L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Biomess Neuromodulation. To the left of the text is a star-like symbol with many points. The text "Biomess" is in a larger font than the text "Neuromodulation" which is directly below it. K103343 Section 5 510(k) Summary APR 2 9 2011 # 510(k) Summary #### Bioness Neuromodulation Ltd., a Bioness Inc. Company. # NESS L300 Plus system 510(k) Summary: NESS L300 Plus System #### Company name: Bioness Neuromodulation Ltd., a Bioness Inc. company. #### Contact person: - 1) Michael Mizrachi Manager, Regulatory Affairs and Quality Assurance Office phone: +972 (0) 9 790-7129 +972 (0) 9 748-5740 Fax: Email: Michael.mizrachi@bioness.co.il 19th Ha-Haroshet st., P.O. Box 2500 / Ra'anana 43654 / Israel Bioness Neuromodulation Ltd. - 2) Adele Shoustal Director, Regulatory and Clinical Affairs Office phone: (661) 362-5968 Fax: (661) 362-6661 Email: adele.shoustal@bioness.com 25103 Rye Canyon Loop / Valencia, CA 91355 / U.S.A Bioness Inc. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for "Bioness Neuromodulation". The logo consists of a stylized sun-like symbol on the left, followed by the word "Bioness" in a distinct font. Below "Bioness" is the word "Neuromodulation" in a smaller font size. # Application Correspondent: Adele Shoustal Director, Regulatory and Clinical Affairs Office phone: (661) 362-5968 Fax: (661) 362-6661 Email: adele.shoustal@bioness.com Bioness, Inc. 25103 Rye Canyon Loop Valencia, CA 91355 # Date prepared: November 12, 2010 # Trade Name: NESS L300 Plus System ### Classification name: External functional neuromuscular stimulator Class: II # Panel Identification: Neurology # Product code: GZI and IPF {2}------------------------------------------------ Image /page/2/Picture/0 description: The image contains the logo for "Bioness Neuromodulation". The logo consists of a stylized star-like symbol on the left, followed by the word "Bioness" in a blocky, outlined font. Below "Bioness" is the word "Neuromodulation" in a smaller, simpler font. The overall design is clean and professional. #### Regulation number: 882.5810 External functional neuromuscular stimulators - 890.5850 Powered muscle stimulators #### Predicate devices: - 1) Company: N.E.S.S (Neuromuscular Electrical Stimulation Systems) Ltd. NESS L300 (K080219) Device: - 2) Company: N.E.S.S (Neuromuscular Electrical Stimulation Systems) Ltd. Device: NESS system (K022776) #### Purpose of the traditional 510(k) notice: The NESS L300 Plus is a new device based on the NESS L300 and on the NESS system. #### Device description: The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. The NESS L300 Plus System is a combination of its two predicate devices of its two predicate devices, the NESS L300 (K080219) and the NESS System (K022776). The NESS L300 Plus System consists of: - . A Control Unit that allows simple operation while displaying real time information regarding the system's status. - Two Functional Stimulation Cuffs (L300 and Thigh, figures 11-2, 11-3 . respectively), that include two surface electrodes and an integrated configurable Radio Frequency Stimulation unit each. - . A Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for "Biomass Neuromodulation". To the left of the word "Biomass" is a symbol that looks like a star or asterisk. The word "Neuromodulation" is written in a smaller font below the word "Biomass". - A Clinician's Programming System with software, which is used for system . programming by a trained clinician during configuration of the system for optimal fitting to the patient. - A L300 Tester. The L300 Tester is utilized for checking the RFSs and FSCs for . functionality. - A power supply with a 3-way splitter cable to charge the Control Unit and both . Radio Frequency Stimulation units. #### Indications for use: The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. During gait, the L300 Plus System electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot and knee flexion or extension, thus it may improve the individual's gait. The L300 Plus System may also: - Facilitate Muscle re-education . - Prevent/retard disuse atrophy . - Maintain or increase joint range of motion . - . Increase local blood flow # Substantial Equivalence: The Ness L300 Plus is a combination of the NESS L300 (K080219) and the thigh module from the NESS system (K022776). The primary predicate device is the NESS L300 which is included in the NESS L300 Plus system almost in its entirety. The NESS L300 Plus incorporates all of the NESS L300 components excluding the control unit which is replaced with a new control unit for the L300 Plus. The NESS L300 Plus also incorporates a version of the thigh module from the NESS system, adapted to the L300 Plus system. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Bioness Neuromodulation. The logo consists of a stylized sun-like symbol on the left, followed by the word "Bioness" in a bold, outlined font. Below "Bioness" is the word "Neuromodulation" in a smaller, less bold font. The logo appears to be for a company that specializes in neuromodulation technology. The NESS L300 Plus shares the intended use, technology and stimulation methods and main components with its predicate devices and in particular with the NESS L300. # Conclusion: Bioness Neuromodulation believes that the NESS L300 Plus is substantially equivalent to the NESS L300 (K080219) and the NESS (K022776) predicate systems without raising any new safety and effectiveness concerns. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle. Public Health Service Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Bioness Inc. % Ms. Adele Shoustal Director, Regulatory and Clinical Affairs 25103 Rye Canyon Loop Valencia, CA 91355 APR 2 9 2011 Re: K103343 Trade Name: NESS L300 Plus System Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class U Regulatory Class: Class II Product Code: GZI, IPF Dated: April 22, 2011 Received: April 25, 2011 Dear Ms. Shoustal: 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) is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices in the indications for use in the indicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date 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 (Act ) with the provisions of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act do not require approval of a premarket approval application (Phig, and Cosmetic Act (Act) that do not recogni approval of a premarket approval application (PMA). You may, therefore, market device, subject to the general controls provisions of the Act. The general controls provisions of the general controls for annual registration, listinal control. provisions of the Act include requirements for annual registration, listing of devices, good manage are are not mot nequirements for amual registration, listing of devices, goo mandacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability and adultereaties. We remind you; however, that device labeling must he stated to contractives. 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 maintention in class I (1) was the the classince (see above) into ether class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affectin device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition of to to the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal {6}------------------------------------------------ Page 2 - Ms. Adele Shoustal 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 Actives Federal agencies. You must comply with all the Act 's requirements, including, but not Federal agencies. You must comply with all the Act 's requirements, including, but no line of the researce of the Retirs requirements, including, but the many, but medical device reporting of medical device-related adverse events of the CFR Part 800 medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems regulation (21 CFR Part 820); and if applicable, the electronic product radiation (05) regulation (21 CFR Part 820); and if applicable, the electronic product radiation contr 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/ucm1115809.html for the Center for Devices and Radiological Healthis (GDBH) in Collect of the for the Center for Devices and Radiological Health's (CDRH) s) Office of Compliance. Also, please note the regulation entitled "Michaeli Also, please note the regulation entitled, "Misbranding by reference to premains notification" (21CFR Part 807 97). For evertise 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/SafetyReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Problem/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 from the Act from the number (800) 638-2041 or (301) 796-7100 or at its Internet Assis. http://www.fdagov/ModicalD-ci http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Rehn Malvina B. Fudaly, M.D. Malvina B. Eydelman, MB. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains a logo with the word "Bioness" in bold, black letters. Above the word "Bioness" is a symbol that looks like a star. Below the word "Bioness" is the word "Neuromodulation" in a smaller, lighter font. /03343 Section 4 Indications for Use Statement # Indications for Use 510(k) Number (if known): Device Name: NESS L300 Plus System Indications for Use: The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. During gait the L300 Plus System electrically stimulates muscles in the affected leg to provide docsifiexion of the foot and knee flexion or extension, thus it may improve the individualis goit. The foot and knee flexion or extensi thus it may improve the individual's gait. The L300 Plus System may also: - Facilitate Muscle re-education - . Prevent/retard disuse atrophy - . Maintain or increase joint range of motion - Increase local blood flow Prescription Use : _ X Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K103343