Elegance Woman's Lubricant is a non-sterile, oil-based personal lubricant formulated to supplement the body's own natural lubricating fluids to provide personal lubrication when vaginal dryness causes discomfort.

Device Description

Elegance Woman's Lubricant is a non-sterile oil-based personal lubricant formulated to supplement the body's own natural lubricating fluids to provide personal lubrication when vaginal dryness causes discomfort.
Ingredients: Natural oils of plant origin: Glycine Willd (soy), Carthamus tinctorius L.(safflower), and Vitis vinifera (grapeseed).

AI/ML Overview

This document describes the 510(k) submission for "Elegance Woman's Lubricant" and primarily focuses on its substantial equivalence to predicate devices, rather than an AI-driven medical device. Therefore, a significant portion of the requested information, which pertains to AI/ML device testing and performance evaluation, is not applicable or available in the provided text.

Specifically, there is no mention of acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample size for test sets (in the context of AI), data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The document details the device description, its intended use, a list of predicate devices, and a summary of non-clinical performance for biocompatibility and subject-use reports.

Here's an attempt to extract relevant information and address the prompt, noting the limitations due to the nature of the submitted device:

1. Table of Acceptance Criteria and Reported Device Performance

As "Elegance Woman's Lubricant" is a conventional medical device (personal lubricant) and not an AI/ML diagnostic or prognostic system, the concept of "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or AUC is not applicable. The documentation focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and biocompatibility.

Criterion Type	Acceptance Criteria (Not explicitly stated as numerical targets)	Reported Device Performance
Technological Characteristics	Highly lubricious, medium-high to high viscosity, liquid, clear, non-irritating, non-sterile. Ingredients Generally Recognized as Safe (GRAS).	Elegance Woman's Lubricant shares these characteristics with predicate devices. Ingredients are natural oils of plant origin: Glycine Willd (soy), Carthamus tinctorius L.(safflower), and Vitis vinifera (grapeseed), all considered GRAS.
Biocompatibility / Safety	Non-irritating, non-sensitizing on skin.	"Non-clinical evidence demonstrates biocompatibility and found no skin irritation or sensitivity." The formulation "does not harm vaginal or penile tissue."
Effectiveness (Intended Use)	Supplements natural lubricating fluids to provide personal lubrication when vaginal dryness causes discomfort.	"Subject-use reports demonstrate that Elegance Woman's Lubricant is nonirritating and effective as a personal lubricant."
Condom Compatibility	Not explicitly stated as an acceptance criterion for the device itself, but rather a safety warning requirement due to incompatibility.	"This product has not been shown to be compatible with condoms. Labeling will contain a warning to this effect." A warning is present for the "Indications for Use" section: "Do not use this lubricant with condoms. It may weaken the condom's physical properties and make it more likely to break."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Subject-use reports" but does not provide any details on the sample size of these reports, the methodology (e.g., retrospective or prospective), or the country of origin of the data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided for this type of device. The evaluation of a personal lubricant does not typically involve "experts establishing ground truth" in the way an AI diagnostic tool would be validated. Evaluations are based on biocompatibility testing and user feedback.

4. Adjudication Method for the Test Set

This information is not applicable and not provided.

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

This information is not applicable. The device is a personal lubricant, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a personal lubricant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For biocompatibility, the "ground truth" would be established through standardized non-clinical laboratory tests demonstrating lack of irritation/sensitization. For effectiveness, the "ground truth" is derived from subjective user reports regarding efficacy in reducing discomfort from vaginal dryness. There is no mention of pathology or objective outcomes data in the provided summary beyond user reports.

8. The Sample Size for the Training Set

This information is not applicable. The device is a personal lubricant; there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable.

Summary

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K070587 510(k) Summary

APR 1 0 2008

I. General Information on Submitter
Product Name:	Elegance Woman's Lubricant
Contact Person:	Julie Williams, PA-C
Address:	1209 Robin TrailRound Rock, TX 78681 USA
Telephone:	512.294.1133
Fax:	512.388.5869
Email:	president@eleganceinfo.com
Date Prepared:	February 10, 2007

II. General Information on Device Trade Name: Elegance Woman's Lubricant Common Name: Vaginal lubricant Classification Name: Lubricant, Vaginal, Patient (21 CFR 880.6375, Product Code: MMS)

III. Predicate Devices

Predicate Device 510 (k) control # K-Y'"" Liquid Personal lubricant (K955648) LifeStyles® Liquid Personal Lubricant (K033076) Durex Play™ Personal Lubricant (K032124)

IV. Description of Device

Ingredients

Natural oils of plant origin: Glycine Willd (soy), Carthamus tinctorius L.(safflower), and Vitis vinifera (grapeseed).

V. Intended Use

This product is a non-sterile, oil-based personal lubricant formulated to supplement the body's own natural lubricating fluids. Elegance Woman's Lubricant is a non-sterile, oil-based personal lubricant formulated to supplement the body's own natural lubricating fluids to provide personal lubrication when vaginal dryness causes discomfort.

The formulation does not harm vaginal or penile tissue.

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VI. Technological Characteristics of Device Compared to Predicate Devices

Elegance Woman's Lubricant shares the following technological characteristics with the predicate devices: highly lubricious, medium-high to high viscosity, liquid, clear, non-irritating, and non-sterile. Although different ingredients were used, all ingredients are found to be Generally Recognized as Safe (GRAS).

This product has not been shown to be compatible with condoms. Labeling will contain a warning to this effect.

VI. Summary of Clinical Performance

Non-clinical evidence demonstrates biocompatibility and found no skin irritation or sensitivity. Subject-use reports demonstrate that Elegance Woman's Lubricant is nonirritating and effective as a personal lubricant.

510(k) Elegance Woman's Lubricant 4.10.08-

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

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

FEB 2 4 2014

Julie Williams, PA-C Owner/Designer 1209 Robin Trail ROUND ROCK TX 78681

Re: K070587 Trade/Device Name: Elegance Woman's Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): March 28, 2008 Received (Date on orig SE ltr): March 31, 2008

Dear Ms. Williams:

This letter corrects our substantially equivalent letter of April 10, 2008.

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

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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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Benjamin R. Fisher -S

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): K070587

Device Name: Elegance Woman's Lubricant

Elegance Woman's Lubricant is a non-sterile, Indications for Use: oil-based personal lubricant formulated to supplement the body's own natural lubricating fluids to provide personal lubrication when vaginal dryness causes discomfort.

Warning: Do not use this lubricant with condoms. It may weaken the condom's physical properties and make it more likely to break.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

thom M. Why

and Radiological Devic 510(k) Number

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.