(309 days)
Not Found
No
The description focuses on the physical and electrical properties of the electrode, with no mention of AI or ML for signal processing or interpretation.
No
The device is used to record electrical signals from the body surface for diagnostic purposes (producing an electrocardiogram), not to provide treatment or therapy.
Yes
The device is an electrocardiograph electrode used to transmit electrical signals from the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram. ECGs are diagnostic tools used to record and analyze the electrical activity of the heart to diagnose conditions such as arrhythmias, myocardial infarction, and other cardiac abnormalities.
No
The device description clearly states it is a physical electrode with a sensing element and adhesive gel, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "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." This describes a device that interacts with the body's electrical signals, not with samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on the physical components and properties of the electrode (self-adhesive, non-sterile, single use, Ag/Agc1 sensing element, hydro gel, foam). This aligns with a device used for external physiological measurement.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This ECG electrode is a device used on the body to capture electrical signals, which is a different category of medical device.
N/A
Intended Use / Indications for Use
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.
ECG electrodes are used to record the following ECGs from a patient: Resting ECG, Exercise ECG and/or ambulatory (Holter) monitoring.
Product codes
DRX
Device Description
Bio Protech electrodes are self-adhesive, non-sterile, single use disposable ECG electrodes. All include an Ag/Agc 1 sensing element and the solid adhesive hydro gel has very low impedance level. Most importantly, the adhesive gel sticks on both skin of patient and the sensing element so that the movement artifact can be significantly lowered. The adhesive qualities of the foam is strong enough to use for stress test and holter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of the body
Indicated Patient Age Range
The intended patient population can be adult, pediatric and neonatal.
Intended User / Care Setting
medical device suppliers, Dentist and Doctor Offices, Clinics, Emergency Response Professionals, Hospitals and other healthcare professionals for the Intended Use purposes below, and will be appropriately labeled in accordance with Title 21 CFR Part 801.
hospital (or clinic), ambulance, or daily use environment (for Holter monitoring).
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 electrical performance of BIO PROTECH ECG electrodes meets the requirements of the Medical Devices Directive: EU Council Directive 93/42/EEC, ANSI/AAMI ec12-2000, and has been issued a Certificate of Conformity (01-KOR-MDD-0003).
The biological safety of the PRO TECH ECG 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.
Data obtained in real time shelf life studies was reviewed and found to substantiate the 24 month shelf life claim.
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
K020003 网上
510(k) SUMMARY
| Submitted For: | BIO PROTECH INC.
303 Boryung B/D 37-10
Kangnam Ku,
Seoul, Korea 135-090 | NOV 7 2002 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Submitted by: | TUCKER & ASSOCIATES
Official Correspondent and United States Agent for
Bio Protech Inc.
JANNA P. TUCKER, President -- CEO
198 Avenue de la D'emerald
Sparks, NV 89434
Phone: 775-342-2612 Fax: 775-342-2613
E-mail: Tuckerjan@aol.com | |
| Date of Submission: | | |
| Classification Name: | ELECTRODE, ELECTROCARDIOGRAPH
Product Code: DRX
Class II Device | |
| Proprietary Name: | (Multiple Labels) Telectrode ECG Electrode | |
| Common Name: | ECG Electrode | |
| Regulatory Reference: | CFR 870.2360 | |
| Predicate Device: | Skintact™ ECG Electrodes (K982521) | |
| Labels/Labeling: | This device will be marketed to medical device suppliers,
Dentist and Doctor Offices, Clinics, Emergency Response
Professionals, Hospitals and other healthcare professionals
for the Intended Use purposes below, and will be
appropriately labeled in accordance with Title 21 CFR
Part 801. | |
| Intended Use: | 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. | |
EXHIBIT K
Page 96 of 97
1
| Description: | Bio Protech electrodes are self-adhesive, non-sterile, single
use disposable ECG electrodes. All include an Ag/Agc 1
sensing element and the solid adhesive hydro gel has very
low impedance level. Most importantly, the adhesive gel
sticks on both skin of patient and the sensing element so
that the movement artifact can be significantly lowered.
The adhesive qualities of the foam is strong enough to use
for stress test and holter. |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | This device is equivalent to those in commercial
distribution for use in general electrocardiographic
procedures where ECG monitoring is deemed necessary
and is ordered by a physician. |
| | Both in its intended use and/or physical characteristics, this
device is equivalent to devices currently marketed by U.S.
companies. It is substantially equivalent to the device
manufactured by Leonhard Lang GmbH under K982521. |
| Performance Summary: | The electrical performance of BIO PROTECH ECG
electrodes meets the requirements of the Medical Devices
Directive: EU Council Directive 93/42/EEC, ANSI/AAMI
ec12-2000, and has been issued a Certificate of Conformity
(01-KOR-MDD-0003) |
| Biocompatibility Testing: | The biological safety of the PRO TECH ECG 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: | Data obtained in real time shelf life studies was reviewed
and found to substantiate the 24 month shelf life claim. |
| Conclusion: | This device is substantially equivalent to the device
approved as K982521. |
EXHIBIT K
Page 97 of 97
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a simple, sans-serif font. The text is likely part of a document or form from the U.S. Department of Health and Human Services.
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font. The text is slightly blurred, suggesting it may be part of a larger document or image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bio ProTech, Inc. c/o Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D'emerald Sparks, NV 89434-9550
Re: K020003
Trade Name: Electrocardiograph (ECG) Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: August 6, 2002 Received: August 9, 2002
Dear Ms. Tucker:
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 – Ms. Janna P. Tucker
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Elis Molles
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
BIO PROTECH, INC. APPLICANT:
510(k) NUMBER:
长020003
ELECTROCARDIOGRAPH (ECG) DEVICE NAME: ELECTRODE
ECG electrodes are used to record the following ECGs from a patient: Resting ECG, Exercise ECG and/or ambulatory (Holter) monitoring.
The intended patient population can be adult, pediatric and neonatal, while the environment of use can be hospital (or clinic), ambulance, or daily use environment (for Holter monitoring).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K020003 |
|---|---|
| --------------- | --------- |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | __________ |
|---|---|
| (Optional Format 1-2-96) |
EXHIBIT B
Page 2 of 97