(145 days)
No
The summary describes a simple, disposable electrode for ECG monitoring and does not mention any AI or ML components or functionalities.
No
The device is used for monitoring ECG signals, which is a diagnostic function, not a therapeutic one. It does not actively treat or alleviate a medical condition.
No
Explanation: The device is an ECG electrode used for monitoring, not for diagnosing a condition. It collects data for observation rather than providing a diagnostic interpretation.
No
The device description clearly outlines physical components like conductive gel, eyelet, cloth substrate, wire, and socket, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Tender-Trode® Prewired electrode is an external electrode placed on the skin to monitor electrical activity of the heart (ECG). It does not analyze any bodily fluids or tissues.
- Intended Use: The intended use clearly states "resting ECG monitoring on neonatal and pediatric patients." This is a non-invasive external measurement, not an in vitro test.
Therefore, based on the provided information, the Tender-Trode® Prewired electrode is a medical device, but it falls under the category of external diagnostic devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Tender-Trode® Prewire is a disposable, noninvasive electrode intended to be used for resting ECG monitoring on neonatal and pediatric patients in a hospital setting. These electrodes can be used for shortterm or long-term applications, up to 24 hours. The Tender-Trode® prewired electrodes are single-use, nonsterile, disposable and are to be used on intact (uninjured) skin.
Product codes
DRX
Device Description
A conductive solid gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated ABS eyelet, an adhesive cloth substrate, vinyl label, 24" wire w/.060 dia. female socket and polystyrene release liner.
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
neonatal and pediatric patients
Intended User / Care Setting
hospital setting
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)
The device was tested and demonstrated conformance with internationally recognized consensus standards. Test results indicate that this device meets or exceeds the performance specifications as established in EC12:2000 for Disposable ECG Electrodes. In addition, the device was found to meet EC12:2000 AAMI standard for labeling, shelf life, packaging and safety. A certification to conformance with this standard has been provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bunny Electrode/Stealth Electrode Pre Wired ECG, Lead-Lok, Inc., K911529
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
JUN 17 2009
510(k) SUMMARY 16.
510(K) SUMMARY of Safety and Effectiveness (as required by 21 CFR 807.92)
Date:
January 12, 2009
(800) 245-4025
Manufacturer:
Vermed, Inc. 9 Lovell Drive Bellows Falls, VT 05101 Registration Number 1219288
Telephone:
Contact Person:
Marc Fillion VP of Quality & Regulatory Affairs (800) 245-4025, Extension 1205 Fax Number: (802) 463-9228
Device Trade Name:
Tender-Trode® Prewired ECG Electrodes
Common Name:
Disposable ECG Monitoring Electrode
Electrocardiograph Electrode Classification Name:
74 DRX Regulatory Reference:
Predicate Device:
Bunny Electrode/Stealth Electrode Pre Wired ECG, Lead-Lok, Inc., K911529
A conductive solid gel electrode consisting of a Description: conductive adhesive gel, a silver/silver chloride plated ABS eyelet, an adhesive cloth substrate, vinyl label, 24" wire w/.060 dia. female socket and polystyrene release liner.
1
Intended Use:
The Tender-Trode® Prewire is a disposable, noninvasive electrode intended to be used for resting ECG monitoring on neonatal and pediatric patients in a hospital setting. These electrodes can be used for shortterm or long-term applications, up to 24 hours. The Tender-Trode® prewired electrodes are single-use, nonsterile, disposable and are to be used on intact (uninjured) skin.
Physical/Technical Comparison:
Tender-Trode® Prewired ECG Electrodes are technologically equivalent to the predicate device. Physical and technical characteristics, including materials used in construction, size, intended use and conductive gel are comparable.
The device was tested and demonstrated conformance Performance Summary: with internationally recognized consensus standards. Test results indicate that this device meets or exceeds the performance specifications as established in EC12:2000 for Disposable ECG Electrodes. In addition, the device was found to meet EC12:2000 AAMI standard for labeling, shelf life, packaging and safety. A certification to conformance with this standard has been provided.
The solid conductive gel underwent skin sensitivity Biocompatibility Testing: testing as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact. These tests include Cytotoxicity, Sensitization, and Primary Skin Irritation (test results attached). The materials were found to be non-irritating, non-cytotoxic, and non-sensitizing.
Shelf Life:
Data obtained in accelerated shelf life studies was reviewed and found to substantiate our claimed shelf life.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
JUN 17 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Vermed, Inc. c/o Mr. Marc Fillion VP of Quality & Regulatory Affairs 9 Lovell Drive Bellows Falls, VT 05101
Re: K090180
Tender-Trode® Prewired ECG Electrodes Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: May 7, 2009 Received: May 8, 2009
Dear Mr. Fillion:
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 vour 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 - Mr. Marc Fillion
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 (OS) 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,
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 5.
510(k) Number (if known):
Device Name: Tender-Trode® Prewired ECG Electrodes
Indications for Use:
The Tender-Trode® Prewired electrode is a disposable, noninvasive electrode that is intended to be used for resting ECG monitoring on neonatal and pediatric patients in a hospital setting. These electrodes can be used for short-term or long-term applications, up to 24 hours. The Tender-Trode of prewired electrodes are single-use, non-sterile, disposable and are to be used on intact (uninjured) skin.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
for B Zuckermo
Division Sign-Off
6/17/09
Division of Cardiovascular Devices
510(k) Number K090180