(45 days)
Not Found
No
The 510(k) summary describes standard ECG electrodes, which are passive components and do not incorporate AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of such technology.
No
The device is described as an accessory to ECG equipment for monitoring and diagnostic procedures, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section states that the electrodes are for "diagnostic procedures."
No
The device is described as "pre-gelled, single patient use, disposable electrocardiographic electrodes," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the electrodes are for "use as an accessory to ECG equipment for long term or short term monitoring and diagnostic procedures". This describes a device used to acquire physiological signals from the body, not to test samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information about a patient's health status based on sample analysis.
Therefore, the ConMed ECG Monitoring Electrodes are considered a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ConMed" ECG Monitoring Electrodes are pre-gelled, single patient use, disposable electrocardiographic electrodes for use as an accessory to ECG equipment for long term or short term monitoring and diagnostic procedures with regular or diaphoretic adhesives.
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K954388, K944849, K944655, K945836, K946273
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
K09/856
P 1/2
510(k) Summary of Safety and Effectiveness
ConMed™ ECG Monitoring Electrodes
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number__
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502 Registration Number: 1320894
AUG 0 7 2009
B. Company Contact
Sandy Coveleski Regulatory Affairs Specialist ConMed Corporation 525 French Road Utica, NY 13502
Phone: 315-624-3435 Fax: 315-624-3225 e-mail: sandy_coveleski@mail.conmed.com
C. Device Name
| Trade Name: | ConMed" ECG Monitoring Electrodes |
|---|---|
| Common Name: | Electrocardiograph Electrode |
| CLASSIFICATION NAME: | Cardiovascular Devices |
| Proposed Class/Device: | Class II |
| Product Code: | DRX |
| Regulation Number: | 21 CFR 870.2360 |
| Panel: | 870 Cardiovascular |
1
K09/856
P2/2
D. Predicate Devices
ConMed 2710 CLEARTRACE 2LT Monitoring ECG Electrode ConMed Corporation 510(k) # K954388
2700 Cleartrace Radiotranslucent Monitoring ECG Electrode ConMed Andover Medical, Inc 510(k) # K944849
ECG Electrode ConMed Andover Medical, Inc 510(k) # K944655
1800 Monitoring ECG Electrode And 1870 Diaphoretic Monitoring ECG Electrodes ConMed Andover Medical, Inc 510(k) # K945836
1700 Monitoring ECG Electrode ConMed Andover Medical, Inc 510(k) # K946273
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
AUG 0 7 2009
ConMed Corporation c/o Ms. Sandra Coveleski Regulatory Affairs Specialist 525 French Road Utica, NY 13502
Re: K091856
Trade/Device Name: ConMed ECG Monitoring Electrode Regulatory Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (Two) Product Code: DRX Dated: July 14, 2009 Received: July 15, 2009
Dear Ms. Coveleski:
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.
3
Page 2 - Ms. Sandra Coveleski
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 (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
una R. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
K691856 510(k) Number (if known)
ConMed" ECG Monitoring Electrodes Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for use:
The ConMed" ECG Monitoring Electrodes are pre-gelled, single patient use, disposable electrocardiographic electrodes for use as an accessory to ECG equipment for long term or short term monitoring and diagnostic procedures with regular or diaphoretic adhesives.
Prescription Use X (Part 21 CFR 801 Subpart D) and/or
Over-the-counter Use (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nina R. Larios
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Ko 9185