(358 days)
No
The device description and performance studies focus on the chemical composition, physical properties, and biocompatibility of a personal lubricant suppository. There is no mention of any computational or algorithmic components, let alone AI or ML.
No.
The primary stated purpose of the device is for lubrication and moisturization to enhance comfort during sexual activity, which falls under personal care or cosmetic use rather than treating or preventing a disease or condition. While it may provide relief, it's not described as a medical treatment.
No.
The document states that the device is a personal lubricant intended to moisturize and lubricate to enhance comfort. It does not mention any diagnostic purpose or function.
No
The device is a physical suppository made of chemical ingredients, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a personal lubricant for vaginal application to moisturize and lubricate, enhance comfort during sexual activity, and supplement natural lubrication. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details the composition and form of a personal lubricant suppository. There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) to provide information about a person's health status, which is the core function of an IVD.
- Lack of Diagnostic Elements: There are no mentions of analyzing biomarkers, detecting diseases, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility and shelf-life, which are relevant for a topical or intravaginal product, not for a diagnostic test.
- Predicate Device: The predicate device is also a moisturizing cream, further indicating a non-diagnostic purpose.
In summary, the Vagisan MoistCream Cremolum is a personal care product intended for lubrication and moisturizing, not for diagnosing any condition or providing information about a person's health status through in vitro analysis.
N/A
Intended Use / Indications for Use
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.
Product codes
NUC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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
1
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
2
Indications for Use
510(k) Number (if known) K193444
Device Name Vagisan MoistCream Cremolum
Indications for Use (Describe)
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.
| 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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3
510(k) Summary - K193444
1. Submitter Information
| Applicant: | Dr. August Wolff GmbH & Co. KG
Arzneimittel |
|------------|---------------------------------------------------|
| Contact: | Dr. Thomas Flötotto
Regulatory Affairs Manager |
| Address: | Sudbrackstraße 56
D-33611 Bielefeld, Germany |
| Phone: | +49-521-8808-460 |
| Email: | thomas.floetotto@drwolffgroup.com |
2. Correspondent Information
| Contact: | Oliver Eikenberg, PhD
Senior Consultant, Quality & Regulatory Affairs
Emergo Global Consulting, LLC |
|----------|-----------------------------------------------------------------------------------------------------------|
| Address: | 2500 Bee Cave Road Building 1, Suite 300
Austin, 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
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.
4
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 shaped |
| suppository | |
| 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) per | |
| USP and | ≤ 100 CFU/g |
| Total yeast and mold count (TYMC) per | |
| USP and | ≤ 10 CFU/g |
| Presence of Pathogens per USP | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |
7. Indications for Use
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.
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 MoistCream
Cremolum
K193444
Subject Device | Vagisan Moisturizing
Cream
K152507
Predicate Device | Comparison |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal | Same |
| Product Code | NUC | NUC | Same |
| Indications for Use | 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. | Vagisan Moisturizing Cream
is a personal lubricant 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. | Same: The indications have
a minor difference in
wording; however, the
intended uses of both devices
are the same |
| Form | Vaginal suppository | Cream | Different: The subject and
predicate devices are
provided in different forms.
Differences in form do not
raise different questions of
safety and effectiveness
(S&E) |
| Water soluble | Yes | Yes | Same |
| Water-Based | No | Yes | Different: The base type of
the subject and predicate
devices is not the same.
Differences in personal
lubricant base type do not
raise different questions of
S&E |
| Primary ingredients | Hydrogenated coco-glycerides
Lactic acid
Calcium acetate
Cetearyl alcohol
PEG-20 glyceryl stearate
Sodium carbomer | Cetyl palmitate
Lactic acid
Sodium lactate
Cetyl steraryl alcohol
Sorbitan stearate
Polysorbate 60
Octyldecanol
Benzyl alcohol
Water | Different: The primary
ingredients of the subject and
predicate devices are not the
same. Differences in
personal lubricant base type
do not raise different
questions 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 (1:1
Dilution factor) | 374 mOsm/kg | Different: The osmolality of
the subject device is higher
than the predicate device.
Differences in personal
lubricant osmolality do not
raise different questions of
S&E |
| Condom Compatibility | Not compatible with natural
rubber latex, polyisoprene, or
polyurethane condoms | Not compatible with natural
rubber latex, polyisoprene, or
polyurethane condoms | Same |
| Biocompatibility Tested | Yes | Yes | Same |
| Antimicrobial
Effectiveness Tested | No | Yes | Different: The subject
device was not assessed for |
| | | | |
| Microbial Limits | Total mold/yeast count ≤ 10 cfu/g
Total aerobic microbial
count ≤ 100 cfu/g
Absence of pathogenic
organisms ( Candida
albicans, Pseudomonas
aeruginosa, Staphylococcus
aureus ) | Total mold/yeast count Candida
albicans, Pseudomonas
aeruginosa, Staphylococcus
aureus ) | this parameter as it is not a
water-based device. This
difference does not raise
different questions of S&E.
Same: |
| Packaging | Foil blister pack | Aluminum tubes and sachets | Different: The packaging
forms are not the same
between the subject and
predicate device. Difference
in packaging do not raise
different questions of S&E |
| Shelf life | 3 years | 2 years | Different: The subject
device has a longer shelf-life
than the predicate device.
Differences in shelf-life do
not raise different questions
of S&E. |
5
6
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
7
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.