(48 days)
The Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode is intended for use in defibrillation procedures, cardioversion, pacing and ECG monitoring on adults.
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.
This document describes the performance summary for the Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by AAMI DF-39) | Reported Device Performance |
|---|---|
| AAMI DF-39 Electrical Tests (Paragraph 3.3.19): Specifications for self-adhesive electrodes for monitoring and defibrillation and pacing. This likely includes parameters such as impedance, current distribution, and other electrical safety and performance metrics relevant to the intended functions. | The device and predicate device were both subjected to AAMI electrical tests as described in DF-39, 3.3.19. 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. |
| Energy Throughput Testing: Assessment of the electrode's ability to efficiently deliver and sustain the energy required for defibrillation procedures. | Both the device and the predicate device underwent energy throughput 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. |
| Simulated Use Testing (per DF-39 specifications): This includes evaluation of performance during: | The device was subjected to simulated use testing. Test results for the device met the specifications as established in DF-39 for self-adhesive electrodes for monitoring, defibrillation and pacing. |
| * Multiple Defibrillation Shocks: Ability to withstand and perform effectively after repeated high-energy electrical discharges. | |
| * Maximum Current Pacing: Capability to deliver and maintain maximum pacing currents. | |
| * ECG Monitoring: Performance in accurately acquiring and transmitting electrocardiogram signals. | |
| Biocompatibility Testing (per ISO-10993, Part I): Evaluation for biological effects such as irritation, cytotoxicity, and sensitization. The criteria would be to show no adverse biological responses. | 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 to substantiate the claimed shelf life of the device under specified storage conditions. | Data obtained in accelerated shelf life studies were reviewed and found to substantiate our claimed shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state the numerical sample size for the test set used in the performance studies. It mentions "the device and the predicate device" were subjected to AAMI electrical tests and energy throughput testing, and "the device" was subjected to simulated use testing. This implies a comparative study against a predicate device and then simulated usage for the new device.
The data provenance (country of origin, retrospective/prospective) is not specified. However, given that this is a 510(k) submission to the FDA, the testing would have been conducted to meet US regulatory requirements, likely by the manufacturer, Graphic Controls Corporation, based in Buffalo, NY, USA. The studies would be considered prospective for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (defibrillation, monitoring, and pacing electrode) typically does not involve human expert interpretation for "ground truth" in the same way an imaging or diagnostic AI device does. The "ground truth" here is defined by the technical specifications and performance standards outlined in AAMI DF-39. The validation involves objective measurements against these predefined engineering and safety standards. Therefore, no "experts" with specific clinical qualifications like radiologists would be used to establish a ground truth for interpretation.
4. Adjudication Method for the Test Set
Not applicable for this type of device and study. The testing involves direct measurement against specified performance criteria as outlined by AAMI DF-39. There is no human interpretation or subjective assessment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not describe an MRMC comparative effectiveness study. The device is a medical electrode, and its performance is evaluated based on technical specifications and functional testing, not on human reader performance with or without AI assistance. There is no AI component mentioned in the context of improving human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in essence. The performance studies described (electrical tests, energy throughput, simulated use, biocompatibility, shelf life) are all evaluating the device itself, functioning independently, against pre-defined technical and safety standards. There is no "human-in-the-loop" component in assessing the intrinsic performance of the electrode. These are tests of the physical device's characteristics and functionality.
7. Type of Ground Truth Used
The ground truth for this device's performance evaluation is based on:
- Established Technical Specifications and Standards: Primarily the requirements outlined in AAMI DF-39 for self-adhesive electrodes for monitoring and defibrillation and pacing.
- Biocompatibility Standards: ISO-10993, Part I.
- Functional Performance Benchmarks: The ability to perform its intended functions (defibrillation, pacing, ECG monitoring) within acceptable parameters during simulated use.
8. Sample Size for the Training Set
Not applicable. This device is a physical electrode, not a software algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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 ControlsSeptember 16, 1998 | |
|---|---|---|
| Manufacturing Facility: | Graphic Controls Corporation189 Van Rensselaer StreetP.O. Box 1271Buffalo, NY 14240Registration Number 1317188 | |
| Telephone: | (716) 853-7500 | |
| Contact Person: | Kathleen SeloverRegulatory Affairs Specialist(716) 853-7500, extension 7630Fax: (716) 847-7531 | |
| Device Trade Name: | Medi-Trace® 1610C Combination Defibrillation,Monitoring and Pacing Electrode | |
| Device Common Name: | Self Adhesive Defibrillation and MonitoringElectrode | |
| Classification Name: | Electrode, Electrocardiograph, Multifunction | |
| Regulatory Reference: | 74MLN | |
| Predicate Device: | Cardiotronics Systems, Inc., a division of BallardMedical Products,.R2® Pads™ Pacing/Defibrillationand ECG Electrode | |
| Description: | A pre-gelled conductive electrode consisting of apre-attached leadwire, and insulating layer of a vinylsubstrate, a secondary vinyl piece covering thecrimped wire connector, a layer of metal foil, aconductive adhesive hydrogel, a pressure sensitiveadhesive (PSA) ring and a release liner. Device ispackaged in pairs in a heat sealed pouch; 10 pouchesare packaged into one shelf box shipper. | |
| Intended/Indications for Use: | Intended for use in defibrillation procedures,cardioversion and pacing. This device is intended foruse on adults. | |
| Physical/Technical Comparison: | Medi-Trace® 1610C Electrode is replaceable withthe Cardiotronics, Inc, a division of Ballard MedicalProducts, R2® Pads™ Pacing/Defibrillation/ECGElectrodes. Physical and technical characteristics,including materials used in construction, size,intended use and conductive gel type of theseelectrodes are comparable. Since the formulation ofconductive gel of the predicate is considered to beproprietary, exact chemical comparison could not bemade. | |
| Performance Summary: | The device and the predicate were subject to AAMIelectrical tests as described in DF-39, 3.3.19 andenergy through put testing. Test results for both thedevice and the predicate meet the specifications asestablished in DF-39 for self adhesive electrodes formonitoring and defibrillation and pacing. | |
| In addition, the device was subjected to simulated usetesting consisting of multiple defibrillation shocks,maximum current pacing and ECG monitoring. Testresults for the device met the specifications asestablished in DF-39 for self adhesive electrodes formonitoring, defibrillation and pacing. | ||
| Biocompatibility Testing: | The device was subjected to biocompatibility testingas recommended in ISO-10993, BiologicalEvaluation of Medical Devices Part I: Evaluationand Testing." The device was found to benon-irritating, non-cytotoxic and non-sensitizing. | |
| Shelf Life: | Data obtained in accelerated shelf life studies werereviewed and found to substantiate our claimed shelflife. |
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510(k) Summary
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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.
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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
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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) |
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(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
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§ 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.