Vagisan MoistCream Cremolum is a personal lubricant, a suppository for vaginal application, intended to moisturize and lubricate, to 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 and synthetic (polyurethane and polyisoprene) condoms.

Device Description

The Vagisan MoistCream Cremolum is a ready-to-use, non-sterile, glycerin-based personal lubricant suppository for intravaginal application that melts after digital insertion to form a smooth cream. The device is intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Vagisan MoistCream Cremolum consists of hydrogenated coco-glycerides, ceteary1 alcohol, lactic acid, calcium lactate, PEG-20 glyceryl stearate, and sodium carbomer. Each vaginal suppository is individually packaged in a foil blister pack, which are sold in boxes of eight or 16 vaginal suppositories.

AI/ML Overview

This document is a 510(k) Summary for a medical device called "Vagisan MoistCream Cremolum." It is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. The information provided does not describe a study involving an AI/Machine Learning device. Instead, it describes non-clinical performance testing for a personal lubricant.

Therefore, many of the requested categories (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI/ML) are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided "Device Specifications" table and summarize the non-clinical performance tests that were conducted.

Acceptance Criteria and Device Performance for Vagisan MoistCream Cremolum

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria	Reported Device Performance
Appearance	Smooth surface, no cracks, torpedo shaped suppository	The device is described as having a smooth surface, no cracks, and being torpedo-shaped.
Color	White	The device is described as white.
pH	4.0-5.0	Meets (Explicitly stated in comparative table)
Osmolality	600 - 1200 mOsm/kg (1:1 Dilution)	The product's osmolality is stated to be within this range.
Average Mass per Ph. Eur. 2.9.5	1960-2040 mg	The product's average mass is stated to be within this range.
Uniformity of Mass per Ph. Eur. 2.9.5	≥18/20 inside ø ± 5 %; 20/20 inside ø ± 10 %	The product's uniformity of mass is stated to meet these criteria.
Disintegration Time per Ph. Eur. 2.9.2	≤30 minutes	The product's disintegration time is stated to be within this limit.
Particle Size	100% ≤150 µm	The product's particle size meets this criteria.
Total aerobic microbial count (TAMC)	≤ 100 CFU/g	The product's TAMC is stated to be within this limit.
Total yeast and mold count (TYMC)	≤ 10 CFU/g	The product's TYMC is stated to be within this limit.
Presence of Pathogens (Pseudomonas aeruginosa)	Absent	Meets (Stated as absent)
Presence of Pathogens (Staphylococcus aureus)	Absent	Meets (Stated as absent)
Presence of Pathogens (Candida albicans)	Absent	Meets (Stated as absent)
Biocompatibility	Non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic	The results of testing demonstrated that Vagisan MoistCream Cremolum meets these criteria.
Shelf-Life	Maintain original specifications for 36 months	Results from testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of a 36-month shelf-life.
Condom Compatibility	Not compatible with natural rubber latex, polyisoprene, or polyurethane condoms (explicitly stated)	Not compatible with natural rubber latex, polyisoprene, or polyurethane condoms. (No testing was conducted, leading to this stated incompatibility.)

Study Details:

This document describes non-clinical performance testing for a personal lubricant, not a study evaluating an AI/Machine Learning device. Therefore, the following AI/ML specific information is largely not applicable.

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

Test Set Sample Size: Not applicable. This document details non-clinical laboratory testing of a physical product, not a data-driven AI/ML model. The "test set" would refer to the batches of product samples used in each specific test (e.g., a certain number of suppositories for mass uniformity, a certain number of samples for microbial count), but specific sample sizes for each test are not provided in this summary.
Data Provenance: Not specified for individual tests. The manufacturer is based in Germany (Dr. August Wolff GmbH & Co. KG Arzneimittel, address D-33611 Bielefeld, Germany). The testing standards cited are international (ISO, Ph. Eur., USP) suggesting internationally recognized lab practices. The submission is to the U.S. FDA.

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. The "ground truth" for the physical and chemical properties (like pH, osmolality, mass, microbial limits) are established by standard analytical and microbiological testing methods, not by expert consensus as would be for clinical image interpretation. Biocompatibility testing results are also based on standardized assays.

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

Not applicable. Adjudication methods like 2+1 are used for expert consensus in fields like clinical image interpretation, not for objective measurements of physical or chemical properties.

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 consensus, pathology, outcomes data, etc)

The ground truth for the device's performance relies on objective laboratory measurements and standardized test procedures as defined by pharmacopeial monographs (Ph. Eur., USP) and ISO standards for biocompatibility.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

Summary

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December 4, 2020

Dr. August Wolff GmbH & Co. KG Arzneimittel % Oliver Eikenberg, Ph.D. Senior Consultant QA/RA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746

Re: K193444

Trade/Device Name: Vagisan MoistCream Cremolum Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: October 30, 2019 Received: November 6, 2019

Dear Oliver Eikenberg:

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. 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/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.

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 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 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

Monica D. Garcia, Ph.D. Acting 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193444

Device Name Vagisan MoistCream Cremolum

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 - K193444

1. Submitter Information

Applicant:	Dr. August Wolff GmbH & Co. KGArzneimittel
Contact:	Dr. Thomas FlötottoRegulatory Affairs Manager
Address:	Sudbrackstraße 56D-33611 Bielefeld, Germany
Phone:	+49-521-8808-460
Email:	thomas.floetotto@drwolffgroup.com

2. Correspondent Information

Contact:	Oliver Eikenberg, PhDSenior Consultant, Quality & Regulatory AffairsEmergo Global Consulting, LLC
Address:	2500 Bee Cave Road Building 1, Suite 300Austin, TX 78746
Phone:	(512) 327-9997
Email:	lst.aus.projectmanagement@ul.com

3. Date prepared: December 3, 2020

4. Device Information

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

5. Predicate Device Information

Device Name:	Vagisan Moisturizing Cream
510(k) Number:	K152507
Manufacturer:	Dr. August Wolff GmbH & Co. KG Arzneimittel
Product Code:	NUC (lubricant, personal)

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

6. Device Description

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Vagisan MoistCream Cremolum consists of hydrogenated coco-glycerides, ceteary1 alcohol, lactic acid, calcium lactate, PEG-20 glyceryl stearate, and sodium carbomer. Each vaginal suppository is individually packaged in a foil blister pack, which are sold in boxes of eight or 16 vaginal suppositories.

The device specifications for Vagisan MoistCream Cremolum are listed in the table below:

		Table 1: Device Specifications for Vagisan MoistCream Cremolum
--	--	----------------------------------------------------------------	--

Property	Specification
Appearance	Smooth surface, no cracks, torpedo shapedsuppository
Color	White
pH	4.0-5.0
Osmolality	600 - 1200 mOsm/kg (1:1 Dilution)
Average Mass per Ph. Eur. 2.9.5	1960-2040 mg
Uniformity of Mass per Ph. Eur. 2.9.5	≥18/20 inside ø ± 5 %20/20 inside ø ± 10 %
Disintegration Time per Ph. Eur. 2.9.2	≤30 minutes
Particle Size	100% ≤150 µm
Total aerobic microbial count (TAMC) perUSP <61> and <1111>	≤ 100 CFU/g
Total yeast and mold count (TYMC) perUSP <61> and <1111>	≤ 10 CFU/g
Presence of Pathogens per USP <62>	Specification
Pseudomonas aeruginosa	Absent
Staphylococcus aureus	Absent
Candida albicans	Absent

7. Indications for Use

8. 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 device.

Table 2: Comparator Table for Subject and Predicate Devices

	Vagisan MoistCreamCremolumK193444Subject Device	Vagisan MoisturizingCreamK152507Predicate Device	Comparison
Device Classification Name	Lubricant, Personal	Lubricant, Personal	Same
Product Code	NUC	NUC	Same
Indications for Use	Vagisan MoistCream Cremolumis a personal lubricant, asuppository for vaginalapplication, intended tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication.This product is not compatiblewith natural rubber latex condomsand synthetic (polyurethane andpolyisoprene) condoms.	Vagisan Moisturizing Creamis a personal lubricant forvaginal application, intendedto moisturize and lubricate, toenhance the ease and comfortof intimate sexual activity andsupplement the body's naturallubrication.This product is notcompatible with naturalrubber latex condoms andsynthetic (polyurethane andpolyisoprene) condoms.	Same: The indications havea minor difference inwording; however, theintended uses of both devicesare the same
Form	Vaginal suppository	Cream	Different: The subject andpredicate devices areprovided in different forms.Differences in form do notraise different questions ofsafety and effectiveness(S&E)
Water soluble	Yes	Yes	Same
Water-Based	No	Yes	Different: The base type ofthe subject and predicatedevices is not the same.Differences in personallubricant base type do notraise different questions ofS&E
Primary ingredients	Hydrogenated coco-glyceridesLactic acidCalcium acetateCetearyl alcoholPEG-20 glyceryl stearateSodium carbomer	Cetyl palmitateLactic acidSodium lactateCetyl steraryl alcoholSorbitan stearatePolysorbate 60OctyldecanolBenzyl alcoholWater	Different: The primaryingredients of the subject andpredicate devices are not thesame. Differences inpersonal lubricant base typedo not raise differentquestions of S&E
Over the counter use	Yes	Yes	Same
Sterile	No	No	Same
pH	4.0-5.0	4.0-5.0	Same
Osmolality	600 - 1200 mOsm/kg (1:1Dilution factor)	374 mOsm/kg	Different: The osmolality ofthe subject device is higherthan the predicate device.Differences in personallubricant osmolality do notraise different questions ofS&E
Condom Compatibility	Not compatible with naturalrubber latex, polyisoprene, orpolyurethane condoms	Not compatible with naturalrubber latex, polyisoprene, orpolyurethane condoms	Same
Biocompatibility Tested	Yes	Yes	Same
AntimicrobialEffectiveness Tested	No	Yes	Different: The subjectdevice was not assessed for

Microbial Limits	Total mold/yeast count ≤ 10 cfu/gTotal aerobic microbialcount ≤ 100 cfu/gAbsence of pathogenicorganisms ( Candidaalbicans, Pseudomonasaeruginosa, Staphylococcusaureus )	Total mold/yeast count <10cfu/gTotal aerobic microbialcount <100 cfu/gAbsence of pathogenicorganisms ( Candidaalbicans, Pseudomonasaeruginosa, Staphylococcusaureus )	this parameter as it is not awater-based device. Thisdifference does not raisedifferent questions of S&E.Same:
Packaging	Foil blister pack	Aluminum tubes and sachets	Different: The packagingforms are not the samebetween the subject andpredicate device. Differencein packaging do not raisedifferent questions of S&E
Shelf life	3 years	2 years	Different: The subjectdevice has a longer shelf-lifethan the predicate device.Differences in shelf-life donot raise different questionsof S&E.

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The subject and predicate device indications for use have a minor difference in wording; however, the intended use of the subject and predicate devices is the same (i.e., provides lubrication during intimate sexual activity).

In addition, the subject and predicate devices have different technological characteristics as shown in the table above. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization 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:

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

The results of this testing demonstrated that the Vagisan MoistCream Cremolum is non-cytotoxic, nonirritating, non-sensitizing, and non-systemically toxic.

Shelf-Life

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K193444 Page 5 of 5

The subject device has a shelf-life of 36-months. Results from testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of its shelf-life.

Condom Compatibility

Condom compatibility testing was not conducted on the subject device, Therefore, the subject device is considered not compatible with natural rubber latex, polyisoprene or polyurethane condoms.

10. Conclusion

The results of the performance testing described above demonstrate that the Vagisan MoistCream Cremolum 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.