(196 days)
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.
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
The provided 510(k) summary describes the Intco Tab Electrode, a disposable ECG electrode. This device does not involve AI or algorithms, so the majority of the requested information about AI model performance, training sets, and expert adjudication is not applicable.
Here's an analysis based on the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ANSI/AAMI EC12:2000/(R)2005 | Conforms to the standard |
| Biocompatibility (ISO 10993-1) | Non-irritating |
| Non-cytotoxic | |
| Non-sensitizing | |
| Shelf life | 24 months (accelerated aging tests performed) |
Study Details
The submission focuses on demonstrating substantial equivalence to a predicate device (Leonard Lang GmbH Skintact ECG Tab Electrode K030509) by showing compliance with recognized consensus standards and comparable physical/technical characteristics.
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Sample size used for the test set and the data provenance: Not explicitly stated as a clinical study with a "test set" in the context of an AI model. The performance evaluation is based on conformance to industry standards and biocompatibility testing. For the standards testing, specific sample sizes for tests within ANSI/AAMI EC12:2000/(R)2005 are not detailed, but standard conformance implies appropriate sampling for those tests. The data provenance is generally from laboratory testing performed by the manufacturer.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study requiring expert-established ground truth for an AI model. Biocompatibility testing results are laboratory-derived, and standard conformance is assessed against defined technical parameters.
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Adjudication method for the test set: Not applicable. There is no expert adjudication process described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrode, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have an algorithm.
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The type of ground truth used:
- Standard Conformance: The "ground truth" is defined by the technical specifications and test methods outlined in the ANSI/AAMI EC12:2000/(R)2005 standard for disposable ECG electrodes. The device performance is measured against these established parameters.
- Biocompatibility: The "ground truth" is established by the accepted scientific methodologies for assessing irritation, cytotoxicity, and sensitization as defined in ISO 10993-1.
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The sample size for the training set: Not applicable. This device does not utilize a training set as it is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable.
Summary of Device Evaluation:
The INTCO Tab Electrode's acceptance criteria and proven performance are primarily based on:
- Conformance to the ANSI/AAMI EC12:2000/(R)2005 consensus standard, which specifies requirements for characteristics such as impedance, DC offset, combined offset and offset instability, and input noise performance for disposable ECG electrodes. The submission states the device "have been tested and conform to recognized consensus standard."
- Biocompatibility testing according to ISO 10993-1, which demonstrated the conductive gel to be non-irritating, non-cytotoxic, and non-sensitizing.
- Accelerated aging tests to substantiate a 24-month shelf life.
The submission aims to demonstrate substantial equivalence to a legally marketed predicate device by showing that the INTCO Tab Electrode meets these established performance and safety benchmarks.
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510(K) Summary
093327
MAY 1 0 2010
| Date: | 10/22/2009 |
|---|---|
| Submitted on behalf of: | Michael ZhuShanghai Intco Electrode Manufacturing Co., Ltd.No. 1299, Hubin Rd, Fengxian DistrictShanghai ChinaTel: ++ 0086-21-57451159Fax: ++ 0086-21-57451877 |
| Submitted by: | Lead-Lok, Inc.814 Airport WaySandpoint, ID 83864 |
| Contact person: | Chris Healy, PresidentTel: 208-263-5071 Fax 208-263-9654 |
| Trade Name:Common Name:Classification NameProduct PanelProduct CodeProduct ClassRegulatory Reference: | INTCO Tab ElectrodeDisposable ECG ElectrodeElectrode, ElectrocardiographCardiovascularDRXClass II DeviceCFR 870.2360 |
| Predicate Device | Leonard Lang GmbH Skintact ECG Tab Electrode K030509 |
| Description: | INTCO Tab electrodes are composed of PET tape, Ag/AgCl or carbonconductive layer, and a conductive gel. These are configured as tenelectrodes applied to a siliconized card, with 10 cards per pouch |
| Intended Use: | INTCO Tab Electrodes are designed for use with generalelectrocardiographic procedures when ECG monitoring is deemednecessary by a physician. Such procedures include ECG surveillance anddiagnosis recording. INTCO Tab Electrodes are non-sterile and are to onlybe used on intact (uninjured) skin. |
| Substantial Equivalence: | INTCO Tab Electrodes with solid adhesive gel are substantially equivalent toSkintact ECG Tab Electrodes (K030509). Physical and technicalcharacteristics, including materials used, intended use, and conformance tostandards are comparable. |
| Performance Summary: | INTCO Tab Electrodes have been tested and conform to recognizedconsensus standard 3-52: ANSI/AAMI EC12:2000/(R)2005 |
| Biocompatibility: | The biological safety of the INTCO Tab electrodes has been assuredthrough the selection of materials which demonstrate appropriate levels ofbiocompatibility. The conductive gel has been tested on the basis of ISO10993-1 and found to be non-irritating, non-cytotoxic, and non sensitizing. |
| Shelf life: | Accelerated aging tests were performed to substantiate an expiration of 24months. |
| Conclusion: | INTO Tab Electrodes are substantially equivalent to the predicate deviceapproved as K020003 and do not introduce new issues of safety oreffectiveness. |
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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.
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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
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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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§ 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.