Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are personal lubricants 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. The products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Device Description

Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are non-sterile, water-based personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.

Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are sold as over-the-counter (OTC) products in tube packaging made of low-density polythethylene (outer layer), ethylene vinyl alcohol copolymer (middle layer) and low-density polyethylene (inner layer), ranging from 0.34 fl oz to 8 fl oz, depending on formulation.

These products are composed of purified water, propanediol, oat beta glucan, hyaluronic acid, gluconolactone, sodium benzoate, steviol glycosides, and Nelumbo Nucifera (Lotus) Root water. Depending on the formulation, the flavored formulations contain natural vanilla 1.5X flavor extract, organic coconut flavor concentrate, or organic mint flavor concentrate.

AI/ML Overview

This FDA 510(k) summary provides information for a personal lubricant and as such, it does not involve an AI/ML device. Therefore, many of the requested sections regarding AI/ML device evaluation criteria, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "Multi reader multi case (MRMC) comparative effectiveness study," "Standalone (i.e. algorithm only without human-in-the loop performance)," "Type of ground truth," "Sample size for the training set," and "How the ground truth for the training set was established," are not applicable to this document.

However, I can provide the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.

Acceptance Criteria and Device Performance for Sutil Luxe Personal Lubricants

The Sutil Luxe Personal Lubricant devices (Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant) were evaluated against several performance parameters to demonstrate their safety and effectiveness.

1. Table of Acceptance Criteria and the Reported Device Performance

Parameter	Test Method	Acceptance Criteria (Specification)	Reported Device Performance (as implied by "met all device specifications")
Physical/Chemical Properties
Appearance	Visual	Viscous liquid	Viscous liquid (met)
Color	Visual	Clear (Sutil Luxe), Brownish (Vanilla), Off-white (Coconut, Mint)	Met specifications for each formulation.
Odor	Organoleptic	No scent (Sutil Luxe), Vanilla (Vanilla), Coconut (Coconut), Mint (Mint)	Met specifications for each formulation.
pH	USP <791>	4.0-5.0 (for all formulations)	Met specification (implied by "met all device specifications").
Viscosity (cps)	USP <911>	900-5,000 (Sutil Luxe, Mint), 900-8,000 (Vanilla), 900-5,500 (Coconut)	Met specifications for each formulation.
Osmolality (mOsm/kg)	USP <785>	675-825 (Sutil Luxe, at 1:4 dilution), 750-900 (Vanilla, at 1:4 dilution), 725-875 (Coconut, Mint, at 1:4 dilution)	Met specifications for each formulation.
Microbiological Properties
Antimicrobial Effectiveness	USP <51>	Meets USP <51> criteria for category 2: Bacteria: No less than 2.0 log reduction from initial count at 14 days, and no increase from the 14-day count at 28 days. Yeast and Molds: No increase from the initial calculated count at 14 days and 28 days.	Met USP <51> criteria (implied by "met all device specifications").
Total Microbial Count (TAMC)	USP <61>	<100 cfu/g	<100 cfu/g (implied by "met all device specifications").
Fungal/Yeast/Mold Limits (TYMC)	USP <61>	<10 cfu/g	<10 cfu/g (implied by "met all device specifications").
Absence of Pathogenic Organisms	USP <62>	Absent (Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella, Escherichia coli, Clostridium species, Candida albicans)	Pathogenic organisms were absent (implied by "met all device specifications").
Other Performance
Shelf-life	Real-time aging studies	Maintain all device specifications for 2 years.	Demonstrated a 2-year shelf-life, meeting all device specifications across this period.
Biocompatibility	ISO 10993-5:2009 (Cytotoxicity)Human Repeat Insult Patch Test (HRIPT) (Skin Irritation and Sensitization)ISO 10993-11:2017 (Acute Systemic Toxicity)	Non-cytotoxic, non-sensitizing, not systemically toxic.	The lubricants were found to be non-cytotoxic, non-sensitizing, and not systemically toxic.
Condom Compatibility	ASTM D7661-18	Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms.	Determined to be compatible with natural rubber latex and polyisoprene condoms, and not compatible with polyurethane condoms, in accordance with ASTM D7661-18.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many units were tested for viscosity, pH, etc.). However, it refers to "testing on samples" for shelf-life, and general "testing" for other parameters. The data provenance (country of origin, retrospective/prospective) is not specified, but the testing would have been conducted as part of a prospective evaluation for regulatory submission.

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 is a physical/chemical product, not an AI/ML device requiring expert ground truth for image or data interpretation. Performance is measured using standardized laboratory test methods.

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

Not applicable. This is a physical/chemical product, and performance is determined by meeting objective industrial/pharmacopoeial standards, not by human adjudication of interpretations.

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 physical/chemical product, not an AI/ML device.

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

Not applicable. This is a physical/chemical product, not an AI/ML device.

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

The "ground truth" for this device is established by meeting predefined, objective specifications and standards set by pharmacopoeias (USP) and international standards organizations (ISO, ASTM). These are laboratory-derived measurements and tests, not human-interpreted ground truth.

8. The sample size for the training set

Not applicable. This is a physical/chemical product, not an AI/ML device that requires a training set.

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

Not applicable. This is a physical/chemical product, not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 21, 2025

Hathor Professional Skincare Ltd. % Rob Packard President Medical Device Academy, Inc. 345 Lincoln Hill Rd Shrewsbury, Vermont 05738

Re: K241443

Trade/Device Name: Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)

Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Received: December 13, 2024

Dear Rob Packard:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael T. Bailey -S

For Monica Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241443

Device Name

Sutil Luxe Personal Lubricant (models 1126, 0009, 0011); Sutilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 118)

Indications for Use (Describe)

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 (K241443)

1. SUBMITTER

Company Name	Hathor Professional Skincare Ltd.
Address	P.O Box 23027 Cook St R.P.O
City, State, Zip	Victoria BC V8T 3S6 Canada
Tel:	+1.604.732.7772
Contact Person:	Carolyn (Mellta) Swift / Leonard Krause
Date Prepared:	January 17, 2025

II. DEVICE

Device Trade Name / Models:

SUTIL LUXE PERSONAL LUBRICANT (Models 1126, 0009, 0010, 0011) ●
SUTIL LUXE VANILLA PERSONAL LUBRICANT (Models 1119, 1120)
SUTIL LUXE COCONUT PERSONAL LUBRICANT (Models 1121, 1122) ●
SUTIL LUXE MINT PERSONAL LUBRICANT (Models 1117, 1118)

Common Name:	Personal Lubricant
Regulation Name:	Condom
Regulation Number:	21 CFR §884.5300
Regulatory Class:	Class II
Product Code:	NUC (lubricant, personal)

III. PREDICATE DEVICE

Predicate Manufacturer:	Good Clean Love, Inc.
Predicate Trade Name:	Desnuda Reflect
Predicate 510(k):	K211998

The predicate device has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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The device specifications are listed in Table 1 below:

Table 1: Device Specifications for Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant,
Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant

Parameter	Test Method	Specification
		Sutil Luxe	Sutil Luxe Vanilla	Sutil Luxe Coconut	Sutil Luxe Mint
Appearance	Visual	Viscous liquid	Viscous liquid	Viscous liquid	Viscous liquid
Color	Visual	Clear	Brownish	Off-white	Off-white
Odor	Organoleptic	No scent	Vanilla	Coconut	Mint
pH	USP <791>			4.0-5.0
Viscosity (cps)	USP <911>	900-5,000	900-8,000	900-5,500	900-5000
Osmolality(mOsm/kg)	USP<785>	675-825(1:4 dilution)	750-900(1:4 dilution)	725-875(1:4 dilution)	725-875(1:4 dilution)
AntimicrobialEffectiveness	USP <51>	Meets USP <51> criteria for category 2.Bacteria: No less than 2.0 log reduction from initial count at 14 days, and no increase from the 14-day count at 28 days.Yeast and Molds: No increase from the initial calculated count at 14 days and 28 days.
Total MicrobialCount (TAMC)	USP <61>	<100 cfu/g
Fungal/Yeast/Mold Limits(TYMC)	USP <61>	<10 cfu/g
Absence ofPathogenicOrganisms(Pseudomonasaeruginosa,Staphylococcusaureus,Salmonella,Escherichia coli,Clostridiumspecies, Candidaalbicans)	USP <62>	Absent

INDICATIONS FOR USE V.

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VI. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table below compares the intended use and technological characteristics of the subject and predicate devices:

	Subject Devices (K241443)	Predicate Device (K211998)
Indications for Use	Sutil Luxe Personal Lubricant, SutilLuxe Vanilla Personal Lubricant, SutilLuxe Coconut Personal Lubricant, andSutil Luxe Mint Personal Lubricant arepersonal lubricants for penile and/orvaginal application, intended tomoisturize and lubricate, to enhance theease and comfort of intimate sexualactivity and supplement the body'snatural lubrication. The products arecompatible with natural rubber latexand polyisoprene condoms. Theseproducts are not compatible withpolyurethane condoms.	Desnuda Reflect is a personal lubricant,for penile and/or vaginal application,intended to moisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity and supplementthe body's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms.
Rx/OTC	OTC	OTC
Water-based	Yes	Yes
Ingredients	Sutil Luxe - Water, Propanediol,Hyaluronic Acid, Nelumbo NuciferaRoot Water (Lotus Root), Beta-Glucan(Oat), Gluconolactone, SodiumBenzoate.Sutil Luxe Vanilla – Water,Propanediol, Hyaluronic Acid Sodium,Natural Vanilla 1.5X Flavor Extract,Nelumbo Nucifera Root Water (LotusRoot), Beta-Glucan (Oat), SteviolGlycosides, Gluconolactone, SodiumBenzoate.Sutil Luxe Coconut - Water,Propanediol, Organic Coconut FlavorConcentrate, Hyaluronic Acid Sodium,Nelumbo Nucifera Root Water (LotusRoot), Beta-Glucan (Oat), SteviolGlycosides, Gluconolactone, SodiumBenzoate.Sutil Luxe Mint - Water, Propanediol,Organic Mint Flavor Concentrate,Hyaluronic Acid Sodium, NelumboNucifera Root Water (Lotus Root),Beta-Glucan (Oat), Steviol Glycosides,Gluconolactone, Sodium Benzoate.	Water, Hyaluronic Acid,Hydroxyethylcellulose, Xanthan Gum,Zemea Propanediol, Sodium Benzoate,Potassium Sorbate, DL Lactic Acid
Sterile	No	No
Condom Compatibility	Natural Rubber Latex and PolyisopreneCondoms	Natural Rubber Latex and PolyisopreneCondoms
Shelf Life	2 years	1 year

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Tested (appearance, color, odor)
pH Tested	Yes	Yes
Osmolality Tested	Yes	Yes
Biocompatibility Tested	Yes	Yes
Microbiology Tested (absence of pathogenic organisms, TAMC, and TYMC)	Yes	Yes
Antimicrobial Effectiveness Tested	Yes	Yes

The subject and predicate device have the same intended use (i.e., provides lubrication during intimate sexual activity). The subject and predicate device have different technological characteristics, including variations in formulations, specifications, and shelf-life durations. The differences in the technological characteristics of the subject and predicate do not raise different questions of safety and effectiveness.

SUMMARY OF PERFORMANCE DATA VII.

The following performance data were provided in support of the substantial equivalence determination.

Shelf-life Testing

The subject devices have a 2-year shelf-life based on the results of real-time aging. Testing on samples showed that the subject devices met all device specifications listed in Table 1 above across the device shelf-life.

Biocompatibility Testing

Biocompatibility testing was performed in accordance with the 2023 FDA guidance document "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process", as follows:

Cytotoxicity per ISO 10993-5:2009 ●
Skin Irritation and Sensitization Human Repeat Insult Patch Test (HRIPT), an alternative test ● method to ISO 10993-10:2021 and ISO 10993-23:2021
Acute Systemic Toxicity per ISO 10993-11:2017 ●

The results of this testing demonstrate that the subject lubricants are non-cytotoxic, nonsensitizing, and not systemically toxic.

Condom Compatibility

The compatibility of the subject devices with condoms was evaluated in accordance with ASTM D7661-18, "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and were determined to be compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms.

VIII. CONCLUSIONS

The results of the performance testing described above demonstrate that Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are as safe and effective as the predicate device and support a determination of 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.