(52 days)
Not Found
No
The 510(k) summary describes a personal lubricant and does not mention any AI or ML capabilities. The device description focuses on physical and chemical properties, and the performance studies relate to condom compatibility.
No.
The document states the device is a personal lubricant intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity, which is not a therapeutic purpose.
No
Explanation: The intended use of the device is to moisturize and lubricate for enhancing comfort during intimate sexual activity, not to diagnose any condition.
No
The device is a personal lubricant, which is a physical substance, not software. The description details its physical properties and testing related to material compatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for penile and/or vaginal application to enhance sexual activity and supplement natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and microbial safety of the gel, not on analyzing biological samples for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of the device being used to test for diseases, conditions, or any other biological markers.
- Performance Studies: The performance study mentioned is related to condom compatibility, which is a functional test, not a diagnostic one.
IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The device 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 compatible with natural rubber latex and polyisoprene condoms.
Product codes
NUC
Device Description
Vaginal Moisturizing Gel is identical to the predicate device except that it is presented in 8 pre-filled applicators for easy use.
Vaginal Moisturizing Gel is intended for use as a personal lubricant. This product is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms. The following parameters are included as part of the product specification:
• Appearance
• Color
• Odor
• pH
• Viscosity
• Osmolality
• Antimicrobial effectiveness
• Total Aerobic Microbial Count (TAMC)
• Total Yeast and Mold Count (TYMC)
• Absence of Pathogenic Organisms (at minimum Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans)
Vaginal Moisturizing Gel has a pH of 4.5-5.0 and a shelf life of 18
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)
Performance Testing- Non-Clinical: The proposed device was tested for condom compatibility according to ASTM D7661-10 and found to be compatible with natural rubber latex and polyisoprene condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2015
Combe Incorporated Pushpa Rao, Ph.D., D.A.B.T., R.A.C. Sr. Director Global Regulatory Affairs/Product Safety 1101 Westchester Avenue White Plains, NY 10604
Re: K150615
Trade/Device Name: Vaginal Moisturizing Gel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 9, 2015 Received: March 10, 2015
Dear Pushpa Rao,
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.
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Page 2 - Pushpa Rao, Ph.D., D.A.B.T., R.A.C.
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-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 vours.
Joyce M. Whang -S
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K150615
Device Name Vaginal Moisturizing Gel
Indications for Use (Describe)
The device is a personal lubricant, for penial 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 compatible with natural rubber latex 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| 510(k) Owner: | Combe Incorporated
1101 Westchester Avenue
White Plains, NY 10604 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Pushpa Rao, Ph.D., D.A.B.T., R.A.C.
Sr. Director Global Regulatory Affairs/Product Safety
Email: prao@combe.com
Phone: (914) 461-4458
Fax: (914) 697-7764 |
| Name of Device | Trade name – Vaginal Moisturizing Gel Classification
name - Personal lubricant Citation: 21 CFR 884.5300
Product Code: NUC Class: II |
| Predicate Device | Internal Hydrating Gel (K141718) |
| Device Description | Vaginal Moisturizing Gel is identical to the predicate device except
that it is presented in 8 pre-filled applicators for easy use.
Vaginal Moisturizing Gel is intended for use as a personal lubricant.
This product is compatible with natural rubber latex and polyisoprene
condoms. This device is not compatible with polyurethane condoms.
The following parameters are included as part of the product
specification:
• Appearance
• Color
• Odor
• pH
• Viscosity
• Osmolality
• Antimicrobial effectiveness
• Total Aerobic Microbial Count (TAMC)
• Total Yeast and Mold Count (TYMC)
• Absence of Pathogenic Organisms (at minimum Pseudomonas
aeruginosa, Staphylococcus aureus, and Candida albicans)
Vaginal Moisturizing Gel has a pH of 4.5-5.0 and a shelf life of 18 |
| Indications for
Use | The device 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 compatible with natural rubber latex and polyisoprene
condoms. |
| Technological
Characteristics | The proposed device, Vaginal Moisturizing Gel has the identical
technological characteristics as the predicate device. |
| Biocompatibility
Data | Biocompatibility of the new applicator was supported with a study of
extractable and leachable materials from the applicator. The new
applicator was subjected to extractable testing according to USP :
Physicochemical Tests for Plastics. Extracts were also analyzed using
infrared analysis, gas chromatography coupled with mass spectrometry
(GC-MS), and inductively coupled plasma mass spectroscopy. Extracted
molecules were only detected after aggressive extraction with ethanol as
determined by GC-MS. Risk analysis showed that ethanol extractable
materials were in amounts much lower than the tolerable intake of any
component. |
| Performance Testing-
Non- Clinical | The proposed device was tested for condom compatibility according to
ASTM D7661-10 and found to be compatible with natural rubber latex
and polyisoprene condoms. |
| Conclusions | Based on the results of non-clinical testing, the proposed device,
Vaginal Moisturizing Gel, is substantially equivalent to the predicate
device. |
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