(68 days)
Intended for use in defibrillation procedures, cardioversion and pacing. This device is intended for use on adults and pediatric patients weighing over 10kg.
A pre-gelled conductive electrode consisting of a pre-attached leadwire, an insulating layer of a vinyl substrate, 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.
The provided text describes the 510(k) summary for the Medi-Trace® 1310P Combination Defibrillation, Monitoring and Pacing Electrode. Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Device Performance |
|---|---|
| AAMI Electrical Tests as described in DF-39, 3.3.19: Specific parameters (e.g., impedance, current distribution) are not detailed in the summary, but the standard DF-39 covers electrical performance for defibrillation electrodes. | The device meets the specifications as established in DF-39 for self-adhesive electrodes for monitoring, defibrillation, and pacing. |
| Energy Throughput Testing: Specific limits or thresholds for energy delivery are not detailed. | The device meets the specifications as established in DF-39 for self-adhesive electrodes for monitoring, defibrillation, and pacing. |
| Simulated Use Testing (Multiple Defibrillation Shocks): No specific number of shocks or performance metrics during shocks are detailed. | The device met the specifications as established in DF-39 for self-adhesive electrodes for monitoring, defibrillation, and pacing. |
| Simulated Use Testing (Maximum Current Pacing): No specific current levels or duration are detailed. | The device met the specifications as established in DF-39 for self-adhesive electrodes for monitoring, defibrillation, and pacing. |
| Simulated Use Testing (ECG Monitoring): No specific signal quality or interference criteria are detailed. | The device met the specifications as established in DF-39 for self-adhesive electrodes for monitoring, defibrillation, and pacing. |
| Biocompatibility (ISO-10993, Part 1): Absence of irritation, cytotoxicity, and sensitization. | The device was found to be non-irritating, non-cytotoxic, and non-sensitizing. |
| Shelf Life: Specific duration of shelf life not explicitly stated in the summary. | Data obtained in accelerated shelf life studies were reviewed and found to substantiate the claimed shelf life. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "the device and the predicate were subject to AAMI electrical tests" and "the device was subjected to simulated use testing." However, it does not specify the sample size for the test set used in any of these tests.
The data provenance is not explicitly stated, but the tests appear to be conducted by the manufacturer, Graphic Controls Corporation, in their facility (189 Van Rensselaer Street, Buffalo, NY). These are likely prospective tests conducted during the development and validation of the device. There is no information provided about countries of origin if external data were used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The performance evaluation relies on meeting specifications established in AAMI DF-39 and ISO-10993, which are standards-based, rather than relying on expert ground truth in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided in the document. The testing described is against established technical standards (DF-39) and biocompatibility standards (ISO-10993), not against adjudicated clinical observations or diagnostic interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretative AI systems where human readers evaluate cases. The Medi-Trace® 1310P is an electrode, and its performance is evaluated against physical and electrical standards, not human diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This concept is not applicable to this device. The Medi-Trace® 1310P is a medical device (electrode), not an algorithm or AI system. Its performance is inherent to its physical and electrical properties.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is based on pre-established engineering and biological standards:
- AAMI DF-39: This standard defines performance requirements for self-adhesive defibrillation and pacing electrodes.
- ISO-10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing: This standard provides guidelines for biocompatibility testing.
- Manufacturer-established specifications: Implicitly, the manufacturer sets internal specifications based on these standards.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided in the document. As this is not an AI/ML device, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
This information is not applicable and therefore not provided in the document, as there is no training set for this device.
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MAY 1 2 1998
Date:
189 Van Rensselaer Street PO Box 1271 Buffalo, New York 14240-1271 USA 716853-7500 Fax: 716 849-6499
510(k) SUMMARY
March 4, 1998
Graphic Controls Graphic Controls Corporation Manufacturing Facility: 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 Medi-Trace® 1310P Combination Defibrillation, Device Trade Name: Monitoring and Pacing Electrode Device Common Name: Self Adhesive Defibrillation and Monitoring Electrode Classification Name: Electrode, Electrocardiograph, Multifunction Regulatory Reference: 74 MLN Physio Controls® Quik-Combo™ Predicate Device: Pacing/Defibrillation/ECG Electrode Description: A pre-gelled conductive electrode consisting of a pre-attached leadwire, an insulating layer of a vinyl substrate, 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.
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510(k) Summary Page 2
Intended/Indications for Use:
Intended for use in defibrillation procedures, cardioversion and pacing. This device is intended for use on adults and pediatric patients weighing over 10kg.
Physical/Technical Comparison:
Medi-Trace® 1310P Electrode is replaceable with the Physio-Controls® Quick Combo™ 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 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, defibrillation and pacing.
In addition, the device was subjected to simulated use testing consisting of multiple defibrillation shocks, maxium 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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 1998
Ms. Kathleen Selover Graphic Controls Corporation 189 Van Rensselaer Street P.O. Box 1271 Buffalo, NY 14240
Re: K980857 Medi Trace® 1310P Combination Defibrillation, Monitoring and Pacing Electrode Requlatory Class: III (three) Product Code: 74 MLN Dated: March 4, 1998 Received: March 5, 1998
Dear Ms. Selover:
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 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, Druq, 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 registration, 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 regulatory 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,
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Page 2 - Ms. Kathleen Selover
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 regulation (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.qov/cdrh/dsmamain.html".
Area P
Sincerely yours,
Thomas J. Callahan
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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510(k) Number, if known:
Device Name: Medi-Trace® 1310P Combination Defibrillation, Monitoring and Pacing Electrode
Indications for Use:
Medi-Trace® 1310P Combination Defibrillation, Monitoring and Pacing Electrode is intended for use on adults and pediatric patients weighing over 10kg.
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| Ship Shows (superior de Property) - All Printers (and Articles of the States of Street Articles (and Articles Station | Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|---|
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Presecription Use
OR
Over-the-Counter
Use (Per 21CFR801.109)
M. Pyzik
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_ K980957
§ 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.