(87 days)
The ORI F6T Dry ECG Monitoring Electrodes are intended for use in adults (persons 18 years and older) in all ECG monitoring applications where standard ECG monitoring electrodes are used. The F6T Electrodes can be used in short term and long term (up to 2 days) ECG monitoring.
The ORI F6T Dry ECG Monitoring Electrode is a non-sterile, single-use, disposable electrode system consisting of a solid, Ag/AgCl-coated conductive polymer element with a mechanical skin interface surface designed to ensure adequate skin interface without the use of a component electrolytic gel. The conductive polymer clement is held in place using a novel adhesive tape patch.
The provided text describes the acceptance criteria and the study conducted for the ORI F6T Dry ECG Monitoring Electrode. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Performance: Meets applicable requirements of ANSI/AAMI EC 12:2000, Disposable ECG Electrodes. | Determined to meet the applicable requirements of ANSI/AAMI EC 12:2000. |
| Biological Safety: Assessed in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. | Biological safety assessed through tests specified in ISO 10993-1. |
| Clinical Performance: Substantially equivalent to predicate device as assessed in clinical testing conducted in accordance with ANSI/AAMI EC 12:2000 and FDA's ECG Electrode 510(k) guidance document. | Performance of the device was substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only mentions "clinical testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. 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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone performance and equivalence of the device to predicate devices, not on human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was done for the device. The "electrical performance of the F6T Electrode was assessed and determined to meet the applicable requirements of ANSI/AAMI EC 12:2000, Disposable ECG Electrodes." This implies testing the device's inherent electrical capabilities without human interpretation or intervention beyond standard usage.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the electrical performance and biological safety was established by adherence to industry standards (ANSI/AAMI EC 12:2000 for electrical, ISO 10993-1 for biological safety). For clinical performance, the ground truth was based on comparison to a predicate device. This means the device's output was compared against the known performance of an existing, legally marketed ECG electrode.
8. The sample size for the training set
The document does not mention a "training set" in the context of machine learning or AI. The device is an ECG electrode, and its performance is evaluated based on standard engineering and clinical testing protocols, not through machine learning models requiring training data.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of machine learning for this device, this question is not applicable. The device's performance is validated against established industry standards and predicate device performance.
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DEC 1 1 2006
510(k) Summary
510(k) Summary of Safety and Effectiveness (as required by 21 CFR § 807.92)
| 510(k) Submitter | Orbital Research Inc.4415 Euclid Ave, Suite 500Cleveland, Ohio 44103 |
|---|---|
| Contact Person | Aaron RoodSenior Research Scientist & Regulatory Affairs AssociatePhone: (216) 649-0399Fax: (216) 649-0347 |
| Date Prepared | 9/14/06 |
| Device Name | Proprietary Name: ORI F6T Dry ECG Monitoring Electrode |
| Common Name: electrocardiograph (ECG) electrode | |
| Classification Name: "electrode, electrocardiograph," a class II deviceper 21 CFR § 870.2360 (product code DRX). | |
| Device Description | The ORI F6T Dry ECG Monitoring Electrode is a non-sterile,single-use, disposable electrode system consisting of a solid,Ag/AgCl-coated conductive polymer element with a mechanicalskin interface surface designed to ensure adequate skin interfacewithout the use of a component electrolytic gel. The conductivepolymer clement is held in place using a novel adhesive tape patch. |
| Intended Use | The ORI F6T Dry ECG Electrode is intended for use in all ECGmonitoring applications where standard ECG monitoring electrodesare used. The F6T Electrode can be used in short term and longterm (up to 2 days) ECG monitoring. |
| Predicate Devices | The F6T Electrode is substantially equivalent to the followinglegally marketed ECG electrodes:-3M Red Dot™ 2570 Monitoring Electrode (K970796) 3M |
| Health Care-AccuHeart™ Electrode Belt (K043361) Advanced BioelectricCorporation | |
| Substantial Equivalence | The F6T Electrode is substantially equivalent in terms of safety andeffectiveness to a combination of the predicate devices cited aboveand is designed to ensure stable ECG monitoring performance overthe life of the device. |
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The biological safety of the F6T Electrodes has been assessed Non-clinical Testing through the tests specified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices.
The electrical performance of the F6T Electrode was assessed and determined to meet the applicable requirements of ANSI/AAMI EC 12:2000, Disposable ECG Electrodes.
The safety and effectiveness of the F6T Electrode was assessed in Clinical Testing clinical testing conducted in accordance with the requirements of the ANSI/AAMI EC 12:2000, Disposable ECG Electrodes and FDA's ECG Electrode 510(k) guidance document. The performance of the device was substantially equivalent to the predicate device.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2006
Orbital Research Inc. Aaron Rood ·Regulatory Affairs Associate 4415 Euclid Ave. Suite 500 Cleveland, OH 44103
Re: K062760
Trade/Device Name: Ori F6T Dry ECG Monitoring Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II Product Code: DRX Dated: November 10, 2006 Received: November 1, 2006
Dear Mr. Rood:
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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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 (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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Q.S.U
CoR 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 Statement |
|---|
| ------------------------------- |
| 510(k) Number: | K062760 |
|---|---|
| Device Name: | ORI F6T Dry ECG Electrode |
Indications for Use: The ORI F6T Dry ECG Monitoring Electrodes are intended for use in adults (persons 18 years and older) in all ECG monitoring applications where standard ECG monitoring electrodes are used. The F6T Electrodes can be used in short term and long term (up to 2 days) ECG monitoring.
| Prescription Use (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|---|---|
| ---------------------------------------------- | --- | -------- | --------------------------------------------- | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Figure 3 Revised
Version 1.1 created 10 November 2006
elsam 12/10/06
(Division Sign-Off) Division of Čardiovascular Devices
KO62760 510(k) Number_
§ 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.