(9 days)
Not Found
No
The 510(k) summary describes a passive electrode device for ECG monitoring and diagnosis, with no mention of AI, ML, or any computational analysis of the ECG data.
No
Explanation: This device, ECG Tab Electrodes, is used for monitoring and diagnosis (ECG surveillance and recording), not for treating a condition.
Yes
The device is described as being used for "ECG diagnosis recording," which indicates a diagnostic function.
No
The device description explicitly states it is composed of physical components (PET tape, Ag/AgCl ink, conductive gel) and is configured as electrodes, 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 where ECG monitoring is deemed necessary and is ordered by a physician." This involves measuring electrical activity of the heart on the patient's body.
- Device Description: The device is an electrode applied to the skin.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device does not perform any analysis on a specimen outside the body.
The device is an accessory used in a diagnostic procedure (ECG), but the diagnostic analysis is performed by the ECG machine and interpreted by a physician, not by the electrode itself.
N/A
Intended Use / Indications for Use
PROTAB ECG Tab Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include patient ECG surveillance and ECG diagnosis recording. PROTAB ECG Tab Electrodes are nonsterile and are to be used on intact (uninjured) skin.
Product codes (comma separated list FDA assigned to the subject device)
DRX
Device Description
ECG Tab electrodes are composed of a PET tape, Ag/AgCl ink and a conductive gel. These are configured as 10 (ten) electrodes applied to a siliconized transparent PET card, ten 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
physician
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)
PROTAB ECG Tab Electrodes have been tested and conforms to ANSI/AAMI EC12:2000.
The biological safety of the PROTAB ECG Tab electrodes has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The tests were selected on the basis of ISO 10993-1, Biological Evaluation of Medical Devices - Part 1 - Guidance on selection of tests.
Accelerated aging testing was performed to substantiate an expiration of 24 months.
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.
Not Found
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.
0
2640784
page 1 of 2
APR - 7 2004
510(k) SUMMARY
Submitted For: Bio Protech Inc. 1720-26, Wonju Medical Instrument Industry Park Taejang-2 dong, Wonju-si, Gangwon-do Korea Submitted by: E. J. Smith
Smith Associates PO Box 4341 Crofton, MD 21114
January 16, 2004 Date of Submission:
Classification Name:
Electrode, Electrocardiograph Product Code DRX
Class II Device
PROTAB ECG TAB ELECTRODE Proprietary Name:
Common Name: ECG Electrode
Regulatory Reference: CFR 870.2360
Predicate Device: Bio Protech, Inc. Telectrode ECG Electrode K020003 Leonard Lang GmbH Skintact® ECG Tab Electrode K030509
Intended Use: PROTAB ECG Tab Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician.
Such procedures include patient ECG surveillance and ECG diagnosis recording. PROTAB ECG Tab Electrodes are nonsterile and are to be used on intact (uninjured) skin.
Description:
ECG Tab electrodes are composed of a PET tape, Ag/AgCl
1
K040784
page 2 of 2
ink and a conductive gel. These are configured as 10 (ten) electrodes applied to a siliconized transparent PET card, ten cards per pouch.
| Substantial Equivalence: | PROTAB ECG Tab Electrodes with solid adhesive gel are
substantially equivalent to the PROTABECG Tab
Electrodes with Skintact@ ECG Tab Electrodes (the
manufacturer's predicate - K030509). The Ag/AgCl ink
layer added for performance is substantially equivalent to
the Bio Protech PRO TECH electrode K020003. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Summary: | PROTAB ECG Tab Electrodes have been tested and
conforms to ANSI/AAMI EC12:2000 |
| Biocompatibility Testing: | The biological safety of the PROTAB ECG Tab electrodes
has been assured through the selection of materials which
demonstrate appropriate levels of biocompatibility. The
tests were selected on the basis of ISO 10993-1, Biological
Evaluation of Medical Devices - Part 1 - Guidance on
selection of tests. |
| Shelf Life: | Accelerated aging testing was performed to substantiate an
expiration of 24 months. |
| Conclusion: | This device is substantially equivalent to the devices
approved as K020003 and K030509 |
2
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 7 2004
Bio Protech, Inc. c/o Mr. Ned Devine Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548
Re: K040784
Trade Name: PROTAB ECG TAB ELECTRODE Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: DRX Dated: January 21, 2004 Received: March 29, 2004
Dear Mr. Smith:
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 - Mr. E. J. Smith
Please be advised that FDA's issuance of a substantial cquivalence 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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dwier R. Lochner
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
510(k) Number (if known): K 0 4 0 7 84
Device Name: PROTAB ECG TAB ELECTRODE
Indications for Use:
PROTAB ECG Tab Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician.
Such procedures include patient ECG surveillance and ECG diagnosis recording. PROTAB ECG Tab Electrodes are non-sterile and are to be used on intact (uninjured) skin.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Nuna R. Lochnes | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices |
510(k) Number_k040784
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(Posted November 13, 2003)