(309 days)
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.
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.
The provided text describes the 510(k) summary for the BIO PROTECH ECG Electrode (K020003). This document aims to demonstrate the substantial equivalence of the new device to a predicate device, not to prove that the device meets specific performance criteria through a detailed study in the way an AI/ML device would. Therefore, many of the requested elements for AI/ML device studies are not applicable or cannot be extracted from this type of regulatory submission.
However, I can provide the available information relevant to acceptance criteria and performance as presented in the Performance Summary section.
Here's a breakdown based on the provided text, emphasizing what is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| Medical Devices Directive: EU Council Directive 93/42/EEC | Meets requirements |
| ANSI/AAMI ec12-2000 | Meets requirements |
| Biocompatibility (based on ISO 10993-1) | Materials demonstrate appropriate levels of biocompatibility |
| Shelf Life (24 months) | Data obtained in real-time shelf life studies substantiates the claim |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The summary refers to compliance with standards, implying internal testing was conducted, but details of the test sets (size, origin, retrospective/prospective nature) are not included.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the evaluation focuses on electrical performance, biocompatibility, and shelf life, not on interpretations requiring expert consensus for images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation does not involve subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where the AI assists human readers. The device in question is a physical ECG electrode.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical electrode, not a software algorithm. The "performance" refers to its electrical and material properties.
7. The Type of Ground Truth Used
- Electrical Performance: Ground truth would be defined by the specifications of the standards (EU Council Directive 93/42/EEC and ANSI/AAMI ec12-2000), which outline acceptable electrical characteristics for ECG electrodes (e.g., impedance, offset voltage).
- Biocompatibility: Ground truth is established by the materials' compliance with ISO 10993-1, typically through laboratory testing for cytotoxicity, sensitization, irritation, etc., against established thresholds.
- Shelf Life: Ground truth is established by demonstrating that the device maintains its specified performance characteristics over the claimed 24-month period through real-time stability testing.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
Summary of the Study Proving Device Meets Acceptance Criteria (based on the provided text):
The provided text states that the "Performance Summary" indicates 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)."
For biocompatibility, it states: "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."
For shelf life, it states: "Data obtained in real time shelf life studies was reviewed and found to substantiate the 24 month shelf life claim."
While these statements confirm that studies were conducted to demonstrate compliance with these standards and claims, the specific methodologies, sample sizes, and detailed results of these internal studies are not provided in this 510(k) summary document. The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, often by showing compliance with applicable recognized standards rather than detailing the full study reports.
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K020003 网上
510(k) SUMMARY
| Submitted For: | BIO PROTECH INC.303 Boryung B/D 37-10Kangnam Ku,Seoul, Korea 135-090 | NOV 7 2002 |
|---|---|---|
| Submitted by: | TUCKER & ASSOCIATESOfficial Correspondent and United States Agent forBio Protech Inc.JANNA P. TUCKER, President -- CEO198 Avenue de la D'emeraldSparks, NV 89434Phone: 775-342-2612 Fax: 775-342-2613E-mail: Tuckerjan@aol.com | |
| Date of Submission: | ||
| Classification Name: | ELECTRODE, ELECTROCARDIOGRAPHProduct Code: DRXClass 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 ResponseProfessionals, Hospitals and other healthcare professionalsfor the Intended Use purposes below, and will beappropriately labeled in accordance with Title 21 CFRPart 801. | |
| Intended Use: | An electrocardiograph electrode is the electrical conductorwhich is applied to the surface of the body to transmit theelectrical signal at the body surface to a processor thatproduces an electrocardiogram or vectorcardiogram. |
EXHIBIT K
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| Description: | Bio Protech electrodes are self-adhesive, non-sterile, singleuse disposable ECG electrodes. All include an Ag/Agc 1sensing element and the solid adhesive hydro gel has verylow impedance level. Most importantly, the adhesive gelsticks on both skin of patient and the sensing element sothat the movement artifact can be significantly lowered.The adhesive qualities of the foam is strong enough to usefor stress test and holter. |
|---|---|
| Substantial Equivalence: | This device is equivalent to those in commercialdistribution for use in general electrocardiographicprocedures where ECG monitoring is deemed necessaryand is ordered by a physician. |
| Both in its intended use and/or physical characteristics, thisdevice is equivalent to devices currently marketed by U.S.companies. It is substantially equivalent to the devicemanufactured by Leonhard Lang GmbH under K982521. | |
| Performance Summary: | The electrical performance of BIO PROTECH ECGelectrodes meets the requirements of the Medical DevicesDirective: EU Council Directive 93/42/EEC, ANSI/AAMIec12-2000, and has been issued a Certificate of Conformity(01-KOR-MDD-0003) |
| Biocompatibility Testing: | The biological safety of the PRO TECH ECG electrodeshas been assured through the selection of materials whichdemonstrate appropriate levels of biocompatibility. Thetests were selected on the basis of ISO 10993-1, BiologicalEvaluation of Medical Devices - Part 1 - Guidance onselection of tests. |
| Shelf Life: | Data obtained in real time shelf life studies was reviewedand found to substantiate the 24 month shelf life claim. |
| Conclusion: | This device is substantially equivalent to the deviceapproved as K982521. |
EXHIBIT K
Page 97 of 97
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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.
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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
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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
§ 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.