(72 days)
Not Found
No
The summary describes disposable electrodes, which are passive accessories for an electrical stimulation device. There is no mention of any computational or algorithmic processing, let alone AI/ML.
No
The device described consists of electrodes that are accessories to an electrical stimulation device, not a therapeutic device itself. Its purpose is to facilitate the electrical stimulation delivered by the main device, which could be therapeutic.
No
The device is described as an accessory for electrical stimulation, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a disposable electrode with physical components (silver/silver chloride conductors, hydrogel, foam/non-woven backing), making it a hardware accessory, not a software-only 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 "electrical stimulation." This is a therapeutic or physiological intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical components of electrodes used for electrical stimulation. There is no mention of analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly described as an accessory for an electrical stimulation device, which falls under the category of medical devices used for treatment or physiological effects, not in vitro diagnosis.
N/A
Intended Use / 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.
Product codes
GXY
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
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 (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
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