(141 days)
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.
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.
This document is a 510(k) summary for the "Internal Hydrating Gel," a personal lubricant. It doesn't contain a detailed study proving the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML device would. Instead, it relies on demonstrating substantial equivalence to a predicate device through various tests.
Therefore, many of the requested fields cannot be directly answered from the provided text as this is not a study on an AI device. However, I can extract the relevant information on reported device performance and the tests performed to support safety and equivalence.
Here's the breakdown based on the provided text, focusing on the closest equivalents to your request:
1. Table of Acceptance Criteria and Reported Device Performance
This document describes the product specifications and the results of various testing conducted to demonstrate safety and substantial equivalence to a predicate device. It doesn't present "acceptance criteria" in the traditional sense of a clinical performance study with defined thresholds for sensitivity, specificity, etc., nor a comparison to an AI/ML algorithm's output. Instead, it lists physical/chemical properties and biological safety tests.
| Acceptance Criteria (Implied by Product Specification & Test Purpose) | Reported Device Performance / Outcome |
|---|---|
| Product Specifications: | |
| Appearance | Colorless, transparent, aqueous gel |
| Color | Colorless |
| Odor | Not specified (implied in spec) |
| pH | 4.5-5.0 |
| Viscosity | Not specified (implied in spec) |
| Osmolality | Not specified (implied in spec) |
| Antimicrobial effectiveness | Test conducted (implies adequate) |
| Total Aerobic Microbial Count (TAMC) | Test conducted (implies within limits) |
| Total Yeast and Mold Count (TYMC) | Test conducted (implies within limits) |
| Absence of Pathogenic Organisms (P. aeruginosa, S. aureus, C. albicans) | Test conducted (implies absent) |
| Shelf Life | 21 months |
| Biocompatibility: | |
| Cytotoxicity | Conducted (implies acceptable) |
| HRIPT (Human Repeat Insult Patch Test) | Conducted (implies acceptable) |
| Zone of Inhibition | Conducted (implies acceptable) |
| Systemic Toxicity | Conducted (implies acceptable) |
| Vaginal Irritation | Conducted (implies acceptable) |
| Guinea Pig Maximization | Conducted (implies acceptable) |
| Condom Compatibility: | |
| Compatibility with polyisoprene condoms | Compatible |
| Compatibility with natural rubber latex or polyurethane condoms | Not compatible |
| Overall Conclusion: | The device is as safe, as effective, and performs as well as the predicate device, demonstrating substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified in the document. The types of tests (e.g., biocompatibility) would involve specific sample sizes per test, but these are not detailed.
- Data provenance: Not specified. Standard pre-clinical and clinical testing for medical devices typically adheres to international guidelines (e.g., ISO for biocompatibility) but the specific origin cannot be determined from this summary. It's prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as this is not an AI/ML device study. Ground truth in this context would refer to objective measurements and expert evaluation in the various tests (e.g., laboratory technicians for microbial counts, toxicologists for biocompatibility assessments, clinical dermatologists for HRIPT, etc.), but explicitly stated expert numbers or qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not a study comparing interpretations, such as in an imaging study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device; therefore, no MRMC study with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device; there is no algorithm, and therefore no standalone performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- "Ground truth" in this context refers to the results of established scientific and laboratory testing methods (e.g., pH meters, viscometers, microbiological culture results, toxicity assays according to ISO standards, clinical observations for irritation). It is based on objective measurements and standardized test protocols rather than expert consensus on, for instance, image interpretation.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device; there is no training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device; there is no training set or associated ground truth.
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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.
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510(k) Summary
| 510(k) Owner: | Combe Incorporated1101 Westchester AvenueWhite Plains, NY 10604 |
|---|---|
| Contact Person | Pushpa Rao, Ph.D., D.A.B.T., R.A.C.Sr. Director Global Regulatory Affairs/Product SafetyEmail: prao@combe.comPhone: (914) 461-4458Fax: (914) 697-7764 |
| Name of Device | Trade name - Internal Hydrating GelClassification name - Personal lubricantCitation: 21 CFR 884.5300Product Code: NUCClass: 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 easyapplication.Internal Hydrating Gel is intended for use as a personallubricant. This product is compatible withpolyisoprene condoms. This device is not compatiblewith natural rubber latex or polyurethane condoms.Accordingly, the following parameters are included aspart 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 minimumPseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans) |
| Internal Hydrating Gel has a pH of 4.5-5.0 and a shelflife of 21 months. | |
| Indications for Use | The device is a personal lubricant, for penile and/orvaginal application, intended to moisturize andlubricate, to enhance the ease and comfort of intimatesexual activity, and supplement the body's naturallubrication. This product is compatible withpolyisoprene condoms. This device is not compatiblewith natural rubber latex or polyurethane condoms. |
| TechnologicalCharacteristics | The proposed device, Internal Hydrating Gel has thesame technological characteristics as the predicatedevice. |
| BiocompatibilityData | The following biocompatibility testing was conductedin support of safety of the proposed device:Pre-Clinical Testing Clinical TestingCytotoxicity HRIPTZone of InhibitionSystemic ToxicityVaginal IrritationGuinea Pig Maximization |
| PerformanceTestingNon-Clinical | An assessment of non-clinical performance data wasconducted and the proposed device performs the sameas the predicate devices. |
| Conclusions | Based the results of the nonclinical and clinical tests(discussed above) that demonstrate that the device isas safe, as effective, and performs as well as thepredicate device. The device is substantiallyequivalent to the predicate device. |
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§ 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.