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510(k) Data Aggregation
(181 days)
SASMAR INC
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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(148 days)
SASMAR INC
SASMAR® CLASSIC 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
SASMAR® ORIGINAL 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
SASMAR® VANILLA 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
SASMAR® WARMING 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
SASMAR® CHERRY 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
SASMAR® MELON 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. This product is compatible with natural rubber latex, polylsoprene, and polyurethane condoms.
SASMAR® PINA COLADA 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
SASMAR® STRAWBERRY 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
SASMAR® ORIGINAL is a non-sterile silicone based personal lubricant for penile and/or vaginal application intended to facilitate condom use, provide additional moisture to relieve vaginal dryness and enhance pleasure during sexual intimacy. The device may be used as a massage lotion and is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. This product is provided in a plastic pump dispenser or a foil laminate sachet and is available over-the-counter.
SASMAR® CLASSIC is a non-sterile water-based personal lubricant for penile and/or vaginal application intended to facilitate condom use, provide additional moisture to relieve vaginal dryness and enhance pleasure during sexual intimacy. The formula is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The device is available in the following variant personal lubricant formulas: SASMAR® Warming, SASMAR® Vanilla, SASMAR® Melon, SASMAR® Cherry, SASMAR® Strawberry or SASMAR® Pina Colada. This product is provided in a plastic pump dispenser, a plastic tube with flip-top closure or a foil laminate sachet and is available over-the-counter.
The provided text describes a 510(k) submission for personal lubricants (SASMAR® ORIGINAL and SASMAR® CLASSIC, and their flavored variants). This type of submission is for medical devices, but the acceptance criteria and study detailed are not related to AI/ML device performance for diagnostic or prognostic purposes, but rather to the physical and chemical properties and biocompatibility of the lubricants. Therefore, many of the requested categories in the prompt are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Condom Compatibility | Testing per ASTM D7661 indicates that the lubricant formulations are compatible with condoms (natural rubber latex, polyisoprene, and polyurethane condoms). |
| Biocompatibility | Testing for cytotoxicity, vaginal irritation, sensitization, and systemic toxicity in accordance with ISO 10993 indicated device biocompatibility. |
| Physical and Chemical Properties | Bench testing indicated that the lubricant has an appropriate viscosity, pH, osmolarity, specific gravity, appearance, color, and odor for substantial equivalence to the predicates. |
| Microbial Quality | USP testing for Total Aerobic Microbial Count, Total Yeast and Mold Count, absence of microbial pathogens, and antimicrobial effectiveness indicated microbial quality. |
| Shelf-Life | Long term, accelerated, and real-time aging tests for physical parameters and microbial characteristics indicate a 30-month shelf-life for the lubricants. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text does not specify sample sizes for any of the tests conducted (e.g., how many condoms were tested for compatibility, how many samples for biocompatibility, etc.). The provenance of the data is also not specified beyond the fact that testing was performed according to international standards (ASTM D7661, ISO 10993, USP).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" here relates to objective physical, chemical, and biological properties, not interpretations by human experts from medical images or clinical data. The tests performed are standardized laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from expert opinions, typically in diagnostic or prognostic studies where there might be disagreement in interpretations. For the physical and chemical tests described, the results are quantitative or qualitative assessments based on predefined measurement methods.
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
Not applicable. This device is a personal lubricant, not an AI-assisted diagnostic or prognostic tool. Therefore, MRMC studies and assessment of AI assistance for human readers are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system. Its performance is assessed directly through laboratory testing of its physical, chemical, and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established through standardized laboratory testing and adherence to specific industry standards (ASTM D7661 for condom compatibility, ISO 10993 for biocompatibility, USP for microbial quality) and internal bench testing for physical characteristics. These methods provide objective, measurable outcomes.
8. The sample size for the training set
Not applicable. The document describes the testing and properties of a physical product (personal lubricant), not the development or training of an AI/ML model. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model.
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