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 Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the Lorenz Biotech S.p.A. FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain details about specific acceptance criteria, a formal study design with sample sizes, expert qualifications, or ground truth establishment in the way typically expected for a medical device performance study, especially for complex algorithms or diagnostic tools.

Instead, the "Performance Testing" section states: "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."

This indicates that the acceptance criteria are likely related to electrical impedance and the study involved a comparative test with predicate devices. Without further details, specific numerical acceptance criteria or performance metrics are not provided.

Given this limitation, I will extract the available information and indicate where specifics are missing.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Specific criteria not explicitly stated beyond meeting "prospectively defined design and performance specifications."	"Side-by-side testing of impedance demonstrates comparable results to those obtained with the predicate devices."
Likely criteria related to electrical impedance characteristics suitable for "cutaneous stimulation electrodes" (as inferred from the device classification and intended use).	The device's impedance "demonstrates comparable results to those obtained with the predicate devices" (NeuroEase, Snap Ease).

Study Details:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document generaly refers to "side-by-side testing of impedance."
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): "Prospectively defined design and performance specifications" suggests a prospective approach to defining criteria, but the nature of the impedance testing itself (e.g., in vitro, ex vivo, in vivo) and its specific origin are not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. For a device like electrodes, "ground truth" would typically refer to established technical standards or physical measurements (e.g., using calibrated equipment to measure impedance), rather than expert clinical consensus.
- Qualifications of Experts: Not applicable/not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not specified. Adjudication methods are typically used for interpreting image or clinical data where human judgment is involved, which is not described for this impedance testing.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human interpretation, which is not the function of these electrodes.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an AI algorithm. This device is an accessory (electrodes) for electrical stimulation, not an AI algorithm. The performance evaluation focuses on its physical and electrical properties.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for impedance testing would likely be technical measurements against established standards or direct comparisons with the measured performance of legally marketed predicate devices, as implied by "comparable results to those obtained with the predicate devices." It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

Summary of Device Safety and Effectiveness Demonstration:

The approval of the Lorenz Biotech S.p.A. FREMS™ SSC Disposable Electrodes (K080902) appears to be based on demonstrating substantial equivalence to existing predicate devices (NeuroEase, Snap Ease) in terms of:

Intended Use: Used for electrical stimulation.
Indications for Use: Same as intended use.
Operational Characteristics: Implied to be similar.
Fundamental Technological Characteristics: Described as "silver/silver chloride conductors covered with Apti-Gel" with foam or non-woven backing, similar to predicate devices.
Performance Characteristics: Demonstrated through "side-by-side testing of impedance" showing "comparable results" to the predicate devices. This suggests that the impedance of the new electrodes falls within an acceptable range or is statistically equivalent to the impedance of the predicate devices, which are deemed safe and effective for their intended use.

The 510(k) pathway relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as the predicate. For accessories like these electrodes, technical performance data (like impedance) demonstrating similarity to approved devices is the primary evidence provided, rather than extensive clinical efficacy studies or complex AI validation methods.

Summary

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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: elio.cirelli@lorenzbiotech.it Date Prepared: March 31, 2008

2. DEVICE NAME

Proprietary Name:	FREMS™ SSC Disposable (Foam and Non-Woven)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.

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5. INTENDED USE

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. - -

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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 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.

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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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041or (240) 276-3150 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

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Indications for Use

510(k) Number (if known):

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

Indications for Use:

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

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).