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K Number
K122194
Device Name
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
Manufacturer
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
Date Cleared
2013-04-04

(254 days)

Product Code
KPIHIR
Regulation Number
876.5320
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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.
More Information

K971541, K990456

Not Found

No
The document describes a passive electrode device for electrical stimulation and EMG feedback, with no mention of AI or ML capabilities.

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 describes a therapeutic purpose.

No

The device is intended to provide electromyographic feedback and electrical stimulation for the purpose of rehabilitation and restoration of neuromuscular control, rather than for diagnosing a condition.

No

The device description clearly details physical probes (vaginal and anal) made of conductive rings or plates, which are hardware components. The summary also discusses cleaning methods and biocompatibility testing for these physical probes.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to provide electromyographic feedback or electrical stimulation to pelvic musculature for the treatment of urinary incontinence. This is a therapeutic and diagnostic (in terms of feedback) use directly on the patient's body.
  • Device Description: The device is a probe designed for insertion into the vaginal or rectal canal. It is a physical device that interacts directly with the patient's tissues.
  • Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens.

The device is a medical device used for treatment and physiological measurement in vivo (within the body).

N/A

Intended Use / 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 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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Pelvic musculature, vaginal canal, rectal 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 Tests:

  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.

Clinical Tests: No particular Clinical Test was conducted for Everyway 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.

K971541, K990456

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

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.

1

K122194 Page 2 of 4

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.

  1. 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
Characteristics | Predicate device
Vaginal Probe | New Device
Vaginal Probe | Predicate Device
Anal Probe | New Devices
Anal Probe |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Model | Hollister K971541
Vaginal 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 K990456
Anal 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 |
| Electrode
Material | Stainless steel | Same | Stainless steel | Same |
| Electrode
Placement | Vaginal | Same | Anal | Same |
| Contact Duration | Intermittent mucosal
contact 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 deviceNew Devices
ModelHollister/K971541PR-02/02APR-03/03APR-04/04 APR-10APR-11APR-14A
Probe Length(inches)2.32.915.833.975.44.092.07
Probe Diameter(inches)0.8411.10.980.780.980.780.78
Electrode Spacing(inches)0.500.710.610.570.18, 0.200.1.0.180.57
Active Surface0.901.1861.220.970.97, 1.220.970.93
Area(inch4/band )

For Anal Probe:

Probe Diameter(inches)Predicate deviceNew Device
ModelHollister/K990456PR-06/06APR-12APR-13/13A
Probe Length(inches)2.3493.424.274.27
Probe Diameter(inches)0.4530.510.770.77
Electrode Spacing(inches)-0.250.310.1, 0.120.42
Active Surface Area (inch²/band)0.350.30.35, 0.380.58

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
  1. 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.

3

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)

4

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.

5

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

6

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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