← Product Code [QPD](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/QPD) · K203377 # VR101 Lubricating Intravaginal Ring (K203377) _J3 Bioscience, Inc. · QPD · May 20, 2021 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/QPD/K203377 ## Device Facts - **Applicant:** J3 Bioscience, Inc. - **Product Code:** [QPD](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/QPD.md) - **Decision Date:** May 20, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.5300 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## 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. ## Device Story VR101 is a lubricating intravaginal ring; hollow biomedical grade hydrophilic polyether urethane (HPU) tube containing a liquid solution of glycerol, water, and sodium chloride. Upon vaginal insertion, the ring provides controlled release of lubricant through the semi-permeable tubing wall for up to seven days. Used by patients for personal lubrication; no hormones or APIs. Output is continuous moisturization of vaginal mucosa. Benefits include enhanced comfort during sexual activity. Device is non-sterile, OTC, and single-use. ## Clinical Evidence Three clinical investigations (CI01, CI02, CI03) were conducted. CI02 (pivotal, double-blind, crossover) evaluated safety over 13 weeks; no serious adverse events reported. CI03 (double-blind, sham-controlled, N=175) evaluated efficacy; primary endpoint (FSFI Lubrication domain score > 4.5) met with statistical significance (p=0.02). Adverse events in CI03 were mild/moderate, including excess secretions, pelvic cramping, and vaginal discomfort. Data support safety and efficacy equivalence to the predicate. ## Technological Characteristics Constructed from biomedical grade hydrophilic polyether urethane (HPU). Lubricant solution: glycerol, water, sodium chloride. Dimensions: 55 ± 2 mm outer diameter. Mechanical specs: 1.0-2.2 N compression at 10% strain; >100 N tensile strength. Non-sterile. Shelf-life: 54 months. No electronic components or software. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Replens® Long-Lasting Vaginal Moisturizer (Pre-filled Applicators) ([K101241](/device/K101241.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) ## 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." {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 <1112> | Water activity ≤ 0.60 | | | Total Microbial Count per USP
<61> | < 100 cfu/g | | | Fungal/Yeast/Mold Limits per USP
<61> | < 10 cfu/g | | | Absence of Pathogenic Organisms
per USP <62> | Absent | | | Ring Specifications | | | | Dimensional Inspection | Outer diameter - 55 ± 2 mm | | | Compression | 1.0-2.2 N at 10% strain | | | Tensile Strength | Failure at > 100 N | | | Ring Breakage | No ring breakage | | | Ring Flatness | Largest measurable gap between
the ring plane and a flat surface is ≤
2 mm | 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

An Ames Test and
Mouse Lymphoma
Assay were conducted
on the device. | Pass | | | Material
Mediated
Pyrogenicity | USP <151>, ISO
10993-11:2017 and
ISO 10993-12:2012

A material mediated
pyrogenicity study was
conducted on the
device. | Pass | | | Implantation | ISO 10993-6:2016 and
ISO 10993-12:2012

A Subcutaneous
Implantation Test was
conducted using the
subject device. | 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. | 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. | | {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ {15}------------------------------------------------ {16}------------------------------------------------ {17}------------------------------------------------ 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. {18}------------------------------------------------ | 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 | {19}------------------------------------------------ | 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). {20}------------------------------------------------ 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). --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/QPD/K203377](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/QPD/K203377) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com