Satisfaite™ is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to supplement the body's natural lubrication, and to enhance the ease and comfort of intimate sexual activity. This product is compatible with natural rubber, latex, and polyisoprene condoms; and is not compatible with polyurethane condoms.

Device Description

Satisfaite™ is a topically applied, water-based personal lubricant for vaginal application, intended to moisturize and lubricate, and to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Satisfaite™ is self-administered to the user via a prefilled unit dose applicator for intravaginal administration. The device consists of the polypropylene plastic applicator pre-filled with the lubricant. The three main ingredients of the lubricant by percent weight are purified water, glycerin and propylene glycol. Each pre-filled applicator holds 1 gram of lubricant and is for a single use in a home environment. Each pre-filled applicator is individually over-wrapped with a disposable polypropylene sleeve and packaged 10 units to a cardboard box. The lubricant makes direct patient contact with the vaginal mucosa and has a contact duration of < 24 hours. The applicator also makes direct patient contact with the vaginal mucosa only at the time of application and is discarded after use.

AI/ML Overview

This document, a 510(k) Summary for the Satisfaite™ personal lubricant, describes the process for demonstrating substantial equivalence to a predicate device, not the acceptance criteria and study proving device performance in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.

The provided text details the regulatory application for a personal lubricant, a physical product, and outlines its properties, chemical composition, and testing results to ensure it is safe and effective and comparable to similar products already on the market (predicate device).

Therefore, I cannot extract the information requested about acceptance criteria and a study that proves a device meets these criteria in the context of an AI/ML-enabled medical device, because this document pertains to a traditional medical device (a lubricant).

The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set sample size) are all highly relevant to the evaluation of AI/ML medical devices, which operate very differently from the product described in the provided text.

Summary

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December 13, 2019

FemmePharma Consumer Healthcare, LLC % Stuart Goldman Sr. Consultant, RA/OA Emergo by UL 2500 Bee Cave Road, Bldg. 1, Suite 300 Austin, TX 78746

Re: K190752

Trade/Device Name: Satisfaite Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 14, 2019 Received: November 15, 2019

Dear Stuart Goldman:

We have reviewed vour 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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 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,

for Sharon M. Andrews 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) K190752

Device Name Satisfaite™M

Indications for Use (Describe)

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

1. Submission Sponsor

FemmePharma Consumer Healthcare, LLC 175 Strafford Ave. Bldg. 4, Suite 275 Wayne, PA 19087 USA Phone: (610) 995-0801 Contact: Gerianne DiPiano Title: Chief Executive Officer Email: gerianne@femmepharma.com

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 USA Phone: (512) 327-9997 Contact: Stuart R. Goldman Title: Sr. Consultant RA/QA Email: Stuart.Goldman@UL.com

3. Date Prepared

December 12, 2019

4. Device Identification

Trade/Proprietary Name: Satisfaite™ Common/Usual Name: Personal Lubricant Classification Name: Condom Regulation Number: 21 CFR 884.5300 Product Code: NUC Class: II Classification Panel: Obstetrics/Gynecology

5. Predicate Device Identification

Replens™ Long-Lasting Vaginal Moisturizer (in 35g Tube with Reusable Applicator) – K101098. The predicate device has not been subject to a design related recall.

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6. Device Description

The following features, characteristics and properties are applicable to Satisfaite™:

a. The device consists of the polypropylene plastic applicator pre-filled with the lubricant. The three main ingredients of the lubricant by percent weight are purified water, glycerin and propylene glycol. Each pre-filled applicator holds 1 gram of lubricant and is for a single use in a home environment.
b. Each pre-filled applicator is individually over-wrapped with a disposable polypropylene sleeve and packaged 10 units to a cardboard box.
c. The lubricant makes direct patient contact with the vaginal mucosa and has a contact duration of < 24 hours. The applicator also makes direct patient contact with the vaginal mucosa only at the time of application and is discarded after use.
d. Specifications for the lubricant include the following:
- i. Appearance: Thick gel
- ii. Color: Off-white
- iii. Odor: Characteristic
- İV. pH@ 25°C: 3.8 - 4.6
- viscosity: 53,000 152,000 cP V.
- osmolality: 2,300 2,800 mOsm/kg vi.
- antimicrobial effectiveness: Meets USP <51> acceptance criteria for Category 2 products vii.
- viiii. total microbial count: < 10 cfu/ g
- fungal/yeast /mold limits: < 10 cfu/g İX.
- absence of pathogenic organisms: Absence confirmed X.

7. Indications for Use

Satisfaite™ is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to supplement the body's natural lubrication, and to enhance the ease and comfort of intimate sexual activity. This product is compatible with natural rubber, latex, and polysoprene condoms; and is not compatible with polyurethane condoms.

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8. Comparison of Technological Characteristics

The subject and predicate devices have similar indications for condom compatibilities. This change does not represent a new intended use. The subject and predicate devices have different technological characteristics, including different formulations, packaging, specifications, and condom compatibilities. The different technological characteristics of the subject devices does not raise different types of safety and effectiveness questions. Table 5-1 compares Satisfaite™ to Replens™ with respect to its indications for use and technological characteristics.

Attributes	SubjectDevice	PredicateDevice	Similarities /Differences
Device Name	Satisfaite™	Replens® Long-LastingVaginal Moisturizer	-
Manufacturer	FemmePharma Consumer Healthcare,LLC	Lil Drug Store Products, Inc.	-
510(k)	K190752	K101098	-
Product Code	NUC	NUC	Same
Regulation	§884.5300	§884.5300	Same
Class	II	II	Same
Review Panel	OBGYN	OBGYN	Same
Indications forUse	Satisfaite™ is a personal lubricant, forvaginal application, intended tomoisturize and lubricate, tosupplement the body's naturallubrication, and to enhance the easeand comfort of intimate sexualactivity. This product is compatiblewith natural rubber, latex, andpolyisoprene condoms; and is notcompatible with polyurethanecondoms.	Replens® is a personallubricant for vaginalapplication, intended tomoisturize and lubricate, toenhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is compatiblewith natural rubber latexcondoms and synthetic(polyurethaneand polyisoprene)condoms.	The subject device isnot compatible withpolyurethane condomswhile the predicatedevice is compatiblewith polyurethanecondoms, and this isclearly stated in theproduct labeling for thesubject and predicatedevices.
List ofIngredients	Purified water, glycerin, propyleneglycol, hydroxyethylcellulose, sodiumhyaluronate, hydrochloric acid,methylparaben, vitamin E	Purified water, glycerin,mineral oil, polycarbophil,carbomer homopolymertype b, hydrogenated palmoil glyceride,methylparaben, sorbic acid,sodium hydroxide	Similar
Area of Use	Vagina	Vagina	Same
Packaging Unit	Ten (10) prefilled vaginal applicatorsper box.	35g tube of gel (enough for14 applications) + 1reusable vaginal applicatorper box.	Similar – the subjectand predicate deviceare both administeredvia a plastic vaginalapplicator.
Dosage	1 gram per applicator.	2.5 grams per application.	Similar
	OTC	OTC	Same
Prescription /OTC			Page 4 of
Sterility	Non-Sterile	Non-Sterile	Same
Color	Off-white	Off-white	Same
pH	3.8 - 4.6	2.9	The subject devicemeasured pH is withinthe normal range ofvaginal pH (4.0 – 5.0).
Specific Gravity	0.98 - 1.08	1.02	Similar
Viscosity	53,000 - 152,000 cP	70,000 cP	Similar
Osmolality	2,300 – 2,800 mOsm/kg	1,177 mOsm/kg	Similar
MicrobiologicalExamination	Conforms withUSP <61> for TAMC	Conforms withUSP <61>	Similar
USP <61>	Conforms withUSP <61> for TYMC	Conforms withUSP <61>	Similar
AntimicrobialEffectivenessUSP <51>	Conforms withUSP <51>	Conforms withUSP <51>	Similar
BiocompatibilityISO 10993-1	ISO 10993-5ISO 10993-10ISO 10993-11	Conforms withISO 10993-1 and itsapplicable parts.	Same
CondomcompatibilityASTM D7661-10	Compatible with natural rubber latex,and polyisoprene condoms.NOT compatible with polyurethanecondoms	Compatible with naturalrubber latex, polyisoprene,and polyurethanecondoms.	The subject device isnot compatible withpolyurethane condoms,while the predicate iscompatible.

Table 5-1 –Comparison of Satisfaite™ vs. Replens®

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The differences in technological characteristics between Satisfaite™ and Replens™ do not raise different questions of safety and effectiveness.

9. Non-Clinical Performance Data

As part of demonstrating substantial equivalence of Satisfaite™ to Replens®, FemmePharma Consumer Healthcare submitted their device for testing in accordance with the applicable parts of the following voluntary standards. Results confirm that the design inputs and performance specifications for the device are met. Satisfaite™ passed all testing in accordance with the standards shown below, and therefore its substantial equivalence to the predicate devices:

. Condom Compatibility (ASTM D7661-10)
- testing showed that Satisfaite™ is compatible with: o
  - . natural rubber latex condoms
  - polyisoprene condoms
- o testing showed that Satisfaite™ is not compatible with:
  - . polyurethane condoms
Biocompatibility studies, including Cytotoxicity, Sensitization, Vaginal Irritation, and Acute Systemic Toxicity Testing were performed in accordance with the 2016 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" and ISO 10993-1:2009 as follows:

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Cytotoxicity (ISO 10993-5:2009) O
o Sensitization (ISO 10993-10:2010)
o Vaginal Irritation (ISO 10993-10:2010)
o Acute Systemic Toxicity (ISO 10993-11:2017)

The results of this testing demonstrated that the subject lubricants are not cytotoxic, not sensitizing, not irritating and non-systemically toxic.

. Microbial - Total Aerobic Microbial Count (USP <61>) testing met the requirements of the standard and demonstrated the device met specifications o
. Microbial - Total Combined Yeast/Mold Count (USP <61>)
- testing met the requirements of the standard and demonstrated the device met specifications o
. Microbial - Antimicrobial Effectiveness (USP <51>)
- testing met the requirements of the standard and demonstrated the device met specifications o
. Microbial – Absence of Pathogenic Organism (USP 61/62)
- o testing met the requirements of the standard and demonstrated the device met specifications

10. Conclusion

The results of the non-clinical testing described above demonstrate that the subject device is as safe and effective as the predicate device and supports 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.