(122 days)
No reference devices were used in this submission.
No
The description focuses on electrical stimulation parameters and hardware components, with no mention of AI/ML terms or functionalities.
Yes
The device is indicated for various therapeutic actions, such as maintaining range of motion, preventing atrophy, muscle re-education, relaxing spasms, and increasing blood circulation, which are all aimed at treating or alleviating medical conditions.
No
The device is indicated for muscle stimulation for therapeutic purposes, such as maintaining range of motion, preventing atrophy, muscle re-education, relaxing spasms, and increasing blood circulation. It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly lists hardware components such as a Controller, Interconnect Cable, Stimulation Array Pads, and Power Cord, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to direct physical therapy and rehabilitation of the quadriceps muscle (maintaining range of motion, preventing atrophy, muscle re-education, relaxing spasms, increasing blood circulation). These are therapeutic applications, not diagnostic ones.
- Device Description: The device provides electrical stimulation to the muscle via electrodes. This is a physical intervention, not a test performed on a sample of biological material.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Niveus Medical Muscle Stimulation System 110 is indicated for:
-
- Maintaining or increasing range of motion of the knee joint
-
- Prevention or retardation of disuse atrophy in the quadriceps
-
- Muscle re-education of the quadriceps
-
- Relaxation of muscle spasms
-
- Increasing local blood circulation
Product codes
IPF
Device Description
The Muscle Stimulation System 110 is a portable, externally-powered device which provides electrical stimulation to the quadriceps using constant current pulses. Pulses are delivered via six independently controlled stimulation channels (3 per leg) and are provided to the patient via electrodes integrated into soft Stimulation Array Pads. An Interconnect Cable allows for communication between the System Controller and Stimulation Array Pads.
The major components of the system consist of a Controller, an Interconnect Cable, a pair of disposable Stimulation Array Pads configured for application to the quadriceps of a patient, a Power Cord, and Instructions for Use. An optional accessory to the system is the Niveus Medical StayCool FlexPaks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
quadriceps, knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The modification to the user interface was evaluated through software verification testing. The change to the Stimulation Array Pads was evaluated through simulated use testing. The shelf-life extension was supported by real-time aging data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2015
Niveus Medical. Inc. c/o Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA, 94010
Re: K150742
Trade/Device Name: Muscle Stimulation System 110 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: June 19, 2015 Received: June 26, 2015
Dear Ms. Domecus,
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
Carlos L. Pena -50/Δ
Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150742
Device Name Muscle Stimulation System 110
Indications for Use (Describe) The Niveus Medical Muscle Stimulation System 110 is indicated for:
-
- Maintaining or increasing range of motion of the knee joint
-
- Prevention or retardation of disuse atrophy in the quadriceps
- Muscle re-education of the quadriceps
-
- Relaxation of muscle spasms
- Increasing local blood circulation
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summarv
I. SUBMITTER
510(k) Owner: Niveus Medical, Inc. 849 Independence Avenue Suite C Mountain View, CA 94043 650-336-7922 (phone)
Contact Person: Cindy Domecus, R.A.C. (US &EU) Principal, Domecus Consulting Services LLC (650) 343-4813 (phone) (650) 343-7822 (fax)
Date Prepared: July 23, 2015
II. DEVICE
| Name of Device: | Muscle Stimulation System 110 |
|---|---|
| Common or Usual Name: | Powered Muscle Stimulator |
| Classification Name: | Powered Muscle Stimulator (21 CFR 890.5850) |
| Regulatory Class: | II |
| Product Code: | IPF |
III. PREDICATE DEVICE
The predicate device is the Niveus Medical Muscle Stimulation System 110 cleared under K123642.
The predicate device has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Muscle Stimulation System 110 is a portable, externally-powered device which provides electrical stimulation to the quadriceps using constant current pulses. Pulses are delivered via six independently controlled stimulation channels (3 per leg) and are provided to the patient via electrodes integrated into soft Stimulation
4
Special 510(k) Niveus Medical, Inc.
Arrav Pads. An Interconnect Cable allows for communication between the System Controller and Stimulation Array Pads.
The major components of the system consist of a Controller, an Interconnect Cable, a pair of disposable Stimulation Array Pads configured for application to the quadriceps of a patient, a Power Cord, and Instructions for Use. An optional accessory to the system is the Niveus Medical StayCool FlexPaks.
V. INDICATIONS FOR USE
The Niveus Medical Muscle Stimulation System 110 is indicated for:
-
- Maintaining or increasing range of motion of the knee joint
-
- Prevention or retardation of disuse atrophy in the quadriceps
-
- Muscle re-education of the quadriceps
-
- Relaxation of muscle spasms
-
- Increasing local blood circulation
The indications for use are unchanged from the predicate.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject device represents minor modifications to the predicate device, as follows:
- Update user interface to reflect user preferences
- Minor changes to allow for improved mounting of touchscreen ●
- A non-functional portion of the bandage material near the Stimulation Array ● Pad's center is separated from rest of pad such that it remains on release liner during application, leaving a region of uncovered skin in treatment region
- Extend expiration date to 18 months
- An instructional label has been added to the Interconnect Cable connector as an indicator for the top side of the connector
PERFORMANCE DATA VII.
The modification to the user interface was evaluated through software verification testing. The change to the Stimulation Array Pads was evaluated through simulated use testing. The shelf-life extension was supported by real-time aging data.
VIII. CONCLUSION
The bench performance data provided in support of the 510(k) confirm that the subject device is as safe and effective and substantially equivalent to the predicate device.