(301 days)
The Disposable Pre-gelled Surface Electrodes are intended for recording/stimulation and monitoring of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potential (EP) signals.
The Rochester Electro-Medical Disposable Pre-gelled Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single use only.
A conductive solid gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated eyelet, an adhesive cloth substrate, label, lead wire with a 0.60" diameter touch-proof female socket per DIN 42802 and polystyrene release liner. These are available in various lead lengths, lead configurations, electrode styles/sizes, and wire colors.
This document is a 510(k) Summary for the Rochester Electro-Medical Disposable Pre-gelled Surface Electrode, demonstrating its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly enumerated with numerical targets in this summary. Instead, the document states that the physical and electrical characteristics of the subject device (Rochester Disposable Adhesive Surface Electrodes) were evaluated against those of the predicate device (Xian Friendship Medical K110289). The overarching acceptance criterion is "substantially equivalent" to the predicate device, meaning there are no new concerns regarding safety or effectiveness.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Physical and electrical characteristics comparable to predicate device. | "Physical and electrical characteristics evaluated during bench testing and in the comparison chart of this submission demonstrate that the design, materials, chemical composition, packaging, intended use, electrical performance and other characteristics of the subject device are comparable to those of the predicate device." |
| Electrode Impedance measurements (comparable to predicate and method similar to K010431). | "Bench testing included electrode impedance measurements of the subject device and the predicate using a 1kHz source and a Digital Multimeter, a method similar to that used in K010431. Details of this testing and performance criteria are included in section 18 of this submission, Performance Testing - Bench." (Specific numerical results are not provided in this summary, but are referenced as being in Section 18). |
| Gel uniformity inspection. | "Additionally gel uniformity was inspected." (Details and specific results not provided in this summary). |
| Biocompatibility (Cytotoxicity, Skin irritation, Skin sensitization). | "The contact material is Tyco hydrogel RG-63 with slight proprietary variations and has been previously tested for material safety and biocompatibility to: Cytotoxicity study – ISO 10993-5, Skin irritation study - ISO 10993-10, Skin sensitization study - ISO 10993-10. There were no changes to the formulation for the new intended use." (Implied successful completion based on original testing of material). |
| Shelf life | "18 Months in unopened pouch." (This is a stated characteristic rather than a performance measure against a predicate in this summary document, but implies it meets expected criteria for stability). |
| No new concerns regarding safety or effectiveness compared to predicate device. | "The Rochester Electro-Medical Disposable Pre-gelled Surface Electrodes are substantially equivalent to the predicate device... There are no new concerns regarding safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "bench testing" that included electrode impedance measurements and gel uniformity inspection. However, the specific sample size used for these tests is not provided in this 510(k) summary. The data provenance is implied to be from internal laboratory testing conducted by Rochester Electro-Medical, Inc. or an affiliated testing facility. It is prospective testing, performed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a physical electrode, and its performance is evaluated against engineering specifications and comparison to a predicate device, not through expert-labeled data for a diagnostic algorithm.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation is based on bench testing of physical and electrical properties, not on expert review of ambiguous cases.
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
This information is not applicable. The device is a physical electrode, not an AI-powered diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by engineering measurements (e.g., electrode impedance, physical dimensions, material composition) and biocompatibility testing standards (ISO 10993 series). The ultimate "ground truth" for regulatory approval relies on demonstrating substantial equivalence to a predicate device that has already been deemed safe and effective based on similar scientific and engineering principles.
8. The sample size for the training set
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as in point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2015
Rochester Electro-Medical, Inc. c/o Wayne Glover TechniReg, Inc. 19404 Pine Valley Drive Odessa. FL 33556
Re: K142159
Trade/Device Name: Disposable Pre-gelled Surface Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: April 28, 2015 Received: May 5, 2015
Dear Mr. Glover,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.
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.
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Felipe Aquel - S
Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142159
Device Name
Disposable Pre-gelled Surface Electrode
Indications for Use (Describe)
The Disposable Pre-gelled Surface Electrodes are intended for recording/stimulation and monitoring of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potential (EP) signals.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for Rochester Electro-Medical. The logo features a stylized graphic of a medical device cable and plug inside of a circle. To the right of the graphic is the company name, "Rochester Electro-Medical", with "Rochester" on top of "Electro-Medical".
510(k) Summary
This 510(k) Summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| Summary Date: | August 1, 2014 |
|---|---|
| Manufacturer: | Rochester Electro-Medical, Inc.4212 Cypress Gulch DriveLutz, FL 33559 |
| Telephone: | (813) 963-2933 |
| EstablishmentRegistration No.: | 2126558 |
| Contact Person: | Mark C. BerkinsVice PresidentPhone: (813) 963-2933, Extension 221Fax: (800) 545-0845 |
| Trade Name: | Disposable Pre-gelled Surface Electrode[1] |
| [1] This submission is intended to be filed as a Cutaneous Electrode (i.e. Common Name)although referenced by the Trade Name throughout this submission. | |
| Common Name: | Cutaneous Electrode |
| Classification Name: 882.1320 Cutaneous Electrode, Class II (performance standards) | |
| Product Code: | GXY |
| Equivalence /Predicate Device: | Friendship Pre-gelled Ag/AgCl Surface Electrodes, 510(k) Number K110289 |
| Description: | A conductive solid gel electrode consisting of a conductive adhesive gel, asilver/silver chloride plated eyelet, an adhesive cloth substrate, label, lead wirewith a 0.60" diameter touch-proof female socket per DIN 42802 and polystyrenerelease liner. These are available in various lead lengths, lead configurations,electrode styles/sizes, and wire colors. |
| Intended Use: | The Rochester Electro-Medical Disposable Pre-gelled Surface Electrodes areintended for use with recording, monitoring and stimulation equipment for thepurpose of stimulating/recording of biopotential signals. Electrodes are appliedin the study of biopotentials such as Electroencephalograph (EEG), surfaceElectromyography (EMG) and Evoked Potential signals (EP). Electrodes are non- |
| Rochester Electro-Medical | |
| invasive as they are applied to the patient's skin using a self-adhesive solid-gelsurface. The electrodes are non-sterile and for single use only. | |
| The surface electrodes are placed cutaneously by a certified physician or atrained clinician or technologist by the order of a physician. | |
| TechnicalComparison: | The Rochester Disposable Adhesive Surface Electrodes are technologicallyequivalent to the predicate device, K110289 Cutaneous Electrode manufacturedby Xian Friendship Medical. |
| Physical and electrical characteristics evaluated during bench testing and in thecomparison chart of this submission demonstrate that the design, materials,chemical composition, packaging, intended use, electrical performance and othercharacteristics of the subject device are comparable to those of the predicatedevice. | |
| Bench testing included electrode impedance measurements of the subject deviceand the predicate using a 1kHz source and a Digital Multimeter, a method similarto that used in K010431. Additionally gel uniformity was inspected. Details ofthis testing and performance criteria are included in section 18 of thissubmission, Performance Testing - Bench. | |
| Biocompatibility: | The contact material is Tyco hydrogel RG-63 with slight proprietary variationsand has been previously tested for material safety and biocompatibility to:Cytotoxicity study – ISO 10993-5 Skin irritation study - ISO 10993-10 Skin sensitization study - ISO 10993-10 |
| There were no changes to the formulation for the new intended use. | |
| Shelf Life: | 18 Months in unopened pouch. |
| Conclusions: | The Rochester Electro-Medical Disposable Pre-gelled Surface Electrodes aresubstantially equivalent to the predicate device, Xian Friendship MedicalElectronics Co., Ltd. |
| There are no new concerns regarding safety or effectiveness. |
4212 Cypress Gulch Drive Lutz, FL 33559 Ph: (800) 328-5544
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§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).