(128 days)
Not Found
Not Found
No
The summary describes a passive ECG electrode and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device's intended use is to transmit electrical signals for the production of an electrocardiogram or vectorcardiogram, which are diagnostic tools, not therapeutic interventions.
Yes
The device is described as transmitting an electrical signal to a processor that produces an electrocardiogram or vectorcardiogram, which are diagnostic tools used to assess heart function.
No
The device description explicitly states it is an "ECG Electrode," which is a physical hardware component used to acquire electrical signals from the body. The 510(k) is for changes to the labeling of this physical electrode.
Based on the provided information, the Nikomed TRACE 1™ ECG Electrode is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the electrode is used "on the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram." This describes a device that interacts with the body externally to capture a physiological signal.
- IVD Definition: In vitro diagnostics are devices used to examine specimens, including blood, urine, and tissue, that are taken from the human body to detect diseases, conditions, or infections. The Nikomed TRACE 1™ ECG Electrode does not involve the examination of specimens taken from the body.
- Anatomical Site: The anatomical site is "on the body," which further supports its external application rather than the analysis of internal specimens.
Therefore, the Nikomed TRACE 1™ ECG Electrode falls under the category of a medical device used for physiological signal acquisition, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nikomed TRACE 1™ ECG Electrode is indicated for use on the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. (CFR 870.2360)
Product codes
DRX
Device Description
The ECG electrode labels will have the TRACE 1™ name and will use pictographic instructions for use. This change applies to all currently marketed and any previously cleared (via premarket-notification) electrodes sold or distributed by NIKOMED USA, Inc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
on the body
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)
All currently 510(k) cleared NIKOMED ECG Electrodes.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
This special 510(k) is only for labeling changes.
§ 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
K022909
JAN 0 9 2003
510(k) Summary
SUBMITTER:
Submitted on behalf of:
| Company Name: | Nikomed U.S.A., Inc. |
|---|---|
| Address: | 206 Airport Blvd. |
| Doylestown, PA 18901 | |
| Telephone: | 215-230-8455 |
| Fax: | 215-230-8446 |
bv: Elaine Duncan, M.S.M.E., RAC
President, Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082 715-549-6035 Telephone: 715-549-5380
CONTACT PERSON: Elaine Duncan
DATE SUMMARY PREPARED: August 26, 2002
NIKOMED TRACE 1™ ECG Electrodes TRADE NAME: COMMON NAME: ECG Electrodes
SUBSTANTIALLY EQUIVALENT TO: All currently 510(k) cleared NIKOMED ECG Electrodes. This special 510(k) is only for labeling changes.
DESCRIPTION of the DEVICE:
Fax:
The ECG electrode labels will have the TRACE 1™ name and will use pictographic instructions for use. This change applies to all currently marketed and any previously cleared (via premarket-notification) electrodes sold or distributed by NIKOMED USA, Inc.
INDICATIONS FOR USE: No change
CLINICAL INFORMATION and SAFETY and EFFECTIVENESS:
This special 510(k) just concerns labeling changes.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines that converge to form the body and wings.
JAN 0 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nikomed U.S.A., Inc. c/o Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082
Re: K022909
Trade Name: Nikomed ECG Electrodes Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: December 9, 2002 Received: December 10, 2002
Dear Ms. Duncan:
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 vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FLA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Elaine Duncan, M.S.M.E., RAC
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), please contact the Office of Compliance at (301) 5944646. 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) you may obtain. 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 vours.
V. Qalattell
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known) | K022909 |
|---|---|
| Device Name: | Nikomed ECG Electrodes |
Indications for Use:
The Nikomed TRACE 1™ ECG Electrode is indicated for use on the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. (CFR 870.2360)
(Please Do Not Write Below This Line-Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over -The-Counter Use |
|---|---|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K022909 |
|---|---|
| --------------- | --------- |