(115 days)
Not Found
No
The device description focuses solely on the physical components and materials of disposable surface electrodes, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is intended for recording electrophysiological activity and for electrical stimulation, which are diagnostic and monitoring functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the electrodes are "intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity." Recording electrophysiological activity for monitoring is a diagnostic function.
No
The device description clearly details physical components like cotton non-woven pads, conductive layers, hydro-gel adhesive layers, leads, connectors, and Ag/AgCl pellets, 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 "recording of electrophysiological activity and for electrical stimulation" using "electrodiagnostic or neurological monitoring equipment." This involves measuring electrical signals from the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a surface electrode applied to the skin. It's designed to interface with the body's electrical signals, not to perform tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to facilitate the recording and stimulation of electrical activity within the body.
N/A
Intended Use / Indications for Use
Spes Medica Disposable Adhesive Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for electrical stimulation. The electrodes are non-sterile and for single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
Spes Medica Disposable Adhesive Surface Electrodes are single patient use, disposable devices. Electrodes are non-invasive as they are applied to the patient's skin using a selfadhesive solid-gel surface. The electrodes consist of 3 different layers of materials.
The upper layer consists in a cotton non-woven pad, the second layer is the sensor and consists in a conductive layer. The lower layer, then the material in direct contact with the patient's skin consist in a solid Hydro-gel adhesive layer.
Spes Medica Disposable Adhesive Surface Electrodes are supplied with leads or with snap connector.
The electrodes which are attached to a lead wire terminate at the opposite end using different type of connectors such us:
- DIN 42802 "touch proof" safety connectors; .
- 0,7 mm "touch proof" pin; .
- Concentric "touch proof" bipolar socket; .
- 2 mm "touch proof" socket; .
The snap connector electrode uses Ag/AgCl pellet(s) as the conductive element. The active surface of the pellet is comprised between the cotton non-woven pad and the Hydro-gel adhesive layer. The pellet is attached to a stainless steel male snap connector which is used as connection.
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
Not Found
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)
Not Found
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
§ 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).
0
Spes Medica s.r.l.
्री
510(k)NOTIFICATION Disposable Adhesive Surface Electrodes
Rev 0 K120494
510 (k) Summary of safety and effectiveness
JUN 1 1 2012
SUBMITTER INFORMATION
- A. Company Name:
- B. Company Address:
- C. Company Phone: Company Fax:
- D. Contact Person:
Spes Medica s.r.l.
Via Europa - Zona industriale Battipaglia (SA) - Italy 84091
- 39 0828 614191 + 39 0828 341788
Alfredo Spadavecchia Quality Assurance and Regulatory Affairs Spes Medica s.r.l. e-mail: a.spadavecchia@spesmedica.com
E. Date Summary Prepared:
February 14, 2012
DEVICE IDENTIFICATION
| A. Device name: | Disposable Adhesive Surface Electrodes |
|---|---|
| B. Trade/Proprietary name: | Disposable Adhesive Surface Electrodes |
| C. Classification name: | Cutaneous Electrode (21 CFR §882.1320) |
| D. Product code: | GXY |
LEGALLY MARKETED DEVICES (PREDICATE DEVICES)
| Predicate device | 510(k) Holder/Applicant | 510(k) number |
|---|---|---|
| RLI Cutaneous Disposable Electrode | Rhythmlink International, LLC | K052188 |
| Bio-logic Disposable Electrode | Bio-logic Systems Corp. | K941799 |
| Sunspots Pre-gelled Surface | ||
| Electrodes | Axon System, Inc. | K062198 |
1
1
DEVICE DESCRIPTION
Spes Medica Disposable Adhesive Surface Electrodes are single patient use, disposable devices. Electrodes are non-invasive as they are applied to the patient's skin using a selfadhesive solid-gel surface. The electrodes consist of 3 different layers of materials.
The upper layer consists in a cotton non-woven pad, the second layer is the sensor and consists in a conductive layer. The lower layer, then the material in direct contact with the patient's skin consist in a solid Hydro-gel adhesive layer.
Spes Medica Disposable Adhesive Surface Electrodes are supplied with leads or with snap connector.
The electrodes which are attached to a lead wire terminate at the opposite end using different type of connectors such us:
- DIN 42802 "touch proof" safety connectors; .
- 0,7 mm "touch proof" pin; .
- Concentric "touch proof" bipolar socket; .
- 2 mm "touch proof" socket; .
The snap connector electrode uses Ag/AgCl pellet(s) as the conductive element. The active surface of the pellet is comprised between the cotton non-woven pad and the Hydro-gel adhesive layer. The pellet is attached to a stainless steel male snap connector which is used as connection.
INTENDED USE
Disposable Adhesive Surface Electrodes are intended for use Spes Medica with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for electrical stimulation. The electrodes are non-sterile and for single patient use only.
TECNOLOGICAL COMPARISON
Technologically. Spes Medica Disposable Adhesive Surface Electrodes are similar to the predicate devices. The electrodes are similar in intended use, design, materials, packaging and other technological characteristics to the predicate devices.
No new technology or basic materials are used in these designs.
CONCLUSION
Spes Medica Disposable Adhesive Surface Electrodes are similar in intended use, design, materials, packaging and other technological characteristics to the predicate devices. After analyzing performance and safety testing, it is the conclusion of Spes Medica s.r.I. that the Disposable Adhesive Surface Electrodes are safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 1 2012
Spes Medica S.r.l. c/o Mr. Alfredo Spadavecchia Ouality Assurance and regulatory Affairs Via Europa, Zona Industriale Battipaglia, Italy 84091
Re: K120494
Trade/Device Name: Disposable Adhesive Surface Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: May 24, 2012 Received: May 29, 2012
Dear Mr. Spadavecchia:
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.
3
Page 2 - Mr. Alfredo Spadavecchia
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Affoang for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
K126494 510(k) Number (if known):
Device Name:
Disposable Adhesive Surface Electrodes
Indications for Use:
Spes Medica Disposable Adhesive Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for electrical stimulation. The electrodes are non-sterile and for single patient use only.
Prescription Use (21 CFR 801 Subpart C) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
N.L.B. Nicholas
Division Sign-Off) unvision of Ophthalmic, Neurological and Ear,
Hose ...d Throat Devices
510(k) Number K120494