Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal lubricant 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. This product is compatible with natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms.

Device Description

Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubrican are non-sterile, translucent, non-greasy, aqueous thick liquid intended for use as a personal lubricant. Luvena Enhanced Moisturizer and Luvena Enhanced Persona Lubricant are packed in a plastic bottle. These devices are neither contraceptives nor spermicidals, nor do they contain any such component. They are compatible with latex and polyisoprene condoms and not compatible with polyurethane condoms as demonstrated in condom compatibility testing conducted according to the standards defined by ASTM D7661.

AI/ML Overview

The provided document is a 510(k) premarket notification summary for
"Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant." It is a regulatory approval document and not a scientific study report on device performance with specific acceptance criteria that are typically described for AI/ML devices or diagnostic tools.

Therefore, the requested information elements related to AI/ML device performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training sets, are not applicable to this document. This document pertains to the regulatory submission for a personal lubricant and moisturizer.

However, I can extract the relevant "acceptance criteria" and "reported device performance" type information from the document as they relate to the product's physical and biological properties.

Here's a summary of the acceptance criteria (as product specifications and testing standards) and reported performance as described in the document, which allowed the device to demonstrate substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Category / Test	Acceptance Criteria (Standard/Specification)	Reported Device Performance
Product Specifications (for final formulation)	Color/Appearance, Odor, pH, Viscosity, Osmolality, Total Aerobic Microbial Count (TAMC), Total Yeast and Mold Count (TYMC), Absence of pathogenic organisms, Antimicrobial Effectiveness.	Specifications met (details of specific values not provided, but implicitly passed to support submission).
Biocompatibility	Generally following ISO 10993-1 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity).	The results demonstrate that the subject lubricants are biocompatible.
Antimicrobial Preservative Effectiveness	USP <51>	Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant passed the Antimicrobial Effectiveness test.
Lubricant-Condom Compatibility	ASTM D7661	Found to be compatible with natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms.
Shelf Life	Not explicitly stated (implied to ensure stability over time).	The results of real time testing support the proposed shelf life for the subject lubricants.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes physical, chemical, and biological testing of a product based on established standards, not a clinical trial or algorithm performance study with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document describes laboratory testing against established physical and biological standards, not the establishment of ground truth for a diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 product demonstrating substantial equivalence to a predicate device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" (or basis for evaluation) for the device's properties was based on established regulatory standards and testing methodologies such as ISO 10993-1 for biocompatibility, USP <51> for antimicrobial effectiveness, and ASTM D7661 for condom compatibility. Product specifications (pH, viscosity, etc.) also serve as internal ground truths for manufacturing control.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 29, 2015

Laclede, Inc. % Seth Mailhot Attorney Michael Best & Friedrich LLP 601 Pennsylvania Ave. NW. Suite 700 Washington, DC 20004

Re: K150841

Trade/Device Name: Luvena Enhanced Personal Moisturizer Luvena Enhanced Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 30, 2015 Received: November 30, 2015

Dear Seth Mailhot.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Glenn B. Bell -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150841

Device Name Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K150841

Submitted by:	Laclede, Inc.
Address:	2103 E. University DriveRancho Dominguez, CA 90220
Telephone:	(310) 605-4280
Facsimile:	(310) 605-4288
Contact Name:	Michael A. Pellico, President
E-mail:	mpellico@laclede.com
Date Submitted:	November 10, 2015
Trade Name:	Luvena Enhanced Personal Moisturizer andLuvena Enhanced Personal Lubricant
Classification Name:	Condom
Common Name:	Personal Lubricant
Product Code /Regulation:	NUC (21 C.F.R. 884.5300)
Predicate Device:	Aqua Lube Personal Lubricant: K110325, Mayer Laboratories, Inc.
Description:	Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricanare non-sterile, translucent, non-greasy, aqueous thick liquid intended for use as apersonal lubricant. Luvena Enhanced Moisturizer and Luvena Enhanced PersonaLubricant are packed in a plastic bottle.These devices are neither contraceptives nor spermicidals, nor do they contain anysuch component. They are compatible with latex and polyisoprene condoms and notcompatible with polyurethane condoms as demonstrated in condom compatibilitytesting conducted according to the standards defined by ASTM D7661.
Product Specifications:	The product specifications for the Luvena Enhanced PersonalMoisturizer and Luvena Enhanced Personal Lubricant includecolor/appearance, odor, pH, viscosity, osmolality, Total AerobicMicrobial Count (TAMC), Total Yeast and Mold Count (TYMC),absence of pathogenic organisms, and antimicrobial effectiveness.
Intended Use:	Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricanis a personal lubricant, for penile and/or vaginal application, intended to moisturizeand lubricate, to enhance the ease and comfort of intimate sexual activity andsupplement the body's natural lubrication. This product is compatible with naturalrubber latex and polyisoprene condoms, but is not compatible with polyurethanecondoms.
Biocompatibility:	Biocompatibility of the final formulation of Luvena Enhanced PersonalMoisturizer and Luvena Enhanced Personal Lubricant were establishedthrough testing generally following ISO 10993-1, and includes cytotoxicity,sensitization, irritation, and acute systemic toxicity testing. The resultsdemonstrate that the subject lubricants are biocompatible.
Physical& OtherTesting:	The physical and other testing performed on Luvena Enhanced PersonalMoisturizer and Luvena Enhanced Personal Lubricant included an AntimicrobialPreservative Effectiveness Validation testing under USP <51>, Lubricant-Condom Compatibility testing per ASTM D7661, and shelf life testing. LuvenaEnhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant passedthe Antimicrobial Effectiveness test and were found to be compatible with naturalrubber latex and polyisoprene condoms, but not compatible with polyurethanecondoms. The results of real time testing support the proposed shelf life for thesubject lubricants.
Conclusion:	The subject lubricants are substantially equivalent to the proposed predicate device.

Substantial

Equivalence: Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant have the same intended use as the predicate device. However, the subject lubricants and the predicate device have different technological characteristics – namely differences in
formulation and specifications. The differences in technological characteristics do not raise different questions of safety and effectiveness.

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Regulation Number and Section

§ 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.