(73 days)
K-Y® Brand SENSUAL MIST™ is intended as a personal lubricant (for penile and vaginal application) compatible with latex condom.
This device is a condom compatible personal lubricant that has been specifically developed to be delivered via a non-aerosol spray pump.
The provided text describes a 510(k) Special Device Modification for the K-Y® Brand SENSUAL MIST™ Personal Lubricant. The filing emphasizes the device's substantial equivalence to predicate devices, particularly K-Y® Brand Liquid. However, the document does not contain explicit acceptance criteria or a study designed to prove the device meets specific performance criteria in the way one might expect for a new, high-risk medical device.
Instead, the submission focuses on demonstrating substantial equivalence to an existing, legally marketed predicate device (K-Y® Brand Liquid). This means the primary "acceptance criterion" is that the modified device performs equivalently to the predicate and is safe and effective for its intended use.
Here's an analysis of the provided information, framed to answer your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative "acceptance criteria" and their corresponding device performance values are not detailed in the provided text (like sensitivity, specificity, accuracy, etc.), I will extrapolate the information based on the nature of a 510(k) substantial equivalence submission for a personal lubricant.
| Acceptance Criteria (Inferred from 510(k) Submission) | Reported Device Performance |
|---|---|
| 1. Condom Compatibility: Compatible with leading commercial brands of latex condoms. | "Laboratory test results demonstrated that the proposed device is compatible with the leading commercial brands of latex condoms." |
| 2. Lubricity: Comparable lubricity to the predicate device. | "Lubricity of the proposed device is comparable to the lubricity of predicate device." |
| 3. Ingredient Safety: Ingredients are generally recognized as safe (GRAS) for use in personal lubricant products. | "The ingredients used in the formulation of the proposed device are generally recognized as safe (GRAS) and the pre-clinical evaluation of the ingredients has determined that they are safe for use in personal lubricant products." |
| 4. Inhalation Safety (Particle Size): Not likely to reach deep lung (alveolar region) upon inhalation. | "The particle size analysis data suggest that any inhalation of the product is not likely to reach the deep lung (i.e., alveolar region)." |
| 5. Non-sensitizing: Does not cause skin sensitization. | "The human RIPT shows that the proposed device is non-sensitizing." |
| 6. Overall Equivalence: Substantially equivalent to currently marketed products in technology, intended use, safety, and suitability. | "The proposed device is substantially equivalent to the currently marketed products in technology, intended use, safety, and suitability characteristics." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of a specific number of instances. The document mentions "leading commercial brands of latex condoms" for compatibility testing, but not the number of condoms tested. For the "human RIPT," it doesn't specify the number of human participants.
- Data Provenance: The studies mentioned ("laboratory testing," "pre-clinical evaluations," and "human RIPT") appear to be prospective studies conducted specifically for this device modification. The country of origin of the data is not specified, but given the submitter's location (Skillman, NJ, USA) and the FDA submission, it's presumed to be conducted or overseen within the US or to standards acceptable for US regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the document. The studies described are more focused on direct physical/chemical properties (condom compatibility, lubricity, particle size) and biological responses (RIPT) rather than expert-based "ground truth" establishment for diagnosis or interpretation.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved to establish a ground truth. The studies for this lubricant are laboratory and pre-clinical in nature.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or is not described. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The K-Y® Brand SENSUAL MIST™ is a personal lubricant, and its evaluation does not involve human readers interpreting "cases."
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Applicable in a different context: While not an "algorithm" in the AI sense, the performance data presented (condom compatibility, lubricity, particle size analysis, RIPT) can be considered "standalone" performance evaluations of the device itself, without human intervention in its efficacy assessment in the way a human-in-the-loop study would assess an AI. The device's properties were tested objectively.
7. Type of Ground Truth Used
- The "ground truth" in this context is established through a combination of:
- Laboratory measurements: For condom compatibility, lubricity (presumably measured by standardized methods), and particle size analysis.
- Pre-clinical evaluations: For ingredient safety.
- Human RIPT (Repeat Insult Patch Test): For skin sensitization, where the "ground truth" is the observed biological reaction (or lack thereof) in human participants.
- Regulatory standards/guidelines: Underlying the expectation for GRAS ingredients and the design of the RIPT.
8. Sample Size for the Training Set
- Not applicable/not provided. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (personal lubricant), not an AI/ML algorithm.
9. How Ground Truth for the Training Set Was Established
- Not applicable/not provided. As there is no training set for an AI/ML model, the establishment of ground truth for such a set is not relevant to this submission.
§ 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.