(89 days)
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No
The summary describes a disposable ECG electrode, a passive device, and contains no mention of AI, ML, or any computational processing.
No
The device is described as ECG electrodes, which are used for diagnostic purposes (recording electrical activity of the heart), not for treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is for "Standard ECG Applications." ECG (Electrocardiography) is a diagnostic tool used to measure and record the electrical activity of the heart to assess cardiac function and diagnose heart conditions. Therefore, a device used in ECG applications serves a diagnostic purpose.
No
The 510(k) summary describes ECG electrodes, which are hardware components used to acquire physiological signals. It does not describe a software-only device.
Based on the provided information, the Ambu General Purpose Disposable ECG Electrodes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "Standard ECG Applications." ECG (Electrocardiogram) is a method of measuring electrical activity of the heart, which is a physiological process within the body.
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological or pathological state.
ECG electrodes are applied to the skin to detect electrical signals from the heart in vivo (within the body). They are part of a system that measures a physiological function, not a device that analyzes a sample outside the body.
N/A
Intended Use / Indications for Use
Ambu General Purpose Disposable ECG Electrodes are intended for use in all Standard ECG Applications. Electrodes are made for single patient use only.
Product codes
DRX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Public Health Service
Image /page/0/Picture/2 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 2004
Ambu, Inc. c/o Mr. Sanjay Parikh Technical and Regulatory Affairs 611 North Hammonds Ferry Road Linthicum, MD 21090-1356
Re: K041734
Trade Name: Ambu Disposable ECG Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: DRX Dated: June 22, 2004 Received: June 25, 2004
Dear Mr. Parikh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave acterings ally marketed predicate devices marketed in interstate 101 use stated in the encrosaly to togally to the Medical Device Amendments, or to connineres provision to May 20, 1978, the excordance with the provisions of the Federal Food. Drug. devices mat have boon results in a were approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercetore, market the act include requirements for annual registration, listing of general controls proficions of aactice, 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 If your device is elassified (600 about of ols. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our acements concerning your device in the Federal Register.
1
Page 2 -- Mr. Sanjay Parikh
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dris brissantes vour device complies with other requirements of the Act that I DA has made a decemments ons administered by other Federal agencies. You must or any I cacial stututios and regeranents, including, but not limited to: registration and listing (21 Comply with an the fict brequirements)01); good manufacturing practice requirements as set CFR Part 6077, adoning (21 CFR Part 820); and if applicable, the electronic forth in the qualis (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) This letter will anow yourse ough finding of substantial equivalence of your device to a legally premarket notication: "The Prix mailing sification 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), please If you desire specific as no and (301) 594-4646. Also, please note the regulation entitled, eonador the Ories of Come to premarket notification" (21CFR Part 807.97) you may obtain. IMisoranding of reference to prescent to promotibilities under the Act may be obtained from the Other general miormation on Journational 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,
B. Simmerman for
Dr. D. Z. Isserman, MD
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K04/734
Device Name: Ambu Disposable ECG Electrode
Indications For Use:
Ambu General Purpose Disposable ECG Electrodes are intended for use in all Standard ECG Applications. Electrodes are made for single patient use only.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Blummmato
(Division Sign. Or
sion of Cardiovascular Det
510(k) Number K041734