(191 days)
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No
The device description and performance studies focus on the physical properties and safety of a personal lubricant, with no mention of AI or ML.
No
The device is a personal lubricant, not intended for a therapeutic purpose like treating a disease or condition. Its function is to facilitate sexual activity.
No.
The device is described as a personal lubricant, and its performance studies focus on compatibility, lubricity, and safety as a lubricant, not on diagnosing any medical condition.
No
The device description explicitly states the devices are "personal lubricants," which are physical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a personal lubricant for penile and vaginal application compatible with latex condom." This describes a product applied to the body for a physical purpose (lubrication), not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The device is described as "personal lubricants compatible with latex condom." This aligns with the intended use and does not suggest any diagnostic function.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The information provided clearly indicates a device intended for topical application for lubrication, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the device is as a personal lubricant compatible with latex condom.
K-Y® Brand YOURS+MINE™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
This proposed device consists of two personal lubricants packaged together.
The devices are personal lubricants compatible with latex condom.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
vaginal or penile areas or a condom
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results from laboratory testing, pre-clinical evaluations and testing, and human use show that the proposed device performs equivalently to the predicate device. Laboratory test results demonstrated that the proposed device is compatible with the leading commercial brands of latex condoms. Lubricity of the proposed device is comparable to the lubricity of predicate device.
The pre-clinical evaluation and testing and human use data show that the proposed device is safe for use as a personal lubricant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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