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510(k) Data Aggregation
(181 days)
CONCEIVE PLUS® is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
CONCEIVE PLUS® is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product can be used in fertility interventions to facilitate entry of diagnostic and therapeutic devices into the vaginal cavity.
CONCEIVE PLUS® is compatible with natural rubber latex and polyurethane condoms. CONCEIVE PLUS® is not for use with polyisoprene condoms.
CONCEIVE PLUS® is non-sterile water-based personal lubricant and vaginal moisturizer that is isotonic. The device contains calcium and magnesium ions and is formulated to meet a pH range that is compatible with sperm survival and migration. CONCEIVE PLUS® supplements the body's own natural moisture and is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. The device is packaged in a plastic tube or a pre-filled applicator for intra-vaginal application.
CONCEIVE PLUS® is formulated using Deionized Water, Hypromellose, Sodium Phosphate, Sodium dihydrogen Phosphate, Potassium Chloride, Sodium Chloride, Magnesium Chloride, Calcium Chloride, Glycerol and Methylparaben.
This device is batch lot tested for appearance, color, odor, viscosity, osmolarity, specific gravity, pH, microbial limits, endotoxin, mouse embryo assay, and human sperm survival assay.
This document describes acceptance criteria and performance data for CONCEIVE PLUS®, a personal lubricant. It is a 510(k) premarket notification (K131355) for a Class II medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (CONCEIVE PLUS®) | Reported Device Performance (CONCEIVE PLUS®) | Predicate Device (Pre-Va Vaginal Lubricant - K072741) |
|---|---|---|---|
| Osmolarity | 290 - 400 mOsm/KG | Met acceptance criteria throughout two-year shelf life. | 260 - 370 mOsm/KG |
| pH | 7.0 - 7.6 | Met acceptance criteria throughout two-year shelf life. | 7.0 - 7.4 |
| Endotoxin (LAL) | ≤ 0.5 EU/ml | Met acceptance criteria throughout two-year shelf life. | ≤ 0.7 EU/ml |
| Mouse Embryo Assay (MEA) | 1-Cell MEA exposed to 10% solution for 1 hour ≥ 80% Blastocysts at 96 hours | Demonstrated normal fertilization and embryo development with no suggestion of toxicity. Met acceptance criteria throughout two-year shelf life. | 1-Cell MEA exposed to 5% solution for 30 mins ≥ 80% Blastocysts at 96 hours |
| Human Sperm Survival Assay (HSSA) | Sperm motility at 2 hours exposure to 10% solution ≥ 80% control | Poses no barrier for sperm penetration or movement and does not harm motility or viability of human sperm. Confirmed not to harm human sperm chromatin (DNA). Met acceptance criteria throughout two-year shelf life. | Sperm motility at 30 min exposure to 10% solution ≥ 80% control |
| Condom Compatibility | Compatible with natural rubber latex and polyurethane condoms. Not for use with polyisoprene condoms. | Confirmed device is compatible with natural latex and polyurethane condoms according to ASTM D7661. (Explicitly states "not for use with polyisoprene condoms" in indications for use). | Compatible with latex and polyurethane condoms. |
| Bovine Cervical Mucus Studies | No hindrance to sperm penetration or migration into cervical mucus. | Confirmed that the device does not hinder the ability of sperm to penetrate and migrate into cervical mucus. | Not explicitly mentioned for predicate in this summary. |
| Biocompatibility - Acute Systemic Toxicity | Not systemically toxic for external communicating devices with limited contact duration. | The device is not systemically toxic (ISO 10993-11:2006). | Not explicitly mentioned for predicate in this summary. |
| Biocompatibility - Cytotoxicity | No cytotoxic effect (mild reactivity). | The device does not have a Cytotoxic effect (mild reactivity) (ANSI/AAMI/ISO 10993-5:2009). | Not explicitly mentioned for predicate in this summary. |
| Biocompatibility - Maximization Test For Delayed-Type Hypersensitivity | Does not elicit sensitization reactions. | The device does not elicit sensitization reactions (ISO 1993-5:2010). | Not explicitly mentioned for predicate in this summary. |
| Biocompatibility - Vaginal Irritation Test | Non-Irritating. | The device is Non-Irritating (ISO 1993-10:2010). | Not explicitly mentioned for predicate in this summary. |
| Appearance, Color, Odor, Viscosity, Specific Gravity, Microbial Limits | Met acceptance criteria (no specific numerical values provided in document). | Testing confirmed that the device in both tube and applicator met all acceptance criteria for appearance, color, odor, viscosity, osmolarity, specific gravity, pH, microbial limits, endotoxin, mouse embryo assay, and human sperm survival assay throughout the entire proposed two year shelf life. | Not explicitly mentioned for predicate in this summary beyond general statement of being "currently marketed." |
| Antimicrobial Effectiveness | Preservative system shown to be effective. | Antimicrobial effectiveness testing has been conducted and the preservative system is shown to be effective. | Not explicitly mentioned for predicate in this summary. |
2. Sample Sizes and Data Provenance
Due to the nature of medical device premarket notifications for lubricants, specific numerical sample sizes for each test are not detailed in this summary. The studies involve laboratory-based assays rather than human clinical trials with 'test sets' in the typical sense of AI/image analysis.
- Data Provenance: The origin of the data is from in vitro (Mouse Embryo Assay, Human Sperm Survival Assay, Bovine Cervical Mucus Studies, Biocompatibility tests) and in situ (Condom Compatibility testing) laboratory testing of the CONCEIVE PLUS® product itself. Given the context of a European manufacturer (SASMAR SPRL, Brussels, Belgium) seeking FDA clearance, these tests would have been performed in compliance with international standards (ISO, ASTM) and likely in designated testing facilities.
- Retrospective or Prospective: All tests would have been prospective, as they were conducted specifically to demonstrate the safety and effectiveness of CONCEIVE PLUS® for its 510(k) submission.
3. Number of Experts and Qualifications
This document does not specify the number or qualifications of experts used to establish ground truth. For these types of laboratory tests, "ground truth" is established by the validated methodologies of the tests themselves (e.g., ISO standards for biocompatibility, established protocols for MEA/HSSA). The expertise lies in the certified laboratories and trained personnel conducting these assays according to recognized standards.
4. Adjudication Method
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used for clinical studies involving interpretation of data (e.g., medical images) by multiple human readers. The tests performed for this lubricant are laboratory-based assays with objective endpoints.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study involving human readers or AI in an assistive capacity for diagnostic tasks.
6. Standalone (Algorithm Only) Performance
Not applicable. This product is a personal lubricant, not an algorithm or AI device. The "performance" refers to its physical and biological compatibility characteristics.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is based on established scientific and regulatory standards for safety and compatibility in laboratory settings:
- Laboratory Assay Results: Objective measurements from tests like osmolarity, pH, endotoxin levels, and direct observation of biological effects (sperm motility, embryo development, cellular response in biocompatibility tests).
- Standardized Test Protocols: Adherence to international standards (e.g., ISO 10993 for biocompatibility, ASTM D7661 for condom compatibility) which define acceptable ranges and methodologies.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML product and does not involve a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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