(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 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.
§ 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.