Poise Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex condoms but is compatible with polyisoprene and polyurethane condoms.

Device Description

Poise Personal Lubricant is a water soluble, clear, colorless, viscous liquid composed of purified water, hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid and sodium hydroxide. Poise Personal Lubricant is presented as a non-sterile product. It is neither a contraceptive nor a spermicide and is sold over-the-counter. The product is packaged in a seventy-four ml plastic, cylindrical pump bottle placed inside a display carton. The outside of the display carton contains a tamper evident seal. Poise Personal Lubricant is a non-greasy and fragrance-free formulation which contains only United States Pharmacopeia (USP) or National Formulary (NF) ingredients.

AI/ML Overview

The Kimberly-Clark Poise® Personal Lubricant is not an AI/ML device, and therefore, the requested information regarding AI/ML acceptance criteria and studies is not applicable.

The provided documentation describes the traditional 510(k) submission process for a medical device (personal lubricant) and focuses on demonstrating substantial equivalence to a predicate device (Durex® Play™ Lubricant). The "acceptance criteria" discussed in this context are related to the safety and effectiveness of the lubricant itself, as proven by various non-clinical laboratory tests.

Here's an overview of the "acceptance criteria" and how the device met them, based on the provided text, adapted to the closest relevant information:

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

Acceptance Criteria (Endpoint of Toxicological Concern)	Study Type	Reported Device Performance (Result)
Cytotoxicity	In Vitro Cytotoxicity	Non-cytotoxic
Sensitization	In Vivo - Guinea Pig Maximization Assay	Non-sensitizing
Vaginal Irritation	Rabbit Vaginal Irritation	Non-irritating
Subacute Toxicity	Two week, Rabbit Vaginal Exposure	Non-systemically toxic
Genotoxicity	In vitro Bacterial Reverse Mutation	Non-genotoxic
Genotoxicity	In vitro Chromosome Aberration	Non-genotoxic
Genotoxicity	In Vivo Mouse Micronucleus	Non-genotoxic
Ocular Irritation	In Vitro, 3D Cell Culture (EpiOcular)	Non-irritating
Microbial Limits	Microbial Limits Test (USP <61> and <62>)	Met specification (≤ 100 cfu/ml)
Oral Toxicity	Oral Toxicity Assessment	Non-Toxic

Note: The cytotoxicity result shows "Non-cytotoxic ≤ 3.13%". The document clarifies that while propylene glycol has moderate cytotoxic potential in vitro, cytotoxicity is not demonstrated in vivo for the lubricant.

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

The document does not specify human "test sets" or "data provenance" in the context of clinical trials as it pertains to AI/ML devices. The studies conducted are non-clinical (laboratory and animal studies).

For Cytotoxicity (In Vitro): Not specified (cell culture).
For Sensitization (In Vivo): Guinea Pig Maximization Assay. Sample size not specified.
For Vaginal Irritation (Rabbit): Rabbit Vaginal Irritation study. Sample size not specified.
For Subacute Toxicity (Rabbit): Two-week Rabbit Vaginal Exposure. Sample size not specified.
For Genotoxicity (In Vitro): Bacterial Reverse Mutation, Chromosome Aberration. Sample sizes not specified (cell culture).
For Genotoxicity (In Vivo): Mouse Micronucleus. Sample size not specified.
For Ocular Irritation (In Vitro): 3D Cell Culture (EpiOcular). Sample size not specified (cell culture).
For Microbial Limits Test: Three process validation lots were used.
For Oral Toxicity Assessment: Based on individual component assessment, not a direct animal or human study for the final product in this context.

All these studies represent preclinical data. The "country of origin" is not specified, but these are standard international laboratory tests.

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

This information is not applicable as there is no "test set" requiring expert ground truth in the context of an AI/ML device. The "ground truth" for the non-clinical studies is established by the results of the specific biological or chemical assays performed in a laboratory setting, following recognized standards (e.g., ISO, OECD, USP).

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

Not applicable. There is no "test set" and no human expert adjudication as would be relevant for an AI/ML device.

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 not an AI device.

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

Not applicable. This is not an AI device.

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

The "ground truth" for the performance of the personal lubricant is based on:

Biological/Chemical Assay Results: For biocompatibility endpoints (e.g., cytotoxicity, sensitization, irritation, genotoxicity, oral toxicity). These are determined by the specific methodologies of the laboratory tests referenced (e.g., ISO 10993 series, OECD guidelines, MatTek EpiOcular MTT Viability Assay).
Microbial Testing Standards: For microbial limits, ground truth is established by meeting predefined USP <61> and <62> criteria (≤ 100 cfu/ml and no objectionable organisms).
Physical/Chemical Property Measurements: For characteristics like pH, viscosity, specific gravity, osmolality, and long-lasting lubricity (coefficient of friction). These are measured and compared to the predicate device and established specifications.
Condom Compatibility Testing Standards: ASTM-D7661-10 was used to determine compatibility with different condom materials.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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දිගු Kimberly-Clark Corporation

K120650

Traditional 510(k) for Kimberly-Clark Poise® Personal Lubricant

JUL 1 1 2012

Section 5. 510(K) Summary

Summary of Safety and Effectiveness Information

Submitter's Name:	Kimberly-Clark Corporation
Submitter's Address:	2100 Winchester RoadNeenah, WI 54956Mailing address for regulatory correspondence:1400 Holcomb Bridge RoadRoswell, GA 30076-2199Contact Person: Swarna Mukund Ph. D.
Submitter's Phone No:	770-587-8083
Submitter's Fax No.	920-225-3632
Date of Preparation:	February 29, 2012
Trade Name:	Poise® Personal Lubricant
Device Common Name:	Personal Lubricant
Classification Name:	Condom
Classification Product Code:	NUC (Lubricant, Vaginal, Patient, Latex Compatible)
Regulation Number:	21CFR884.5300
Regulatory Class:	Class II
Legally marketed device to which equivalency is claimed:	Durex® Play™ Lubricant (K032124) (Marketed as Durex® Play™ More)
Intended Use:	Poise Personal Lubricant is a personal lubricant, for penileand/or vaginal application, intended to moisturize and lubricate,enhance the ease and comfort of intimate sexual activity andsupplement the body's natural lubrication. This product is notcompatible with natural rubber latex condoms but is compatiblewith polyisoprene and polyurethane condoms.

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Kimberly-Clark Corporation

Traditional 510(k) for Kimberly-Clark Poise® Personal Lubricant

Description of the device:

Summary of technological characteristics compared to the predicate device:

Poise Personal Lubricant has been shown to be substantially equivalent to the predicate device Durex Play More in terms of technological characteristics such as being water-based and non-sterile, color/appearance/odor, pH, viscosity, specific gravity, osmolality and longlasting lubricity measured as coefficient of friction. Poise Personal Lubricant and Durex Play More contain identical formulation components. Stability studies conducted in accordance with ICH Q1a and Consumer Health Products Association (CHPA) stability guidelines confirm a shelf life of two years for the Poise Personal Lubricant product; the same as that for the predicate device, Durex Play More.

Durex Play More is labeled as condom compatible whereas the label for Poise Personal Lubricant says that the product is not compatible with natural rubber latex condoms but is compatible with polyisoprene and polyurethane condoms in condom compatibility testing conducted according to the standards defined by ASTM-D7661-10. No new questions of safety or effectiveness are presented.

Based on the comparisons above, nonclinical performance data, biocompatibility review and testing and safety data, we conclude that Poise Personal Lubricant and Durex Play More are substantially equivalent with regards to the general intended use, safety and efficacy.

Brief description of preclinical toxicology (biocompatibility) tests:

Table 5-1 provides the biocompatibility tests conducted and the results obtained for Poise Personal Lubricant.

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23 Kimberly-Clark Corporation

| 20650

Traditional 510(k) for Kimberly-Clark Poise® Personal Lubricant

Biocompatibility Test Results of Poise Personal Lubricant Table 5-1:

Endpoint ofToxicologicalConcern	Study Type	Reference	Result
Cytotoxicity	In Vitro Cytotoxicity	10993-05	*Non-cytotoxic$≤$ 3.13%
Sensitization	In Vivo - Guinea Pig MaximizationAssay	10993-10	Non-sensitizing
Vaginal Irritation	Rabbit Vaginal Irritation	10993-10	Non-irritating
Subacute Toxicity	Two week, Rabbit Vaginal Exposure	10993-11	Non-systemicallytoxic
Genotoxicity	In vitro Bacterial Reverse Mutation	10993-03,OECD 471	Non-genotoxic
	In vitro Chromosome Aberration	10993-03,OECD 473	Non-genotoxic
	In Vivo Mouse Micronucleus	10993-03,OECD 474	Non-genotoxic
Ocular Irritation	In Vitro, 3D Cell Culture (EpiOcular)	MatTekEpiOcular MTTViability Assay	Non-irritating

*This formulation contains Propylene Glycol which in vitro has a moderate cytotoxic potential. Cytotoxicity is not demonstrated in vivo for propylene glycol or for Poise Personal Lubricant.

Oral Toxicity Assessment: The components of the Poise Personal Lubricant formulation have been individually assessed for oral toxicity. These components are Generally Recognized as safe (GRAS) with use levels significantly less than accepted ingestible amounts. Hence, the lubricant product is assessed as Non-Toxic with regards to oral toxicity.

Preclinical Microbiological Testing:

Microbial Limits Test was conducted on three process validation lots as per USP <61> and <62>. The product release specification for this test is ≤ 100 cfu (colony forming unit)/ml and no objectionable organisms to meet lot acceptance criteria. It was found that all three process validation lots met the specification for microbial limits testing by meeting the USP criteria.

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K120650

Traditional 510(k) for Kimberly-Clark Poise® Personal Lubricant

Safety and Effectiveness Assessment:

The subject 510(k) device has undergone extensive biocompatibility, microbiological, stability, and nonclinical laboratory performance testing as described above and in subsequent sections. The results of these studies support the conclusion that the subject 510(k) device is equivalent and as safe and effective as the predicate device, Durex Play More.

Conclusions:

Based on the results of biocompatibility testing and nonclinical performance testing, Poise Personal Lubricant is safe for its intended use and is substantially equivalent to the predicate device, Durex Play More, in terms of general intended use, safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Swarna Mukund, Ph.D. Regulatory Affairs Technical Leader Kimberly-Clark Corporation 1400 Holcomb Bridge Road ROSWELL GA 30076

JUL 1 1 2012

Re: K120650

Trade/Device Name: Kimberly-Clark* Poise® Personal Lubricant Regulation Number: 21 CFR$ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: July 2, 2012 Received: July 3, 2012

Dear Dr. Mukund:

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 I ou may , and so visions 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-relation adverse events) (21 CER Part 820); and if applicable, the electronic forth in the quant) 2500 m (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 11 10 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 I ou may 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Tucker

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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(Kimberly-Clark Corporation

INDICATIONS FOR USE

Applicant:	Kimberly-Clark Corporation
510(k) Number:	K120650
Device Name:	Kimberly-Clark* Poise® Personal Lubricant
Indications for use:	Poise Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex condoms but is compatible with polyisoprene and polyurethane condoms.

Prescription Use Per 21CFR 801.109 Subpart D Over-The-Counter X Per 21CFR 801.109 Subpart C

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Hels Rumer

on Sidn-C of Reproductive, Gastro-Renal, and 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.