LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE

K122194 · Everyway Medical Instruments Co.,Ltd · KPI · Apr 4, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K122194
• Device Name: LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
• Applicant: Everyway Medical Instruments Co.,Ltd
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Apr 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Everyway Incontinence Stimulation Electrode, model PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A for Life-Care Vaginal Probe & PR-06/06A, PR-12A, PR-13/13A for Life-Care Anal Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Device Story

Lightweight vaginal/anal probes; cylinder-shaped with conductive rings/plates; used for pelvic floor muscle rehabilitation and urinary incontinence treatment. Inputs: electrical signals from pelvic musculature (EMG) or delivery of electrical stimulation. Operation: single-user, intermittent use in home or clinic; reusable for up to one year; requires manual cleaning. Output: EMG feedback or electrical stimulation to pelvic muscles. Healthcare provider/patient uses output to monitor or stimulate muscle activity; aids in restoring neuromuscular control. Benefits: non-invasive rehabilitation of weak pelvic floor muscles.

Clinical Evidence

No clinical data conducted. Evidence based on bench testing, including performance assessment, cleaning validation for reuse, and biocompatibility testing per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Cylindrical vaginal/anal probes; stainless steel electrodes; 2 or 3 independent conductive channels; watertight construction; standard female or pigtail wire connectors. Biocompatibility per ISO 10993-5/10. Non-sterile, reusable.

Indications for Use

Indicated for patients with urinary incontinence requiring pelvic floor muscle rehabilitation or neuromuscular control restoration via electromyographic feedback or electrical stimulation.

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)
• Anal Stimulation/EMG Probe-w/Stop (K990456)

Submission Summary (Full Text)

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#### EVERYWAY MEDICAL INSTRUMENTS CO.,LTD.

3F1., No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,

## 510(K) SUMMARY

APR 0 4 2013

This summary of 510(k) safety and effectiveness information is being prepared in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 at June 15, 2011.

The assigned 510(k) number is: K122194.

- 1. Submitter's Identifications:
Establishment:EVERYWAY MEDICAL INSTRUMENT CO., LTD. Address: 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd., Shenkeng Hsiang, Taipei Hsien 222, Taiwan Registration Number: 9616877 Operations: Manufacturer

Owner/Operator:EVERYWAY MEDICAL INSTRUMENT CO., LTD. Address : 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd., Shenkeng Hsiang, Taipei Hsien 222, Taiwan Contact Person: Robert Tu Phone : [phone] Fax No: 886-2-2664-5566 e-mail : [e-mail]

- 2. Name of the Device: Everyway Incontinence Stimulation Electrode Model: PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A. PR-14A for Life-Care Vaginal Probe & PR-06/06A, PR-12A, PR-13/13A for Life-Care Anal Probe.
- Information of the 510(k) Cleared Device (Predicate Device): 3. Hollister Vaginal Stimulation/EMG Probe-Tampon (K971541) and Anal Stimulation/EMG Probe-w/Stop(K990456)
- 4. Classification Information: Trade/Device Name: Everyway Incontinence Stimulation Electrode, model PR-02/02A, PR-03/03A. PR-04/04A. PR-10A. PR-11A. PR-14A for Life-Care Vaginal Probe & PR-06/06A, PR-12A, PR-13/13A for Life-Care Anal Probe. Regulation Number: 21 CFR Part 876.5320 & 21 CFR Part 884.1425 Classification Name: Stimulator, Electrical, Non-implantable, For Incontinence & Perineometer. Requiatory Class: II

Product Code: KPI & HIR

- 5. Device Description:
The Life-Care Vaginal Probe models PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A 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 as above mentioned and easy for 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 for reuse according to the validated cleaning method as recommended in user manual.

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3F1. No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,

The Life-Care Anal Probe models PR-06/06A, PR-12A, PR-13/13A are the light weight cylinder consisting of two or three independent conductive rings that are paired and isolated, physically and electrically. The cylinder is shaped with a waist and handle for comfort positioning in rectal canal for incontinent treatment as above mentioned and easy for 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 for reuse according to the validated cleaning method

To fit with different type of device connection, the lead wire of device was provided with two different type of wire connection terminals, the standard female plug terminal and pigtail terminal. For the model with pigtail connection terminal, the letter "A" in the last of model name (e.g. PR-02A ) to separate them from the model with standard female plug terminal.

6. Intended Use:

The Everyway Incontinence Stimulation Electrode, model PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A for Life-Care Vaginal Probe & PR-06/06A, PR-12A, PR-13/13A for Life-Care Anal Probe 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.

| Electrode<br>Characteristics | Predicate device<br>Vaginal Probe | New Device<br>Vaginal Probe | Predicate Device<br>Anal Probe | New Devices<br>Anal Probe |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Model | Hollister K971541<br>Vaginal Stimulation/<br>EMG Probe-Tampon | Everyway Vaginal Stimulation<br>/EMG Probe, PR-02 / PR-02A,<br>PR-03 / PR-03A, PR-04 / PR-04A,<br>PR-10A, PR-11A, PR-14A | Hollister K990456<br>Anal Stimulation/<br>EMG Probe-w/Stop | Everyway Vaginal Stimulation<br>/EMG Probe, PR-06 / PR-06A,<br>PR-12A, PR-13 / PR-13A |
| Usage Conditions | Reusable-Single Patientl | Same | Reusable-Single Patientl | Same |
| Electrode<br>Material | Stainless steel | Same | Stainless steel | Same |
| Electrode<br>Placement | Vaginal | Same | Anal | Same |
| Contact Duration | Intermittent mucosal<br>contact<30 min/ session-<br>Stim<1 hour/session- EMG<br>not exceeding 1 hr combined | Same | Intermittent mucosal contact <30<br>min/ session-<br>Stim<1hour/session-<br>EMG not exceeding 1 hr combined | Same |
| Indications for<br>Use | Electrical stimulation of the<br>pelvic floor muscles for the<br>treatment of urinary<br>incontinence. EMG sensing<br>of the pelvic floor muscles | Same | Electrical stimulation of the pelvic<br>floor muscles for the treatment of<br>urinary incontinence. EMG<br>sensing of the pelvic floor muscles | Same |

#### 7. Comparison to the 510(k) Cleared Device (Predicate Device):

The following features are completely identical among the predicate device

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3F1. No. 5. Lane 155. Sec. 3.Peishen Rd. Shen Keng Hsiang. Taipei Hsien. Taiwan,

### Different Features Assessment:

As mentioned on the comparison table, there exists the following feature difference:

- 1> Electrode orientation: PR-02/02A new device provide the shell type of orientation, the other models provide circular type of orientation.
- 2> The number of electrodes: PR-10A/PR-11A for Everyway Vaginal probe and PR-12A for Everyway Anal probe provide 3 independent stimulation channels. The other models provide 2 independent stimulation channels.
- 3> Device Connector: For Everyway's probes two different type of connectors are provided, the cord with standard plug and the cord with pigtail plug. But for the predicate device, only the cord with standard plug is to be provided.
- 4> The dimensions of the device is different as the following table:
- For Vaginal Probe:

| Probe Diameter(inches) | Predicate device | | | New Devices | | | |
|---------------------------|-------------------|-----------|-----------|-------------|------------|----------|--------|
| Model | Hollister/K971541 | PR-02/02A | PR-03/03A | PR-04/04 A | PR-10A | PR-11A | PR-14A |
| Probe Length(inches) | 2.3 | 2.91 | 5.83 | 3.97 | 5.4 | 4.09 | 2.07 |
| Probe Diameter(inches) | 0.841 | 1.1 | 0.98 | 0.78 | 0.98 | 0.78 | 0.78 |
| Electrode Spacing(inches) | 0.50 | 0.71 | 0.61 | 0.57 | 0.18, 0.20 | 0.1.0.18 | 0.57 |
| Active Surface | 0.90 | 1.186 | 1.22 | 0.97 | 0.97, 1.22 | 0.97 | 0.93 |
| Area(inch4/band ) | | | | | | | |

For Anal Probe:

| | Probe Diameter(inches) | Predicate device | New Device | | |
|--|----------------------------------|-------------------|------------|------------|-----------|
| | Model | Hollister/K990456 | PR-06/06A | PR-12A | PR-13/13A |
| | Probe Length(inches) | 2.349 | 3.42 | 4.27 | 4.27 |
| | Probe Diameter(inches) | 0.453 | 0.51 | 0.77 | 0.77 |
| | Electrode Spacing(inches) | -0.25 | 0.31 | 0.1, 0.12 | 0.42 |
| | Active Surface Area (inch²/band) | 0.35 | 0.3 | 0.35, 0.38 | 0.58 |

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

- 1> Usage Conditions ..
- 2> Body Material.
- 3> Electrode(Conductive) Material.
- 4> Electrode Placement.
- 5> Contact Duration.
- 6> Indication for Use

8. Discussion of Non-Clinical Tests Verification Activities Performed to Determine the Safety and Performance of the devices are as the followings:

- 1> The assessment and test report for the device performance performed by manufacturer.
- 2> The validation test report for the recommended cleaning method for reuse conducted and reported by the manufacturer.
- 3> The biocompatibility conformity test report according to ISO 10993-5 and ISO 10993-10 performed by the accredited testing laboratory.
- Discussion of Clinical Test Validation Activities Performed to Determine the Effectiveness of ு. Device are as the followings:

No particular Clinical Test was conducted for Everyway Incontinence Stimulation Electrode.

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3F1. No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,

## 10. Conclusions_

The Everyway Incontinence Stimulation Electrode, model PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A for Life-Care Vaginal Probe & PR-06/06A, PR-12A, PR-13/13A for Life-Care Anal Probe, has the same intended use and technological characteristics as the cleared device of Hollister Vaginal Stimulation/EMG Probe-Tampon (K971541) and Anal Stimulation/EMG Probe-w/Stop(K990456). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted model could maintain the same safety and effectiveness as that of cleared device.

In the other words, Everyway Incontinence Stimulation Electrode, model PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A for Life-Care Vaginal Probe & PR-06/06A, PR-12A, PR-13/13A for Life-Care Anal Probe are substantial equivalent with the Hollister Vaginal Stimulation/EMG Probe-Tampon (K971541) and Anal Stimulation/EMG Probew/Stop(K990456)

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 4, 2013

EVERYWAY MEDICAL INSTRUMENTS CO., LTD. % Mr. Robert Tu President and Operator Owner 3FL., No. 5, Lane 155, Section 3, Peishen Rd. SHENKENG HSIANG, TAIPEI HSIEN CHINA (TAIWAN) 222

Re: K122194

Trade/Device Name: Everyway Incontinence Stimulation Electrode, model PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A for Life-Care Vaginal Probe & PR-06/06A, PR-12A, PR-13/13A for Life-Care Anal Probe Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI, HIR

Dated: March 25, 2013

Received: March 29, 2013

Dear Mr. Tu:

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.

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Page 2 - Mr. Robert Tu

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be device and in 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 I va must compy "Haran 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements modified in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the as set form in the mail on 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 11 you desire specific ad 1700 2011 DA/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Benjamin R. Fisher -S

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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3F1., No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,

## Indications For Use

510(k) Number (if known): K122194

Device Name: Everyway Incontinence Stimulation Electrode, model PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A for Life-Care Vaginal Probe & PR-06/06A, PR-12A, PR-13/13A for Life-Care Anal Probe.

Indications For Use:

The Everyway Incontinence Stimulation Electrode, model PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A for Life-Care Vaginal Probe & PR-06/06A, PR-12A, PR-13/13A for Life-Care Anal Probe are intended to provide electromyo graphic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Prescription Use V (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Benjamin R Fisher S |
|-----------------------------|
| 2013.04.04 18:02:30 -04'00' |

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122194 510(k) Number

167 of K122194 Response

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