(114 days)
No
The device is a personal lubricant and the description focuses on its physical properties, ingredients, and compatibility with condoms. There is no mention of any computational or analytical capabilities that would suggest the use of AI/ML.
No.
The device is a personal lubricant intended to moisturize and lubricate to enhance the comfort of intimate sexual activity, which is not considered a therapeutic function.
No
Explanation: The device is described as a personal lubricant intended to moisturize and lubricate to enhance comfort during sexual activity. Its purpose is not to diagnose any condition or disease.
No
The device description clearly states it is a "non-sterile, water-based, over-the-counter personal lubricant" and is packaged in a "polyethylene terephthalate bottle," indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of the Wet Organics Personal Lubricant is 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 is a topical application for physical comfort and function, not for analyzing biological specimens.
- Device Description: The description reinforces its function as a lubricant applied externally, not a device for testing samples.
The information provided clearly indicates this is a personal lubricant for external use during sexual activity, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Wet Organics Personal Lubricant 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. The product is compatible with natural rubber latex and Polyisoprene condoms. This product is not compatible with Polyurethane condoms.
Product codes
NUC
Device Description
The Wet Organics Personal Lubricant is a non-sterile, water-based, over-the-counter personal lubricant. The proposed device contains a blend of organic aloe and other ingredients similar to ingredients found in the predicate device.
The device is designed to supplement the body's own natural lubrication fluids during intimate sexual activity. The device is also compatible for use with natural rubber latex and polyisoprene condoms. The device is neither a contraceptive nor a spermicide.
The Wet Organics Personal Lubricant is packaged in 3 oz. polyethylene terephthalate bottle with a dispensing bottle cap with a disc top.
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
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 per ISO 10993-5:2009
- Sensitization per ISO 10993-10:2010
- Vaginal Irritation per ISO 10993-10:2010
- Acute Systemic Toxicity per ISO 10993-11:2006
The results of testing demonstrated the subject device is not cytotoxic, not sensitizing, not irritating and is not acutely systemically toxic.
Condom compatibility testing was performed per ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" on three marketed brands of natural rubber latex condoms, one brand of polyisoprene condoms, and one brand of polyurethane condoms. The results demonstrated that the Wet Organics Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. The results also demonstrated that the product is not compatible with polyurethane condoms.
The results of real time studies demonstrated that the Wet Organics Personal Lubricant is shown to have a 12 months shelf-life and met the device specifications as listed in Table 1 of this 510(k) Summary.
Key Metrics
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.
0
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 21, 2018
Trigg Laboratories DBA Wet International % Louie Goryoka Regulatory & Quality Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301
Re: K182027
Trade/Device Name: Wet Organics Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 23, 2018 Received: October 25, 2018
Dear Louie Goryoka:
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 mav, 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 avare 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, 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Sharon M. Andrews -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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Indications for Use
510(k) Number (if known) K182027
Device Name Wet Organics Personal Lubricant
Indications for Use (Describe)
The Wet Organics 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. The product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with 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 K182027 Wet Organics Personal Lubricant
| Company Name: | Trigg Laboratories DBA Wet International |
|---|---|
| Company Address: | 4220 W Windmill Lane, Suite 140 |
| Las Vegas, NV 89139 | |
| Contact Number: | Phone: (702) 957-4400 |
| Email: mdci@m-dci.us | |
| Contact Person: | Louie Goryoka – Regulatory & Quality Consultant |
| Med-Device Consulting, Inc. | |
| Phone: (818) 735-0488 | |
| Email: mdci@m-dci.us | |
| Summary Preparation Date: | November 21, 2018 |
| Device Trade Name: | Wet Organics Personal Lubricant |
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR §884.5300 |
| Product Code: | NUC (lubricant, personal) |
| Device Class: | Class II |
| Predicate Devices: | Aloe Cadabra Personal Lubricant |
| 510(k) Number: | K124044 |
| Manufacturer: | Seven Oaks Ranch, Inc. |
| Product Code: | NUC |
The predicate device has not been subject to a design-related recall.
Device Description
The Wet Organics Personal Lubricant is a non-sterile, water-based, over-the-counter personal lubricant. The proposed device contains a blend of organic aloe and other ingredients similar to ingredients found in the predicate device.
The device is designed to supplement the body's own natural lubrication fluids during intimate sexual activity. The device is also compatible for use with natural rubber latex and polyisoprene condoms. The device is neither a contraceptive nor a spermicide.
The Wet Organics Personal Lubricant is packaged in 3 oz. polyethylene terephthalate bottle with a dispensing bottle cap with a disc top.
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510(K) SUMMARY K182027 Wet Organics Personal Lubricant
The device specifications are listed in the table below:
| Property | Specification |
|---|---|
| Appearance | Clear to slightly cloudy, semi-viscous, particle-free liquid |
| Color | brown |
| Odor | Odorless (Characteristic) |
| Viscosity@25°C Spindle LV#3hu@10rpm (cps) | 1,000 cps – 2,300 cps |
| Specific Gravity@25°C | 0.95 - 1.05 |
| pH | 4.0 to 5.0 |
| Osmolality | |
| Total aerobic microbial count (TAMC) per USP and | and |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| E. Coli | Absent |
| Salmonella | Absent |
| Candida albicans | Absent |
Indications for Use
The Wet Organics Personal Lubricant 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. The product is compatible with natural rubber latex and Polyisoprene condoms. This product is not compatible with Polyurethane condoms.
Predicate Device Comparison
The table below lists the comparative intended use and technological characteristics of the subject and predicate device.
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510(K) SUMMARY K182027 Wet Organics Personal Lubricant
Table 2: Comparator Table for Subject Device –Wet Organics Personal Lubricant and Predicate Device Aloe Cadabra Personal Lubricant.
| Characteristic/Feature | Wet Organics Personal Lubricant | Aloe Cadabra Personal Lubricant
(k) number K124044 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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.
The product is compatible with
natural rubber latex and
polyisoprene condoms.
This product is not compatible with
polyurethane condoms | 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.
This product is not compatible
with polyurethane condoms. |
| Primary Ingredients | Purified Water
Organic aloe barbadensis leaf juice
Zemea Select Propanediol
Vegeluron Gel
Cellosize QP-30000-H
Xanthan Gum
Sodium Hyaluronate
Microcare SB
Citric Acid
Co Extract Blend | Organic aloe vera
Xanthan Gum
Citric Acid
Potassium Sorbate
Sodium Benzoate |
| Over-the-Counter Use | Yes | Yes |
| Condom compatibility | Natural rubber latex and
polyisoprene | Natural rubber latex and
polyisoprene |
| Sterile | No | No |
| Shelf life | 12 months | 3 years |
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The subject and predicate device have the same intended use - for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
The Wet Organics Personal Lubricant contains similar ingredients to other cleared lubricants, including the predicate device. However, the subject and predicate device have slightly different formulations, different specifications and different shelf life. These differences do not raise different types of safety and effectiveness questions.
Summary of Performance Data:
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 per ISO 10993-5:2009
- Sensitization per ISO 10993-10:2010
- Vaginal Irritation per ISO 10993-10:2010
- Acute Systemic Toxicity per ISO 10993-11:2006
The results of testing demonstrated the subject device is not cytotoxic, not sensitizing, not irritating and is not acutely systemically toxic.
Condom Compatibility
Condom compatibility testing was performed per ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" on three marketed brands of natural rubber latex condoms, one brand of polyisoprene condoms, and one brand of polyurethane condoms. The results demonstrated that the Wet Organics Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. The results also demonstrated that the product is not compatible with polyurethane condoms.
Shelf Life Testing
The results of real time studies demonstrated that the Wet Organics Personal Lubricant is shown to have a 12 months shelf-life and met the device specifications as listed in Table 1 of this 510(k) Summary.
Conclusion
The Wet Organics Personal Lubricant has the same intended use as the predicate device. In addition, the Wet Organics Personal Lubricant has similar technological characteristics as compared to the predicate device. Differences in technological characteristics between the subject and predicate device did not raise different questions of safety and effectiveness. Performance testing conducted on the Wet Organics Personal Lubricant demonstrated that it was as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate.