(243 days)
Not Found
No
The 510(k) summary describes a passive electrode for EKG procedures and makes no mention of AI or ML technology.
No.
The device is described as an EKG electrode used for diagnostic procedures, specifically for obtaining electrical signals from the heart, rather than for treatment or therapy.
No
The device, a 3M Red Dot™ Resting EKG Electrode, is a component used during an EKG diagnostic procedure. It is applied to the patient's skin to conduct electrical signals to an electrocardiograph, which is the diagnostic device. The electrode itself performs no diagnostic function.
No
The device description clearly states it is a physical electrode with conductive adhesive and backing, which are hardware components.
Based on the provided information, the 3M Red Dot™ Resting EKG Electrode is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- The 3M Red Dot™ Resting EKG Electrode is applied to the patient's skin to capture electrical signals from the heart. It is a device used on the patient, not with a specimen taken from the patient.
The description clearly states its use is for an EKG diagnostic procedure while resting, applied to the patient's skin. This aligns with the definition of a medical device used for diagnosis in vivo (on the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The 3M Red Dot™ Resting EKG Electrode can be used on a patient undergoing an EKG diagnostic procedure while resting. These electrodes are applied to the patient's skin for short term use. These electrodes are disposable and are for single use. They are not indicated for use in long term monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DRX
Device Description
3M Red Dot™ Resting EKG Electrode, Catalog Number 2360 has a conductive adhesive which is laminated to a conductive Ag/AgCl backing. The conductive backing has a tab end for connection to the electrocardiograph leadwire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
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)
Performance Testing:
The electrical performance of the 3M Red Dot™ 2360 Resting EKG Electrode has been tested and meets the voluntary standard requirements under ANSI/AAMI EC12/1991, for Disposable ECG Electrodes.
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.
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.
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JUL 26 1998
510(k) Premarket Notification Submission 3M Red Dot™ Resting EKG Electrode, 2360
Page 44 of 45
510(K) Summary
Name and address of device Manufacturer submitting 510(k) Notification:
3M Medical Markets Group 3M Health Care 3M Center St. Paul, MN 55144-1000
Regulatory Correspondent of Device Manufacturer:
Linda Johnsen Requlatory Affairs Specialist 3M health Care Building 275-3E-08 612 737-4376
Date Summary was prepared: November 21, 1997
Name of Device: 3M Red Dot™ Resting EKG Electrode, Catalog Number 2360
Classification: Electrocardiograph electrodes, class II, 21 CFR 870.2360
Description:
3M Red Dot™ Resting EKG Electrode, Catalog Number 2360 has a conductive adhesive which is laminated to a conductive Ag/AgCl backing. The conductive backing has a tab end for connection to the electrocardiograph leadwire.
Indications for Use:
The 3M Red Dot™ Resting EKG Electrode can be used on a patient undergoing an EKG diagnostic procedure while resting. These electrodes are applied to the patient's skin for short term use. These electrodes are disposable and are for single use. They are not indicated for use in long term monitoring.
Predicate Device:
The predicate device used for the purpose of substantial equivalence and used for comparison was 3M Red Dot™ Resting EKG Electrode, Catalog Number 2330 which was filed and cleared under 510(k) Number K932454. The significant difference between the 2330 and 2360 is that the 2360 introduces a new conductive adhesive which increases the adhesion of the electrode. The electrode backing and liner of the 2360 are also different but the changes are minor when compared to the 2330.
1
Safety and Efficacy:
Biocompatibility Testing:
The biological safety of the Red Dot™ 2360 Resting EKG Electrode has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. Tests were selected on the basis of Part-1 of ISO 10993-1, "Biological Evaluation of Medical Devices".
Performance Testing:
The electrical performance of the 3M Red Dot™ 2360 Resting EKG Electrode has been tested and meets the voluntary standard requirements under ANSI/AAMI EC12/1991, for Disposable ECG 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 a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL -26 1998
Ms. Linda Johnsen Regulatory Affairs Specialist 3M Health Care 3M Center, Building 275-3E-08 St. Paul, MN 55114-1000
K974445 Re : 3M Red Dot™ Resting EKG Electrode Model 2360 Regulatory Class: II (two) Product Code: DRX Dated: April 22, 1998 Received: April 27, 1998
Dear Ms. Johnsen:
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 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 regulations 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 Failure to comply with the GMP requlation may result in assumptions. regulatory 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 regulations.
3
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" (21 CFR 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahane
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (If Known): ________
Device Name: 3M Red Dot™ 2360 EKG Resting Electrode
Indications For Use:
The 3M Red Dot™ Resting EKG Electrode can be used on a patient undergoing an EKG diagnostic procedure while resting. These electrodes are applied to the patient's skin for short term use. These electrodes are disposable and are for single use. They are not indicated for use in long term monitoring.
These electrodes will include the precaution statement: U.S.A. Federal Law restricts this device to sale by or on the order of a physician.
(Please do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the Counter Use
(Optional Format 1-2-96)
| Labels | Values |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K974445 |