technical Comparison: | Medi-Trace® 1610C Electrode is replaceable with
the Cardiotronics, Inc, a division of Ballard Medical
Products, R2® Pads™ Pacing/Defibrillation/ECG
Electrodes. Physical and technical characteristics,
including materials used in construction, size,
intended use and conductive gel type of these
electrodes are comparable. Since the formulation of
conductive gel of the predicate is considered to be
proprietary, exact chemical comparison could not be
made. | |
| Performance Summary: | The device and the predicate were subject to AAMI
electrical tests as described in DF-39, 3.3.19 and
energy through put testing. Test results for both the
device and the predicate meet 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 use
testing consisting of multiple defibrillation shocks,
maximum current pacing and ECG monitoring. Test
results for the device met the specifications as
established in DF-39 for self adhesive electrodes for
monitoring, defibrillation and pacing. | |
| Biocompatibility Testing: | The device was subjected to biocompatibility testing
as recommended in ISO-10993, Biological
Evaluation of Medical Devices Part I: Evaluation
and Testing." The device was found to be
non-irritating, non-cytotoxic and non-sensitizing. | |
| Shelf Life: | Data obtained in accelerated shelf life studies were
reviewed and found to substantiate our claimed shelf
life. | |
1
510(k) Summary
Page 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 5 1998
Susan A. Krasny, Ph.D. Graphic Controls Corporation 189 Van Rensselaer Street P.O. Box 1271 Buffalo, NY 14240-1271
K983287 Re: Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode Requlatory Class: III (Three) Product Code: 74 MLN Dated: September 16, 1998 Received: September 18, 1998
Dear Dr. Krasny:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Susan A. Krasny, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _ 1 _ of ________________________________________________________________________________________________________________________________________________________________
510(k) Number, if known: _____________________________________________________________________________________________________________________________________________________ K983287
Medi-Trace® 1610C Combination Defibrillation, Device Name: Monitoring and Pacing Electrode
Indications for Use:
The Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode is intended for use in defibrillation procedures, cardioversion, pacing and ECG monitoring on adults.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Kramer
| Prescription Use | OR | Over-the-Counter Use (Per 21 CFR 801.109) |
|---|---|---|
| ------------------ | ---- | ------------------------------------------- |
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
| 510(k) Number | |
|---|---|
| --------------- | -- |