(261 days)
Not Found
No
The device description and performance studies focus on the chemical composition, physical properties, and biocompatibility of a vaginal cream, with no mention of AI or ML technologies.
No.
The product is intended primarily for lubrication to enhance sexual activity and supplement natural lubrication, and while it does moisturize, it is not described as treating or preventing a disease or condition.
No
The Intended Use section clearly states that Vagisan® Moisturizing Cream is a personal lubricant for vaginal application, intended to moisturize and lubricate. There is no mention of it being used to diagnose conditions or diseases.
No
The device is a vaginal cream, which is a physical substance and not software. The description clearly outlines its composition and delivery method as a cream in a tube or sachet.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's 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 describes a device used on the body for physical comfort and function, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description of a "non-sterile, water-based, white, non-irritating, non-greasy, non-staining vaginal cream" further reinforces its nature as a topical or applied product.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility, irritation, sensitization, and stability – all relevant to a topical or applied medical device, not an IVD.
- Predicate Device: The predicate device (Replens® Vaginal Moisturizer) is also a vaginal moisturizer, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Vagisan Moisturizing Cream is a non-sterile, water-based, white, non-irritating, non-greasy, non-staining vaginal cream delivered in a tube with a reusable applicator or sachet (sample size) as a long-lasting moisturizer for vaginal dryness.
The quantitative formulation is considered confidential commercial information.
The specifications for the subject device include appearance, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total microbial count, fungal/yeast/mold limits, and absence of pathogenic organisms.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of pre-clinical and clinical evaluations were used to demonstrate that Vagisan Moisturizing Cream is substantially equivalent to the predicate device and meets safety, and effectiveness criteria.
Biocompatibility Testing: The results of three clinical studies conducted on the subject lubricant, cytotoxicity testing, and a toxicological risk assessment were used to demonstrate the biocompatibility of the subject lubricant.
- Human repeat insult patch test (HRIPT) was conducted on 106 human subjects. The study consisted of a 14 day induction phase followed by a 7 day rest period before a 48 hour challenge phase for delayed hypersensitivity. Visual assessments of the treatment site were conducted on six days during the induction phase and following the challenge phase. 104 of 106 (98%) subjects did not show any signs or symptoms of cutaneous irritation. The HRIPT results demonstrated that the subject device is non-irritating and non-sensitizing.
- A prospective, multicenter, controlled, randomized study was conducted on 117 human subjects in whom the subject lubricant was compared to a previously cleared lubricant. The subjects were given either the subject lubricant or control lubricant for a 28 day therapy period followed by a 14 day rest period before another 28 day therapy period with the second lubricant. Vaginal examinations were conducted on days 1 and 29 of both therapy periods for a total of four assessments per subject. The subjects also recorded self-assessed symptoms daily in a patient diary. The subject lubricant tolerability was assessed as very good or good by 93% of study subjects and 100% of physicians. The results demonstrated the subject lubricant is non-irritating and non-sensitizing.
- A prospective, non-randomized, non-controlled study was also conducted on 117 human subjects undergoing breast cancer treatment. The study subjects were given the subject lubricant for a 28 day therapy period. Vaginal examinations were conducted on days 1 and 29 for each subject. The study subjects also selfreported symptoms in a patient diary. The subject lubricant tolerability was assessed as very good or good by 90% of study subjects and 91% of physicians. The results demonstrated good tolerability of the subject lubricant.
Cytotoxicity testing was also conducted on the subject lubricant in accordance with ISO 10993-5:2009. Although the results showed a concentration-dependent cytotoxic effect, this is not uncommon for lubricants tested neat (worse-case exposure conditions) and does not preclude clearance of a personal lubricant. The subject lubricant also performed better than several other previously cleared lubricants. Based on the results from the clinical studies, the in vitro cytotoxicity testing does not raise significant safety concerns.
A toxicological risk assessment was also performed on the subject lubricant based on the total amount of each ingredient to assess for systemic toxicity. The toxicological risk assessment demonstrated that the total amount of each ingredient in the lubricant is less than the tolerable exposure values obtained from a literature review.
Stability Testing: The results of a real time aging study demonstrate that the subject lubricant maintains its specifications over 24 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Human repeat insult patch test (HRIPT): 104 of 106 (98%) subjects did not show any signs or symptoms of cutaneous irritation.
Prospective, multicenter, controlled, randomized study: subject lubricant tolerability was assessed as very good or good by 93% of study subjects and 100% of physicians.
Prospective, non-randomized, non-controlled study: subject lubricant tolerability was assessed as very good or good by 90% of study subjects and 91% of physicians.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
Dr. August Wolff Gmbh & Co. Kg Arzeimittel % Alan Curtis Regulatory Affairs Consultant AEC Medical Device Consulting LLC 8300 E. Dixileta Drive 285 Scottsdale, AZ 85266
Re: K152507
Trade/Device Name: Vagisan® Moisturizing Cream Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: April 15, 2016 Received: April 18, 2016
Dear Alan Curtis,
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.
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 device
1
related 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 yours,
Image /page/1/Picture/8 description: The image shows the text "Herbert P. Lerner -S" in a large, bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and easy to read. The overall impression is clean and professional.
for 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
2
Indications for Use
510(k) Number (if known) K152507
Device Name Vagisan® Moisturizing Cream
Indications for Use (Describe)
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.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the text "DR.AUGUST.WOLFF" in a bold, sans-serif font. A curved line is drawn beneath the text, creating a visual underline. The text and line are centered in the image.
SECTION 5 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
(Prepared August 31, 2015)
REGULATORY AUTHORITY
This 510(k) Summary is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME
Dr. August Wolff GmbH & Co. KG Arzneimittel Sudbrackstrasse 56 33611 Bielefeld, Germany
Contact Person:
Alan Curtis, RAC Scottsdale, AZ
NAME OF DEVICE
| Trade Name: | Vagisan® Moisturizing Cream |
|---|---|
| Common Name: | Personal Lubricant |
| Device Product Code: | NUC |
| Classification Name: | Condom (21 CFR 884.5300) |
| Device Panel: | Obstetrical and Gynecological Device |
| Device Classification: | Class II |
PREDICATE DEVICE
- Replens® Vaginal Moisturizer (K101098) ●
DEVICE DESCRIPTION
Vagisan Moisturizing Cream is a non-sterile, water-based, white, non-irritating, non-greasy, non-staining vaginal cream delivered in a tube with a reusable applicator or sachet (sample size) as a long-lasting moisturizer for vaginal dryness.
The quantitative formulation is considered confidential commercial information.
The specifications for the subject device include appearance, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total microbial count, fungal/yeast/mold limits, and absence of pathogenic organisms.
4
INDICATION FOR USE STATEMENT
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.
SUBSTANTIAL EQUIVALENCE COMPARISON
Comparison to Predicate Devices
The predicate device (K101098) has the same intended use as the subject device. The subject and predicate devices are water-based lubricants with similar primary ingredients. However, since the formulations of the subject and predicate devices are not identical, the devices do not have the same technological characteristics. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.
PERFORMANCE DATA
Results of pre-clinical and clinical evaluations were used to demonstrate that Vagisan Moisturizing Cream is substantially equivalent to the predicate device and meets safety, and effectiveness criteria.
Biocompatibility Testing: The results of three clinical studies conducted on the subject lubricant, cytotoxicity testing, and a toxicological risk assessment were used to demonstrate the biocompatibility of the subject lubricant. The following clinical studies were conducted on the subject lubricant and applicator:
- Human repeat insult patch test (HRIPT) was conducted on 106 ● human subjects. The study consisted of a 14 day induction phase followed by a 7 day rest period before a 48 hour challenge phase for delayed hypersensitivity. Visual assessments of the treatment site were conducted on six days during the induction phase and following the challenge phase. 104 of 106 (98%) subjects did not show any signs or symptoms of cutaneous irritation. The HRIPT results demonstrated that the subject device is non-irritating and non-sensitizing.
- A prospective, multicenter, controlled, randomized study was conducted on 117 human subjects in whom the subject lubricant was compared to a previously cleared lubricant. The subjects were given either the subject lubricant or control lubricant for a 28 day therapy period followed by a 14 day rest period before
CONFIDENTIAL
5
another 28 day therapy period with the second lubricant. Vaginal examinations were conducted on days 1 and 29 of both therapy periods for a total of four assessments per subject. The subjects also recorded self-assessed symptoms daily in a patient diary. The subject lubricant tolerability was assessed as very good or good by 93% of study subjects and 100% of physicians. The results demonstrated the subject lubricant is non-irritating and non-sensitizing.
- A prospective, non-randomized, non-controlled study was also ● conducted on 117 human subjects undergoing breast cancer treatment. The study subjects were given the subject lubricant for a 28 day therapy period. Vaginal examinations were conducted on days 1 and 29 for each subject. The study subjects also selfreported symptoms in a patient diary. The subject lubricant tolerability was assessed as very good or good by 90% of study subjects and 91% of physicians. The results demonstrated good tolerability of the subject lubricant.
Cytotoxicity testing was also conducted on the subject lubricant in accordance with ISO 10993-5:2009. Although the results showed a concentration-dependent cytotoxic effect, this is not uncommon for lubricants tested neat (worse-case exposure conditions) and does not preclude clearance of a personal lubricant. The subject lubricant also performed better than several other previously cleared lubricants. Based on the results from the clinical studies, the in vitro cytotoxicity testing does not raise significant safety concerns.
A toxicological risk assessment was also performed on the subject lubricant based on the total amount of each ingredient to assess for systemic toxicity. The toxicological risk assessment demonstrated that the total amount of each ingredient in the lubricant is less than the tolerable exposure values obtained from a literature review.
Stability Testing: The results of a real time aging study demonstrate that the subject lubricant maintains its specifications over 24 months.
CONCLUSION
Vagisan Moisturizing Cream is substantially equivalent to the proposed predicate device.
CONFIDENTIAL