(89 days)
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.
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.
Here's an analysis of the provided text regarding the Fuji Dynamics Incontinence Stimulation Electrode, focusing on acceptance criteria and study details:
This document is a 510(k) summary for a medical device submitted to the FDA. It does not contain a detailed study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or clinical outcomes.
Instead, this 510(k) outlines the device's substantial equivalence to predicate devices based on identical intended use, technological characteristics, and safety testing (biocompatibility). The FDA's 510(k) pathway determines if a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily that it meets specific, predefined performance thresholds through a clinical study.
Therefore, many of your requested points related to performance studies (like sample size for test sets, number of experts, MRMC studies, standalone performance, training set details) will not be present in this type of document because such studies were not required for this specific 510(k) submission.
Here's a breakdown of the information that is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, this document does not present a table of specific quantitative "acceptance criteria" for device performance (e.g., a specific accuracy or sensitivity). The "acceptance" for this 510(k) is based on demonstrating substantial equivalence to the predicate devices. The "reported device performance" is primarily about its physical and functional characteristics matching or being acceptably different from the predicates.
| Feature / Characteristic | Predicate Device Specification (Hollister K971541 / K990456) | Subject Device Specification (Fuji Dynamics ) | Equivalence Assessment |
|---|---|---|---|
| Vaginal Probe (K971541 vs. Fuji-01/02/03/04/05/06/07/14/15) | |||
| Number of Electrodes | 2-Stimulation / EMG | Same | Identical |
| Usage Conditions | Reusable - single patient | Same | Identical |
| Electrode Material | Stainless steel | Same | Identical |
| Electrode Placement | Vaginal | Same | Identical |
| Contact Duration | Intermittent mucosal contact < 30 min/session -Stim < 1 hour/session -EMG not exceeding hr combined Stim/EMG | Same | Identical |
| Indications for use | Electrical stimulation of the pelvic floor muscles for the treatment of urinary incontinence. EMG sensing of the pelvic floor muscles. | Same | Identical |
| Electrode Orientation | Circular type | Shell type (Fuji-01/02/11/12/14/15) or Circular type (Fuji-03/04/05/06/07/08/09/10/13) | Different (Assessed not to raise safety/effectiveness concerns) |
| Device Connector | Cord with standard 2.0 mm plug | Cord with custom designed plug | Different (Assessed not to raise safety/effectiveness concerns) |
| Dimensions (various models) | Probe Length, Diameter, Electrode Spacing, Active Surfaces Area | Different dimensions (See tables on page 6) | Different (Assessed not to raise safety/effectiveness concerns) |
| Anal Probe (K990456 vs. Fuji-08/09/10/11/12/13/14/15) | |||
| Number of Electrodes | 2-Stimulation / EMG | Same | Identical |
| Usage Conditions | Reusable - single patient | Same | Identical |
| Electrode Material | Stainless steel | Same | Identical |
| Electrode Placement | Anal | Same | Identical |
| Contact Duration | Intermittent mucosal contact < 30 min/session -Stim < 1 hour/session – EMG not exceeding hr combined Stim/EMG | Same | Identical |
| Indications for use | Electrical stimulation of the pelvic floor muscles for the treatment of urinary incontinence. EMG sensing of the pelvic floor muscles. | Same | Identical |
| Electrode Orientation | Circular type | Shell type (Fuji-01/02/11/12/14/15) or Circular type (Fuji-03/04/05/06/07/08/09/10/13) | Different (Assessed not to raise safety/effectiveness concerns) |
| Device Connector | Cord with standard 2.0 mm plug | Cord with custom designed plug | Different (Assessed not to raise safety/effectiveness concerns) |
| Dimensions (various models) | Probe Length, Diameter, Electrode Spacing, Active Surfaces Area | Different dimensions (See tables on page 6) | Different (Assessed not to raise safety/effectiveness concerns) |
The overall "acceptance criteria" here is that the differences in features (electrode orientation, connector, dimensions) between the subject device and the predicate devices do not raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical performance test set was used for this 510(k) submission. The assessment was a comparison to existing predicate devices and non-clinical biocompatibility testing. The data provenance for the biocompatibility test (ISO 10993) is a recognized international standard, but specific country of origin for the test itself is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There was no clinical test set requiring expert ground truth establishment for performance evaluation in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an electrode for electrical stimulation/EMG biofeedback, not an AI-powered diagnostic device, and no MRMC study was conducted or required for this 510(k).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the biocompatibility test: The "ground truth" is adherence to ISO 10993 standards and obtaining results within acceptable limits for biological safety.
- For substantial equivalence: The "ground truth" is the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI/algorithm-driven device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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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 (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 Plaza788 Cheung Sha Wan Road, KowloonHong 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 ElectrodeModels: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/ EMGProbe-w/Stop | Fuji- 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 | |
| Number ofElectrode | 2-Stimulation / EMG | Same | 2-Stimulation / EMG | Same |
| UsageConditions | Reusable - singlepatient | Same | Reusable - singlepatient | Same |
| ElectrodeMaterial | Stainless steel | Same | Stainless steel | Same |
| ElectrodePlacement | Vaginal | Same | Anal | Same |
| ContactDuration | Intermittent mucosalcontact < 30min/session -Stim <1 hour/session -EMG not exceedinghr combinedStim/EMG | Same | Intermittent mucosalcontact < 30min/session -Stim < 1hour/session – EMGnot exceeding hrcombined Stim/EMG | Same |
| Indications foruse | Electrical stimulationof the pelvic floormuscles for thetreatment of urinaryincontinence. EMGsensing of the pelvicfloor muscles. | Same | Electrical stimulationof the pelvic floormuscles for thetreatment of urinaryincontinence. EMGsensing of the pelvicfloor muscles. | Same |
Different Features Assessment
As listed in comparison table, the following feature is different:
-
- 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.
-
- 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.
-
- The dimensions of the device is different as the following table :
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For Vaginal Probe :
| Model | Probe Length(cm) | Probe Diameter(cm) | ElectrodeSpacing (cm) | Active Surfaces,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(cm) | Probe Diameter(cm) | ElectrodeSpacing (cm) | Active Surfaces,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.
§ 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).