Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15

K161055 · Fuji Dynamics , Ltd. · KPI · Jul 12, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: 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
• Applicant: Fuji Dynamics , Ltd.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Jul 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Lightweight cylindrical electrodes; two or three independent conductive rings/plates; vaginal or anal insertion. Device provides electromyographic (EMG) feedback or electrical stimulation to pelvic musculature. Used in home or clinic settings by single user; reusable for up to one year. Requires manual washing/drying between uses. Healthcare provider uses output to monitor muscle activity or deliver stimulation for incontinence treatment; patient benefits from improved pelvic floor muscle strength and neuromuscular control.

Clinical Evidence

No clinical data provided. Biocompatibility testing conducted per ISO 10993.

Technological Characteristics

Cylindrical probe; stainless steel electrodes; shell or circular orientation; custom connector plug. Reusable, non-sterile, watertight design. Dimensions vary by model (length 5.6-15.9 cm, diameter 1.1-3.4 cm).

Indications for Use

Indicated for patients requiring pelvic floor muscle rehabilitation or neuromuscular control restoration for the treatment of urinary incontinence.

Regulatory Classification

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).

Predicate Devices

• Hollister Vaginal Stimulation/EMG Probe-Tampon (K971541)
• Hollister Anal Stimulation/EMG Probe-w/Stop (K990456)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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.<br>Unit 2301-03, Laws Commerical Plaza<br>788 Cheung Sha Wan Road, Kowloon<br>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<br>Models:<br>Fuji-01 / 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Classification Name : | Stimulator, Electrical, Non-implantable, For Incontinence ,<br>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/<br>EMG Probe-Tampon | Fuji-01/ 02 / 03/ 04 /<br>05/ 06/ 07/ 14/ 15 | Anal Stimulation/ EMG<br>Probe-w/Stop | Fuji- 08/ 09/ 10/ 11/ 12<br>/ 13/ 14/ 15 |
| Number of<br>Electrode | 2-Stimulation / EMG | Same | 2-Stimulation / EMG | Same |
| Usage<br>Conditions | Reusable - single<br>patient | Same | Reusable - single<br>patient | Same |
| Electrode<br>Material | Stainless steel | Same | Stainless steel | Same |
| Electrode<br>Placement | Vaginal | Same | Anal | Same |
| Contact<br>Duration | Intermittent mucosal<br>contact < 30<br>min/session -Stim <<br>1 hour/session -<br>EMG not exceeding<br>hr combined<br>Stim/EMG | Same | Intermittent mucosal<br>contact < 30<br>min/session -Stim < 1<br>hour/session – EMG<br>not exceeding hr<br>combined Stim/EMG | Same |
| Indications for<br>use | Electrical stimulation<br>of the pelvic floor<br>muscles for the<br>treatment of urinary<br>incontinence. EMG<br>sensing of the pelvic<br>floor muscles. | Same | Electrical stimulation<br>of the pelvic floor<br>muscles for the<br>treatment of urinary<br>incontinence. EMG<br>sensing of the pelvic<br>floor muscles. | Same |

#### Different Features Assessment

As listed in comparison table, the following feature is different:

- 1. Electrode orientation : Model Fuji-01/ 02/ 11/ 12/ 14/ 15 of subject device provide the shell type of orientation, Model Fuji-03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 13 and the predicate device provide circular type of orientation.
- 2. Device connector: For Fuji Dynamics Probes, the connector provided is the cord with custom designed plug. But for the predicate device, only the cord with standard 2.0 mm plug is to be provided.
- 3. The dimensions of the device is different as the following table :

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# For Vaginal Probe :

| Model | Probe Length<br>(cm) | Probe Diameter<br>(cm) | Electrode<br>Spacing (cm) | Active Surfaces,<br>Area (cm² / band) |
|-------------------|----------------------|------------------------|---------------------------|---------------------------------------|
| Predicate Device | | | | |
| Hollister K971541 | 5.8 | 2.1 | 1.3 | 5.8 |
| Subject Devices | | | | |
| FUJI-01 | 8.0 | 2.8 | 1.4 | 4.1 |
| FUJI-02 | 8.0 | 2.8 | 1.4 | 3.9 |
| FUJI-03 | 15.9 | 2.8 | 1.5 | 7.9 |
| FUJI-04 | 10.0 | 2.5 | 1.8 | 7.9 |
| FUJI-05 | 14.5 | 2.5 | 0.5 | 7.9 |
| FUJI-06 | 12.0 | 2.5 | 0.4 | 7.9 |
| FUJI-07 | 5.6 | 2.0 | 2.2 | 6.3 |
| FUJI-14 | 7.8 | 3.4 | 2.9 | 3.1 |
| FUJI-15 | 8.6 | 2.4 | 1.6 | 2.4 |

## For Anal Probe :

| Model | Probe Length<br>(cm) | Probe Diameter<br>(cm) | Electrode<br>Spacing (cm) | Active Surfaces,<br>Area (cm² / band) | |
|-------------------|----------------------|------------------------|---------------------------|---------------------------------------|--|
| Predicate Device | | | | | |
| Hollister K990456 | 5.8 | 1.1 | 0.6 | 2.3 | |
| Subject Devices | | | | | |
| FUJI-08 | 8.5 | 1.4 | 0.8 | 1.8 | |
| FUJI-09 | 10.3 | 1.6 | 0.3 | 3.1 | |
| FUJI-10 | 10.3 | 1.6 | 1.1 | 3.1 | |
| FUJI-11 | 8.8 | 1.8 | 0.3 | 8.5 | |
| FUJI-12 | 12.9 | 1.8 | 0.3 | 8.5 | |
| FUJI-13 | 6.4 | 1.6 | 0.6 | 1.6 | |
| FUJI-14 | 7.8 | 3.4 | 2.9 | 3.1 | |
| FUJI-15 | 8.6 | 2.4 | 1.6 | 2.4 | |

Since most of significant features of the predicate device and the subject devices as the following listing are completely identical, we considered it is reasonable to claim substantial equivalence between the subject devices

- l Usage conditions

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- . Body Material
- Electrode (conductive) material
- Electrode placement
- Contact duration
- Indication for use.

# 7. 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 8.

No clinical test was conducted on Fuji Dynamics Incontinence Stimulation Electrode.

### 9. Sterilization

The electrodes do not require sterilization, but requires washing and drying between uses.

#### 10. Conclusion

Based upon the information presented above, the Fuji Dynamics Incontinence Stimulation Electrode has the same intended use and technological characteristics as the predicate device of Hollister Vaginal Stimulation/EMG Probe-Tampon Stimulation/EMG Probe-Tampon (K971541) and Anal Stimulation/EMG Probe-w/Stop (K990456). The differences between the subject devices and the predicate devices do not raise question in safety and effectiveness. Therefore, it is concluded that Fuji Dynamics Incontinence Stimulation Electrodes are substantial equivalent to the predicate device.