The Urinary Incontinence Probe, model PR-51 Vaginal Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

The Urinary Incontinence Probe, model PR-51 Vaginal Probe & PR-52 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 Description

The Urinary Incontinence Probe, model PR-51 Vaginal Probe & PR-52 Anal Probe are the light weight cylinder consisting of two independent conductive rings that are paired and isolated, physically and electrically. The cylinder is shaped with a handle for comfort positioning in vaginal/anal 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 probe 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.

To fit with different type of device connection, the lead wire of device was provided with three different type of wire connection terminals, 2mm pigtail, 3.5mm femelle and 2.35 mm femelle. Either of the PR-51 Vaginal Probe & PR-52 Anal Probe can be connected to any one of three connection terminals.

AI/ML Overview

The provided document describes a 510(k) premarket notification for an "Electrode for Urinary Incontinence" (Models PR-51, PR-52). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study with acceptance criteria.

Therefore, many sections of your request related to acceptance criteria, sample sizes, ground truth, expert adjudication, and clinical study outcomes cannot be directly extracted from this document, as these types of studies were explicitly stated as "Not applicable" (# 9 Brief discussion of clinical tests: Not applicable).

The document primarily addresses non-clinical performance and biological evaluation.

Here's a breakdown of the information that can be extracted or inferred, and what cannot:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. No specific acceptance criteria (e.g., in terms of clinical efficacy, sensitivity, specificity, accuracy) or reported performance metrics are listed because no clinical performance study was conducted or required for this 510(k) submission. The submission focuses on substantial equivalence based on technological characteristics and non-clinical testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. No clinical test set. The non-clinical tests (biological evaluation and standards compliance) do not typically refer to "test sets" in the same way clinical studies do. The manufacturer is Guangzhou Finecure Medical Equipment Co., Ltd. from China.

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/Not provided. No clinical test set requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No clinical test set requiring adjudication.

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 urinary incontinence, not an AI diagnostic imaging device. No MRMC study was conducted or is relevant.

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

Not applicable. This device is a medical electrode, not a software algorithm.

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

Not applicable. For the non-clinical tests, the "ground truth" would be compliance with the standards referenced (e.g., biocompatibility testing for ISO 10993).

8. The sample size for the training set

Not applicable/Not provided. No clinical study was conducted.

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

Not applicable/Not provided. No clinical study was conducted.

Summary of what the document does provide regarding device performance and acceptance:

The device's acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (Everyway Incontinence Stimulation Electrode, K122194) and compliance with specific non-clinical standards.

Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) submission strategy):

Acceptance Criteria Category	Specific Criteria (from standard)	Reported Device Performance/Compliance
Biocompatibility	ISO 10993-1:2009: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.	The device conforms to ISO 10993-1. (Implies a risk management process led to appropriate biological testing and a favorable outcome).
	ISO 10993-5:2009: Biological evaluation of medical devices Part 5: Tests for In Vitro cytotoxicity.	The device conforms to ISO 10993-5. (Implies the device material does not exhibit cytotoxicity).
	ISO 10993-10:2010: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.	The device conforms to ISO 10993-10. (Implies the device material does not cause irritation or skin sensitization).
Technological Equivalence	Same intended use, design principle, and similar material composition as predicate device.	"The proposed device and the Predicate device have the same intended use, design principle, and similar material composition. The differences do not exert adverse effect on the proposed device. The proposed device is substantially equivalent to the predicate devices." (Stated in Section 7 of the 510(k) Summary). Key technological features like independent conductive rings, handle for comfort, watertight design, and lead wire connections are described as part of the device description.
Cleaning/Reuse	Watertight to allow washing; validated cleaning method for repeated intermittent use up to one year.	"It is watertight to allow for washing with soap and water between uses. The probe 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." (Described in Section 4). Implies validated cleaning procedures meet acceptable criteria for reuse.

Study Proving Device Meets Acceptance Criteria:

The "study" in this context refers to the non-clinical tests and analysis performed to demonstrate substantial equivalence and safety/effectiveness.

Non-Clinical Testing: The document explicitly states that the "Electrode for Urinary Incontinence conforms to the following standards:" and then lists the three ISO 10993 standards mentioned above. This indicates that appropriate biocompatibility testing was performed and passed, leading to compliance with these standards.
Comparison to Predicate Device: The 510(k) submission itself is a "study" of comparison, wherein the manufacturer presents arguments and data (including the declaration of compliance with standards) to demonstrate that their device is "substantially equivalent" to an already cleared predicate device. The FDA's review and clearance (K140265) indicate that they agreed with this assessment.

In conclusion, this regulatory document focuses on establishing substantial equivalence for market clearance, rather than reporting on a clinical effectiveness study with defined acceptance criteria for efficacy. The "acceptance criteria" are compliance with relevant safety standards (biocompatibility) and demonstration of similar technological characteristics and intended use as an existing cleared device.

Summary

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

January 23, 2015

Guangzhou Finecure Medical Equipment Co., Ltd % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. 4th Floor, Jinhui Building, Nanhai Blvd, Nanshan District, Shenzhen, 518000 China

Re: K140265

Trade/Device Name: Electrode for Urinary Incontinence Regulation Number: 21 CFR 876.5320 Regulation Name: Non-Implanted electrical continence device Regulatory Class: II Product Code: KPI, HIR Dated: December 10, 2014 Received: December 14, 2014

Dear Field Fu,

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 mav 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/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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Indications for Use

510(k) Number (if known) K140265

Device Name Electrode for Urinary Incontinence

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Product: Electrode for Urinary Incontinence

SECTION 05 510(k) Summary

This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.

1 Administrative Information

Date of Summaryprepared	Jan, 19, 2014
Manufacturerinformation	Company title:Guangzhou Finecure Medical Equipment Co.,Ltd.
	Company address:
	F19, No.1 Kesheng Road, Baiyun Torch
	Building, No.1633 Beitai Road, Baiyun District
	Guangzhou, CHINA
	Phone: +86(020) 2802 6079
	Fax: +86(020) 2802 6059
	Contact Person: Chiping Ma
	E-mail: Finecure_export@163.com
SubmissionCorrespondent	Shenzhen Joyantech Consulting Co., Ltd.
	4th Floor, Jinhui Building, Nanhai BLVD,
	Nanshan District, Shenzhen, Guangdong,
	China.
	Contact person: Mr. Field.Fu
Image: Joyantech logo	E-Mail: cefda13485@163.com
	QQ: 670312758
	Website: www.cefda.com
Establishment registrationnumber	No.

2 Device Information

Type of 510(k) submission:	Traditional
Trade Name:	Electrode for Urinary Incontinence
Model:	PR-51, PR-52

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Guangzhou Finecure Medical Equipment Co., LTD

SEC_005:001_510K Summary

Version:A/0

Product: Electrode for Urinary Incontinence

Classification name:	Stimulator, electrical, non-implantable, forincontinence;Perineometer.
Review Panel:	Gastroenterology/Urology;Obstetrics/Gynecology.
Product Code:	KPI; HIR
Device Class:	II
Regulation Number:	876.5320;884.1425

3 Predicate Device Information

Sponsor:	VERYWAY MEDICAL INSTRUMENT CO., LTD
Device:	Everyway Incontinence Stimulation ElectrodeModel: PR-02/02A, PR-03103A, PR-04104A, PR-10A,PR-h1A, PR-14A for Life-Care VaginalProbe & PR-06/06A, PR-1 2A, PR-1 3/13A for Life-Care Anal Probe.
510(K) Number:	K122194

4 Device Description

5 Intended Use

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Version:A/0

Product: Electrode for Urinary Incontinence

6 Indication for Use

The Urinary Incontinence Probe. model PR-51 Vaginal Probe & PR-52 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.

7 Technological characteristics of the proposed device compared to the predicate device

The proposed device and the Predicate device have the same intended use, design principle, and similar material composition. The differences do not exert adverse effect on the proposed device. The proposed device is substantially equivalent to the predicate devices.

8 Brief discussion of the nonclinical tests

Electrode for Urinary Incontinence conforms to the following standards:

& ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process;
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for � In Vitro cytotoxicity;
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests � for irritation and skin sensitization.

9 Brief discussion of clinical tests

Not applicable.

10 Other information (such as required by FDA guidance)

No other information.

11 Conclusions

The subject device---Electrode for Urinary Incontinence PR-51, PR-52 are substantially equivalent to Everyway Incontinence Stimulation Electrode whose 510(k) number is K122194.

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).