(254 days)
Not Found
No
The description focuses on mechanical resistance, vibration biofeedback based on direct force sensing, and audio guidance. There is no mention of AI/ML terms, data training, or complex algorithms that would suggest AI/ML is used for analysis or decision-making.
Yes
The device is intended for strengthening pelvic floor muscles to help women with urinary incontinence, which is a therapeutic purpose.
No
The device is described as an exercise device intended to strengthen pelvic floor muscles. While it provides biofeedback to verify correct muscle use, its primary function is therapeutic (strengthening muscles) rather than diagnostic (identifying a disease or condition). The biofeedback is for user verification of exercise, not for medical diagnosis.
No
The device description explicitly states it is an intra-vaginal exercise device consisting of a Main Body, Resistance Sheaths, a PCB assembly, and a battery. It also mentions mechanical testing, biocompatibility testing, and electrical safety testing, all of which are associated with hardware components. While it contains software, it is not solely software.
Based on the provided information, the Vibrance® Pelvic Trainer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "strengthening of the pelvic floor muscles," which is a therapeutic purpose, not a diagnostic one.
- Device Description: The device description focuses on its mechanical and electronic components for providing resistance and biofeedback during exercise. It does not describe any components or processes for analyzing biological samples (like blood, urine, or tissue) to diagnose a condition.
- Mechanism of Action: The device works by providing resistance and biofeedback to help the user perform exercises. It does not perform any tests or analyses on biological samples.
- Performance Studies: The performance studies described (mechanical testing, biocompatibility, electrical safety, software, risk analysis) are typical for a therapeutic or exercise device, not an IVD. IVD performance studies would typically involve evaluating the device's ability to accurately detect or measure a specific analyte or condition in a biological sample.
In summary, the Vibrance® Pelvic Trainer is a device designed for physical therapy and exercise, not for diagnosing a disease or condition by examining samples taken from the human body.
N/A
Intended Use / Indications for Use
The Vibrance® Pelvic Trainer is intended for the strengthening of the pelvic floor muscles, which has been found to help women with urinary incontinence.
Product codes (comma separated list FDA assigned to the subject device)
HIR
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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use.
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)
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.
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 (4th edition) Medical electrical equipment - Part 1-2: General requirements 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.
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.
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
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
4
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.
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.
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
5
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 pelvic | |||
| floor muscles, which has been | |||
| found to help women with | |||
| urinary incontinence | strengthening of the pelvic floor | ||
| muscles, which has been found | |||
| to help women with urinary | |||
| incontinence. | |||
| Over the | |||
| Counter (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 Use | |||
| or Reusable | Reusable | Reusable | Identical |
| Provided Sterile | Clean, but not sterile | Clean, but not sterile | Identical |
| Biofeedback | |||
| display | |||
| information | No | No | Identical |
| Device Design | Handheld device consisting of | ||
| the Main Body and three | |||
| gradual Resistance Sheaths | Handheld device consisting of | ||
| the Main Body and three | |||
| gradual Resistance Sheaths | Identical | ||
| Material | Main Body: ABS Plastic, PCB | ||
| Assembly, rechargeable lithium | |||
| polymer battery (140 mAh, 3.7 | |||
| V) with USB charger | |||
| Sheaths: Medical grade silicone | |||
| (polydimethylsiloxane) | Main Body: ABS Plastic, PCB | ||
| Assembly, two low electrical | |||
| energy coin cell batteries | |||
| (CR1220) | |||
| Sheaths: Medical grade | |||
| silicone | |||
| (polydimethylsiloxane) | The main | ||
| difference | |||
| between these | |||
| two devices is | |||
| the | |||
| replacement of | |||
| the two low | |||
| electrical | |||
| energy coin cell | |||
| batteries with a | |||
| rechargeable | |||
| battery with | |||
| USB charger. | |||
| RoHs Compliant | Yes | Yes | Identical |
| Operating Principle | Resistive pelvic floor strengthener | Resistive pelvic floor strengthener | Identical |
| Resistance | |||
| Component | The Vibrance® Pelvic Trainer | ||
| (VPT) Electromechanical | |||
| spring contact offers 3 levels | |||
| of resistance sheaths with | |||
| increasing stiffness | The Vibrance Kegel Device | ||
| Electromechanical spring contact | |||
| offers 3 levels of resistance | |||
| sheaths with increasing stiffness | |||
| Biocompatibility | Guidelines set forth in ISO | ||
| 10993 testing results indicate | |||
| the material is biocompatible, | |||
| nontoxic, and well tolerated by | |||
| mucosal membranes. | Guidelines set forth in ISO | ||
| 10993 testing results indicate | |||
| the material is biocompatible, | |||
| nontoxic, and well tolerated by | |||
| mucosal 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 biocompatibility | ||
| testing per ISO 10993 | Addressed by biocompatibility | ||
| testing per ISO 10993 | Identical | ||
| Instructions for Use | Manual | Manual | |
| Energy Use and/or | |||
| Delivered | Energy is supplied by a | ||
| rechargeable lithium polymer | |||
| battery (140mAh, 3.7 V) with USB | |||
| charging capability | Energy is supplied by two | ||
| independent replaceable 3.0 Volt | |||
| CR-1220 lithium | |||
| /manganese dioxide (Li/MnO2) | |||
| Button Cell batteries | Different - The | ||
| difference | |||
| between these | |||
| two devices is the | |||
| replacement of | |||
| the two low | |||
| electrical energy | |||
| coin cell batteries | |||
| with a | |||
| rechargeable | |||
| battery with USB | |||
| charger. | |||
| Packaging | Device in sealed plastic bag and | ||
| manual in cardboard box | Device in sealed plastic bag and | ||
| manual in cardboard box | Identical | ||
| Dimensions | 6 cm x 2 cm | 6 cm x 2 cm | Identical |
Table 5A – Comparison of Characteristics
6
7
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.
8
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.