(167 days)
Sage 2-in-1 Personal Lubricant and Moisturizer is 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms
Sage 2-in-1 Personal Lubricant and Moisturizer™ is a non-sterile, water-soluble personal lubricant for over-the-counter (OTC) use. The lubricant will be provided in a 1.6 oz tube and will also be supplied with a low-density polyethylene applicator.
This document is a 510(k) Pre-Market Notification for a medical device called "Sage 2-in-1 Personal Lubricant and Moisturizer™". It asserts substantial equivalence to a predicate device, which inherently means it meets the same safety and effectiveness standards, rather than defining novel acceptance criteria or conducting a comparative effectiveness study.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Sage 2-in-1 Personal Lubricant and Moisturizer™ are primarily based on established standards and physical/chemical properties, as well as biological safety. The "reported device performance" is essentially that the device met these specifications.
| Parameter | Test Method | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|---|
| Appearance | Visual inspection | Opaque Gel | Met (Implied by FDA clearance) |
| Odor | Odor via smell of gel | Slight rose and sage odor | Met (Implied by FDA clearance) |
| pH | USP | 4.25-5.5 | Met (Implied by FDA clearance) |
| Viscosity | USP | 3000-12000cps | Met (Implied by FDA clearance) |
| Osmolality | USP | 240-370 mOsmo/kg | Met (Implied by FDA clearance) |
| Antimicrobial Effectiveness | USP | Bacteria: Not less than 2.0 log reduction from the initial count at 14 days, and no increase from the 14 days' count at 28 days | |
| Yeast and Molds: No increase at 14 and 28 relative to initial count. | Met (Implied by FDA clearance) | ||
| Total Aerobic Microbial Count (TAMC) | USP | ||
| Biocompatibility: | |||
| - Cytotoxicity | ISO 10993-5:2009 | Compliant | Met (Implied by FDA clearance) |
| - Sensitization | ISO 10993-10:2010 | Compliant | Met (Implied by FDA clearance) |
| - Vaginal Irritation | ISO 10993-10:2010 | Compliant | Met (Implied by FDA clearance) |
| - Acute Systemic Toxicity (lubricant only) | ISO 10993-11:2006 | Compliant | Met (Implied by FDA clearance) |
| Condom Compatibility | ASTM D7661-10 | Compatible with natural rubber latex condoms. Not compatible with polyisoprene and polyurethane condoms. | Met (Confimed compatibility with natural rubber latex) |
| Shelf-Life | Accelerated aging study | All device specifications met at timepoints assessed (equivalent to 0-16 months of real-time aging). | 16 months (accelerated aging study results met all specs) |
2. Sample Size for the Test Set and Data Provenance
This document describes a 510(k) submission, which relies on non-clinical performance testing rather than a clinical "test set" in the sense of patient data for algorithm evaluation.
- Sample Size: Not explicitly stated as a single "test set" in the context of device performance in humans.
- For biocompatibility tests (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity), these are typically performed on in vitro models or animal models. The exact number of samples or animals is not specified in this summary.
- For condom compatibility, the standard ASTM D7661-10 would specify the number of condoms and lubricant samples tested. This information is not provided in detail.
- For shelf-life, samples of the product would be subjected to accelerated aging conditions. The number of samples is not specified.
- For physical/chemical/microbiological tests, these are typically performed on batches of the manufactured product. The exact number of samples per test is not detailed.
- Data Provenance: The tests are standard laboratory tests (e.g., USP, ISO, ASTM standards). The data would be generated in a laboratory setting, likely in the country where Fairhaven Health, LLC operates (USA), and would be considered prospective data for the purpose of validating the manufacturing and product characteristics. It is not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable in the context of this 510(k) submission. "Ground truth" established by experts typically refers to clinical diagnosis or evaluation from medical images/records, which is not part of this device's validation. The "ground truth" here is adherence to scientific standards and specifications, which are validated by laboratory personnel qualified in their respective testing domains (e.g., microbiology, chemistry, toxicology).
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study involving human readers or expert consensus on clinical findings. The "adjudication" (or rather, verification) is through the test methods themselves and their interpretation by trained laboratory personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This document does not describe a MRMC comparative effectiveness study. It is a 510(k) for a personal lubricant, which does not involve human readers evaluating cases or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This device is a personal lubricant, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on:
- Established scientific standards and specifications: (e.g., USP for pH, ISO 10993 for biocompatibility, ASTM D7661-10 for condom compatibility).
- Laboratory measurements and observations: Direct measurements of physical, chemical, and microbiological properties.
- Safety assessment: Demonstrating non-toxicity, non-irritancy, and non-sensitization based on biocompatibility standards.
- The overall "ground truth" for a 510(k) submission is that the device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning model that requires a training set. The "training set" concept does not apply to the validation of a personal lubricant.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this 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.