The Vibrance® Pelvic Trainer is intended for the strengthening of the pelvic floor muscles, which has been found to help women with urinary incontinence.

Device Description

The Vibrance® Pelvic Trainer is a repeat use, non-sterile intra-vaginal exercise device intended to strengthen the pelvic floor musculature by offering resistance to an individual's voluntary contractions of these muscles. The Vibrance® Pelvic Trainer incorporates an active vibration biofeedback mechanism for the identification of the pelvic floor muscles, and the sheaths provide graduated resistance levels for the progressive strengthening of the pelvic floor muscle. The device is intended for home use.

The therapeutic effect is from the user using the device to exercise the pelvic floor muscles in accordance with the exercise program included in the instructions. The device provides biofeedback information that allows the user to verify the use of the correct muscles in the exercise routine and thus the effectiveness of the exercises undertaken. The device also includes a resistive component to the training program to strengthen the pelvic floor muscle via physiologic principles. The biofeedback mechanism works by directly sensing the force applied by the pelvic floor muscle.

The device consists of the Main Body and three Resistance Sheaths with varying degrees of stiffness. It has a PCB assembly and is a battery-powered device (140mAh, 3.7V lithium polymer battery) with USB charging capability, operating on two independent, enclosed electronic circuits for the vibration biofeedback loop and the other for audio guided training. The maximum diameter of the Vibrance® Pelvic Trainer shaft is 2.4 cm. The maximum inserted length of the shaft is 6 cm.

AI/ML Overview

The provided text is a 510(k) summary for the Vibrance® Pelvic Trainer (K162689). It details the device's characteristics, its intended use, and its comparison to a predicate device (Vibrance® Kegel Device, K141893) to establish substantial equivalence.

However, the document does not contain information about acceptance criteria, device performance studies, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training data was established.

The document focuses on non-clinical performance data to demonstrate safety and effectiveness for a Class II device, specifically:

Mechanical Testing: To measure forces required for sensor vibration and sheath removal.
Biocompatibility Testing: In vitro cytotoxicity, skin sensitization, and vaginal irritation tests performed according to ISO 10993.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Compliance with IEC 60601 standards.
Software Information: Provided in accordance with FDA guidance.
Risk Analysis: Performed according to ISO 14971.

The studies mentioned are primarily engineering and bench testing to demonstrate that the device meets safety and functional requirements, rather than clinical performance studies demonstrating diagnostic accuracy or efficacy improvement (as would be typical for an AI/ML medical device).

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies in the context of an AI/ML device from the provided text. The device described, a pelvic trainer with biofeedback and resistance, is a mechanical and electrical device, not an AI/ML diagnostic or prognostic system.

Summary

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July 3, 2018

Bioinfinity (M) Sdn. Bhd. % Carrie Hetrick Senior Consultant, RA Emergo Group 2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746

Re: K162689

Trade/Device Name: Vibrance® Pelvic Trainer Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: Class II Product Code: HIR Dated: May 2, 2017 Received: May 4, 2017

Dear Carrie Hetrick:

This letter corrects our substantially equivalent letter of June 8, 2017.

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. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device 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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael T. Bailey -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) K162689

Device Name Vibrance® Pelvic Trainer

Indications for Use (Describe)

The Vibrance® Pelvic Trainer is intended for the strengthening of the pelvic floor muscles, which has been found to help women with urinary incontinence.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Vibrance® Pelvic Trainer

K162689

1. Submission Sponsor

Bioinfinity (M) Sdn. Bhd.

No. 21, Jalan 4/62A, Bandar Menjalara, Kepong

52200 Kuala Lumpur

Malaysia

Phone: +603-6270236

Fax: +603-62720093

Contact: Mr. Ng Shea Kang

Title: Chief Executive Officer

2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78701

Cell Phone: (720) 838-413

Office Phone: (512) 327.9997

Contact: Carrie Hetrick, Senior Consultant, RA

Email: project.management@emergogroup.com

3. Date Prepared

May 2, 2017

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4. Device Identification

Trade/Proprietary Name:	Vibrance® Pelvic Trainer
Common/Usual Name:	Perineometer
Classification Name:	Perineometer
Regulation Number:	21 CFR § 884.1425
Product Code:	HIR (Perineometer)
Device Class:	Class II
Classification Panel:	Obstetrics/Gynecology

5. Legally Marketed Predicate Device(s)

K141893, Bioinfinity (M) Sdn. Bhd. Vibrance® Kegel Device (VKD)

The predicate device has not been subject to a design-related recall.

Device Description 6.

Main Body

The chassis of the device consists of an Acrylonitrile Butadiene Styrene (ABS) plastic frame with the biofeedback mechanism. It is incorporated within a tubular sheath made of medical grade silicone rubber which encloses the whole chassis. This main body and resistance sheath are the parts of the device that directly contact the user's intravaginal cavity (mucosal membrane contact, ≤24hr). The base of the tubular sheath and chassis are winged to prevent total ingestion of the vaginal

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canal.

Resistance Sheath

Three Resistance Sheaths, each with varying levels of stiffness are included with the Vibrance® Pelvic Trainer. When a Resistance Sheath is placed over the Main Body, the challenge of the exercise is increased.

7. Indication for Use Statement

The Vibrance® Pelvic Trainer (VPT) is intended for the strengthening of the pelvic floor muscles, which has been found to help women with urinary incontinence.

8. Substantial Equivalence Discussion

The following table compares the Vibrance® Pelvic Trainer to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Manufacturer	Bioinfinity (M) Sdn. Bhd.	Bioinfinity (M) Sdn. Bhd.	Significant
Trade Name	Vibrance® Pelvic Trainer	Vibrance Kegel Device	Differences
	Image: Vibrance Pelvic Trainer product packaging and device	Image: Vibrance Kegel Device product packaging and device
510(k) Number	K162689	K141893	Not applicable
Product Code	HIR	HIR	Identical
Regulation Number	21 CFR § 884.1425	21 CFR § 884.1425	Identical
Regulation Name	Perineometer	Perineometer	Identical
Indications for Use	The Vibrance® Pelvic Trainer(VPT) is intended for the	The Vibrance Kegel Device (VKD)is intended for the	Identical
Manufacturer	Bioinfinity (M) Sdn. Bhd.	Bioinfinity (M) Sdn. Bhd.	Significant
Trade Name	Vibrance® Pelvic Trainer	Vibrance Kegel Device	Differences
	strengthening of the pelvicfloor muscles, which has beenfound to help women withurinary incontinence	strengthening of the pelvic floormuscles, which has been foundto help women with urinaryincontinence.
Over theCounter (OTC)	Yes	Yes	Identical
Anatomical Sites	Vagina	Vagina	Identical
Feature	Resistive vaginal exerciser	Resistive vaginal exerciser	Identical
Target Population	Women with mild incontinence	Women with mild incontinence	Identical
Anatomical Site	Vagina	Vagina	Identical
Single Patient Device	Yes	Yes	Identical
Single Useor Reusable	Reusable	Reusable	Identical
Provided Sterile	Clean, but not sterile	Clean, but not sterile	Identical
Biofeedbackdisplayinformation	No	No	Identical
Device Design	Handheld device consisting ofthe Main Body and threegradual Resistance Sheaths	Handheld device consisting ofthe Main Body and threegradual Resistance Sheaths	Identical
Material	Main Body: ABS Plastic, PCBAssembly, rechargeable lithiumpolymer battery (140 mAh, 3.7V) with USB chargerSheaths: Medical grade silicone(polydimethylsiloxane)	Main Body: ABS Plastic, PCBAssembly, two low electricalenergy coin cell batteries(CR1220)Sheaths: Medical gradesilicone(polydimethylsiloxane)	The maindifferencebetween thesetwo devices isthereplacement ofthe two lowelectricalenergy coin cellbatteries with arechargeablebattery withUSB charger.
RoHs Compliant	Yes	Yes	Identical
Operating Principle	Resistive pelvic floor strengthener	Resistive pelvic floor strengthener	Identical
ResistanceComponent	The Vibrance® Pelvic Trainer(VPT) Electromechanicalspring contact offers 3 levelsof resistance sheaths withincreasing stiffness	The Vibrance Kegel DeviceElectromechanical spring contactoffers 3 levels of resistancesheaths with increasing stiffness
Biocompatibility	Guidelines set forth in ISO10993 testing results indicatethe material is biocompatible,nontoxic, and well tolerated bymucosal membranes.	Guidelines set forth in ISO10993 testing results indicatethe material is biocompatible,nontoxic, and well tolerated bymucosal membranes.	Identical
Manufacturer	Bioinfinity (M) Sdn. Bhd.	Bioinfinity (M) Sdn. Bhd.	Significant
Trade Name	Vibrance® Pelvic Trainer	Vibrance Kegel Device	Differences
Chemical Safety	Addressed by biocompatibilitytesting per ISO 10993	Addressed by biocompatibilitytesting per ISO 10993	Identical
Instructions for Use	Manual	Manual
Energy Use and/orDelivered	Energy is supplied by arechargeable lithium polymerbattery (140mAh, 3.7 V) with USBcharging capability	Energy is supplied by twoindependent replaceable 3.0 VoltCR-1220 lithium/manganese dioxide (Li/MnO2)Button Cell batteries	Different - Thedifferencebetween thesetwo devices is thereplacement ofthe two lowelectrical energycoin cell batterieswith arechargeablebattery with USBcharger.
Packaging	Device in sealed plastic bag andmanual in cardboard box	Device in sealed plastic bag andmanual in cardboard box	Identical
Dimensions	6 cm x 2 cm	6 cm x 2 cm	Identical

Table 5A – Comparison of Characteristics

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The differences in technological characteristics do not raise different questions of safety and effectiveness.

9. Non-Clinical Performance Data

The following testing has been performed to support substantial equivalence:

Mechanical Testing – Compression testing was conducted on the Vibrance® Pelvic Trainer to measure the forces required to vibrate the sensor for each of the three levels of resistance sheath. Pull off test was also conducted to evaluate how much force is needed for the sheath to be removed from the main body when the device is in use but is adequate for removal of a sheath after use. A correlation measurement test was then conducted to evaluate the test results of the compression test. The mechanical testing concluded that the different components of the device would function properly and safely when exposed to loads and configurations representative of normal use.

Biocompatibility - The biological safety of the Vibrance® Pelvic Trainer was evaluated in accordance with ISO 10993-1:2009 and guidance document entitled Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process" dated 16 June 2016. Under these, for the stated indications for use, each component of the device's biological safety was evaluated for in vitro cytotoxicity, skin sensitization, and vaginal irritation.

In Vitro Cytotoxicity test was performed according to ISO 10993-12 and ISO 10993- 5, with the results suggesting that the test articles did not induce a cytotoxic effect.
Skin Sensitization (Maximization Test) was performed according to ISO 10993-10, with the results suggesting that the device extracts did not produce skin sensitization in guinea pigs.
. Irritation (Vaginal Irritation Study) was performed on New Zealand White Rabbits according to ISO 10993-10, with the results showing that there were no significant clinical signs and gross findings in either the control or test group, and there were no mortalities.

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Electrical Safety and Electromagnetic Compatibility - The Vibrance® Pelvic Trainer complies with the applicable voluntary standards which include:

. IEC 60601-1:2005 + A1:2012 Medical Electrical Equipment: Part 1: General Requirements for Basic Safety and Essential Performance.
IEC 60601-1-11 Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment (Recognition Number 19-6)
IEC 60601-1-2:2014 (4" edition) Medical electrical equipment - Part 1-2: General reguirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances

The Vibrance® Pelvic Trainer complies with these voluntary standards for Electrical Safety, Electromagnetic Compatibility, and for systems used in the home healthcare environment.

Software - Software information was provided in accordance with the FDA Guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005.

Risk Analysis - Formal Risk Assessment of the Vibrance® Pelvic Trainer was performed in accordance with ISO 14971. With respect to perceivable conditions in which the device would be subjected to a worst-case environmental or human error scenario, Bioinfinity believes the outcomes of these risks are considered acceptable within the context of ISO 14971, and that all potential risks have been mitigated to the lowest form.

10. Performance Testing Summary

As part of demonstrating safety and effectiveness of Vibrance® Pelvic Trainer and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Bioinfinity (M) Sdn. Bhd. completed a number of tests. The Vibrance® Pelvic Trainer meets all the requirements for overall design, biocompatibility, and electrical safety testing performance confirm that the output meets the design inputs and specifications. The Vibrance® Pelvic Trainer passed all testing stated above as shown by the acceptable results obtained.

The Vibrance® Pelvic Trainer complicable voluntary standards for biocompatibility. The device passed all the testing in accordance with national and international standards.

11. Statement of Substantial Equivalence

lt has been shown in this 510(k) submission that the differences between the Vibrance® Pelvic Trainer and the predicate device do not raise any different questions regarding its safety and effectiveness. The performance testing provided demonstrates that the subject device is as safe and effective as the predicate device. The Bioinfinity (M) Sdn. Bhd. Vibrance® Pelvic Trainer, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.

Regulation Number and Section

§ 884.1425 Perineometer.

(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).