(141 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technology.
No.
The device is a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity, which is not considered a therapeutic function based on the provided information.
No
The device is described as a personal lubricant intended to moisturize and lubricate for enhancing intimate sexual activity, not for diagnosing any medical condition.
No
The device description clearly indicates it is a physical gel product in a tube with syringes, not a software application.
No, 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 comfort during sexual activity and supplement natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the gel (colorless, transparent, aqueous, hydrating) and its application method. The listed parameters (pH, viscosity, osmolality, microbial counts) are quality control measures for a topical product, not diagnostic tests performed on a biological sample.
- Lack of Diagnostic Function: An IVD is designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform any such examination or provide diagnostic information.
- Anatomical Site: While the anatomical site is relevant to the device's application, it doesn't make it an IVD. Many non-IVD devices are applied to specific anatomical sites.
In summary, this device is a personal lubricant, which is a type of medical device, but it does not fit the definition of an In Vitro Diagnostic device.
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 polyisoprene condoms. This device is not compatible with natural rubber latex or polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Internal Hydrating Gel is a colorless, transparent, aqueous, hydrating gel in tube with 8 syringes for easy application.
Internal Hydrating Gel is intended for use as a personal lubricant. This product is compatible with polyisoprene condoms. This device is not compatible with natural rubber latex or polyurethane condoms. Accordingly, 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)
Internal Hydrating Gel has a pH of 4.5-5.0 and a shelf life of 21 months.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Pre-Clinical Testing Clinical Testing
Cytotoxicity HRIPT
Zone of Inhibition
Systemic Toxicity
Vaginal Irritation
Guinea Pig Maximization
An assessment of non-clinical performance data was conducted and the proposed device performs the same as the 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.
HYALO GYN® Vaginal Hydrating Gel(K094039)
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus-like symbol with three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2015
Combe Incorporated Pushpa Rao Senior Director, Global Regulatory Affairs & Product Safety 1101 Westchester Avenue White Plains. NY 10604
Re: K141718 Trade/Device Name: Internal Hydrating Gel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: October 14, 2014 Received: October 15, 2014
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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,
Benjamin R. Fisher -A
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K141718
Device Name Internal Hydrating Gel
Indications for Use (Describe)
The device is a personal lubricant, for pental 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 polyisoprene condoms. This device is not compatible with natural rubber latex or polyurethane condoms.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
× 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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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."
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510(k) Summary
| 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 - Internal Hydrating Gel
Classification name - Personal lubricant
Citation: 21 CFR 884.5300
Product Code: NUC
Class: II |
| Predicate Device | HYALO GYN® Vaginal Hydrating Gel(K094039) |
| Device Description | Internal Hydrating Gel is a colorless, transparent,
aqueous, hydrating gel in tube with 8 syringes for easy
application.
Internal Hydrating Gel is intended for use as a personal
lubricant. This product is compatible with
polyisoprene condoms. This device is not compatible
with natural rubber latex or polyurethane condoms.
Accordingly, 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) |
| | Internal Hydrating Gel has a pH of 4.5-5.0 and a shelf
life of 21 months. |
| 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
polyisoprene condoms. This device is not compatible
with natural rubber latex or polyurethane condoms. |
| Technological
Characteristics | The proposed device, Internal Hydrating Gel has the
same technological characteristics as the predicate
device. |
| Biocompatibility
Data | The following biocompatibility testing was conducted
in support of safety of the proposed device:
Pre-Clinical Testing Clinical Testing
Cytotoxicity HRIPT
Zone of Inhibition
Systemic Toxicity
Vaginal Irritation
Guinea Pig Maximization |
| Performance
Testing
Non-Clinical | An assessment of non-clinical performance data was
conducted and the proposed device performs the same
as the predicate devices. |
| Conclusions | Based the results of the nonclinical and clinical tests
(discussed above) that demonstrate that the device is
as safe, as effective, and performs as well as the
predicate device. The device is substantially
equivalent to the predicate device. |
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