(327 days)
Not Found
No
The device description is for simple ECG electrodes, and there is no mention of AI, ML, or any processing capabilities beyond basic signal acquisition.
No
The device is described as "ECG monitoring electrodes for short-term use," which are diagnostic tools used to record electrical activity of the heart, not to directly treat a condition. While monitoring can inform therapeutic decisions, the electrodes themselves do not provide therapy.
No
Explanation: The intended use states "ECG monitoring electrodes for short-term use." The device description further details its construction and packaging. While ECG monitoring is a step in diagnosing, the electrodes themselves are for data collection (monitoring), not for providing a diagnosis.
No
The device description explicitly details physical components (pregelled electrodes, sensor element, adhesive part, packaging) and does not mention any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "ECG monitoring electrodes for short-term use." This clearly indicates the device is used to acquire physiological signals from the body (electrical activity of the heart) for monitoring purposes.
- Device Description: The description details the physical components of an electrode designed to be placed on the skin to pick up electrical signals.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests in vitro (outside the living body) on biological samples. This device is used in vivo (on the living body) to acquire electrical signals.
N/A
Intended Use / Indications for Use
ECG monitoring electrodes for short-term use.
Product codes (comma separated list FDA assigned to the subject device)
DRX
Device Description
Pregelled electrodes are of Aq/AqCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K950473, K950475, K950474, K950480, K950477
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
DEC - 6 1999
510 (k) SUMMARY
ADMINISTRATIVE 1.
- Maersk Medical A/S Submitter: Niko Business Unit Engmosen 1 DK-3540, Lynge Denmark Phone No .: 011 45 48 16 70 30
Contact Person: Mr. Christian Pelch
Date of Preparation: January 11, 1999
ll. DEVICE NAME
Proprietary Name: Niko ECG Monitoring Electrodes Common Name: ECG Electrode Classification Name: Electrocardiograph Electrode
== PREDICATE DEVICES
Disposable ECG Monitoring Electrode Models 4500 (K950473), 4530 and 4540 (K950475), 4533 (K950474), 4539 (K950480) and 4560 (K950477); Nikomed USA, Inc.
IV. DEVICE DESCRIPTION
Pregelled electrodes are of Aq/AqCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.
v. INTENDED USE
ECG monitoring electrodes for short-term use.
1
VI. COMPARISON TO PREDICATE DEVICES
The Niko ECG Monitoring Electrodes are identical in composition, function and design, and have the same intended use as the legally marketed disposable ECG monitoring electrodes Models 4500 (K950473), 4530 and 4540 (K950475), 4533 (K950474), 4539 (K950480) and 4560 (K950477); Nikomed USA, Inc. Accordingly Maersk Medical A/S concluded that the Niko ECG Monitoring Electrodes Models 4500, 4530, 4533, 4539, 4540 and 4560 are safe and effective for their intended use and perform at least as well as other disposable ECG monitoring electrodes.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized eagle or bird-like figure with three curved lines above it, representing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 1999
Maersk Medical A/S c/o Mr. Richard A. Hamer Consultant to Maersk Medical A/S . Richard Hamer Associates, Inc. P.O. Box 16598 Ft. Worth, TX 76132
Re: K990113 Disposable ECG Monitoring Electrodes Models 4500, 4530, 4533, 4539, 4540 and 4560 Regulatory Class: II (two) Product Code: DRX Dated: October 15, 1999 Received: October 18, 1999
Dear Mr. Hamer:
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 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 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 Requlation (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 requlation 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 requlations.
3
Page 2 - Mr. Richard A. Hamer
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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Don Vh Tilli
ia M. Witten, Ph.D., M.D. Acting 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):
Niko ECG Monitoring Electrodes Device Name:
Indications for Use:
ECG monitoring electrodes for short term use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number ___[K990113](https://510k.innolitics.com/search/K990113)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use ___
(Optional Format 1-2-96)