(441 days)
Not Found
No
The device description and performance studies focus on the chemical composition, biocompatibility, and stability of a personal lubricant, with no mention of AI or ML technology.
No.
This device is described as a personal lubricant intended to moisturize and lubricate to enhance comfort during intimate sexual activity, which falls under the category of a personal lubricant rather than a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
Explanation: The device is described as a personal lubricant intended to moisturize and lubricate, not to diagnose any condition. Its intended use is to enhance comfort during sexual activity and supplement natural lubrication.
No
The device description clearly states it is a "non-sterile, non-greasy, water-based personal lubricant delivered in single-use, pre-filled vaginal applicators," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is a "personal lubricant, 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." This describes a product for direct application to the body for physical purposes, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description reinforces that it's a "non-sterile, non-greasy, water-based personal lubricant delivered in single-use, pre-filled vaginal applicators." This aligns with a topical or applied product, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide information about a person's health status or disease.
- Performance Studies: The performance studies focus on biocompatibility, stability, and condom compatibility, which are relevant for a personal lubricant, not an IVD.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Long Lasting Vaginal Moisturizer is a personal lubricant, 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. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Long Lasting Vaginal Moisturizer is a non-sterile, non-greasy, water-based personal lubricant delivered in single-use, pre-filled vaginal applicators. Long Lasting Vaginal Moisturizer can be used daily to supplement the body's natural lubrication. Long Lasting Vaginal Moisturizer contains ingredients commonly found in cleared personal lubricants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or 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)
Biocompatibility Testing: The following biocompatibility testing has been performed on Long Lasting Vaginal Moisturizer:
- Cytotoxic evaluation following the EN ISO 10993-5 rule .
- Delayed hypersensivity test Guinea-Pig Maximisation Test (GPMT) according . to ISO 10993-10:2010
- Acute Vaginal Irritation hybrid test .
- Acute Systemic Toxicity hybrid test ●
Stability Data: Stability data confirms a shelf life of 24 months for Long Lasting Vaginal Moisturizer.
Compatibility Testing: Recent condom compatibility testing conducted per ASTM D7661-10 demonstrates that Long Lasting Vaginal Moisturizer is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Conclusion: Long Lasting Vaginal Moisturizer is substantially equivalent to its proposed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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K112217 510(k) Summary
Polichem SA Long Lasting Vaginal Moisturizer
4.0 510(k) Summary
Submitter:
Wisconsin Pharmacal Company, LLC US Agent for Polichem SA 1 Pharmacal Way Jackson, WI 53037
Contact Person:
John Nygaard Quality Assurance Manager jnygaard@pharmacalway.com (262) 677-7112
Date Submitted:
Proprietary Names:
Me Again® Long Lasting Vaginal Moisturizer and vH Essentials® Long Lasting Vaginal Moisturizer
Common Name:
Personal Lubricant
Classification Name:
21 CFR 884.5300 Lubricant, Patient, Vaginal, Condom Product Code: NUC Class: -Review Panel: Obstetrics/Gynecology
Predicate Devices:
Device Name: Replens Long-Lasting Vaginal Moisturizer 510(k) Number: K101241 Product Code: NUC
Device Name: CVS Personal Lubricant & Moisturizer 510(k) Number: K062682 Product Code: NUC, MMS
Intended Use:
Long Lasting Vaginal Moisturizer is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of
OCT 16 2012
1
K112217 510(k) Summary
suitable where metal-to-metal contact and lubrication is required. This product is
intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Description of Device:
Long Lasting Vaginal Moisturizer is a non-sterile, non-greasy, water-based personal lubricant delivered in single-use, pre-filled vaginal applicators. Long Lasting Vaginal Moisturizer can be used daily to supplement the body's natural lubrication. Long Lasting Vaginal Moisturizer contains ingredients commonly found in cleared personal lubricants.
Technological Characteristics of the Device:
Long Lasting Vaginal Moisturizer is substantially equivalent to the identified previously cleared vaginal moisturizer predicates with respect to its design and materials, principles of operation, function, formulation, and intended use.
Summary of Performance Data:
Biocompatibility Testing: The following biocompatibility testing has been performed on Long Lasting Vaginal Moisturizer:
- Cytotoxic evaluation following the EN ISO 10993-5 rule .
- Delayed hypersensivity test Guinea-Pig Maximisation Test (GPMT) according . to ISO 10993-10:2010
- Acute Vaginal Irritation hybrid test .
- Acute Systemic Toxicity hybrid test ●
Stability Data: Stability data confirms a shelf life of 24 months for Long Lasting Vaginal Moisturizer.
Compatibility Testing: Recent condom compatibility testing conducted per ASTM D7661-10 demonstrates that Long Lasting Vaginal Moisturizer is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Conclusion: Long Lasting Vaginal Moisturizer is substantially equivalent to its proposed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Polichem SA
% Mr. John Nygaard
Quality Assurance Manager
Wisconsin Pharmacal Company
1 Pharmacal Way
JACKSON WI 53037
OCT 16 2012
Re: K112217
Trade/Device Name: Me Again® Long Lasting Vaginal Moisturizer vH Essentials® Long Lasting Vaginal Moisturizer
Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 20, 2012 Received: September 24, 2012
Dear Mr. Nygaard:
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
3
Page 2 -
device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Twitchell
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
4
K112217 Indications for Use Form
Indications for Use
510(k) Number: K112217
Device Name: Me Again® Long Lasting Vaginal Moisturizer
Indications for Use:
Me Again® Long Lasting Vaginal Moisturizer is a personal lubricant, 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. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
/Concurrence of CDRH, Office of Device Evaluation (ODE)
Hryu'h Khan
tive, Gastro-Renal, and
Page 1 of 1
5
K112217 Indications for Use Form
Polichem SA Long Lasting Vaqinal Moisturizer
Indications for Use
510(k) Number: K112217
Device Name: vH Essentials® Long Lasting Vaginal Moisturizer
Indications for Use:
vH Essentials® Long Lasting Vaginal Moisturizer is a personal lubricant, 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. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ X (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vorga Th Khan
n Sian-Off Reproductive, Gastro-Renal, Page 1 of 1