(89 days)
Not Found
No
The device description focuses on the physical characteristics and function of electrodes for electrical stimulation and EMG feedback, with no mention of AI or ML.
Yes
The device is intended for the "rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence," which classifies it as a therapeutic device.
No
The device is intended to provide electromyographic feedback or electrical stimulation for rehabilitation purposes, not for diagnosing a condition.
No
The device description clearly details a physical electrode, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Fuji Dynamics Incontinence Stimulation Electrodes are used directly on the body (in the vaginal canal or anal area) to provide electrical stimulation or measure electrical activity (EMG) of the pelvic muscles. They are not used to examine specimens outside of the body.
- Intended Use: The intended use is for rehabilitation and restoration of neuromuscular control, not for diagnosing a condition by analyzing a bodily specimen.
Therefore, based on the provided information, the Fuji Dynamics Incontinence Stimulation Electrodes fall under the category of a therapeutic or diagnostic device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fuji Dynamics Incontinence Stimulation Electrodes are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
Product codes (comma separated list FDA assigned to the subject device)
KPI, HIR
Device Description
The Fuji Dynamics Incontinence Stimulation Electrode models Fuji-01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 are the light weight cylinder consisting of two or three independent conductive rings or plates that are paired and isolated, physically and electrically. The cylinder is shaped with a waist and handle for comfort positioning in vaginal canal for incontinent treatment and easy in removing after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing and drying between uses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic musculature, vaginal canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home or clinic
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)
Non-clinical Testing: Biocompatibility test was conducted on Fuji Dynamics Incontinence Stimulation Electrode Fuji-01 according to ISO 10993, International Standards Organization (ISO) Standard. Based upon the test results, the materials used to fabricate Fuji Dynamics Incontinence Stimulation Electrodes are biocompatible and appropriate for their intended use.
Clinical Test: No clinical test was conducted on Fuji Dynamics Incontinence Stimulation Electrode.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure, with three profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2016
Fuji Dynamics Ltd. Kam Tim Ng Engineer 1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road Hong Kong China
Re: K161055 Trade/Device Name: Fuji Dynamics Incontinence Stimulation Electrode, Models: Fuji - 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Codes: KPI, HIR Dated: April 5, 2016 Received: April 14, 2016
Dear Kam Tim Ng:
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.
1
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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours.
Joyce M. Whang -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161055
Device Name
Fuji Dynamics Incontinence Stimulation Electrode Models : Fuji - 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15
Indications for Use (Describe)
The Fuji Dynamics Incontinence Stimulation Electrodes are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510 (k) Summary
Date of submission prepared : 5 April 2016
The assigned 510(k) number is :
1. Submitter's Information
| Submitter: | Fuji Dynamics Ltd.
Unit 2301-03, Laws Commerical Plaza
788 Cheung Sha Wan Road, Kowloon
Hong Kong |
|-----------------|------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kam Tim Ng |
| Tel: | (852) 2786 4218 |
| Fax: | (852) 2744 6775 |
2. General Device Informaion
| Name of Device : | Fuji Dynamics Incontinence Stimulation Electrode
Models:
Fuji-01 / 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Classification Name : | Stimulator, Electrical, Non-implantable, For Incontinence ,
Perineometer & EMG Biofeedback System |
| Product Code : | KPI, HIR |
| Regulatory Class : | Class II |
3. Predicate Device Information
Hollister Vaginal Stimulation/EMG Probe-Tampon (K971541) and Anal Stimulation /EMG Probe-w/Stop (K990456)
4. Device Description
The Fuji Dynamics Incontinence Stimulation Electrode models Fuji-01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 are the light weight cylinder consisting of two or three independent conductive rings or plates that are paired and isolated, physically and electrically. The cylinder is shaped with a waist and handle for comfort positioning in vaginal canal for incontinent treatment and easy in removing after treatment. It is
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E. 510 (k) Summary (per 21 CFR 807.92)
watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing and drying between uses.
5. Intended use
The Fuji Dynamics Incontinence Stimulation Electrode, model Fuji-01/ 02/ 03/ 04 / 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
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Comparison to the Predicate Device 6.
The following features are identical among the predicate device and our models.
| Characteristic | Vaginal Probe | Anal Probe | ||
|---|---|---|---|---|
| Predicate device | Subject device | Predicate device | Subject device | |
| Model | Hollister K971541 | Fuji Dynamics | Hollister K990456 | Fuji Dynamics |
| Vaginal Stimulation/ | ||||
| EMG Probe-Tampon | Fuji-01/ 02 / 03/ 04 / | |||
| 05/ 06/ 07/ 14/ 15 | Anal Stimulation/ EMG | |||
| Probe-w/Stop | Fuji- 08/ 09/ 10/ 11/ 12 | |||
| / 13/ 14/ 15 | ||||
| Number of | ||||
| Electrode | 2-Stimulation / EMG | Same | 2-Stimulation / EMG | Same |
| Usage | ||||
| Conditions | Reusable - single | |||
| patient | Same | Reusable - single | ||
| patient | Same | |||
| Electrode | ||||
| Material | Stainless steel | Same | Stainless steel | Same |
| Electrode | ||||
| Placement | Vaginal | Same | Anal | Same |
| Contact | ||||
| Duration | Intermittent mucosal | |||
| contact |