Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and clinical efficacy of a lubricating intravaginal ring, with no mention of AI or ML technology. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No.
The essential function of the device is to moisturize and lubricate to enhance comfort during sexual activity, supplementing natural lubrication. While it alleviates symptoms like vaginal dryness, it is categorized as a personal lubricant and moisturizer rather than treating a disease or medical condition in a therapeutic sense. The device does not contain hormones or APIs, and its intended use is for comfort and lubrication. Its predicate device, Replens, also functions as a topical moisturizer for vaginal dryness.

Diagnostic

No

Explanation: The "Intended Use / Indications for Use" states that the device is intended "to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication." This description indicates a therapeutic or assistive function, not a diagnostic one (identifying or characterizing a disease or condition). The device description further elaborates on its lubricating mechanism, reinforcing its non-diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical intravaginal ring constructed from a hollow tube filled with a liquid solution, indicating it is a hardware device, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is clearly stated as "to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication." This is a physical function, not a diagnostic test performed in vitro (outside the body).
Device Description: The description details a physical ring that releases a lubricating solution. It does not describe any components or mechanisms for analyzing biological samples or detecting specific substances.
Lack of IVD Indicators: There is no mention of analyzing samples (like blood, urine, or tissue), detecting biomarkers, or providing diagnostic information about a disease or condition.
Clinical Studies: The clinical studies focus on the device's ability to relieve symptoms of vaginal dryness and improve lubrication during sexual activity, which are related to its physical function, not a diagnostic capability.

In summary, the VR101 Lubricating Intravaginal Ring is a medical device intended for lubrication and moisturization, not for performing diagnostic tests.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

VR101 Lubricating Intravaginal Ring is a personal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex and synthetic (polyurethane and polyisoprene) male condoms and FC2 female condoms.

Product codes (comma separated list FDA assigned to the subject device)

QPD

Device Description

The VR101 Lubricating Intravaginal Ring device is a lubricating intravaginal ring designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. VR101 Lubricating Intravaginal Ring is constructed from a hollow biomedical grade hydrophilic polyether urethane (HPU) tube filled with a liquid vaginal lubricating solution comprised of a solution of glycerol (also known as glycerin), water, and sodium chloride. Upon insertion of VR101 Lubricating Intravaginal Ring in the vagina, the lubricating solution in the lumen ring is released through the semi-permeable wall of the tubing into the vagina, moisturizing and lubricating the vaginal mucosa without the use of any hormones or active pharmaceutical ingredients (APIs).

Each VR101 Lubricating Intravaginal Ring provides moisturization and lubrication for up to seven (7) days.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Vagina / Vaginal Mucosa

Indicated Patient Age Range

The clinical investigations included participants with ages ranging from 21 years to 79 years.

Intended User / Care Setting

Not Found

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)

Safety and Performance Tests:

Visual Inspection of Packaging: Each pouch was visually inspected by trained individuals for holes and gross damage prior to removal of the VR101 Lubricating Intravaginal Ring sample.
- Results: Pass. No holes or defects were seen.
Cytotoxicity: ISO 10993-5:2009 L929 MEM Elution Method and Agar Overlay was conducted to assess the cytotoxic potential of the device.
- Results: Pass.
Sensitization: ISO 10993-10:2010 and ISO 10993-12:2012. A Guinea Pig Maximization Test was conducted on the device.
- Results: Pass.
Irritation: ISO 10993-10:2010 and ISO 10993-12:2012. A Vaginal Mucosal Irritation Test was conducted to assess the irritation potential of the device.
- Results: Pass.
Acute Systemic Toxicity: ISO 10993-11:2006 and ISO 10993-12:2012. Intraperitoneal and Intravenous Systemic Injection routes were used when conducting the acute systemic toxicity study on the device.
- Results: Pass.
Genotoxicity: ISO 10993-3:2014 and ISO 10993-12:2012. An Ames Test and Mouse Lymphoma Assay were conducted on the device.
- Results: Pass.
Material Mediated Pyrogenicity: USP , ISO 10993-11:2017 and ISO 10993-12:2012. A material mediated pyrogenicity study was conducted on the device.
- Results: Pass.
Implantation: ISO 10993-6:2016 and ISO 10993-12:2012. A Subcutaneous Implantation Test was conducted using the subject device.
- Results: Pass.
Chemical Characterization and Toxicological Risk Assessment: ISO 10993-18:2005. A chemical characterization and toxicological risk assessment were conducted on the device to address chronic systemic toxicity.
- Results: Pass.
Visual Inspection of Intravaginal Rings: VR101 Lubricating Intravaginal Ring test articles were visually inspected to determine if rings are intact, not broken, are colorless and translucent, and are odor free.
- Results: Pass. All samples exposed to accelerated aging conditions equivalent to 54 months storage under ambient conditions exhibited a yellow tint but met all other acceptance criteria. Samples aged under ambient room-temperature condition for 57 months exhibited no discoloration. All unaged (t=0) samples met acceptance.
VR101 Lubricating Intravaginal Ring Dimensional Inspection: The outer diameter (OD) of the VR101 Lubricating Intravaginal Ring tubing and the ring measured both parallel (OD1) and perpendicular (OD2) to the joint surface were determined.
- Results: Pass. All t=0 samples and samples exposed to accelerated aging conditions equivalent to 54 months storage under ambient conditions met all dimensional acceptance criteria.
Intravaginal Ring (IVR) Massing Test: The mass of each VR101 Lubricating Intravaginal Ring test article was determined using a calibrated analytical balance.
- Results: Pass. All t=0 samples and samples exposed to accelerated aging conditions equivalent to 54 months storage under ambient conditions met the acceptance criterion for mass.
Force of Compression Test: Each of the VR101 test articles was subjected to compression testing on two perpendicular axes using a tensile testing apparatus.
- Results: Pass. All t=0 samples and samples exposed to accelerated aging conditions equivalent to 54 months storage under ambient conditions met the acceptance criterion for the force required to compress the devices by 10% of initial outer diameter on 2 axes.
IVR Tensile Strength Test: VR101 Lubricating Intravaginal Ring test articles were subjected to tensile tests using a tensile testing apparatus to assess weld integrity.
- Results: Pass. All t=0 samples and samples exposed to accelerated aging conditions equivalent to 54 months storage under ambient conditions met the acceptance criterion.
IVR Glycerol Release Test: The release of lubricating solution from VR101 test articles was assessed using a colorimetric assay to quantify glycerol present in the release medium after immersion for 24, 48, and 72 hours at 37°C.
- Results: Pass. All samples exposed to accelerated aging conditions equivalent to 54 months storage under ambient conditions met the release criteria.
Lubricating Solution Viscosity Determination: Viscosity of the lubricating solution in each VR101 sample was assessed at 25°C and 10 rpm using a calibrated viscometer.
- Results: Pass. All samples exposed to accelerated aging conditions equivalent to 54 months storage under ambient conditions met the viscosity specification.
Lubricating and Packaging Solution Osmolality Determination: Osmolality of the lubricating solution in each VR101 sample was assessed using a calibrated osmometer.
- Results: Pass. All as-prepared lubricating and packaging solution samples and lubricating solution samples exposed to accelerated aging conditions equivalent to 54 months storage under ambient conditions met the specification for osmolality.
Lubricating Solution pH Determination: The pH of the lubricating glycerol solution in each VR101 sample was assessed using litmus paper.
- Results: Pass. All samples exposed to accelerated aging conditions equivalent to 54 months storage under ambient conditions met the specification for pH.
Lubricating and Packaging Solution Water Activity Determination: The water activity of the lubricating glycerol solution in each VR101 Lubricating Intravaginal Ring sample was assessed using a calibrated water activity meter.
- Results: All lubricating and packaging solution samples exposed to real-time and accelerated aging storage conditions exhibited sufficiently low water activity to justify reduced microbial testing.
Determination of compatibility of lubricating solution with male condoms composed of natural rubber latex, polyurethane, and polyisoprene and female condoms composed of nitrile rubber: ASTM 7661-10. Condom samples were soaked in the lubricating solution for one hour and the tensile and burst properties of the condoms exposed to the lubricating solution were compared to those of control condoms.
- Results: All condoms met the acceptance criterion for burst after exposure to the lubricating solution, allowing labeling of the device that documents its compatibility with male condoms composed of natural rubber latex, polyurethane, and polyisoprene and female condoms composed of nitrile rubber.

Clinical Studies:

CI01: A Pilot Study to Evaluate the Preliminary Feasibility and Safety of a Lubricating Intravaginal Ring to Relieve the Symptoms of Vaginal Dryness (pilot investigation). Sample size N=21.
CI02: A Pivotal Clinical Investigation to Evaluate the Safety and Efficacy of J3 Bioscience Lubricating Intravaginal Ring (VR101) in Relieving Symptoms of Vaginal Dryness (pivotal, double-blind, crossover randomized trial). 890 total VR101 Lubricating Intravaginal Ring devices were used by study participants. No serious adverse device effects were observed. The primary efficacy endpoint was not met as specified.
CI03: A Clinical Investigation to Evaluate Efficacy of the J3 Bioscience Lubricating Intravaginal Ring VR101 as a Personal Lubricant Device in Women (double-blind, two-site, randomized, sham-controlled trial). Enrolled 175 participants, with 166 (94.9%) completing the study. 87 participants in the treatment group and 88 in the sham group.
- Effectiveness: The primary efficacy hypothesis was met (p = 0.02) demonstrated by a statistically significant improvement in the lubrication domain of the female sexual function index (FSFI) when compared to a sham, non-lubricating ring.
- Safety: 95 adverse events reported, none serious. 36 were unrelated to the device. Most common adverse events (VR101 and Sham groups combined) were excess vaginal secretions (17), pelvic cramping (14), vaginal pain/discomfort (5), and non-menstrual bleeding (5). Other reports: urinary tract/bladder infection (3), vaginal irritation/vaginitis (2), and yeast infection (2). All adverse events were rated Mild or Moderate.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Primary efficacy endpoint meta during CI03 study:

Lubrication domain of the FSFI (FSFI-LD > 4.5)
p = 0.02

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.

K101241

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

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.

Summary

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 29, 2021

J3 Bioscience, Inc. R. Tyler McCabe, Ph.D. President/CEO 825 North 300 West, Suite N231 Salt Lake City, UT 84103

Re: K203377 Trade/Device Name: VR101 Lubricating Intravaginal Ring Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: QPD

Dear R. Tyler McCabe:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 20, 2021. Specifically, FDA is updating this SE Letter as an administrative correction. The original 510(k) summary states that the VR101 Lubricating Intravaginal Ring has a shelf-life of 3 years; however, the device was reviewed and cleared with a shelf-life of 54 months. Therefore, this SE Letter is being updated to correct the shelf-life in the 510(k) summary.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Monica Garcia, Ph.D., Office of GastroRenal, ObGyn, General Hospital and Urology Devices at Monica. Garcia@fda.hhs.gov.

Sincerely,

Monica D. Garcia -S

Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

1

Image /page/1/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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 20, 2021

J3 Bioscience, Inc. R. Tyler McCabe, Ph.D. President/CEO 825 North 300 West, Suite N231 Salt Lake City, UT 84103

Re: K203377

Trade/Device Name: VR101 Lubricating Intravaginal Ring Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: QPD Dated: April 20, 2021 Received: April 21, 2021

Dear R. Tyler McCabe:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

2

You must comply with all the Act's 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason Roberts -S

for Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K203377

Device Name VR101 Lubricating Intravaginal Ring

Indications for Use (Describe)

VR101 Lubricating Intravaginal Ring is a personal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex and synthetic (polyurethane and polyisoprene) male condoms and FC2 female condoms.

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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4

O J3 BIOSCIENCE

510(k) Summary 21 CFR 807.92(a)

| General

Provisions	Submitter Name:	J3 Bioscience, Inc.
	Address:	825 North 300 West, Suite N231
Salt Lake City, UT 84103
	Contact Person:	R. Tyler McCabe, PhD
	Telephone Number:	801-550-9956 (mobile)
	Fax Number:	866-768-9341
	Date of Preparation:	29 October 2021
	Submitted By/Principal Contact:
Principle and
Regulatory
Contacts	Contact Name:	R. Tyler McCabe, PhD
	Title:	President/CEO
		J3 Bioscience, Inc.
	Address:	825 North 300 West, Suite N231
Salt Lake City, UT 84103
	Phone Number:	801-550-9956 (mobile)
	Fax Number:	866-768-9341
	Email:	tmccabe@j3bio.com
	Regulatory Contact:
	Name:	Moj Eram, PhD
	Title:	QA/RA Representative
Sage BioPartners, LLC
	Phone Number:	801-230-8611
	Email:	moj.eram@sagebiopartners.com
Subject
Device	Trade Name:	VR101 Lubricating Intravaginal Ring
	Common Name:	Personal Lubricant Ring
	Classification Name:	Condom
	Classification:	Class II
	Product Code:	QPD
	Regulation Number:	21 CFR 884.5300
	Regulatory Panel:	Obstetrics/Gynecology
		Predicate Trade Name: Replens® Long-Lasting Vaginal Moisturizer (Pre-
filled Applicators) – (hereafter Replens®)
Predicate
Device	Manufacturer:	LIL' DRUG STORE PRODUCTS, INC.
	510(k) Number:	K101241
	Classification Name:	Condom
	Classification:	Class II
	Product Code:	NUC
	Regulation Number:	21 CFR 884.5300
	Regulatory Panel:	Obstetrics/Gynecology

5

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

6

The VR101 Lubricating Intravaginal Ring device is a lubricating intravaginal ring designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. VR101 Lubricating Intravaginal Ring is constructed from a hollow biomedical grade hydrophilic polyether urethane (HPU) tube filled with a liquid vaginal lubricating solution comprised of a solution of glycerol (also known as glycerin), water, and sodium chloride. Upon insertion of VR101 Lubricating Intravaginal Ring in the vagina, the lubricating solution in the lumen ring is released through the semi-permeable wall of the tubing into the vagina, moisturizing and lubricating the vaginal mucosa without the use of any hormones or active pharmaceutical ingredients (APIs).

Each VR101 Lubricating Intravaginal Ring provides moisturization and lubrication for up to seven (7) days.

	Parameter	Specification
Device Description	Lubricant Specifications
	Appearance	Colorless, Translucent
	Odor	Odorless
	pH	6.5-7.5
	Viscosity	71-292 cP
	Osmolality	498-603 mOsm/kg at 20x dilution
(9,960-12,060 mOsm/kg)
	Antimicrobial Effectiveness per
USP	Water activity ≤ 0.60
	Total Microbial Count per USP

       |         |  | Absent                                                                           |

The VR101 device specifications can be seen in the table below.

7

Outer Tubing Deformities	No deformities or damage observed in the outer tubing
Weld misalignment	Any detectable misalignment in the weld is $\leq$ 0.13 mm
Weld Flashing	Maximum height of any detectable weld flashing is $\leq$ 0.25 mm
Bubbles in the Weld	Number of bubbles in weld volume is $\leq$ 10
Tubing and Weld Diameter	No visible apparent change in diameter between the tubing and weld plugs
Weld Volume Bubble Size	Diameter of the largest bubble is $\leq$ 0.5 mm
Foreign Material	No visually detectable loose foreign material, loose flash, or embedded foreign material in the ring
Ring/Lubricant System Specifications
Mass	4.3 – 4.7 g
Glycerol Release (in vitro)	>70% glycerol released by 48 hours

VR101 Lubricating Intravaginal Ring is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural Indications for lubrication. This product is compatible with natural rubber latex and Use synthetic (polyurethane and polyisoprene) male condoms and FC2 female condoms.

8

| | Device
Characteristics | Subject Device | Predicate Device | Comparison |
|---------------------------------------------------------|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Technological
Comparison
with Predicate
Device | Device Name | VR101
Lubricating
Intravaginal
Ring | Replens Long
Lasting Vaginal
Moisturizer | N/A |
| | Sponsor | J3 Bioscience,
Inc. | Lil' Drug Store
Products, Inc. | N/A |
| | 510(k) Number | K203377 | K101241 | N/A |
| | Indications for
Use Statement | VR101
Lubricating
Intravaginal
Ring is a
personal
lubricant for
vaginal
application
intended to
moisturize and
lubricate, to
enhance the
ease and
comfort of
intimate sexual
activity and
supplement the
body's natural
lubrication.
This product is
compatible with
natural rubber
latex and
synthetic
(polyurethane
and
polyisoprene)
male condoms
and FC2 female
condoms. | Replens is a
personal lubricant
for vaginal
application,
intended to
moisturize and
lubricate, to
enhance the ease
and comfort of
sexual activity and
supplement the
body's natural
lubrication. This
product is
compatible with
natural rubber latex
condoms and
synthetic
(polyurethane and
polyisoprene)
condoms. | Similar |
| | Condom
Compatibility | NRL,
Polyisoprene,
Polyurethane, | NRL,
Polyisoprene,
Polyurethane | Different |
| | FC2 female
condoms | | | |
| Base Type | Glycerol/water | Water | Similar | |
| Primary
Ingredient | Glycerol
Water
Sodium
Chloride | Purified water
Glycerin
Mineral oil
Polycarbophil
Carbon
homopolymer type
B
Hydrogenated
palm oil glyceride
Sorbic acid
Sodium hydroxide | Different | |
| Ring Component | Yes | No | Different | |
| Ring Material | Hydrophilic
polyurethane | N/A | Different | |
| Appearance/color | Clear | Smooth
homogenous
gel/white to off-
white | Different | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Shelf-life | 54 months | 3 years | Different | |
| Application | 7 days
continuous | Intermittent (every
3 days and/or as
needed) | Different | |
| OTC use | OTC | OTC | Same | |

9

Although the formulation of the predicate device lubricant is different from the subject device, it does not pose any concern for safety and effectiveness of the subject device when compared to the predicate device. The results of the subject device non-clinical and clinical performance testing demonstrate that performance and safety of the lubricants are equivalent.

In both the subject device, VR101 Lubricating Intravaginal Ring, and the predicate device, Replens® Long-Lasting Vaginal Moisturizer (Pre-filled Applicators), lubricant is delivered from within a polymeric container. The

10

predicate device is a single-use applicator for bolus application, while VR101 Lubricating Intravaginal Ring, is a single-use hollow ring for controlled release of lubricant solution for up to seven (7) days. No different questions of safety and efficacy are raised for the subject device by differences in the formulation or incorporation of different polymeric container components.

11

To establish substantial equivalence and a shelf-life period for the subject device, VR101 Lubricating Intravaginal Ring, the tests identified in the table below were performed with results demonstrating that acceptance criteria were met and demonstrated that the subject device is substantially equivalent in performance as compared to the cited predicate device, Replens® Long-Lasting Vaginal Moisturizer (Pre-filled Applicators).

Risk management, including a failure mode and effects analysis (FMEA), of the subject device was conducted in accordance with BS EN ISO 14971:2007 and 2012, Medical Devices – Application of risk management to medical devices.

| Summary of Performance Tests Conducted on VR101 Lubricating

Intravaginal Ring
	Test	Test Method Summary	Results
Safety and
Performance
Tests	Visual
Inspection of
Packaging	Each pouch was
visually inspected by
trained individuals for
holes and gross
damage prior to
removal of the VR101
Lubricating
Intravaginal Ring
sample.	Pass
No holes or defects
were seen.
	Cytotoxicity	ISO 10993-5:2009
L929 MEM Elution
Method and Agar
Overlay was conducted
to assess the cytotoxic
potential of the device.	Pass
	Sensitization	ISO 10993-10:2010
and ISO 10993-
12:2012
A Guinea Pig
Maximization Test was
conducted on the
device.	Pass
Irritation		Pass
	ISO 10993-10:2010
and ISO 10993-12:2012

A Vaginal Mucosal
Irritation Test was
conducted to assess the
irritation potential of
the device. | | |
| Acute Systemic
Toxicity | ISO 10993-11:2006
and ISO 10993-12:2012

Intraperitoneal and
Intravenous Systemic
Injection routes were
used when conducting
the acute systemic
toxicity study on the
device. | Pass | |
| Genotoxicity | ISO 10993-3:2014 and
ISO 10993-12:2012

A chemical
characterization and
toxicological risk
assessment were
conducted on the
device to address
chronic systemic
toxicity. | Pass | |
| Visual Inspection
of Intravaginal
Rings | VR101 Lubricating
Intravaginal Ring test
articles were visually
inspected to determine if
rings are intact, not
broken, are colorless and
translucent, and are odor
free. | Pass

All samples exposed
to accelerated aging
conditions equivalent
to 54 months storage
under ambient
conditions exhibited a
yellow tint but met all
other acceptance
criteria. Samples aged
under ambient room-
temperature condition
for 57 months
exhibited no
discoloration. All
unaged (t=0) samples
met acceptance | |
| VR101 | Outer diameter (OD) of | Pass | |
| Lubricating
Intravaginal
Ring
Dimensional
Inspection | the VR101 Lubricating
Intravaginal Ring
tubing and the ring
measured both parallel
(OD1) and
perpendicular (OD2) to
the joint surface were
determined. | All t=0 samples and
samples exposed to
accelerated aging
conditions equivalent to
54 months storage under
ambient conditions met
all dimensional
acceptance criteria. | |
| Intravaginal Ring
(IVR) Massing
Test | The mass of each VR101
Lubricating Intravaginal
Ring test article was
determined using a
calibrated analytical
balance. | Pass
All t=0 samples and
samples exposed to
accelerated aging
conditions equivalent to
54 months storage under
ambient conditions met
the acceptance criterion
for mass. | |
| Force of
Compression
Test | Each of the VR101 test
articles was subjected to
compression testing on
two perpendicular axes
using a tensile testing
apparatus. | Pass
All t=0 samples and
samples exposed to
accelerated aging
conditions equivalent to
54 months storage under
ambient conditions met
the acceptance criterion
for the force required to
compress the devices by
10% of initial outer
diameter on 2 axes. | |
| IVR Tensile
Strength Test | VR101 Lubricating
Intravaginal Ring test
articles were subjected to
tensile tests using a
tensile testing apparatus
to assess weld integrity. | Pass
All t=0 samples and
samples exposed to
accelerated aging
conditions equivalent to
54 months storage under
ambient conditions met
the acceptance criterion. | |
| IVR Glycerol
Release Test | The release of lubricating
solution from VR101 test
articles was assessed
using a colorimetric assay
to quantify glycerol
present in the release
medium after immersion
for 24, 48, and 72 hours
at 37°C. | Pass
All samples exposed to
accelerated aging
conditions equivalent to
54 months storage under
ambient conditions met
the release criteria. | |
| Lubricating
Solution
Viscosity
Determination | Viscosity of the
lubricating solution in
each VR101 sample was
assessed at 25°C and 10
rpm using a calibrated
viscometer. | Pass
All samples exposed to
accelerated aging
conditions equivalent to
54 months storage under
ambient conditions met
the viscosity
specification. | |
| Lubricating and
Packaging
Solution
Osmolality
Determination | Osmolality of the
lubricating solution in
each VR101 sample was
assessed using a
calibrated osmometer. | Pass
All as-prepared
lubricating and
packaging solution
samples and lubricating
solution samples
exposed to accelerated
aging conditions
equivalent to 54 months
storage under ambient
conditions met the
specification for
osmolality. | |
| Lubricating
Solution pH
Determination | The pH of the lubricating
glycerol solution in each
VR101 sample was
assessed using litmus
paper. | Pass
All samples exposed to
accelerated aging
conditions equivalent to
54 months storage under
ambient conditions met
the specification for pH. | |
| Lubricating and
Packaging
Solution Water
Activity
Determination | The water activity of the
lubricating glycerol
solution in each VR101
Lubricating Intravaginal
Ring sample was assessed
using a calibrated water
activity meter. | All lubricating and
packaging solution
samples exposed to real-
time and accelerated
aging storage conditions
exhibited sufficiently
low water activity to
justify reduced microbial
testing. | |
| Determination of
compatibility of
lubricating
solution with
male condoms
composed of
natural rubber
latex,
polyurethane,
and polyisoprene
and female
condoms
composed of
nitrile rubber | ASTM 7661-10

Condom samples were
soaked in the lubricating
solution for one hour and
the tensile and burst
properties of the condoms
exposed to the lubricating
solution were compared
to those of control
condoms. | All condoms met the
acceptance criterion for
burst after exposure to
the lubricating solution,
allowing labeling of the
device that documents
its compatibility with
male condoms
composed of natural
rubber latex,
polyurethane, and
polyisoprene and female
condoms composed of
nitrile rubber. | |

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J3 Bioscience, Inc. sponsored three clinical investigations (CI01, CI02, and CI03) to assess the safety and efficacy of VR101 Lubricating Intravaginal Ring device.

Study summaries

The first, CI01 VR101: A Pilot Study to Evaluate the Preliminary Feasibility and Safety of a Lubricating Intravaginal Ring to Relieve the Symptoms of Vaginal Dryness, was a pilot investigation conducted to assess the feasibility of VR101 Lubricating Intravaginal Ring as a personal lubricant device.

The second, CI02, A Pivotal Clinical Investigation to Evaluate the Safety and Efficacv of J3 Bioscience Lubricating Intravaginal Ring (VR101) in Relieving Symptoms of Vaginal Dryness, was a pivotal, double-blind, crossover randomized trial that demonstrated the safety of VR101 Lubricating Intravaginal Ring during long-term continuous use (up to 13 weeks). In CI02, 890 total VR101 Lubricating Intravaginal Ring devices were used by study participants, and no serious adverse device effects were observed. The primary efficacy endpoint was not met as specified in the study protocol. Drawing a pivotal conclusion on efficacy from these data was ultimately confounded by the pre-specified missing data imputation plan and unexpected period and sequence effects in the cross-over design.

Summary of Clinical Data

In the third study, J3 Bioscience further evaluated the efficacy of VR101 Lubricating Intravaginal Ring as a personal lubricant device in clinical investigation titled CI03: A Clinical Investigation to Evaluate Efficacy of the J3 Bioscience Lubricating Intravaginal Ring VR101 as a Personal Lubricant Device in Women. The study was a double-blind, two-site, randomized, sham-controlled trial conducted in the United States. In this study, the efficacy of VR101 Lubricating Intravaginal Ring to meet the intended use was successfully demonstrated by a statistically significant improvement in the lubrication domain of the female sexual function index (FSFI) when compared to a sham, non-lubricating ring. The study enrolled 175 participants, with 166 (94.9%) completing the study. There were 87 participants in the treatment group and 88 in the sham group.

Demographics

The tables below provide summaries of clinical investigations CI01, CI02, and CI03 participant demographics, menopausal status, and race/ethnicity representation.

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VR101 Lubricating Intravaginal Ring Clinical Investigation (CI01, CI02, CI03) Baseline Participant Demographics
	Age (Years)	Height (Inches)	Weight (Pounds)
CI01
Minimum	38	59	105
Maximum	70	69	240
Mean	55.3	64.1	161.2
CI02
Minimum	36	59	113
Maximum	79	69	350
Mean	59.2	64.4	178.1
CI03
Minimum	21	57	84
Maximum	76	74	290
Mean	49.3	65.0	180.6

VR101 Lubricating Intravaginal Ring Clinical Investigation (CI01, CI02, and CI03) Menopausal Status

	CI01 (N=21)	CI02 (N=72*)	CI03 (N=175*)
Pre-Menopausal	0/21	1/72	51/175
Peri-Menopausal			15/175
Post-Menopausal	21/21	71/72	109/175
Other	0/21	0/72	0/175
*includes both VR101 Lubricating Intravaginal Ring and Sham

VR101 Lubricating Intravaginal Ring Clinical Investigation (CI01, CI02, and CI03) Race/Ethnicity Representation
Participant-Reported Race/Ethnicity	Number
CI01 Race/Ethnicity
White	19/21
Not Latina/Hispanic	18/19
Latina/Hispanic	1/19
White and Native American	1/21
Black/African-American	1/21
Not Latina/Hispanic	1/1
Latina/Hispanic	0/1
CI02 Race/Ethnicity
Caucasian/White	70/72
Not Latina/Hispanic	63/70
Latina/Hispanic	7/70

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Black/African-American	2/72
Not Latina/Hispanic	2/2
Latina/Hispanic	0/2
CI03 Race/Ethnicity
Caucasian/White	170/175
Latina/Hispanic	10/170
Not Latina/Hispanic	160/170
Native Hawaiian/Other	1/175
Black/African-American	2/175
Latina/Hispanic	1/2
Not Latina/Hispanic	1/2
Asian	2/175

Effectiveness:

The primary efficacy hypothesis in the CI03 study was defined as follows: Compared to the sham device, a significantly greater proportion of participants who use VR101 for 4 consecutive weeks will experience increased vaginal lubrication that enhances ease and comfort of intimate sexual activity as assessed by the Lubrication domain of the FSFI (FSFI-LD > 4.5). The study results support the primary endpoint was met (p = 0.02).

Safety:

Adverse event data collected in CI03 support the prior conclusions from Cl02 that VR101 Lubricating Intravaginal Ring is safe for its intended use. In the CI03 study, there were 95 adverse events reported, none of which were serious. Of the 95 adverse events, 36 were determined to be unrelated to the device. The most common adverse events reported in the study (including both VR101 Lubricating Intravaginal Ring and Sham) were excess vaginal secretions (17), pelvic cramping (14), vaginal pain/discomfort (5), and non-menstrual bleeding (5). There were also reports of urinary tract/bladder infection (3), vaginal irritation/vaginitis (2), and yeast infection (2). All adverse events in CI03 were rated as Mild or Moderate.

In summary, VR101 Lubricating Intravaginal Ring clinical results demonstrate that VR101 Lubricating Intravaginal Ring is safe and effective for the intended use and support substantial equivalence of safety and efficacy to the predicate device, Replens® Long-Lasting Vaginal Moisturizer (Pre-filled Applicators).

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VR101 Lubricating Intravaginal Ring has the same intended use as the predicate device, Replens® Long-Lasting Vaginal Moisturizer (Pre-filled Applicators) - (K101241), and although it has some different technological characteristics, they do not raise different questions of safety or efficacy. Summary of Performance data support that the VR101 Lubricating Intravaginal Ring is as Substantial Equivalence safe and effective as the predicate device. The subject device, VR101 Lubricating Intravaginal Ring, is substantially equivalent to its predicate device, Replens® Long-Lasting Vaginal Moisturizer (Pre-filled Applicators) (K101241).