The Viberect® device is a hand held medical device intended for use by the person at home for the purpose of stimulating the nerves of the penis for the purpose of activating several nerve reflexes which are responsible for initiation of penile erection and rigidity. This device is unique in that it has two gentle vibrating motors that allow simultaneous vibratory stimulation of both the upper and lower surfaces of the penis. As each side of the male penis is supplied by different nerves, simultaneous stimulation of the upper and lower surfaces increases sexual response.

The device is held by one hand easily, like holding a hair straightener. The penis is placed between the vibrating 'soft pads'. As pressure is increased to the device, it is automatically activated. The device can be deactivated by releasing the hand pressure which immediately shuts off the vibrating 'soft pads'. The touch pad on the Viberect provides further control by the user whereby the user can increase and decrease the frequency of vibration according to comfort and response. Finally, there are individual modes for the vibratory movement of the upper housing only, lower housing only, and both. The device is powered by rechargeable batteries. Vibratory stimulation for approximately 3-10 minutes is recommended.

AI/ML Overview

The provided text describes the Viberect Penile Vibratory Stimulation Device and its 510(k) submission for over-the-counter (OTC) use. Let's break down the information to address your specific questions about acceptance criteria and the study that proves the device meets them.

Overview of the Device:
The Viberect® Penile Vibratory Stimulation Device is a hand-held medical device designed to stimulate nerves of the penis to provoke erections in men experiencing erectile dysfunction. It features two vibrating motors for simultaneous stimulation of both upper and lower penile surfaces. It is powered by rechargeable batteries and allows users to adjust vibration frequency via a touchpad.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the performance of the device in terms of clinical efficacy metrics (e.g., success rate of provoking erections). Instead, the acceptance criteria are generally implied through the non-clinical performance data and the demonstration of substantial equivalence to a predicate device.

The "acceptance criteria" primarily revolve around the device meeting established performance standards for safety (biocompatibility, electrical safety, EMC), mechanical integrity (shipping, drop, cleaning), and usability for OTC use. Clinical efficacy is largely inferred from the predicate device's established performance and the proposed device having identical technological characteristics and a reduced (or identical, for the remaining part) indication for use.

Here's a table based on the non-clinical performance data presented for the proposed device:

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Biocompatibility	ISO 10993-1	Passed (determined acceptable)
Electrical Safety	IEC 60601-1	Passed (determined acceptable)
Electromagnetic Compatibility	IEC 60601-1-2	Passed (determined acceptable)
Usability	Not specified (performed for OTC indications)	Passed (determined acceptable to support OTC indications)
Shipping	Not specified	Passed (determined acceptable)
Drop Testing	Not specified	Passed (determined acceptable)
Cleaning Testing	Not specified	Passed (determined acceptable)
Overall Design/Input	Meets requirements for overall design and output to input	Output meets design inputs and specifications (confirmed)
Voluntary Standards	Applicable national and international standards	Complies with applicable voluntary standards (biocompatibility, electrical safety, EMC)

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that no clinical testing was required or performed to support the medical device for its primary indication (provoking erections for men with erectile dysfunction) because the indications for use are considered equivalent to the predicate device. Therefore, there is no sample size for a clinical test set for this specific aspect.

However, Usability testing was performed. The document states:

"Usability testing was performed and determined to be acceptable to support OTC indications for use."
"Usability study performed (per discussion with the FDA); refer to Section 18 and Exhibit 18-D and 18-E for Usability Protocol and Report."

Unfortunately, the provided excerpt does not include the sample size used for the usability test set or the data provenance (e.g., country of origin, retrospective/prospective) for that usability study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical efficacy study was conducted for the device's primary function, there was no test set for clinical performance requiring experts to establish ground truth.

For the usability study, the document does not specify the number or qualifications of experts involved in establishing ground truth (e.g., for evaluating usability issues).

4. Adjudication Method for the Test Set

As no clinical efficacy test set was used, there was no adjudication method described for clinical performance.

For the usability study, the document does not specify any adjudication method 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

No MRMC comparative effectiveness study was done. This device is a directly applied therapeutic vibratory stimulation device, not an AI-assisted diagnostic or interpretative system that would involve "human readers" or "AI assistance" in the sense of interpreting images or other data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the Viberect device. It is a physical medical device for direct therapeutic application, not an algorithm or software. Its performance inherently involves human interaction (the user applying the device).

7. The Type of Ground Truth Used

For clinical efficacy: The "ground truth" for the device's ability to provoke erections is implicitly based on the established safety and efficacy of the predicate device (Viberect, K110566), which has been on the market for several years. The current submission's device has identical technological characteristics and a similar indication for use.
For non-clinical performance (biocompatibility, electrical safety, etc.): The ground truth is adherence to established national and international standards (e.g., ISO 10993-1, IEC 60601-1, IEC 60601-1-2).
For usability: The ground truth would have been established through methodologies aligned with usability engineering processes (e.g., user performance, satisfaction, error rates), as determined in the usability study mentioned. The specifics are not provided in this excerpt.

8. The Sample Size for the Training Set

This question is not applicable. The Viberect device is not an AI/ML algorithm that requires a "training set" in the computational sense. It is a physical medical device.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest a sense of community and support.

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

October 3. 2014

Reflexonic, LLC % Julie Powell Vice President, Ouality Assurance Emergo Group 816 Congress Ave., Suite 1400 Austin, TX 78701

Re: K142304

Trade/Device Name: Viberect Penile Vibratory Stimulation Device Regulation Number: 21 CFR& 884.5960 Regulation Name: Genital Vibrator for Therapeutic Use Regulatory Class: II Product Code: KXQ Dated: August 15, 2014 Received: August 18, 2014

Dear Julie Powell.

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

{1}------------------------------------------------

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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Herbert P. Lerner -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)

K142304

Device Name Viberect® Penile Vibratory Stimulation Device

Indications for Use (Describe)

Viberect® Penile Vibratory Stimulation Device is a hand held medical to provoke erections for men who experience erectile dysfunction.

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

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)

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

for

Viberect® Penile Vibratory Stimulation Device

1. Submission Sponsor

Reflexonic, LLC 915 Toll House Avenue, Suite 205 Frederick, MD 21701 USA Phone: 1 301.378.8433 Fax: 1800.886.1470 Contact: Dr. Kambiz Tajkarimi, President

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: PHONE Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Julie Powell, VP, QA Email: project.management@emergogroup.com

3. Date Prepared

August 15, 2014

4. Device Identification

Viberect® Penile Vibratory Stimulation Device (Viberect) Trade/Proprietary Name: Common/Usual Name: Vibrator Classification Name: Vibrator for Therapeutic Use Classification Regulation: 884.5960 Product Code: KXQ Device Class: Class II Classification Panel: Obstetrics /Gynecology

5. Legally Marketed Predicate Device(s)

Viberect® Penile Vibratory Stimulation Device Manufactured by Reflexonic, LLC 510(k) K110566

{4}------------------------------------------------

6. Device Description

7. Indication for Use Statement

Viberect " Penile Vibratory Stimulation Device is a hand held medical device indicated to provoke erections for men who experience erectile dysfunction. For Over-the-Counter (OTC) use.

8. Substantial Equivalence Discussion

The following table compares the Viberect OTC device to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Table 12A – Device Comparison Chart: Similarities and Differences
	Proposed Device	Predicate Device
Manufacturer	Reflexonic, LLC	Reflexonic, LLC	Significant Differences
Trade Name	Viberect Penile VibratoryStimulation Device	Viberect Penile VibratoryStimulation Device
510(k) Number	NA	K110566	N/A
Product Code	KXQ	KXQ	Same
Regulation Number	884.5960	884.5960	Same
Regulation Name	Vibrator for Therapeutic Use	Vibrator for Therapeutic Use	Same
Indications for Use	Viberect Penile VibratoryStimulation Device is a handheld medical device indicatedto provoke erections for menwho experience erectiledysfunction.	Viberect Penile VibratoryStimulation Device is a handheld medical device indicatedto provoke erections for menwho experience erectiledysfunction and to provokeejaculation for spinal cordinjured men.	Removed the indication for use inspinal cord injured men, asrecommended by the FDA
Intended forPrescription or OTC	OTC	Prescription	For OTC use; Usability studyperformed (per discussion with
	Proposed Device	Predicate Device
Manufacturer	Reflexonic, LLC	Reflexonic, LLC	Significant Differences
Trade Name	Viberect Penile VibratoryStimulation Device	Viberect Penile VibratoryStimulation Device
Use			the FDA); refer to Section 18 andExhibit 18-D and 18-E forUsability Protocol and Report
Class	II	II	Same
Provided Sterile orNon-Sterile	Non-Sterile	Non-Sterile	Same
Basic Design	Hand held vibratory devicewhich upon activationstimulates the nerves of thepenis. This device has twogentle vibrating motors thatallow simultaneous vibratorystimulation of both surfaces(top and bottom) of the penis.	Hand held vibratory devicewhich upon activationstimulates the nerves of thepenis. This device has twogentle vibrating motors thatallow simultaneous vibratorystimulation of both surfaces(top and bottom) of thepenis.	Same
Length	Approximately 10 inches	Approximately 10 inches	Same
Width	Approximately 2 inches (atwidest point)	Approximately 2 inches (atwidest point)	Same
Reusable	Yes – provided with cleaninginstructions	Yes - provided with cleaninginstructions	Same
Power Source	Rechargeable Nickel MetalHydride (NiMH) batteries.Rechargeable (Ni-Cd)6/1.2V/0.35Ah. The batterywill last a minimum of 20minutes (at 100hz and 2.5mm).	Rechargeable Nickel MetalHydride (NiMH) batteries.Rechargeable (Ni-Cd)6/1.2V/0.35Ah. The batterywill last a minimum of 20minutes (at 100hz and2.5mm).	Same
Patient ContactingMaterials	Vibrating Soft PadsPolyurethane/ PolyurethaneFoam(IROGRAN®)	Vibrating Soft PadsPolyurethane/ PolyurethaneFoam(IROGRAN®)	Same
Frequency	70-110 Hz	70-110 Hz	Same
Amplitude Range(peak to valley)	2 – 3 mm	2 – 3 mm	Same
Adjustability of aboveparameters	Full range by touch pad control	Full range by touch padcontrol	Same
Type of motion	Pulsatile	Pulsatile	Same
Auto safety shut off	Yes	Yes	Same
Complies with ISO10993-1	Yes	Yes	Same
Charger, main voltage	100-120 / 200-240 volts	100-120 / 200-240 volts	Same
Electrical SafetyTesting Passed	Yes	Yes	Same

Device Comparison Chart: Similarities and Differences

{5}------------------------------------------------

9. Non-Clinical Performance Data

The following testing has been performed and determined to be acceptable to support substantial equivalence:

Biocompatibility testing in accordance with ISO 10993-1 .
. Electrical Safety testing in accordance with IEC 60601-1
Electromagnetic Compatibility testing in accordance with IEC 60601-1-2 ●
Usability testing

{6}------------------------------------------------

Shipping testing
Drop testing
Cleaning testing

As part of demonstrating safety and effectiveness of Viberect device and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, Reflexonic, LLC completed a number of tests. The Viberect device meets all the requirements for overall design, biocompatibility, and electrical safety, and has been confirmed that the output meets the design inputs and specifications. The Viberect device passed all testing stated above as shown by the acceptable results obtained.

The Viberect device complies with the applicable voluntary standards for biocompatibility, electrical safety and electromagnetic compatibility. The device passed all the testing in accordance with national and international standards.

10. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The predicate device, Viberect has been on the market for several years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

Usability testing was performed and determined to be acceptable to support OTC indications for use.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. The Viberect device has reduced the indications for use from the predicate device and has the identical technological characteristics as the predicate device. The new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

Regulation Number and Section

§ 884.5960 Genital vibrator for therapeutic use.

(a)
Identification. A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the pelvic floor to increase muscle tone).(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 884.9.