(227 days)
The NeoLead Hydrocolloid/ Hydrogel electrode is intended to be used for resting ECG monitoring on neonatal and pediatric patients in a hospital setting.
The Neolead is a self-adhesive, disposeable sensor, which receives electrical impulses from the body in a non-invasive manner. These impulses are then transmitted to a monitor, which displays the electrographic patterns of cardiac activity. Hydrogel is the pectin based conductive material between the skin and the sensor. Hydrocolloid is the pectin based adhesive.
This document outlines the acceptance criteria and study findings for the Neolead device, as extracted from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (AAMI for Disposable ECG Electrodes) | Reported Device Performance (Neoleads) |
|---|---|
| 3.2.2.1 AC Impedance | Meets standard |
| 3.2.2.2 DC Offset Voltage | Meets standard |
| 3.2.2.3 Combined Offset Instability and Internal Noise | Meets standard |
| 3.2.2.4 Defibrillation Overload Recovery | Meets standard |
| 3.2.2.5 Bias Current Tolerance | Meets standard |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The information rather refers to meeting "basic performance standards" of AAMI (Association for the Advancement of Medical Instrumentation) for Disposable ECG Electrodes. This implies a general compliance check rather than a specific clinical trial with a defined test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The provided text does not mention the use of experts to establish ground truth for a test set. The evaluation is based on meeting technical performance standards, not on expert interpretations of clinical data.
4. Adjudication Method for the Test Set
The provided text does not describe an adjudication method for a test set. The evaluation is based on technical performance against AAMI standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The Neolead is an ECG electrode, a hardware device for signal acquisition, not a software or AI-based diagnostic tool that would typically undergo such a study to assess reader improvement. Therefore, there is no information on effect size for human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
The provided text does not describe a standalone performance study in the context of an algorithm. The Neolead is a physical device (an electrode), and its performance is evaluated based on its ability to acquire electrical signals according to established technical standards.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Neoleads is based on technical performance standards outlined by the AAMI for Disposable ECG Electrodes (specifically sections 3.2.2.1 to 3.2.2.5). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's regulatory review.
8. The Sample Size for the Training Set
The provided text does not mention a training set sample size. As the Neolead is a hardware device evaluated against technical standards, there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, there is no information on how its ground truth was established.
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KO 11554 p/2
JAN 0 3 2002
510 K SUMMARY
DESCRIPTION OF DEVICE
The Neolead is a self-adhesive, disposeable sensor, which receives electrical impulses from the body in a non-invasive manner. These impulses are then transmitted to a monitor, which displays the electrographic patterns of cardiac activity. Hydrogel is the pectin based conductive material between the skin and the sensor. Hydrocolloid is the pectin based adhesive.
INTENDED USE OF THE DEVICE
Neoleads are designed as a desposeable, self-adhesive sensor to be placed on the skin of the newborn and pediatric patient in order to gather, transmit and record cardiac electrical activity.
TECHNICAL CHARACTERISTICS
The Neolead is equivalent to legally marketed electrodes in the marketplace now. The addition of the hydrocolloid as the adhesive is based on the recommendations of the Neonatal Nurses National Association guidelines as well as a long history of its skin friendly properties.
SUBSTANTIAL EQUIVLENCE
The Neolead is substantially equivalent to the following predicated electrodes
Kittvcat-Kendall-LTP Neotrode-ConMe Corp Klear-Trace-CAS Medical Systems, Inc SilveReez-Clinimark H/P -HewlettPackard
The Hydrocolloid adhesive used with the Neolead is substantially equivalent to the Hydrocolloid in other Neotech predicated devices.
| NeoBar | NeoSmile |
|---|---|
| NeoBridge | NeoHold |
| NeoShades | NeoBond |
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p. 2/2
510 K SUMMARY CONTINUED
ELECTRICAL PERFORMANCE SUMMARY
The Neoleads meet the basic performance standards (3.2.2.1 AC Impedance, 3.2.2.2 DC Offset Voltage, 3.2.2.3 Combined Offset Instability and Internal Noise, 3.2.2.4 Defibrillation Overload Recovery, 3.2.2.5 Bias Current Tolerance) of the AAMI for Disposable ECG Electrodes.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized caduceus symbol, which features a staff entwined with a serpent.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 3 2002
Arnold M. Heyman, M.D. Neotech Products, Inc. 9135-F Alabama Ave. Chatsworth, CA 91311
Re: K011564 Trade Name: NeoLead Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: Not Dated Received: October 5, 2001
Dear Dr. Heyman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Arnold M. Heyman, M.D
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Donlin Telle
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indication for Use
The NeoLead Hydrocolloid/ Hydrogel electrode is intended to be used for resting ECG monitoring on neonatal and pediatric patients in a hospital setting.
Division of Cardiovascular & Respiratory Devices
510(k) Number K011564
Prescription Use
(Per 21 CFR 801.109)
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.