(107 days)
Not Found
No
The summary describes a functional electrical stimulation device that uses a gait sensor to trigger stimulation. There is no mention of AI, ML, or any learning or adaptive algorithms.
Yes
The device is intended to treat a condition (foot drop) and improve various physiological functions like gait, muscle re-education, and joint range of motion, which are characteristics of a therapeutic device.
No
The device description indicates it is a therapeutic device that stimulates muscles to provide dorsiflexion, improve gait, and facilitate muscle re-education. It does not mention diagnosis or detection of diseases or conditions.
No
The device description explicitly states that the system consists of a Control Unit and an Intelli-Sense Gait Sensor, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- NESS L300 Function: The NESS L300 Foot Drop System is a device that applies electrical stimulation directly to the body (muscles in the leg) to improve gait. It does not analyze any specimens taken from the body.
The description clearly indicates it's a therapeutic device used for functional electrical stimulation, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals (adults and pediatrics) who have foot drop following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.
Product codes
GZI, IPF
Device Description
The L300 Foot Drop System consists of - ්රි - Control Unit . - . Intelli-Sense Gait Sensor
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, foot, leg
Indicated Patient Age Range
adults and pediatrics
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 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 bold, sans-serif font. Below "Bioness" is the word "Neuromodulation" in a smaller, serif font. The logo is simple and modern, with a focus on the company name.
Section 5 510(k) Summary
510(k) Summary
DEC 2 7 2012
| 510(k) Summary | L300® System |
|---|---|
| Company name | Bioness Inc. |
| Contact persons | Kim Tompkins, VP, Regulatory and Clinical Affairs |
| Office phone: (661) 362-5968 | |
| Fax: (661) 362-6661 | |
| Email: Kim.Tompkins@bioness.com | |
| Date prepared | October 30, 2012 |
| Trade Name | L300® Foot Drop System or NESS L300 Foot Drop System |
| Classification name | External functional neuromuscular stimulator |
| Classification | II |
| Panel Identification | Neurology |
| Product code(s) | GZI and IPF |
| Regulation numbers | 882.5810 External functional neuromuscular stimulators |
| 890.5850 Powered muscle stimulators | |
| Purpose of the 510(k) | To modify the indications for use |
Predicate devices
-
- NESS (Neuromuscular Electrical Stimulation Systems) Ltd. (currently known as Bioness Neuromodulation Ltd., a Bioness Inc. Company) NESS L300 System (K120853, SE 4.20.2012)
-
- Innovative Neurotronics Walkaide System (K052329, SE 9.21.2005)
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Image /page/1/Picture/0 description: The image shows the logo for Bioness Neuromodulation. The logo consists of a symbol on the left, followed by the word "Bioness" in a bold, sans-serif font. Below "Bioness" is the word "Neuromodulation" in a smaller, serif font. The symbol on the left appears to be a stylized representation of a neural network or a similar concept related to neuromodulation.
Device description
The L300 Foot Drop System consists of
- ්රි
- Control Unit .
- . Intelli-Sense Gait Sensor
Indications for use
The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals (adults and pediatrics) who have foot drop following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.
Substantial Equivalence
The L300 System subject device is identical to the L300 System (K120853). It is similar to the Walkaide System (K052329) currently marketed for pediatric use. Electrical stimulation is well documented in the literature and confirmed in clinical performance as a safe and effective treatment for functional electrical stimulation.
Conclusion
The L300 System modified indications for use is substantially equivalent to the cleared L300 System and the cleared Walkaide System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Bioness. Inc. % Ms. Kim Tompkins VP of Regulatory and Clinical Affairs 25103 Rye Canyon Loop Valencia, CA 91355
Re: K122784 ·
Trade Name: NESS L300® System Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator. Regulatory Class: Class II Product Code: GZI & IPF Dated: November 2, 2012 Received: November 5, 2012
Dear Ms. Tompkins:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
DEC 27 2012
3
Page 2 - Ms. Kim Tompkins
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
Victor Krauthamer, Ph.D. for Acting Director Division of Neurological and Physical Medicine Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Bioness Neuromodulation. The logo consists of a stylized starburst symbol to the left of the word "Bioness" in a bold, sans-serif font. Below "Bioness" is the word "Neuromodulation" in a smaller font size. The logo is black and white.
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: NESS L300® System
Indications for Use:
The NESS L300 Foot Drop System is intended to provide ankle dorsifiexion in individuals (adults and pediatrics) who have foot drop following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.
Prescription Use : _ X
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ AND/OR (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 | K122784 |