(299 days)
VagiVital Aktivgel 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 compatible with polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.
VagiVital Aktivgel is a water-based personal lubricant containing water, hypromellose, benzoic acid, lactic acid, and sodium hydroxide. VagiVital Aktivgel is provided in a 36 ml aluminum tube and may be packaged together with a reusable applicator.
The provided text describes the predicate device information and a summary of performance data for the VagiVital Aktivgel (K200098), which is a personal lubricant. It does not describe an AI/ML medical device. Therefore, I cannot extract information related to acceptance criteria for an AI device.
However, I can extract the acceptance criteria and study data relevant to the performance of this non-AI medical device.
Acceptance Criteria and Reported Device Performance (Non-AI Device)
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance (as demonstrated by studies) |
|---|---|---|
| Appearance/Color | Clear gel with fine visible particles | Maintained over 24-month shelf-life |
| Odor | Odorless | Maintained over 24-month shelf-life |
| pH | 3.6-4.0 | Maintained over 24-month shelf-life |
| Viscosity per USP <912> | 13800-75000 s | Maintained over 24-month shelf-life |
| Osmolality per USP <785> | 32-150 mOsmol/kg | Maintained over 24-month shelf-life |
| Antimicrobial Effectiveness per USP <51> | Category 2 per USP <51> | Maintained over 24-month shelf-life |
| Total Microbial Count per USP <61> | <100 cfu/ml | Maintained over 24-month shelf-life |
| Fungal/Yeast/Mold Limits per USP <61> | <10 cfu/ml | Maintained over 24-month shelf-life |
| Absence of Pathogenic Organisms per USP <62> (Pseudomonas aeruginosa, Staphylococcus aureous, Candida albicans) | Absent | Maintained over 24-month shelf-life |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic | Demonstrated to be non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic |
| Condom Compatibility | Compatible with polyisoprene condoms | Determined to be compatible with polyisoprene condoms |
| Shelf-life | 24 months | Demonstrated to maintain specifications for 24 months (accelerated aging and real-time stability study) |
As this device is not an AI/ML medical device, the following points are not applicable and therefore cannot be extracted from the provided text:
- Sample sized used for the test set and the data provenance: Not applicable for a chemical product. Performance testing focused on physical, chemical, and biological properties, not a "test set" of data for algorithm evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a personal lubricant's properties is established by laboratory testing against scientific standards, not expert consensus on image/data interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this non-AI device, the "ground truth" for its properties (pH, viscosity, biocompatibility, etc.) is established through standardized laboratory testing and analytical chemistry methods as per USP and ISO standards, not expert consensus or pathology.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 10, 2020
Peptonic Medical AB % Jane Campbell President J & D Campbell Associates, Inc. 164 Hammock Ave. Pawleys Island, South Carolina 29585
K200098 Trade/Device Name: VagiVital Aktivgel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 30, 2020 Received: October 13, 2020
Dear Jane Campbell:
Re:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal. ObGyn. General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200098
Device Name VagiVital Aktivgel
Indications for Use (Describe)
Vagi Vital Aktivgel 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 compatible with polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane 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)
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510(K) SUMMARY – K200098
| Applicant: | Peptonic Medical ABGustavslundsvägen 143SE-167 51 BrommaSwedenPhone: +46 8 530 20 110 |
|---|---|
| Contact Person: | Dan MarkussonChief Operating OfficerGustavslundsvägen 143SE-167 51 BrommaSweden |
| Date Prepared: | November 5, 2020 |
| Proprietary Name: | VagiVital Aktivgel |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (Lubricant, Personal) |
| Regulatory Class: | II |
Predicate Device:
- HyaloGYN Hydrating Gel, Fidia Farmaceutici, S.p.A. K150883 .
The predicate device has not been subject to a design-related recall.
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Device description
VagiVital Aktivgel is a water-based personal lubricant containing water, hypromellose, benzoic acid, lactic acid, and sodium hydroxide. VagiVital Aktivgel is provided in a 36 ml aluminum tube and may be packaged together with a reusable applicator.
Device specifications are listed in the table below:
| Parameter | Specification |
|---|---|
| Appearance/Color | Clear gel withfine visibleparticles |
| Odor | Odorless |
| pH | 3.6-4.0 |
| Viscosity per USP <912> | 13800-75000 s |
| Osmolality per USP <785> | 32-150 mOsmol/kg |
| Antimicrobial Effectiveness perUSP <51> | Category 2 perUSP <51> |
| Total Microbial Count per USP<61> | <100 cfu/ml |
| Fungal/Yeast/Mold Limits perUSP <61> | <10 cfu/ ml |
| Absence of PathogenicOrganisms per USP <62>Pseudomonas aeruginosaStaphylococcus aureousCandida albicans | Absent |
Indications for use
VagiVital Aktivgel 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 compatible with polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.
Comparison of Intended Use and Technological Characteristics of the subject and predicate device:
A comparison of the intended use and technological features of the subject and predicate devices is provided in the table below:
| Device & Predicate Device(s): | VagiVital AktivgelSubject Device (K200098) | HyloGyn Hydrating GelPredicate Device(K150883) |
|---|---|---|
| ------------------------------- | ------------------------------------------------ | -------------------------------------------------------- |
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| General Device Characteristics | ||
|---|---|---|
| Indications for Use | VagiVital Aktivgel is a personallubricant for vaginal applicationintended to moisturize andlubricate, to enhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is compatible withpolyisoprene condoms. Thisproduct is not compatible withnatural rubber latex andpolyurethane condoms. | HyaloGYN is a personallubricant for vaginalapplication intended tomositurize and lubricate,to enhance the ease andcomfort to intimatesexual activity andsupplement for body'snatural lubrication. Thisproduct is compatiblewithpolyisoprenecondoms. |
| Primary Ingredients | WaterS-lactic acidSodium Hydroxide 2M solutionBenzoic AcidHydroxypropyl methylcellulose | Hyaluronic Acid(Hydeal-D)Propylene glycolCarbopol 974P(carbomer)Sodium hydroxidePurified water |
| Condom compatibility | Compatible with polyisoprenecondoms | Compatible withpolyisoprenecondoms |
| Base Type | Water | Water |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
The subject and predicate device have similar indications for use statements and have the same intended use.
The subject device and predicate device have different technological characteristics, including different formulations. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
Summary of Performance Data:
Shelf life:
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VagiVital Aktivgel has a shelf-life of 24 months in accordance with the results of an accelerated aging and real-time stability study. Results from testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of its shelflife.
Biocompatibility:
Biocompatibility studies were performed in accordance with the 2016 FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993- 1:2009 as follows:
- Cytotoxicity (ISO 10993-5: 2009) ●
- Vaginal Irritation (ISO 10993-10: 2010) .
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010)
- . Acute Systemic Toxicity (ISO 10993-11: 2006)
The biocompatibility testing demonstrated that the subject device is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.
Condom Compatibility:
Vagi Vital Aktivgel was tested in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and was determined to be compatible with polyisoprene condoms. It was determined not to be compatible with natural rubber latex and polyurethane condoms.
Conclusion:
The results of the performance testing described above demonstrate that the VagiVital Aktivgel is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.