A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® oil-based Personal Lubricant is not compatible with natural rubber latex, polyurethane or polyisoprene condoms.

A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® water-based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® Vaginal Moisturizer is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

YES® oil-based Personal Lubricant: This non-sterile and oil-based personal lubricant consists primarily of Sunflower oil and Shea butter, and is not compatible with condoms. It is neither a contraceptive nor a spermicide. The formulation is a cream-colored thick paste that melts at body temperature. The product is packaged in a high density polyethylene (HDPE) tube with a flip-top cap.

YES® water-based Personal Lubricant: This non-sterile and water-based personal lubricant contains Aloe vera and other components, and is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is neither a contraceptive nor a spermicide. The formulation is a lightly opaque, non-greasy liquid gel. The product is packaged in a HDPE tube with a flip-top cap, and a HDPE single-use applicator.

YES® Vaginal Moisturizer: This non-sterile and water-based personal lubricant contains Aloe vera and other components, and is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is neither a contraceptive nor a spermicide. The formulation is a lightly opaque, non-greasy liquid gel. The product is packaged in a HDPE tube with a flip-top cap, and a HDPE single-use applicator.

AI/ML Overview

The provided document is a 510(k) premarket notification for personal lubricants. It does not contain information about a study proving a device meets acceptance criteria in the manner requested (e.g., involving AI, human experts, or clinical comparative effectiveness). Instead, it details the acceptance criteria in the form of product specifications for three personal lubricant products and briefly mentions performance testing to demonstrate their safety and effectiveness compared to predicate devices.

Therefore, many of the requested fields cannot be directly answered from this document as they are not applicable to the type of device and study described. However, I can extract the acceptance criteria (product specifications) and the performance testing mentioned for the device.

1. Table of Acceptance Criteria and the Reported Device Performance

The document provides product specifications for each lubricant, which serve as the acceptance criteria. The "Reported Device Performance" refers to the results of the performance testing.

YES® oil-based Personal Lubricant

Parameter	Acceptance Criteria (Specification)	Reported Device Performance
Color	Opaque paste	Met (implied by "met all device specifications")
Odor	Slight beeswax and/or cocoa odor	Met (implied by "met all device specifications")
Viscosity	N/A (not feasible to measure)	N/A
Total yeast/mold count	<10 cfu/g (USP<61>)	Met (implied by "met all device specifications")
Total aerobic mesophilic count	<100 cfu/g (USP<61>)	Met (implied by "met all device specifications")
Absence of Pathogenic bacteria (Staphylococcus aureus, Candida albicans, gram negative bacteria e.g., Pseudomonas aeruginosa)	Absent in 1g (USP<62>)	Met (implied by "met all device specifications")
Biocompatibility (Cytotoxicity)	Non-cytotoxic (ISO 10993-5:2009(R)2014)	Non-cytotoxic
Biocompatibility (Vaginal Irritation)	Non-irritating (ISO 10993-10:2010(R)2014)	Non-irritating
Biocompatibility (Sensitization)	Non-sensitizing (ISO 10993-10:2010(R)2014)	Non-sensitizing
Biocompatibility (Acute Systemic Toxicity)	Non-systemically toxic (ISO 10993-11:2006)	Non-systemically toxic
Condom Compatibility (Polyurethane)	Not compatible per ASTM D7661-10	Not compatible with polyurethane condoms
Condom Compatibility (Natural rubber latex, Polyisoprene)	Not compatible (testing not performed)	Not compatible with natural rubber latex or polyisoprene condoms
Shelf Life	9 months, met all device specifications	Met all device specifications for 9 months

YES® water-based Personal Lubricant

Parameter	Acceptance Criteria (Specification)	Reported Device Performance
Color	Opaque gel	Met (implied by "met all device specifications")
Odor	Slight-mild, delicate linseed / leather note	Met (implied by "met all device specifications")
Viscosity	2,000 - 20,000 cP	Met (implied by "met all device specifications")
pH	3.70 - 4.50	Met (implied by "met all device specifications")
Osmolality	100 - 400 mOsm/kg	Met (implied by "met all device specifications")
Antimicrobial Effectiveness	At least 2.0 log reduction at 14 days; no increase from 14 days at 28 days; no increase from initial calculated count at 14 and 28 days (USP <51>)	Met (implied by "met all device specifications")
Total yeast/mold count	<10 cfu/g (USP<61>)	Met (implied by "met all device specifications")
Total aerobic mesophilic count	<100 cfu/g (USP<61>)	Met (implied by "met all device specifications")
Absence of Pathogenic bacteria (Staphylococcus aureus, Candida albicans, gram negative bacteria e.g., Pseudomonas aeruginosa)	Absent in 1g (USP<62>)	Met (implied by "met all device specifications")
Biocompatibility (Cytotoxicity)	Non-cytotoxic (ISO 10993-5:2009(R)2014)	Non-cytotoxic
Biocompatibility (Vaginal Irritation)	Non-irritating (ISO 10993-10:2010(R)2014)	Non-irritating
Biocompatibility (Sensitization)	Non-sensitizing (ISO 10993-10:2010(R)2014)	Non-sensitizing
Biocompatibility (Acute Systemic Toxicity)	Non-systemically toxic (ISO 10993-11:2006)	Non-systemically toxic
Condom Compatibility (Natural rubber latex, Polyisoprene)	Compatible per ASTM D7661-10	Compatible with natural rubber latex and polyisoprene condoms
Condom Compatibility (Polyurethane)	Not compatible per ASTM D7661-10	Not compatible with polyurethane condoms
Shelf Life	9 months, met all device specifications	Met all device specifications for 9 months

YES® Vaginal Moisturizer

Parameter	Acceptance Criteria (Specification)	Reported Device Performance
Color	Opaque gel	Met (implied by "met all device specifications")
Odor	Slight-mild, delicate linseed / leather	Met (implied by "met all device specifications")
Viscosity	2,000 - 20,000 cP	Met (implied by "met all device specifications")
pH	3.50 - 4.50	Met (implied by "met all device specifications")
Osmolality	250 - 400 mOsm/kg	Met (implied by "met all device specifications")
Antimicrobial Effectiveness	At least 2.0 log reduction at 14 days; no increase from 14 days at 28 days; no increase from initial calculated count at 14 and 28 days (USP <51>)	Met (implied by "met all device specifications")
Total yeast/mold count	<10 cfu/g (USP<61>)	Met (implied by "met all device specifications")
Total aerobic mesophilic count	<100 cfu/g (USP<61>)	Met (implied by "met all device specifications")
Absence of Pathogenic bacteria (Staphylococcus aureus, Candida albicans, gram negative bacteria e.g., Pseudomonas aeruginosa)	Absent in 1g (USP<62>)	Met (implied by "met all device specifications")
Biocompatibility (Cytotoxicity)	Non-cytotoxic (ISO 10993-5:2009(R)2014)	Non-cytotoxic
Biocompatibility (Vaginal Irritation)	Non-irritating (ISO 10993-10:2010(R)2014)	Non-irritating
Biocompatibility (Sensitization)	Non-sensitizing (ISO 10993-10:2010(R)2014)	Non-sensitizing
Biocompatibility (Acute Systemic Toxicity)	Non-systemically toxic (ISO 10993-11:2006)	Non-systemically toxic
Condom Compatibility (Natural rubber latex, Polyisoprene)	Compatible per ASTM D7661-10	Compatible with natural rubber latex and polyisoprene condoms
Condom Compatibility (Polyurethane)	Not compatible per ASTM D7661-10	Not compatible with polyurethane condoms
Shelf Life	9 months, met all device specifications	Met all device specifications for 9 months

Regarding the Study Information:

The document describes performance testing rather than a "study" in the sense of clinical trials or AI model validation. The testing focused on biocompatibility, condom compatibility, and shelf-life/microbial limits.

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

Sample Size: Not specified in the document for any of the tests.
Data Provenance: Not specified, but implied to be laboratory testing conducted by Biotech Lubricants Ltd. or its contracted labs. This would be considered prospective experimental testing.

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

Number of experts: Not applicable. The "ground truth" for these tests are physical/chemical measurements and biological responses from laboratory assays, not expert consensus on medical images or diagnoses.
Qualifications of experts: Not applicable.

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

Not applicable. This is not a study requiring adjudication of expert opinions.

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 is not an MRMC comparative effectiveness study, nor does it involve AI.

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

No, this is not an algorithm, but a physical device (lubricant). Performance testing was conducted on the product itself.

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

The "ground truth" for the performance testing cited standard methodologies and specifications. For example:
- Biocompatibility: ISO 10993 series standards.
- Condom Compatibility: ASTM D7661-10.
- Microbial Limits: USP <61> and USP <62>.
- Antimicrobial Effectiveness: USP <51>.
- These standards define the methods and criteria for evaluating the safety parameters of the device.

8. The sample size for the training set:

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

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

Not applicable. There is no training set or AI model.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

June 9, 2017

Biotech Lubricants Ltd % Karen Cornelius Senior Associate Maetrics BioCity Nottingham, Pennyfoot Street Nottingham, NG1 1GF United Kingdom

K162569 Re:

Trade/Device Name: YES® oil-based Personal Lubricant, YES® water-based Personal Lubricant, YES® Vaginal Moisturizer Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 9, 2017 Received: May 11, 2017

Dear Karen Cornelius:

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.

{1}------------------------------------------------

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 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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162569

Device Name

YES® oil-based Personal Lubricant, YES® water-based Personal Lubricant, YES® Vaginal Moisturizer

Indications for Use (Describe) Device Name: YES® oil-based Personal Lubricant

Indications for Use:

Device Name: YES® water-based Personal Lubricant

Indications for Use:

A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® water-based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Name: YES® Vaginal Moisturizer

Indications for Use:

A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® Vaginal Moisturizer is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.

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

| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter:	Biotech Lubricants LimitedRamshillPetersfieldGU31 4ATUnited KingdomPhone: +44 (0) 3450 94 11 41Email: sarah@biotechlubricants.com
Official Correspondent:	Karen CorneliusMaetricsBioCity Nottingham, Pennyfoot StreetNottingham, NG1 1GFUnited KingdomPhone: +44 (115) 921 6200Email: kcornelius@maetrics.com
Date Prepared:	June 9, 2017
Device Proprietary Names:	YES® oil-based Personal LubricantYES® water-based Personal LubricantYES® Vaginal Moisturizer
Device Common Name:	Personal Lubricant
Classification:	Condom (21 CFR 884.5300)
Regulatory Class:	II
Product Code:	NUC (lubricant, personal)
Predicate Device:	K124044 Aloe Cadabra Personal Lubricant (Seven Oaks Ranch, Inc.)K122477 Lifestyles Luxe Premium Personal Lubricant (Ansell Healthcare Products LLC)

The predicate devices have not been subject to a design-related recall.

Device Description:

Parameter	Specification
Color	Opaque paste
Odor	Slight beeswax and/or cocoa odor
Viscosity	N/A: measuring viscosity is not feasible, since changes in phase during measurement lead to differences in viscosity readings
Total yeast/mold count	<10 cfu/g (USP<61>)
Total aerobic mesophilic count	<100 cfu/g (USP<61>)
Absence of Pathogenic bacteria:Staphylococcus aureus, Candida	Absent in 1g (USP<62>)

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albicans, and gram negative bacteria
(e.g., Pseudomonas aeruginosa)

Parameter	Specification
Color	Opaque gel
Odor	Slight-mild, delicate linseed / leather note
Viscosity	2,000 - 20,000 cP
pH	3.70 - 4.50
Osmolality	100 - 400 mOsm/kg
Antimicrobial Effectiveness	At least 2.0 log reduction from the initial count at 14 days; no increase from the 14 days count at 28 days; no increase from the initial calculated count at 14 and 28 days (USP <51>)
Total yeast/mold count	<10 cfu/g (USP<61>)
Total aerobic mesophilic count	<100 cfu/g (USP<61>)
Absence of Pathogenic bacteria:Staphylococcus aureus, Candida albicans, and gram negative bacteria (e.g., Pseudomonas aeruginosa)	Absent in 1g (USP<62>)

Parameter	Specification
Color	Opaque gel
Odor	Slight-mild, delicate linseed / leather
Viscosity	2,000 – 20,000 cP
pH	3.50–4.50
Osmolality	250-400 mOsm/kg
Antimicrobial Effectiveness	At least 2.0 log reduction from the initial count at 14 days; no increase from the 14 days count at 28 days; no increase from the initial calculated count at 14 and 28 days (USP <51>)
Total yeast/mold count	<10 cfu/g (USP<61>)
Total aerobic mesophilic count	<100 cfu/g (USP<61>)
Absence of Pathogenic bacteria:	Absent in 1g (USP<62>)

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Staphylococcus aureus, Candidaalbicans, and gram negativebacteria (e.g., Pseudomonasaeruginosa)
-------------------------------------------------------------------------------------------------------------	--

Indications for Use:

YES® oil-based Personal Lubricant: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® oil-based Personal Lubricant is not compatible with natural rubber latex, polyurethane or polyisoprene condoms.

YES® water-based Personal Lubricant: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® water-based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

YES® Vaginal Moisturizer: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® Vaginal Moisturizer is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms.

	YES® oil-based Personal Lubricant		Comparison
510(k) #	K162569	K122477
Device Name	YES® oil-based personallubricant	LifeStyles Luxe PremiumPersonal Lubricant
Manufacturer	Bio-tech Lubricants Ltd	Ansell Healthcare Products,LLC
Classification	884.5300	884.5300
Product code	NUC	NUC
Description	Personal Lubricant	Personal Lubricant	Same
Indications for use	A personal lubricant, forvaginal and penileapplication, intended tomoisturize and lubricate, toenhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is notcompatible with naturalrubber latex, polyurethaneor polyisoprene condoms.	LifeStyles Luxe PremiumPersonal Lubricant Is apersonal lubricant, for penileand/or vaginal application,intended to moisturize andlubricate, to enhance the easeand comfort of intimatesexual activity andsupplement the body's naturallubrication. This product iscompatible with naturalrubber latex, polyurethane,and polyisoprene condoms.	Different: The subject andpredicate devices indicationfor use statements differ inregards to compatibilitywith condoms. Differencesnoted do not represent anew intended use.
Oil-based lubricant	YES	YES	Same: the subject andpredicate devices are bothoil-based lubricants;however, the specific oils inthe formulation are

Comparison of Intended Use and Technological Characteristics of Subject and Predicate Devices:

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YES® oil-based Personal Lubricant	Comparison
Ingredients	Sunflower seed oil, Sheabutter, Sweet almond oil,Bees wax, Cocoa seedbutter, Vitamin E	Not known	Different: The difference iningredients do not raisedifferent questions of S &E.
Biocompatible	YES	YES	Same
Non-sterile	YES	YES	Same
Containspreservatives	NO	NO	Same
Microbial limits(TAMC, TYMC, andabsence ofpathogenic bacteria)	See product specificationstable(USP <61> & <62>)	Meets the requirements ofUSP <61> & <62>	Different: the microbiallimits of the predicate arenot known; however thisdoes not raise differentquestions of S & E as themicrobial limitsspecifications are within theaccepted ranges for thesetypes of devices.
CondomCompatibility	Not compatible with naturalrubber latex, polyurethane,or polyisoprene condoms.	Compatible with naturalrubber latex, polyurethane,and polyisoprene condoms.	Different: The condomcompatibility for the subjectand predicate devices aredifferent; However, thisdifference does notrepresent a new intendeduse.

As noted in the table above the subject and predicate devices indications are similar in that they are both used to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. However, they do differ in regards to condom compatibility as the subject device is not compatible with condoms, while the predicate is condom compatible. Differences in condom compatibility between the subject and predicate devices do not represent a new intended use. In regards to technology, the subject and predicate devices are similar in that they are both non-sterile and are oil-based. Differences do exist as described in the table above (e.g., product formulations, specifications for microbial limits, condom compatibility, etc.). The differences identified do not raise different questions of safety and effectiveness as discussed in the table above

YES® water-based Personal Lubricant	Comparison
510(k) #	K162569	K124044
Device name	YES® water-basedPersonal Lubricant	Aloe Cadabra Personallubricant
Manufacturer	Bio-tech Lubricants Ltd	Seven Oaks Ranch, Inc.
Classification	884.5300	884.5300
Product code	NUC	NUC
Description	Personal Lubricant	Personal Lubricant	Same
Indications for use	A personal lubricant, forvaginal and penileapplication, intended tomoisturize and lubricate, to	Aloe Cadabra Lubricant andAloe CadabraFlavored/Scented Lubricantsare personal lubricants for	Same: The subject andpredicate devices have thesame indication for use,and therefore have the.
	YES® water-based Personal Lubricant		Comparison
Water-basedlubricant	enhance the ease andcomfort of intimate sexualactivity and supplementthe body's naturallubrication. YES® water-based Personal Lubricantis compatible with naturalrubber latex andpolyisoprene condoms.This product is notcompatible withpolyurethane condoms.	penile and/or vaginalapplication, intended tomoisturize and lubricate, toenhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is compatiblewith natural rubber latex andpolyisoprene condoms. Thisproduct is not compatiblewith polyurethane condoms.	same intended use.
Ingredients	Water, Aloe vera, Flaxseed extract, Guar gum,Locust bean gum, Xanthangum, Sodium chloride,Potassium sorbate, Citricacid, Phenoxyethanol	Aloe vera	Different: The differencein ingredients do not raisedifferent questions of S &E.
Biocompatible	YES	YES	Same
Non-sterile	YES	YES	Same
Containspreservatives	YES	YES	Same
Microbial limits(TAMC, TYMC,and absence ofpathogenicbacteria)	See product specificationstable(USP <61> & <62>)	Not known	Different: the microbiallimits of the predicate arenot known; however thisdoes not raise differentquestions of S & E as thesespecifications are withinthe accepted range forthese types of devices.
Viscosity	2,000 - 20,000 cP	Not known	Different: the viscosity ofthe predicate is not known.This does not raisedifferent questions of S &E as the viscosityspecification is within theaccepted range for thesetypes of devices.
pH	3.70 - 4.50	Not known	Different: the pH of thepredicate is not known.This does not raisedifferent questions of S &E as the pH specification iswithin the accepted rangefor these types of devices.
Osmolality	100 - 400 mOsm/kg	Not known	Different: the osmolality ofthe predicate is not known.This does not raisedifferent questions of S &E as the osmolalityspecification is within theaccepted range for thesetypes of devices.
	YES® water-based Personal Lubricant		Comparison
CondomCompatibility	Compatible with naturalrubber latex andpolyisoprene condoms.Not compatible withpolyurethane condoms.	Compatible with naturalrubber latex andpolyisoprene condoms. Notcompatible withpolyurethane condoms.	Same

{7}------------------------------------------------

{8}------------------------------------------------

As noted in the table above the subject and predicate devices have indication for use and intended use. In addition, the subject and predicate devices are similar in that they are both non-sterile, compatible with the same types of contain Aloe vera, and are water-based. Differences do exist as described in the table above (e.g., product formulations, specifications for microbial limits, viscosity, etc.). The differences identified do not raise different questions of safety and effectiveness as discussed in the table above.

YES® Vaginal Moisturizer		Comparison
510(k) #	K162569	K124044
Device Name	YES® VM (VaginalMoisturizer)	Aloe Cadabra Personallubricant
Manufacturer	Bio-tech Lubricants Ltd	Seven Oaks Ranch, Inc.
Classification	884.5300	884.5300
Product code	NUC	NUC
Description	Personal Lubricant	Personal Lubricant	Same
Indications for use	A personal lubricant, forvaginal and penileapplication, intended tomoisturize and lubricate, toenhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.YES® Vaginal Moisturizeris compatible with naturalrubber latex andpolyisoprene condoms. Thisproduct is not compatiblewith polyurethane condoms.	Aloe Cadabra Lubricant andAloe CadabraFlavored/Scented Lubricantsare personal lubricants forpenile and/or vaginalapplication, intended tomoisturize and lubricate, toenhance the ease and comfortof intimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with naturalrubber latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms.	Same: The subject andpredicate devices have thesame indication for use, andtherefore have the sameintended use.
Water-basedlubricant	YES	YES	Same
Ingredients	Water, Aloe vera, Flax seedextract, Guar gum, Locustbean gum, Xanthan gum,Sodium chloride, Potassiumsorbate, Citric acid,Phenoxyethanol	Aloe vera	Different: The difference iningredients do not raisedifferent questions of S & E
Biocompatible	YES	YES	Same
Non-sterile	YES	YES	Same
Containspreservatives	YES	YES	Same
Microbial Limits	See product specifications	Not known	Different: the microbial

{9}------------------------------------------------

	YES® Vaginal Moisturizer		Comparison
(TAMC, TYMC, andabsence ofpathogenic bacteria)	table(USP <61> & <62>)		limits of the predicate arenot known; however thisdoes not raise differentquestions of S & E as thesespecifications are within theaccepted range for thesetypes of devices.
Viscosity	2,000 - 20,000 cP	Not known	Different: the viscosity ofthe predicate is not known.This does not raise differentquestions of S & E as theviscosity specification iswithin the accepted rangefor these types of devices
pH	3.50-4.50	Not known	Different: the pH of thepredicate is not known. Thisdoes not raise differentquestions of S & E as the pHspecification is within theaccepted range for thesetypes of devices.
Osmolality	250-400 mOsm/kg	Not known	Different: the osmolality ofthe predicate is not known.This does not raise differentquestions of S & E as theosmolality specification iswithin the accepted rangefor these types of devices.
CondomCompatibility	Compatible with naturalrubber latex andpolyisoprene condoms. Notcompatible withpolyurethane condoms.	Compatible with naturalrubber latex and polyisoprenecondoms. Not compatiblewith polyurethane condoms.	Same

As noted in the table above the subject and predicate devices have the same indication for use and intended use. In addition, the subject and predicate devices are similar in that they are both non-sterile, compatible with the same types of contain Aloe vera, and are water-based. Differences do exist as described in the table above (e.g., product formulations, specifications for microbial limits, viscosity, etc.). The differences identified do not raise different questions of safety and effectiveness as discussed in the table above.

Performance Testing:

Biocompatibility:

Testing was conducted to assess the biocompatibility of the YES® oil-based Personal Lubricant, YES® water-based Personal Lubricant and YES® Vaginal Moisturizer. Testing included assessments for Cytotoxicity (ISO 10993-5:2009(R)2014), Vaginal Irritation (ISO 10993-10:2010(R)2014), Sensitization (ISO 10993-10:2010(R)2014), and Acute Systemic Toxicity (ISO 10993-11:2006).

The results of testing demonstrated that they are non-cytotoxic, non-irritating, non-sensitizing and nonsystemically toxic.

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Condom Compatibility:

YES® oil-based Personal Lubricant: Condom compatibility testing was performed for polyurethane condoms per ASTM D7661-10. The results indicate that the device is not compatible with polyurethane condoms. Additionally, compatibility testing was not performed for natural rubber latex or polyisoprene condoms; therefore, the device is not compatible with natural rubber latex or polyisoprene condoms.

YES® Vaginal Moisturizer and YES® water-based Personal Lubricant: Condom compatibility testing was performed per ASTM D7661-10. The results indicated that the devices are compatible with natural rubber latex and polyisoprene condoms, but are not compatible with polyurethane condoms.

Shelf Life and Microbial Limits:

YES® oil-based Personal Lubricant, YES® water-based Personal Lubricant, and YES® Vaginal Moisturizer have a 9-month shelf life. The results of shelf-life testing demonstrated that the subject lubricants met all device specifications as shown in the Device Description section for the duration of the 9-month shelf-life.

Conclusion:

YES® oil-based Personal Lubricant, YES® water-based Personal Lubricant, and YES® Vaginal Moisturizer have the same intended use and similar technological characteristics as the predicate devices. The results of the performance testing conducted on the subject demonstrate that they are as safe and effective as the predicate devices and support substantial equivalence.

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.