Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, to enhance condom use and the ease of intimate activity.

Device Description

The FDS Intimate Lubricant formula is non-sticky, non-staining, non-greasy and is compatible with latex condoms in laboratory testing. It is a water soluble, clear, high viscosity, gel-like liquid. Because it is water soluble, FDS Intimate Lubricant is easily rinsed off with water. The product can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according to the standards as defined by ASTM D 3492. FDS Intimate Warming Lubricant is neither a contraceptive nor a spermicide. The product is packaged in a convenient to use pump bottle.

The FDS Intimate Warming Lubricant is a non-sticky, non-staining, non-greasy gel for use as a personal lubricant. This product imparts a gentle warming sensation when applied to the skin. The product can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according to the standards as defined by ASTM D 3492. FDS Intimate Warming Lubricant is neither a contraceptive nor spermicide.

It contains only United States Pharmacopeia (USP) or National Formulary (NF) ingredients, all of which are listed as "generally recognized as safe".

AI/ML Overview

This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, many of the requested elements (like sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, or specific quantitative performance metrics against acceptance criteria) are not typically included or required in this type of submission.

However, based on the provided text, I can extract and infer the following:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance
Biocompatibility:
- Not a contact sensitizing agent	- FDS Intimate Lubricant and FDS Warming Lubricant were not considered to be contact sensitizing agents (based on ISO 10993 and G95-1 studies).
- No systemic toxicity	- FDS Intimate Lubricant and FDS Warming Lubricant were not associated with systemic toxicity (based on ISO 10993 and G95-1 studies).
- No acute vaginal mucosal irritation	- FDS Intimate Lubricant did not have any significant effect on cell viability and tissue morphology in the Acute Vaginal Mucosal Irritation Assay. - FDS Intimate Warming Lubricant induced a decrease of cell viability after 24 hours of contact and showed histological alterations after 10 minutes of contact in the same assay. (This indicates some irritation, but the submission still declares substantial equivalence, implying it was within acceptable limits compared to predicates or deemed clinically insignificant for the intended use given predicate equivalence for similar warming lubricants).
- No acute eye irritation	- FDS Intimate Lubricant was found to be a non-irritant in the Acute Eye Irritation Assay. - FDS Intimate Warming Lubricant was found to be very slightly irritant and induced histological alterations after 10 minutes of contact. (Similar to vaginal irritation, some irritation was noted, but was likely considered acceptable given predicate equivalence and "very slightly irritant" finding).
Condom Compatibility (Latex):
- Compatible with latex condoms (per ASTM D 3492)	- FDS Intimate Lubricant and FDS Intimate Warming Lubricant compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according to ASTM D 3492. (Results are compared against water-treated controls and KY Jelly predicate).
Consumer Perceptions/Performance Claims:
- Non-Messy. Convenient Pump!	- Evaluated in an In-Home Consumer Use Study against this claim. Results not explicitly detailed beyond stating statistical analysis was performed.
- Warming Intimate Lubricant	- Evaluated in an In-Home Consumer Use Study against this claim. Results not explicitly detailed beyond stating statistical analysis was performed.
- Warms on Contact	- Evaluated in an In-Home Consumer Use Study against this claim. Results not explicitly detailed beyond stating statistical analysis was performed.
- For Enhanced Intimacy and Pleasure	- Evaluated in an In-Home Consumer Use Study against this claim. Results not explicitly detailed beyond stating statistical analysis was performed.
- Fragrance Free	- Evaluated in an In-Home Consumer Use Study against this claim. Results not explicitly detailed beyond stating statistical analysis was performed.
- Gentle, Long-Lasting Formula	- Evaluated in an In-Home Consumer Use Study against this claim. Results not explicitly detailed beyond stating statistical analysis was performed.

2. Sample sized used for the test set and the data provenance

Preclinical Testing: The preclinical tests (Biocompatibility, Condom Compatibility, Vaginal Mucosal Irritation, Eye Irritation) were conducted in a laboratory setting. No specific sample sizes for these in-vitro tests are provided beyond "duplicate cultures" for some cell viability assays. The provenance is "an outside laboratory, in compliance with Good Laboratory Practices (GLPs)." This implies a controlled, prospective study environment for the tests.
Human Repeated Insult Patch Test: Not specified.
In-Home Consumer Use Study: Not specified. The provenance is "an independent market research firm." This would be a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission relies on laboratory test results (e.g., cell viability, physical integrity of condoms), and consumer survey responses, not expert human interpretation of medical images or data requiring ground truth establishment by experts in that sense.

4. Adjudication method for the test set

Not applicable. The tests are primarily objective measurements (e.g., cell viability, strength tests for condoms) or consumer feedback.

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

No. This device is a personal lubricant, not an AI-assisted diagnostic or therapeutic device. Such a study would not be relevant.

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

This question is not applicable as the device is not an algorithm or AI. The performance studies are for a physical product (lubricant).

7. The type of ground truth used

Biocompatibility: Laboratory assay results (e.g., MTT assay for cell viability, histological analysis for tissue alteration).
Condom Compatibility: ASTM D 3492 standard measurements for strength and leakage, compared against a water-treated control and a predicate substance (KY Jelly).
Human Repeated Insult Patch Test: Clinical observations by dermatologists/study personnel for contact sensitization.
In-Home Consumer Use Study: Consumer feedback and perceptions relative to marketing claims.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. See response to #8.

Summary

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K060145

APR 1 4 2006

Image /page/0/Picture/2 description: The image shows the words "ALBERTO CULVER" in a stylized font. The text is white against a black background. A thin line underlines the text.

ALBERTO-CULVER COMPA

RESEARCH AND DEVELOPMENT

SECTION V 510(k) SUMMARY

Alberto-Culver USA, Inc. Submitter 2525 Armitage Avenue Melrose Park, IL 60106
Richard E. Main Contact Person Senior Manager, Global Regulatory Affairs Fax: (708) 450-2551 Phone: (708) 450-3153
January 20, 2006 Date Submitted
Proprietarv Name(s)FDS Intimate Lubricant, FDS Intimate Warming Lubricant

Predicate Name(s): K-Y® Brand ULTRAgeI™MC Personal Lubricant manufactured by Personal Products Company Division of McNeil-PPC, Inc. (K020827)

Astroglide® Brand Personal Lubricant manufactured by Biofilm, Inc. (K935299)

K-Y® Brand Warming Liquid™ Personal Lubricant manufactured by Personal Products Company Division of McNeil-PPC, Inc. (K021492)

Astroglide® Warming Liquid manufactured by Biofilm, Inc. (K041432)

Lubricant, Patient, Vaginal, Latex Compatible Common Name

Classification Name 21 CFR 884.5300 Product Code NUC

Description of Device

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enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according to the standards as defined by ASTM D 3492. FDS Intimate Warming Lubricant is neither a contraceptive nor a spermicide. The product is packaged in a convenient to use pump bottle.

It contains only United States Pharmacopeia (USP) or National Formulary (NF) ingredients, all of which are listed as "generally recognized as safe".

Intended Use

FDS Intimate Lubricant and FDS Warming Lubricant are intended as personal lubricant to be used with or without a condom.

The lubricous nature of this product helps to supplement the body's own natural lubricating fluids, thereby relieving friction to help enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissues for purpose of lubrication, and moisturization and is compatible with latex condoms. FDS Intimate Warming Lubricant has the additional benefit of imparting a warming sensation when applied to the genital area.

Regulatory Status

Per 21 CFR, 880.6375, Patient lubricant is defined as a Class I medical device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. Patient lubricants are not exempt from 510(k) clearance. Additionally when used as an accessory to a condom, (a Class II medical device) the lubricant is considered, by FDA, as a Class II Medical Device requiring 510(k) clearance.

Technological Characteristics

The FDS Intimate Lubricant and FDS Warming Lubricant formulas are proprietary. The products have no exceptional technological characteristics and consist mainly of safe water-soluble GRAS status ingredients similar to K-Y® Brand ULTRAge!™MC Personal Lubricant manufactured by Personal Products Company, Division of McNeil-PPC, Inc., Skillman, NJ, Astroglide® Brand Personal Lubricant manufactured by Biofilm, Inc., K-Y® Brand Warming Liquid™ Personal Lubricant manufactured by Personal Products Company, Division of McNeil-PPC, Inc., Skillman, NJ, and Astroglide® Warming Liquid manufactured by Biofilm, Inc

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Substantial Equivalence

FDS Intimate Lubricant and FDS Warming Lubricant have been shown, in laboratory tests, to be substantially equivalent to the currently marketed to K-Y® Brand ULTRAgel™MC Personal Lubricant manufactured by Personal Products Company, Division of McNeil-PPC, Inc., Skillman, NJ, Astroglide® Brand Personal Lubricant manufactured by Biofilm, Inc., K-Y® Brand Warming Liquid™ Personal Lubricant manufactured by Personal Products Company, Division of McNeil-PPC, Inc., Skillman, NJ, and Astroglide® Warming Liquid manufactured by Biofilm, Inc.

Both devices have the same intended use with a minor variation in formula ingredients. The gentle warming technology is the special feature of the FDS Warming Lubricant product.

Summary of Performance Data:

Preclinical Testing of Formulation:

Biocompatibility safety studies according to International Standard ISO 10993 and General Program Memorandum G95-1 on FDS Intimate Lubricant and FDS Warming Lubricant were conducted by an outside laboratory, in compliance with Good Laboratory Practices (GLPs). Results from these studies demonstrated that FDS Intimate Lubricant and FDS Warming Lubricant were not considered to be contact sensitizing agents, nor were they associated with systemic toxicity.

Compatibility Testing of FDS Personal Lubricant with Latex Condoms

Using ASTM Method D3492: lubricated and Non-lubricated latex condoms are exposed to the test substance for prescribed time periods and conditions. After exposure, condoms undergo strength and leakage tests to determine the effect of exposure on the physical integrity using water treated control condoms as comparators. A predicate substance. KY Jelly, is also tested for comparative purposes.

Acute Vaginal Mucosal Irritation Assay using the SkinEthic In-Vitro Reconstituted Human Vaginal Epithelial Tissue Model The test products were evaluated for their capacity to induce cytopathic effects on the SkinEthic in vitro reconstituted human vaginal enithelial tissue model .After topical application of the product onto reconstituted vaginal mucosa, cultures were incubated at 37°C, 5% CO2 for 10 minutes, 1 hour, 3 hours and 24 hours.

Cell viability was assessed by the MTT assay for each time point, on duplicate cultures: FDS Intimate Warming Lubricant induced a decrease of cell viability after 24 hours of contact: histology analysis showed histological alterations already after 10 minutes of contact. FDS Intimate Lubricant did not have any significant effect on cell viability and on tissue morphology.

Acute Eve Irritation Assay Using Reconstituted Human Corneal Epithelial Tissue

The test products were evaluated for their capacity to induce cytopathic effects on human corneal epithelium reconstituted by in vitro cell culture. After topical application of each

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product onto human corneal epithelium, cultures were incubated at 37°C, 5% CO2 for 10 minut4es, 1 hour, 3 hours and 24 hours. Cell viability was assessed by MTT assay for each time point, on duplicate cultures, according to the viability test (qualitative results). FDS Intimate Lubricant Warming was found to be very slightly irritant, and the FDS Intimate Lubricant a non-irritant. FDS Intimate Lubricant Warming inducted histological alterations already after 10 minutes of contact. The FDS Intimate Lubricant did not have any significant effect on tissue morphology.

Human Clinical Testing

A) In a Human Repeated Insult Patch Test, this product was compared to the currently marketed K-Y® Brand Warming Liquid 101 Personal Lubricant for its potential for contact sensitization. Under the conditions of this test no evidence of contact sensitization was elicited.

B) An In-Home Consumer Use Study was conducted by an independent market research firm to determine how well the FDS Lubricant delivers against expectation set by the packaging language. Statistical analysis and interpretation of the test results were made relative to the targeted performance claims:

"Non-Messy. Convenient Pump!" "Warming Intimate Lubricant" "Warms on Contact" "For Enhanced Intimacy and Pleasure" "Fragrance Free" "Gentle, Long-Lasting Formula"

Preclinical and Clinical testing have provided scientific evidence that this device is as safe, as effective, and performs as well as or better than the predicate device.

Study Characteristics

N/A

Identifying Numbers of all applicable IDE's, NDA's, IND's, PMA's, PDP's or 510(k)'s previously submitted by the applicant for this device

None

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

APR 1 4 2006

Mr. Rick Main Senior Manager Global Regulatory Affairs Alberto Culver Company 2525 Armitage Avenue MELROSE PARK IL 60160-1163

Re: K060145

Trade/Device Name: FDS Intimate Lubricant, FDS Intimate Warming Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 19, 2006 Received: January 19, 2006

Dear Mr. Main:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/4/Picture/10 description: The image is a circular seal or logo. The central element is the letters 'FDA' in a stylized font, stacked on top of the word 'Centennial'. Above the letters 'FDA' are the years '1906 - 2006'. Below the word 'Centennial' are three stars arranged horizontally. The entire design is encircled by text, which appears to be part of the organization's name or a commemorative phrase.

Protesting and Promoting Public Health

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology) 240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology) 240-276-0115
21 CFR 892.xxxx	(Radiology) 240-276-0120
Other	240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL

SECTION IV

INDICATIONS FOR USE STATEMENT

660145 510 (K) Number (if known)

Device Name:

FDS Intimate Lubricant, FDS Intimate Warming Lubricant

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED Conference of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ OR Over the Counter (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 000014 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.