(196 days)
No
The device description and intended use are for simple ECG electrodes, which are passive components and do not incorporate AI/ML. There is no mention of AI, ML, or related concepts in the summary.
No.
The device is used for ECG monitoring and diagnosis recording, which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" states that the electrodes are designed for "ECG surveillance and diagnosis recording," indicating they are used in diagnostic procedures.
No
The device description clearly states it is composed of physical components (PET tape, Ag/AgCl or carbon conductive layer, conductive gel) and is applied to a siliconized card, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general electrocardiographic procedures when ECG monitoring is deemed necessary by a physician." This involves measuring electrical activity of the heart on the body, not analyzing samples outside the body.
- Device Description: The description details components like PET tape, conductive layers, and gel, which are typical for electrodes applied to the skin for physiological measurement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a component used in a procedure that measures a physiological signal directly from the body.
N/A
Intended Use / Indications for Use
INTCO Tab Electrodes are designed for use with general electrocardiographic procedures when ECG monitoring is deemed necessary by a physician. Such procedures include ECG surveillance and diagnosis recording. INTCO Tab Electrodes are non-sterile and are to only be used on intact (uninjured) skin.
Product codes
DRX
Device Description
INTCO Tab electrodes are composed of PET tape, Ag/AgCl or carbon conductive layer, and a conductive gel. These are configured as ten electrodes applied to a siliconized card, with 10 cards per pouch
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
INTCO Tab Electrodes have been tested and conform to recognized consensus standard 3-52: ANSI/AAMI EC12:2000/(R)2005
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(K) Summary
093327
MAY 1 0 2010
| Date: | 10/22/2009 |
|---|---|
| Submitted on behalf of: | Michael Zhu |
| Shanghai Intco Electrode Manufacturing Co., Ltd. | |
| No. 1299, Hubin Rd, Fengxian District | |
| Shanghai China | |
| Tel: ++ 0086-21-57451159 | |
| Fax: ++ 0086-21-57451877 | |
| Submitted by: | Lead-Lok, Inc. |
| 814 Airport Way | |
| Sandpoint, ID 83864 | |
| Contact person: | Chris Healy, President |
| Tel: 208-263-5071 Fax 208-263-9654 | |
| Trade Name: | |
| Common Name: | |
| Classification Name | |
| Product Panel | |
| Product Code | |
| Product Class | |
| Regulatory Reference: | INTCO Tab Electrode |
| Disposable ECG Electrode | |
| Electrode, Electrocardiograph | |
| Cardiovascular | |
| DRX | |
| Class II Device | |
| CFR 870.2360 | |
| Predicate Device | Leonard Lang GmbH Skintact ECG Tab Electrode K030509 |
| Description: | INTCO Tab electrodes are composed of PET tape, Ag/AgCl or carbon |
| conductive layer, and a conductive gel. These are configured as ten | |
| electrodes applied to a siliconized card, with 10 cards per pouch | |
| Intended Use: | INTCO Tab Electrodes are designed for use with general |
| electrocardiographic procedures when ECG monitoring is deemed | |
| necessary by a physician. Such procedures include ECG surveillance and | |
| diagnosis recording. INTCO Tab Electrodes are non-sterile and are to only | |
| be used on intact (uninjured) skin. | |
| Substantial Equivalence: | INTCO Tab Electrodes with solid adhesive gel are substantially equivalent to |
| Skintact ECG Tab Electrodes (K030509). Physical and technical | |
| characteristics, including materials used, intended use, and conformance to | |
| standards are comparable. | |
| Performance Summary: | INTCO Tab Electrodes have been tested and conform to recognized |
| consensus standard 3-52: ANSI/AAMI EC12:2000/(R)2005 | |
| Biocompatibility: | The biological safety of the INTCO Tab electrodes has been assured |
| through the selection of materials which demonstrate appropriate levels of | |
| biocompatibility. The conductive gel has been tested on the basis of ISO | |
| 10993-1 and found to be non-irritating, non-cytotoxic, and non sensitizing. | |
| Shelf life: | Accelerated aging tests were performed to substantiate an expiration of 24 |
| months. | |
| Conclusion: | INTO Tab Electrodes are substantially equivalent to the predicate device |
| approved as K020003 and do not introduce new issues of safety or | |
| effectiveness. |
1
Image /page/1/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, and three human faces in profile are visible within the eagle's body. The seal is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAY 1 0 2010
Shanghai Intco Electrode Manufacturing Co., Ltd c/o Mr. Chris Healy Lead-Lok, Inc. 814 Airport Way Sandpoint, ID 83864
Re: K093327
Trade/Device Name: Intco Tab Electrode Regulatory Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: II (two) Product Code: 74 DRX Dated: April 23, 2010 Received: April 27, 2010
Dear Mr. Healy:
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.
2
Page 2 - Mr. Chris Healy
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 (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.
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/ResourcesforYou/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
3
Indications for Use
KO73327 510(k) Number (if known):
Device Name: INTCO Tab Electrode
Indications for Use:
INTCO Tab Electrodes are designed for use in general electrocardiographic procedures where EG monitoring is deemed necessary and is ordered by a physician. Such procedures include patient ECG surveillance and ECG diagnosis recording. INTCO Tab Electrodes are non-sterile and are to be used on intact (uninjured) skin.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.C.
diovascular Devices
510(k) Number K093327
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