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.

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.

AI/ML Overview

The provided text is a 510(k) summary for Disposable Adhesive Surface Electrodes by Spes Medica s.r.l. It asserts that the device is substantially equivalent to legally marketed predicate devices. However, it does not include a study that proves the device meets specific acceptance criteria in the manner requested.

Instead, the document details a technological comparison to establish substantial equivalence, which is a regulatory pathway to market a device based on its similarity to existing, legally marketed devices (predicates). This pathway typically relies on demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, and MRMC studies are not present in the provided document, as these are typically part of a de novo classification or premarket approval (PMA) application, not a 510(k) for substantial equivalence based on technological comparison.

Here's a breakdown of what can be extracted and what cannot:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Claim)

The document does not define specific performance acceptance criteria for the new device or present a study comparing its performance against such criteria. Instead, it states:

"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."

This suggests that the "acceptance criteria" were implied to be "as safe and effective as the predicate devices," and the "study" was an analysis of the device's characteristics against those of the predicates.

Other Requested Information (Not Present in the Document)

The document does not contain information regarding:

Sample sizes used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
Adjudication method for the test set: No adjudication method is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a physical electrode, not software with an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study against a ground truth is described.
The sample size for the training set: No training set is described.
How the ground truth for the training set was established: Not applicable.

Device Description and Basis for Substantial Equivalence:

The document's "study" consists of a comparison to the following 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

The conclusion is based on the new device being similar in:

Intended use
Design
Materials
Packaging
Other technological characteristics

The document explicitly states: "No new technology or basic materials are used in these designs."

In summary, the provided text is a 510(k) premarket notification for a Class II medical device, seeking clearance based on substantial equivalence to existing devices. It does not present a study with quantitative acceptance criteria and performance data as would be found in different types of regulatory submissions for novel devices or significant modifications.

Summary

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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 SurfaceElectrodes	Axon System, Inc.	K062198

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DEVICE DESCRIPTION

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; .

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.

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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.

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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

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INDICATIONS FOR USE

K126494 510(k) Number (if known):

Device Name:

Disposable Adhesive Surface Electrodes

Indications for Use:

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

Regulation Number and Section

§ 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).