(184 days)
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.
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.
Here's a breakdown of the requested information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: VR101 Lubricating Intravaginal Ring
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by the "Specification" column, and the reported performance is in the "Results" column. Many of the reported results indicate "Pass" or adherence to the specification.
| Parameter | Specification | Reported Device Performance |
|---|---|---|
| Lubricant Specifications | ||
| Appearance | Colorless, Translucent | Pass (All unaged samples met; aged samples had yellow tint but met other criteria) |
| Odor | Odorless | Pass (All unaged samples met; aged samples had yellow tint but met other criteria) |
| pH | 6.5-7.5 | Pass (Met specification after accelerated aging) |
| Viscosity | 71-292 cP | Pass (Met specification after accelerated aging) |
| Osmolality | 498-603 mOsm/kg at 20x dilution (9,960-12,060 mOsm/kg) | Pass (Met specification after accelerated aging) |
| Antimicrobial Effectiveness | Water activity ≤ 0.60 | All samples exhibited sufficiently low water activity |
| Total Microbial Count | < 100 cfu/g | Not explicitly stated as "Pass" but inferred by water activity |
| Fungal/Yeast/Mold Limits | < 10 cfu/g | Not explicitly stated as "Pass" but inferred by water activity |
| Absence of Pathogenic Organisms | Absent | Not explicitly stated as "Pass" but inferred by water activity |
| Ring Specifications | ||
| Dimensional Inspection (OD) | Outer diameter - 55 ± 2 mm | Pass (Met all dimensional criteria after accelerated aging) |
| Compression | 1.0-2.2 N at 10% strain | Pass (Met acceptance criterion after accelerated aging) |
| Tensile Strength | Failure at > 100 N | Pass (Met acceptance criterion after accelerated aging) |
| Ring Breakage | No ring breakage | Not explicitly stated as "Pass" but inferred by visual inspection and tensile strength tests |
| Ring Flatness | Largest measurable gap between the ring plane and a flat surface is ≤ 2 mm | Not explicitly stated as "Pass" |
| Outer Tubing Deformities | No deformities or damage observed | Not explicitly stated as "Pass" but covered by visual inspection |
| Weld Misalignment | Any detectable misalignment ≤ 0.13 mm | Not explicitly stated as "Pass" but covered by visual inspection |
| Weld Flashing | Maximum height of any detectable weld flashing ≤ 0.25 mm | Not explicitly stated as "Pass" but covered by visual inspection |
| Bubbles in the Weld | Number of bubbles in weld volume ≤ 10 | Not explicitly stated as "Pass" but covered by visual inspection |
| Tubing and Weld Diameter | No visible apparent change in diameter | Not explicitly stated as "Pass" but covered by visual inspection |
| Weld Volume Bubble Size | Diameter of the largest bubble ≤ 0.5 mm | Not explicitly stated as "Pass" but covered by visual inspection |
| Foreign Material | No visually detectable loose foreign material, loose flash, or embedded material | Not explicitly stated as "Pass" but covered by visual inspection |
| Ring/Lubricant System Specifications | ||
| Mass | 4.3 – 4.7 g | Pass (Met acceptance criterion after accelerated aging) |
| Glycerol Release (in vitro) | >70% glycerol released by 48 hours | Pass (Met release criteria after accelerated aging) |
| Other Tests | ||
| Visual Inspection of Packaging | No holes or gross damage | Pass (No holes or defects were seen) |
| Biocompatibility Tests | (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Genotoxicity, Material Mediated Pyrogenicity, Implantation, Chemical Characterization) | All "Pass" |
| Condom Compatibility | Condom burst properties met criteria after exposure to lubricating solution | All condoms met acceptance criteria for burst after exposure |
| Clinical Efficacy | Statistically significant improvement in FSFI lubrication domain (> 4.5) | Met (p = 0.02 in CI03) |
| Clinical Safety | No serious adverse device effects; adverse events rated Mild or Moderate | CI02 (890 devices, no serious AEs), CI03 (95 AEs, none serious, all Mild/Moderate) |
2. Sample Size for the Test Set and Data Provenance
Non-Clinical (Performance/Biocompatibility) Test Set:
- The exact sample sizes for each non-clinical test are not explicitly detailed in the summary. However, tests were conducted on "all t=0 samples and samples exposed to accelerated aging conditions equivalent to 54 months storage" and "all as-prepared lubricating and packaging solution samples". This implies multiple samples were used for each test condition.
- Data Provenance: Not specified, but generally these are conducted in laboratory settings (in-vitro or animal studies, as indicated by ISO standards).
Clinical Test Set (CI03 study, which demonstrated efficacy for the primary endpoint):
- Sample Size: 175 participants (87 in treatment group, 88 in sham group). 166 (94.9%) completed the study.
- Data Provenance: United States (two-site clinical investigation), prospective (randomized, sham-controlled trial).
3. Number of Experts used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
- Non-Clinical Tests: Ground truth is established by the test methodologies themselves (e.g., ISO standards, USP standards, ASTM standards) and objective measurements. No human experts establishing a subjective "ground truth" are mentioned for these tests.
- Clinical Tests (CI03): The primary efficacy endpoint for CI03 was assessed using the Female Sexual Function Index (FSFI) - Lubrication domain (FSFI-LD). This is a patient-reported outcome measure, meaning the "ground truth" reflecting the efficacy is based on the participants' subjective experience and reporting, not on expert consensus. The study was double-blind, aiming to minimize bias in both participants' and researchers' assessments.
4. Adjudication Method for the Test Set
- Non-Clinical Tests: No adjudication method described; results are objective measurements against defined specifications.
- Clinical Tests (CI03): No external adjudication method is mentioned for the clinical trial results. Data collection for FSFI is typically self-reported by participants. The study was double-blind, implying that neither the participants nor the investigators knew which treatment (VR101 or sham) each participant received, which serves as a method to mitigate bias in outcome assessment.
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 study was done. This device is a medical device (intravaginal ring) for lubrication, not an AI-powered diagnostic or imaging device that would typically involve human readers or AI assistance. Therefore, this question is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The VR101 is a physical medical device, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The Type of Ground Truth Used
- Non-Clinical Tests: Objective measurements against established scientific/regulatory standards (ISO, USP, ASTM) and device specifications.
- Clinical Tests (CI03): Patient-reported outcomes (Female Sexual Function Index - Lubrication domain) for efficacy, and adverse event reporting for safety.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set." The clinical studies (CI01, CI02, CI03) served as research and development and pivotal studies to demonstrate safety and efficacy.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As stated above, there is no "training set" for this type of device.
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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
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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.
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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
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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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O J3 BIOSCIENCE
510(k) Summary 21 CFR 807.92(a)
| GeneralProvisions | Submitter Name: | J3 Bioscience, Inc. |
|---|---|---|
| Address: | 825 North 300 West, Suite N231Salt 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 andRegulatoryContacts | Contact Name: | R. Tyler McCabe, PhD |
| Title: | President/CEO | |
| J3 Bioscience, Inc. | ||
| Address: | 825 North 300 West, Suite N231Salt 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 RepresentativeSage BioPartners, LLC | |
| Phone Number: | 801-230-8611 | |
| Email: | moj.eram@sagebiopartners.com | |
| SubjectDevice | 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®) | ||
| PredicateDevice | 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 |
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This device has not been subject to a design-related recall.
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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 perUSP <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 Organismsper 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 betweenthe ring plane and a flat surface is ≤2 mm |
The VR101 device specifications can be seen in the table below.
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| 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.
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| DeviceCharacteristics | Subject Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| TechnologicalComparisonwith PredicateDevice | Device Name | VR101LubricatingIntravaginalRing | Replens LongLasting VaginalMoisturizer | N/A |
| Sponsor | J3 Bioscience,Inc. | Lil' Drug StoreProducts, Inc. | N/A | |
| 510(k) Number | K203377 | K101241 | N/A | |
| Indications forUse Statement | VR101LubricatingIntravaginalRing is apersonallubricant forvaginalapplicationintended tomoisturize andlubricate, toenhance theease andcomfort ofintimate sexualactivity andsupplement thebody's naturallubrication.This product iscompatible withnatural rubberlatex andsynthetic(polyurethaneandpolyisoprene)male condomsand FC2 femalecondoms. | Replens is apersonal lubricantfor vaginalapplication,intended tomoisturize andlubricate, toenhance the easeand comfort ofsexual activity andsupplement thebody's naturallubrication. Thisproduct iscompatible withnatural rubber latexcondoms andsynthetic(polyurethane andpolyisoprene)condoms. | Similar | |
| CondomCompatibility | NRL,Polyisoprene,Polyurethane, | NRL,Polyisoprene,Polyurethane | Different | |
| FC2 femalecondoms | ||||
| Base Type | Glycerol/water | Water | Similar | |
| PrimaryIngredient | GlycerolWaterSodiumChloride | Purified waterGlycerinMineral oilPolycarbophilCarbonhomopolymer typeBHydrogenatedpalm oil glycerideSorbic acidSodium hydroxide | Different | |
| Ring Component | Yes | No | Different | |
| Ring Material | Hydrophilicpolyurethane | N/A | Different | |
| Appearance/color | Clear | Smoothhomogenousgel/white to off-white | Different | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Shelf-life | 54 months | 3 years | Different | |
| Application | 7 dayscontinuous | Intermittent (every3 days and/or asneeded) | Different | |
| OTC use | OTC | OTC | Same |
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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
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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.
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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 LubricatingIntravaginal Ring | |||
|---|---|---|---|
| Test | Test Method Summary | Results | |
| Safety andPerformanceTests | VisualInspection ofPackaging | Each pouch wasvisually inspected bytrained individuals forholes and grossdamage prior toremoval of the VR101LubricatingIntravaginal Ringsample. | PassNo holes or defectswere seen. |
| Cytotoxicity | ISO 10993-5:2009L929 MEM ElutionMethod and AgarOverlay was conductedto assess the cytotoxicpotential of the device. | Pass | |
| Sensitization | ISO 10993-10:2010and ISO 10993-12:2012A Guinea PigMaximization Test wasconducted on thedevice. | Pass | |
| Irritation | Pass | ||
| ISO 10993-10:2010and ISO 10993-12:2012A Vaginal MucosalIrritation Test wasconducted to assess theirritation potential ofthe device. | |||
| Acute SystemicToxicity | ISO 10993-11:2006and ISO 10993-12:2012Intraperitoneal andIntravenous SystemicInjection routes wereused when conductingthe acute systemictoxicity study on thedevice. | Pass | |
| Genotoxicity | ISO 10993-3:2014 andISO 10993-12:2012An Ames Test andMouse LymphomaAssay were conductedon the device. | Pass | |
| MaterialMediatedPyrogenicity | USP <151>, ISO10993-11:2017 andISO 10993-12:2012A material mediatedpyrogenicity study wasconducted on thedevice. | Pass | |
| Implantation | ISO 10993-6:2016 andISO 10993-12:2012A SubcutaneousImplantation Test wasconducted using thesubject device. | Pass | |
| ChemicalCharacterizationandToxicologicalRiskAssessment | ISO 10993-18:2005A chemicalcharacterization andtoxicological riskassessment wereconducted on thedevice to addresschronic systemictoxicity. | Pass | |
| Visual Inspectionof IntravaginalRings | VR101 LubricatingIntravaginal Ring testarticles were visuallyinspected to determine ifrings are intact, notbroken, are colorless andtranslucent, and are odorfree. | PassAll samples exposedto accelerated agingconditions equivalentto 54 months storageunder ambientconditions exhibited ayellow tint but met allother acceptancecriteria. Samples agedunder ambient room-temperature conditionfor 57 monthsexhibited nodiscoloration. Allunaged (t=0) samplesmet acceptance | |
| VR101 | Outer diameter (OD) of | Pass | |
| LubricatingIntravaginalRingDimensionalInspection | the VR101 LubricatingIntravaginal Ringtubing and the ringmeasured both parallel(OD1) andperpendicular (OD2) tothe joint surface weredetermined. | All t=0 samples andsamples exposed toaccelerated agingconditions equivalent to54 months storage underambient conditions metall dimensionalacceptance criteria. | |
| Intravaginal Ring(IVR) MassingTest | The mass of each VR101Lubricating IntravaginalRing test article wasdetermined using acalibrated analyticalbalance. | PassAll t=0 samples andsamples exposed toaccelerated agingconditions equivalent to54 months storage underambient conditions metthe acceptance criterionfor mass. | |
| Force ofCompressionTest | Each of the VR101 testarticles was subjected tocompression testing ontwo perpendicular axesusing a tensile testingapparatus. | PassAll t=0 samples andsamples exposed toaccelerated agingconditions equivalent to54 months storage underambient conditions metthe acceptance criterionfor the force required tocompress the devices by10% of initial outerdiameter on 2 axes. | |
| IVR TensileStrength Test | VR101 LubricatingIntravaginal Ring testarticles were subjected totensile tests using atensile testing apparatusto assess weld integrity. | PassAll t=0 samples andsamples exposed toaccelerated agingconditions equivalent to54 months storage underambient conditions metthe acceptance criterion. | |
| IVR GlycerolRelease Test | The release of lubricatingsolution from VR101 testarticles was assessedusing a colorimetric assayto quantify glycerolpresent in the releasemedium after immersionfor 24, 48, and 72 hoursat 37°C. | PassAll samples exposed toaccelerated agingconditions equivalent to54 months storage underambient conditions metthe release criteria. | |
| LubricatingSolutionViscosityDetermination | Viscosity of thelubricating solution ineach VR101 sample wasassessed at 25°C and 10rpm using a calibratedviscometer. | PassAll samples exposed toaccelerated agingconditions equivalent to54 months storage underambient conditions metthe viscosityspecification. | |
| Lubricating andPackagingSolutionOsmolalityDetermination | Osmolality of thelubricating solution ineach VR101 sample wasassessed using acalibrated osmometer. | PassAll as-preparedlubricating andpackaging solutionsamples and lubricatingsolution samplesexposed to acceleratedaging conditionsequivalent to 54 monthsstorage under ambientconditions met thespecification forosmolality. | |
| LubricatingSolution pHDetermination | The pH of the lubricatingglycerol solution in eachVR101 sample wasassessed using litmuspaper. | PassAll samples exposed toaccelerated agingconditions equivalent to54 months storage underambient conditions metthe specification for pH. | |
| Lubricating andPackagingSolution WaterActivityDetermination | The water activity of thelubricating glycerolsolution in each VR101Lubricating IntravaginalRing sample was assessedusing a calibrated wateractivity meter. | All lubricating andpackaging solutionsamples exposed to real-time and acceleratedaging storage conditionsexhibited sufficientlylow water activity tojustify reduced microbialtesting. | |
| Determination ofcompatibility oflubricatingsolution withmale condomscomposed ofnatural rubberlatex,polyurethane,and polyisopreneand femalecondomscomposed ofnitrile rubber | ASTM 7661-10Condom samples weresoaked in the lubricatingsolution for one hour andthe tensile and burstproperties of the condomsexposed to the lubricatingsolution were comparedto those of controlcondoms. | All condoms met theacceptance criterion forburst after exposure tothe lubricating solution,allowing labeling of thedevice that documentsits compatibility withmale condomscomposed of naturalrubber latex,polyurethane, andpolyisoprene and femalecondoms composed ofnitrile 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).
§ 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.