(264 days)
Not Found
No
The device description and performance studies focus on the chemical composition, physical properties, and biocompatibility of a personal lubricant, with no mention of AI or ML.
No
The device is a personal lubricant intended to enhance comfort during intimate sexual activity and supplement natural lubrication, which is not considered a therapeutic function. It is classified as an over-the-counter personal lubricant and is not designed to treat a medical condition.
No
The device is described as a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose any condition.
No
The device description clearly indicates it is a physical product (water-based personal lubricant) packaged in a syringe, with specifications related to its physical and chemical properties and performance studies focused on biocompatibility, condom compatibility, and microbial testing. There is no mention of software.
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 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 device used for physical lubrication and comfort, not for diagnosing a condition or examining specimens from the body.
- Device Description: The description focuses on the physical properties and ingredients of the lubricant.
- Performance Studies: The performance studies listed are related to biocompatibility, condom compatibility, microbial testing of the product itself, and shelf life. These are relevant for a personal lubricant, but not for an IVD. IVD performance studies would typically involve evaluating the device's ability to accurately detect or measure a substance or characteristic in a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, wettrust D2care is a personal lubricant and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
wettrust D2care 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 not compatible with natural rubber latex or polyurethane condoms. This product is compatible with synthetic polyisoprene condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
wettrust D2care is a water-based personal lubricant that is packaged in a single use prefilled one-push syringe. The primary ingredients include water, glycerin, and hydroxethylcellulose. The device specifications include appearance, color, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The following tests were completed on wettrust D2care in accordance with national and international standards to support substantial equivalence to the predicate device.
- Biocompatibility (per ISO 10993-1). including cytotoxicity, sensitization, irritation, and acute systemic toxicity, demonstrating that the subject device is biocompatible
- Condom Compatibility Testing (per ASTM D7661) demonstrating that the subject device is compatible with synthetic polyisoprene condom
- Antimicrobial Effectiveness Testing (per USP )
- Total Aerobic Microbial Counts (per USP )
- Total Combined Yeast and Mold Counts (per USP
- Absence of Pathogenic Organisms (per USP )
- Shelf Life (per ASTM F1980) demonstrating that the subject device meets its specifications over the duration of its proposed shelf life
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.
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December 6, 2017
Wettrust Korea Co., Ltd. % Jigar Shah Consultant mdi Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021
Re: K170797 Trade/Device Name: wettrust D2care Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 24, 2017 Received: October 26, 2017
Dear Jigar Shah:
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.
1
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); 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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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Indications for Use
510(k) Number (if known) K170797
Device Name wettrust D2care
Indications for Use (Describe)
wettrust D2care 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 not compatible with natural rubber latex or polyurethane condoms. This product is compatible with synthetic 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)
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3
510(k) Summary
Date Prepared: December 5, 2017
-
- Company and Correspondent:
| Company | |
|---|---|
| Name | Wettrust Korea Co., Ltd. |
| Address | 312 The Prau, 27 Jeongjail-ro, Bundang-gu |
| Seongnam, Gyeonggi-do, Korea | |
| 463-480 | |
| Phone | |
| Fax | |
| Contact | +82(31) 719-8394 |
| +82(31) 719-8395 | |
| Sungho Lee / Director |
2. Device:
| Proprietary Name | wettrustD2care |
|---|---|
| Common Name | Personal Lubricant |
| Classification Name | Condom (21 CFR 884.5300) |
| Product code | NUC (lubricant, personal) |
| Class | II |
3. Predicate Device:
Replens Long-lasting Vaginal Moisturizer (K101241) The predicate device has not been subject to a design-related recall.
4. Description:
wettrust D2care is a water-based personal lubricant that is packaged in a single use prefilled one-push syringe. The primary ingredients include water, glycerin, and hydroxethylcellulose. The device specifications include appearance, color, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.
5. Indications for use:
wettrust D2care 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 not compatible with natural rubber latex or polyurethane condoms. This product is compatible with synthetic polyisoprene condoms.
4
6. Substantial Equivalence Discussion
The following tables outline the similarities and differences between wettrust D2care and the predicate device.
| Device Name | WettrustD2care
(Subject Device) | Replens Long-lasting Vaginal
Moisturizer
(Predicate Device) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K170797 | K101241 |
| Manufacturer | Wettrust Korea Co., Ltd. | Lil Drug Store Products, Inc. |
| Indications for
Use statement | wettrust D2Care 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 not
compatible with natural rubber latex
or polyurethane condoms. This
product is compatible with synthetic
polyisoprene condoms. | Replens 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 natural rubber latex
condoms and synthetic (polyurethane
and polyisoprene) condoms. |
| Ingredients | Purified water
Glycerin
Hydroxyethylcellulose
Sodium Lactate
Methylparaben
Aloe Barbadensis Leaf Juice
Butylene glycol
Camellia Sinensis Leaf Extract
Lactic acid
Chamomilla Recutita (Matricaria)
Flower Extract
Morus Alba Bark Extract
Disodium EDTA
SodiumHyaluronate | Purified water
Glycerin Mineral
Oil
Polycarbophil
Carbomer Homoploymer Type B
Sorbic Acid
Sodium Hydroxide.
Methylparaben
Hydrogenated Palm Oil Glyceride |
5
| Condom
Compatibility | Synthetic polyisoprene condoms | Natural rubber latex condoms and
synthetic (polyurethane and
polyisoprene) condoms |
|--------------------------|--------------------------------|------------------------------------------------------------------------------------------|
| Sterilization | Non-sterile | Non-sterile |
| Single Use
Applicator | Yes | Yes |
The subject and predicate device have the same intended use – supplementation of lubrication during intercourse.
The subject and predicate device have different technological characteristics, including ingredients and specifications. These differences in technological characteristics do not raise different questions of safety and effectiveness.
7. Non-Clinical Performance Data
The following tests were completed on wettrust D2care in accordance with national and international standards to support substantial equivalence to the predicate device.
- . Biocompatibility (per ISO 10993-1). including cytotoxicity, sensitization, irritation, and acute systemic toxicity, demonstrating that the subject device is biocompatible
- . Condom Compatibility Testing (per ASTM D7661) demonstrating that the subject device is compatible with synthetic polyisoprene condom
- . Antimicrobial Effectiveness Testing (per USP )
- . Total Aerobic Microbial Counts (per USP )
- Total Combined Yeast and Mold Counts (per USP
- Absence of Pathogenic Organisms (per USP )
- . Shelf Life (per ASTM F1980) demonstrating that the subject device meets its specifications over the duration of its proposed shelf life
6
8. Conclusion
The wettrust D2care is substantially equivalent to the proposed predicate device.