LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE by EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

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.

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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Everyway Incontinence Stimulation Electrodes, comparing them to predicate devices. The submission focuses on demonstrating substantial equivalence rather than presenting an independent performance study with acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth establishment are not applicable or not provided in this document. The submission argues for equivalence based on similar intended use and technological characteristics, supported by non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific performance acceptance criteria for the Everyway Incontinence Stimulation Electrode. Instead, it relies on demonstrating substantial equivalence to predicate devices (Hollister Vaginal Stimulation/EMG Probe-Tampon K971541 and Anal Stimulation/EMG Probe-w/Stop K990456).

The table provided is a comparison of characteristics between the new device and the predicate devices, not acceptance criteria for a new performance study. The key assertion is that the "new device could maintain the same safety and effectiveness as that of cleared device."

Electrode Characteristics	Predicate Device (Vaginal)	New Device (Vaginal)	Predicate Device (Anal)	New Device (Anal)
Model	Hollister K971541	Everyway PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A	Hollister K990456	Everyway PR-06/06A, PR-12A, PR-13/13A
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 <30 min/session (Stim), <1 hour/session (EMG), not exceeding 1 hr combined	Same	Intermittent mucosal contact <30 min/session (Stim), <1 hour/session (EMG), not exceeding 1 hr combined	Same
Indications for Use	Electrical stimulation of pelvic floor muscles for urinary incontinence treatment; EMG sensing of pelvic floor muscles	Same	Electrical stimulation of pelvic floor muscles for urinary incontinence treatment; EMG sensing of pelvic floor muscles	Same
Different Features:
Electrode Orientation	(circular type implied)	PR-02/02A: shell type; Others: circular type	(circular type implied)	(circular type implied)
Number of Electrodes	(implies 2)	PR-10A/PR-11A (Vaginal) & PR-12A (Anal): 3 independent stimulation channels; Others: 2 independent stimulation channels	(implies 2)	PR-12A: 3 independent; Others: 2 independent
Device Connector	Standard plug cord only	Standard plug cord & pigtail plug cord	Standard plug cord only	Standard plug cord & pigtail plug cord
Dimensions	Specific dimensions listed	Specific dimensions listed	Specific dimensions listed	Specific dimensions listed

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. No clinical test or specific test set with patient data was conducted or described for evaluating the device's performance against specific acceptance criteria.
Data Provenance: Not applicable. No clinical data provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth was established from expert consensus for a test set, as no clinical performance study was performed.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication was used.

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 incontinence stimulation electrode, not an AI-assisted diagnostic or therapeutic device requiring human reader interpretation or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical instrument, not an algorithm, so standalone performance in that context is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices through comparison of technical characteristics and non-clinical tests (device performance, cleaning validation, biocompatibility), not on direct clinical outcomes or expert-derived ground truth.

8. The sample size for the training set

Not applicable. No training set was used as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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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 : 886-2-2662-0038 Fax No: 886-2-2664-5566 e-mail : tu922@ms35.hinet.net

1. 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)
1. 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

1. 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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K122194 Page 2 of 4

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

Intended Use:

ElectrodeCharacteristics	Predicate deviceVaginal Probe	New DeviceVaginal Probe	Predicate DeviceAnal Probe	New DevicesAnal Probe
Model	Hollister K971541Vaginal Stimulation/EMG Probe-Tampon	Everyway Vaginal Stimulation/EMG Probe, PR-02 / PR-02A,PR-03 / PR-03A, PR-04 / PR-04A,PR-10A, PR-11A, PR-14A	Hollister K990456Anal Stimulation/EMG Probe-w/Stop	Everyway Vaginal Stimulation/EMG Probe, PR-06 / PR-06A,PR-12A, PR-13 / PR-13A
Usage Conditions	Reusable-Single Patientl	Same	Reusable-Single Patientl	Same
ElectrodeMaterial	Stainless steel	Same	Stainless steel	Same
ElectrodePlacement	Vaginal	Same	Anal	Same
Contact Duration	Intermittent mucosalcontact<30 min/ session-Stim<1 hour/session- EMGnot exceeding 1 hr combined	Same	Intermittent mucosal contact <30min/ session-Stim<1hour/session-EMG not exceeding 1 hr combined	Same
Indications forUse	Electrical stimulation of thepelvic floor muscles for thetreatment of urinaryincontinence. EMG sensingof the pelvic floor muscles	Same	Electrical stimulation of the pelvicfloor muscles for the treatment ofurinary incontinence. EMGsensing 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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K122-194 Page 3 of 4

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

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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K122194 Page 4 of 4

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 (800) 638-2041 or (301) 796-7100 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

Page 1 of 1

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Regulation Number and Section

§ 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).