(90 days)
Not Found
Not Found
No
The device description lists only condoms and lubricants, and there is no mention of AI, ML, or any related technologies in the provided text.
No
The description lists condoms and lubricants, which are typically for contraception and comfort, not for treating a disease or condition.
No
The device description lists condoms and lubricants, which are preventative and protective measures, not diagnostic tools. The "Intended Use / Indications for Use" section is "Not Found," preventing definitive identification of a diagnostic purpose.
No
The device description explicitly lists physical medical devices (condoms and lubricants) as components of the kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: The kit contains latex male condoms and personal lubricants. These are physical barrier devices and topical products, not devices intended for the in vitro examination of specimens derived from the human body.
- Intended Use / Indications for Use: While this section is "Not Found," the nature of the included devices strongly suggests their use is for preventing pregnancy and sexually transmitted infections, and for enhancing sexual activity, not for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Loving Smarter- Safer Sex Kit, as described, does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The medical devices and drugs contained in The Loving Smarter- Safer Sex Kit are:
1.Latex Male Condoms
- Personal Lubricants, Water-based
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 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.
0
K963679
DEC 1 2 1006
ENCLOBURE C
Summary of Information on Safety and Effectiveness
The medical devices and drugs contained in The Loving Smarter- Safer Sex Kit are:
1.Latex Male Condoms
- Personal Lubricants, Water-based
A research of medical journals supports a finding that these products are safe and effective. Some individuals may have allergic reaction to some of the products.
All medical devices and drugs contained in the Loving Smarter- Safer Sex Kit will be purchased from manufacturers and distributors. The products will be substantially equivalent to products that are legally marketed in the United States.
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