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510(k) Data Aggregation
(253 days)
ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT
Astroglide® TTC 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. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Astroglide® TTC Fertility Friendly Personal Lubricant is a non-sterile, clear, and water-based personal lubricant for penile and/or vaginal application. Astroglide® TTC has a pH and osmolarity that is compatible with sperm survival and migration. The device is packaged in pre-filled tube applicators which may be used for single use intra-vaginal application or applied directly to penis or vagina. Astroglide® TTC is formulated using water, propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, and sodium hydroxide. This device is batch lot tested for appearance, color, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay and human sperm survival assay.
The provided text discusses the premarket notification for Astroglide TTC Fertility Friendly Personal Lubricant, detailing its characteristics and comparison to a predicate device. It includes a summary of performance data to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the studies mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (from Predicate) | Reported Device Performance (Astroglide TTC) |
|---|---|---|
| pH | 7.20-7.45 | 7.2-7.6 |
| Osmolarity | 260 to 370 mOsm/kg | 220-400 mOsm/kg |
| Endotoxin by LAL methodology | ≤ 0.7 EU/mL | ≤ 0.7 EU/mL |
| Mouse Embryo Assay (MEA) | Using 1-cell MEA exposed to 5% solution for 30 minutes, > 80% expanded blastocysts at 96 hrs. | Using 1-cell MEA exposed to 10% solution for 30 minutes, > 80% expanded blastocysts at 96 hrs. |
| Human Sperm Survival Assay (HSSA) | After exposure to 10% Pre-Va for 30 min, ≥ 80% of the control. | After exposure to 10% TTC for 2 hours, ≥ 80% of the control. |
| Condom Compatibility | Compatible with latex and polyurethane condoms. | Compatible with latex, polyurethane, and polyisoprene condoms. |
| Cytotoxicity (Formula) | Not explicitly stated, likely "not considered cytotoxic." | Not considered to have a cytotoxic effect. |
| Sensitization (Formula) | Not explicitly stated, likely "did not elicit sensitization." | Did not elicit sensitization reactions. |
| Vaginal Irritation (Formula) | Not explicitly stated, likely "non-irritating." | Considered non-irritating to the vaginal mucosa in New Zealand White Rabbits. |
| Systemic Toxicity (Formula) | Not explicitly stated, likely "met requirements." | Met the requirements of ISO 10993-11. No test animals exhibited any biological reactivity. |
| Cytotoxicity (Applicator) | Not explicitly stated, likely "not considered cytotoxic." | Not considered to have a cytotoxic effect. |
| Sensitization (Applicator) | Not explicitly stated, likely "did not elicit sensitization." | Did not elicit sensitization reactions. |
| Vaginal Irritation (Applicator) | Not explicitly stated, likely "non-irritating." | Minimally irritating when extracted in saline; non-irritating when extracted in cottonseed oil. |
| Shelf-life Stability | (Implied by predicate) Effective over shelf-life. | Met acceptance criteria for 8-month shelf-life. |
| Antimicrobial Effectiveness | (Implied by predicate) Preservative system effective. | Preservative system is effective. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the test sets (e.g., number of mouse embryos, human sperm samples, or animals for biocompatibility). The studies performed are laboratory-based and animal studies (New Zealand White Rabbits for irritation, Guinea Pig for sensitization, mice for embryo assay). The data provenance is not explicitly stated as "country of origin" but implies controlled laboratory settings, which are typically retrospective in terms of analyzing the results from a pre-defined experiment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or diagnostic studies. The ground truth for these types of in vitro and in vivo studies is established by the experimental protocols themselves, with results interpreted against scientific and regulatory standards (e.g., ISO standards for biocompatibility).
4. Adjudication Method for the Test Set
Not applicable. The studies described are laboratory, animal, and in vitro tests, not clinical trials requiring adjudication of observer interpretations.
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 is a medical device (personal lubricant) and the studies do not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study and effect size in human reader improvement are not relevant.
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.
7. The Type of Ground Truth Used
The ground truth used in these studies is primarily:
- Experimental Results against predefined thresholds/standards: For pH, osmolarity, endotoxin, MEA, HSSA, and condom compatibility, the "ground truth" is whether the measured values or observed outcomes meet the established scientific and regulatory criteria (e.g., >80% expanded blastocysts, ≥80% sperm survival).
- Biocompatibility Standards: For cytotoxicity, sensitization, irritation, and systemic toxicity, the ground truth is whether the device passes the requirements of specific ISO 10993 standards.
- Functional Assays: For sperm function (penetration, motility, DNA integrity) and IVF, the ground truth is the scientific demonstration that the device does not impede or harm these biological processes.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
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