(143 days)
Not Found
None
No
The summary describes a standard ECG electrode and does not mention any AI or ML components or functionalities.
No
The device is described as electrodes used to transmit electrical signals for producing an electrocardiogram or vectorcardiogram, which are diagnostic tools rather than therapeutic interventions.
Yes
The device is used to produce an electrocardiogram or vectorcardiogram by transmitting electrical signals from the body surface to a processor. An electrocardiogram is a diagnostic tool used to assess heart conditions.
No
The device description explicitly mentions "ECG electrodes" which are hardware components applied to the body surface.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram." This describes a device that measures physiological signals directly from the body surface.
- Anatomical Site: The anatomical site is the "surface of the body." This further reinforces that the device interacts with the body directly, not with a sample taken from the body.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The description of this device does not involve the analysis of any such specimen.
Therefore, this device falls under the category of a medical device that measures physiological signals, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ECG electrodes is applied to surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for measuring ECG under Anaesthesia.
Product codes
DRX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Anaesthesia use
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2002
Medicotest, A/S c/o Ms. Emalee G. Murphy Kirkpatrick & Lockhart LLP 1800 Massachusetts Avenue, NW Suite 200 Washington, DC 20036-1221
Re: K020382
Trade Name: ECG Electrode for Anesthesia use Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: May 3, 2002 Received: May 6, 2002
Dear Ms. Murphy:
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.
1
Page 2 - Ms. Emalee G. Murphy
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,
Donna-Bea Tillman, Ph.D.
Acting Director
Division of Cardiovascular
and Respiratory Devices
and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K020382
Page of ﻠﺴﻨﺎ 1
K020382 510 (k) Number (if known):
Device Name: ECG Electrode for Anaesthesia use
Indications For Use:
The ECG electrodes is applied to surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for measuring ECG under Anaesthesia.
(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 | |
| and Respiratory Devices | |
| 510(k) Number | K020382 |
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
| OR |
|---|
| ---- |
| Over-The-Counter Use
| (Optional format 1-2-96) | |
|---|---|
| -------------------------------------------------- | -- |