(45 days)
Not Found
No
The document describes a passive electrode designed to acquire ECG signals. There is no mention of any processing or analysis of these signals using AI/ML.
No.
The device is intended to acquire ECG signals, which is for diagnostic and monitoring purposes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The CenterRidge Diagnostic ECG Electrode is a diagnostic, single use (single patient), disposable ECG electrode."
No
The device is described as ECG surface electrodes, which are physical hardware components used to acquire ECG signals. The description details the materials and construction of these electrodes, indicating it is a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the CenterRidge ECG Electrodes are intended to "acquire ECG signals from the surface of the body." This is a non-invasive process that measures electrical activity of the heart from the skin.
- No Mention of Samples: There is no mention of collecting or analyzing any biological samples from the patient.
Therefore, the device falls under the category of medical devices used for physiological monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The subject devices are ECG surface electrodes and will be manufactured in two configurations: one for diagnostic ECG use (CenterRidge Diagnostic ECG Electrode) and one for monitoring ECG use (CenterRidge Monitoring ECG Electrode).
The CenterRidge Diagnostic ECG Electrode is a diagnostic, single use (single patient), disposable ECG electrode. This electrode is intended to acquire ECG signals from the surface of the body. The intended population is adults and pediatrics. The intended duration of body contact is less than 24 hours.
The CenterRidge Monitoring ECG Electrode is a monitoring, single use (single patient). disposable ECG electrode. This electrode is intended to acquire ECG signals from the surface of the body. The intended population is adults and pediatrics. The intended duration of body contact is greater than 24 hours but less than 30 days.
Product codes (comma separated list FDA assigned to the subject device)
DRX
Device Description
The CenterRidge ECG Electrodes are non-traditional tab electrodes, capable of diagnostic or monitoring use, depending on materials used in construction, and are intended to acquire ECG signals from the surface of the body. Both the CenterRidge Diagnostic ECG Electrode and CenterRidge Monitoring ECG Electrode are of multilayer construction, using medical grade foam or cloth backing material, a silver/silver chloride coated sensing element and solid hydrogel. The raw materials used in the CenterRidge Electrodes are equivalent to the materials used in the predicate legally marketed ECG electrodes specified above. The intended patient population is adult and pediatric. The skin surface contact area and proportional electrode size will be adjusted to fit the specific procedure and patient population. The primary difference between the CenterRidge Electrodes and the predicate devices are geometry and shape. The 3M Health Care model 2330 and the Bio-Detek model DE1070 are traditional tab electrodes with a tab sensing element located on the perimeter of the electrode, whereas the Team Innovation CenterRidge electrode has the sensing element located within the body of the electrode. The internal location of the CenterRidge sensing element emulates the snap on the Bio-Detek models LT301SG(PSG), LT401SG(PSG) and LT401SG(PSG).
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of the body
Indicated Patient Age Range
The intended population is adults and pediatrics.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The CenterRidge electrodes were subjected to non-clinical, bench testing for electromagnetic compatibility conformance to the industry standard ANSI/AAMI EC12:2000/(R)2005. The CenterRidge electrodes passed all electrical performance tests per the ANSI/AAMI EC12:2000/(R)2005 standard. The CenterRidge electrodes were not clinically tested. Based on the CenterRidge electrodes satisfactorily passing all electrical compatibility tests and conforming to ANSVAAMI EC12:2000/(R)2005, the CenterRidge ECG Electrodes are as safe and effective as the predicate devices.
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.
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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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Image /page/0/Picture/0 description: The image shows the logo for "TEAM innovations". The logo features a heart shape formed by a stethoscope, with the word "TEAM" in bold, uppercase letters and the word "innovations" in lowercase letters below it. The stethoscope is positioned to the left of the text, with the earpieces forming the top of the heart and the tubing extending down to the chest piece.
510(K) Summary
101576
July 17, 2010
510(K) Owner and Submitter: Team Innovations, Inc. 2521 S. 98th Street West Allis, WI 53227
JUL 2 2 2010
Phone Number: 262-617-6980 Fax Number: 262-789-9183
Principal point of contact: Mark Tiegs Direct Phone Number for Mark Tiegs: 262-617-6980
This 510(K) submission is for:
Trade Name: CenterRidge Diagnostic ECG Electrode, and CenterRidge Monitoring ECG Electrode Common Name: Electrocardiograph (ECG) electrode Class II device Classification panel 74 Product Code DRX Regulation number 870.2360
Team Innovations claims that the CenterRidge electrodes are substantially equivalent to several predicate legally marketed devices:
- 3M Health Care, Red Dot Resting EKG Electrode, catalog number 2330 covered t by 510(K) number K932454, and
- Bio-Detek. Inc., Trace Rite Solid Gel ECG Electrodes, part numbers DE1070, . LT301SG(PSG), LT401SG(PSG) and LT601SG(PSG), covered by 510(K) number K964213.
The CenterRidge ECG Electrodes are non-traditional tab efectrodes, capable of diagnostic or monitoring use, depending on materials used in construction, and are intended to acquire ECG signals from the surface of the body. Both the CenterRidge Diagnostic ECG Electrode and CenterRidge Monitoring ECG Electrode are of multilayer construction, using medical grade foam or cloth backing material, a silver/silver chloride coated sensing element and solid hydrogel. The raw materials used in the CenterRidge Electrodes are equivalent to the materials used in the predicate legally marketed ECG electrodes specified above. The intended patient population is adult and
2521 South 98th Street · West Allis, WI 53227 · 414.687.1078
1
pediatric. The skin surface contact area and proportional electrode size will be adjusted to fit the specific procedure and patient population.
The primary difference between the CenterRidge Electrodes and the predicate devices are geometry and shape. The 3M Health Care model 2330 and the Bio-Detek model DE1070 are traditional tab electrodes with a tab sensing element located on the perimeter of the electrode, whereas the Team Innovation CenterRidge electrode has the sensing element located within the body of the electrode. The internal location of the CenterRidge sensing element emulates the snap on the Bio-Detek models LT301SG(PSG), LT401SG(PSG) and LT401SG(PSG).
The CenterRidge electrodes were subjected to non-clinical, bench testing for electromagnetic compatibility conformance to the industry standard ANSI/AAMI EC12:2000/(R)2005. The CenterRidge electrodes passed all electrical performance tests per the ANSI/AAMI EC12:2000/(R)2005 standard. The CenterRidge electrodes were not clinically tested. Based on the CenterRidge electrodes satisfactorily passing all electrical compatibility tests and conforming to ANSVAAMI EC12:2000/(R)2005, the CenterRidge ECG Electrodes are as safe and effective as the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol representing human services, often referred to as the "Human Services Insignia," which is composed of three abstract shapes resembling people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Team Innovations, Inc. c/o Mr. Mark D. Tiegs VP & General Manager 2521 South 98th Street West Allis, Wisconsin 53227
1JUL 2 2 2010
Re: K101576
Trade/Device Name: CenterRidge Diagnostic ECG Electrode: and, CenterRidge Monitoring ECG Electrode
Regulatory Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrodes Regulatory Class: Class II (Two) Product Code: DRX Dated: June 1, 2010 Received: June 7, 2010
Dear Mr. Tiegs:
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 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 - Mr. Mark D. Tiegs
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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Image /page/4/Picture/0 description: The image shows the logo for "TEAM innovations". To the left of the text is a drawing of a heart with a question mark inside. A line extends from the bottom of the heart to the bottom of the image, resembling a pen or writing utensil. The text "TEAM" is in bold, uppercase letters, while "innovations" is in lowercase letters.
Indication for Use
101576
510(k) Number K101576:
Device Name: CenterRidge Diagnostic ECG Electrode, and CenterRidge Monitoring ECG Electrode
Indication For Use:
The subject devices are ECG surface electrodes and will be manufactured in two configurations: one for diagnostic ECG use (CenterRidge Diagnostic ECG Electrode) and one for monitoring ECG use (CenterRidge Monitoring ECG Electrode).
The CenterRidge Diagnostic ECG Electrode is a diagnostic, single use (single patient), disposable ECG electrode. This electrode is intended to acquire ECG signals from the surface of the body. The intended population is adults and pediatrics. The intended duration of body contact is less than 24 hours.
The CenterRidge Monitoring ECG Electrode is a monitoring, single use (single patient). disposable ECG electrode. This electrode is intended to acquire ECG signals from the surface of the body. The intended population is adults and pediatrics. The intended duration of body contact is greater than 24 hours but less than 30 days.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or --
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Exaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(K)
tic Device Evaluation and Safety (OIVLD
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number
Page 6.1
2521 South 98th Street . West Allis, WI 53227 . 414.687.1078