FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058

K080902 · Lorenz Biotech S.P.A. · GXY · Jun 13, 2008 · Neurology

Device Facts

• Record ID: K080902
• Device Name: FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058
• Applicant: Lorenz Biotech S.P.A.
• Product Code: GXY · Neurology
• Decision Date: Jun 13, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Lorenz Biotech S.p.A. FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes are accessories to the Lorenz Biotech Aptiva™ and are intended to be used for electrical stimulation. They are non-sterile and for single patient use only.

Device Story

FREMS™ SSC Disposable Electrodes are cutaneous stimulation accessories for the Lorenz Biotech Aptiva™ device. They consist of silver/silver chloride conductors coated with Apti-Gel medical hydrogel, available with either foam or non-woven backing. The electrodes interface with the skin to deliver electrical stimulation as part of the Aptiva™ system. They are non-sterile and intended for single patient use.

Clinical Evidence

Bench testing only. Side-by-side impedance testing demonstrated comparable results to predicate devices.

Technological Characteristics

Silver/silver chloride conductors; Apti-Gel medical hydrogel coupling agent; foam or non-woven backing; non-sterile; single patient use; cutaneous electrode (21 CFR 882.1320).

Indications for Use

Indicated for use as accessories to the Lorenz Biotech Aptiva™ for electrical stimulation. Single patient use only.

Regulatory Classification

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.

Predicate Devices

• NeuroEase (K831785)
• Snap Ease (K822224, K854513)

Submission Summary (Full Text)

{0}------------------------------------------------

K080902

JUN 1 3 2008

# 510(k) Summary (per 21 CFR 807.92) Lorenz Biotech S.p.A. FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes

#### 1. SPONSOR

Lorenz Biotech S.p.A. Via Statale 151/A 41036 Medolla Italy

Contact Person: Mr. Elio Cirelli Email address: [e-mail] Date Prepared: March 31, 2008

#### 2. DEVICE NAME

| Proprietary Name: | FREMS™ SSC Disposable (Foam and Non-Woven)<br>Electrodes |
|----------------------|----------------------------------------------------------|
| Common/Usual Name: | Cutaneous stimulation electrodes |
| Classification Name: | Cutaneous electrodes |

#### · 3. PREDICATE DEVICES

- NeuroEase (K831785, Andover Medical Inc.; currently shown as being . manufactured and listed by Empi)
- Snap Ease (K822224, K854513, Empi; currently shown as being manufactured and 0 listed by Empi)

#### DEVICE DESCRIPTION 4.

The Lorenz Biotech S.p.A. FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes are accessories for Lorenz Biotech Aptiva™. The silver/silver chloride conductors are covered with Apti-Gel, a medical hydrogel coupling agent. The FREMS™ SSC Disposable Electrodes are provided with either foam or non-woven backing in sealed pouches of 30 electrodes.

{1}------------------------------------------------

#### 5. INTENDED USE

The Lorenz Biotech S.p.A. FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes are accessories to the Lorenz Biotech Aptiva™ and are intended to be used for electrical stimulation. They are non-sterile and for single patient use only.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Lorenz Biotech S.p.A. FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes are substantially equivalent to specified predicate devices based on intended use; indications for use, operational characteristics, fundamental technological characteristics, and performance characteristics. A detailed side-by-side comparison of the FREMS™ SSC Disposable Electrodes with cited predicate devices is included in this premarket notification.

#### PERFORMANCE TESTING 7.

Performance testing of the FREMS™ SSC Disposable Electrodes demonstrates that they meet prospectively defined design and performance specifications. Side-by-side testing of impedance demonstrates comparable results to those obtained with the predicate devices. - -

{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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2008

Lorenz Biotech S.p.A % Medical Device Consultants, Inc. Ms. Rosina Robinson, RN, MEd, RAC Principal Consultant, Regulatory Services 49 Plain Street North Attleboro, Massachusetts 02760

K080902 Re:

Trade/Device Name: FREMS" SSC Disposable (Foam and Non-Woven) Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 31, 2008 Received: April 2, 2008

Dear Ms. Robinson:

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.

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.

{3}------------------------------------------------

### Page 2 - Ms. Rosina Robinson, RN, MEd, RAC

This letter will allow you to begin marketing your device as described in your Scction 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone]or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millikan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes

Indications for Use:

The Lorenz Biotech S.p.A. FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes are accessories to the Lorenz Biotech Aptiva™ and are intended to be used for electrical stimulation. They are non-sterile and for single patient use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Dylan Forman

(Division Sign-O Division of General, Restorative, and Neurological Devices

**510(k) Number** K080902