Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a personal lubricant and does not mention any AI or ML components or functionalities.

Therapeutic

No.
The device moisturizes and lubricates to enhance comfort during sexual activity, which is not considered a therapeutic function; it does not treat or cure a disease or medical condition.

Diagnostic

No

The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "non-sterile, water-based personal lubricant" and is provided in "HDPE bottles," indicating it is a physical product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for personal lubrication during sexual activity, applied to the penile and/or vaginal areas. This is a topical application for physical comfort and enhancement, not for diagnosing a condition or analyzing a sample taken from the body.
Device Description: The description confirms it's a water-based personal lubricant for external application.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This personal lubricant does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Wet Essential95 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.

Product codes

NUC

Device Description

The Wet Essential95 Personal Lubricant is a non-sterile, water-based personal lubricant 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. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists primarily of 95% aloe barbadensis leaf juice. Wet Essential95 Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 4 oz and 6 oz HDPE bottles.

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

Over-The-Counter Use

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)

Biocompatibility
Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 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." The following testing was conducted:

Acute Systemic Toxicity (ISO 10993-11:2017)
Cytotoxicity (Direct Contact, ISO 10993-5:2009)
Sensitization (Guinea Pig Maximization Sensitization, ISO 10993-10:2010)
Irritation (Vaginal Irritation, ISO 10993-10:2010)
The results of this testing demonstrate that the subject lubricant is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.

Condom Compatibility
The compatibility of Wet Essential95 Personal Lubricant with condoms was evaluated in accordance with ASTM D7661-10(R) 2017 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results of this test showed Wet Essential95 Personal Lubricant to be compatible with natural rubber latex and polyisoprene condoms. Results showed Wet Essential95 Personal Lubricant not to be compatible with polyurethane condoms.

Shelf-Life
The subject device has a shelf-life of 8.5 months. Results from accelerated testing demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K124044

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 7, 2022

Trigg Laboratories, Inc. Marla Bolden Regulatory/Ouality Control Manager 4220 W. Windmill Lane. Suite 140 Las Vegas, NV 89139

Re: K220534

Trade/Device Name: Wet Essential95 Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 7, 2022 Received: June 7, 2022

Dear Marla Bolden:

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, 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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,

For 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

2

Indications for Use

510(k) Number (if known) K220534

Device Name Wet Essential95 Personal Lubricant

Indications for Use (Describe)

Wet Essential95 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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☐ Transaction involving USDA-funded Child Nutrition Programs	☑ Direct Farm to Consumer sales
--------------------------------------------------------------	---------------------------------

| | 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 K220534 Wet Essential95 Personal Lubricant

1. Submitter Information

Company Name:	Trigg Laboratories, Inc.
Company Address:	4220 W Windmill Lane, Suite 140
Las Vegas, NV 89139
Company Phone:	(702) 957-4400
Contact Person:	Marla Bolden
Regulatory and Quality Control Manager
Trigg Laboratories, Inc.
Email: marlab@trigglabs.com

July 1, 2022 Date Prepared:

2. Subject Device

Device Trade Name:	Wet Essential95 Personal Lubricant
Common Name:	Personal Lubricant
Regulation Name:	Condom
Regulation Number:	21 CFR 884.5300
Device Class:	Class II
Product Code:	NUC (lubricant, personal)

1. Predicate Device

Device Name	Aloe Cadabra Personal Lubricant and Aloe Cadabra
	Flavored/Scented Lubricants
510(k) number	K124044
Manufacturer	Seven Oaks Ranch, Inc.

The predicate device has not been subject to a design-related recall.

4. Device Description

The Wet Essential95 Personal Lubricant is a non-sterile, water-based personal lubricant 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. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists primarily of 95% aloe barbadensis leaf juice. Wet Essential95 Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 4 oz and 6 oz HDPE bottles.

4

The specifications for Wet Essential95 Personal Lubricant are described in Table 1.

Property	Specification
Appearance	Semi-opaque, particle-free, liquid gel
Color	Light tan to brown
Odor	Vanilla
Viscosity@25°C Spindle LV#3 @20rpm (cps)	400 cps - 3,200 cps
Specific Gravity@25°C per USP	0.99 – 1.04
pH per USP	4.5 - 5.5
Osmolality per USP	150-300 mOsm/kg, 1:10 dilution
Antimicrobial effectiveness per USP	Meets USP acceptance criteria for
Category 2 products
Total aerobic microbial count (TAMC) per USP
and
and

	Table 1: Device Specifications for the Wet Essential95 Personal Lubricant

5. Indication for Use Statement

Wet Essential95 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

6. Comparison of Intended Use and Technological Characteristics

The following table compares the intended use and technological characteristics of the subject and predicate device:

of the Subject and Predicate Device
	K220534
Subject Device	K124044
Predicate Device	Comparison
Device Name	Wet Essential95
Personal Lubricant	Aloe Cadabra Lubricant,
Aloe Cadabra
Flavored/scented Lubricants
Indications for
Use	Wet Essential95 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. This product is
compatible with natural rubber	Aloe Cadabra® Lubricant
and Aloe Cadabra®
Flavored/Scented
Lubricants are personal
lubricants, for penile
and/or vaginal
application, intended to
moisturize and lubricate,
to enhance the ease and
comfort of intimate sexual	The indications for
use for the subject
and predicate
device are the
same. Therefore,
the subject and
predicate device
have the same
intended use.

	latex and polyisoprene
condoms. This product is not
compatible with polyurethane
condoms.	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.
Rx/OTC	OTC	OTC	Same
Base Type	Water	Water	Same
Sterile	No	No	Same
Primary
Ingredients	Aloe Barbadensis Leaf
Juice; Chamomilla Recuitita
(Matricaria) Extract;
Chamomilla Recuitita
(Chamomile) Flower
Extract; Cyamopsis
Tetragonoloba (Guar) Gum;
Xanthan Gum; Vanilla
Flavor; Potassium Sorbate;
Sodium Benzoate; Stevia
Rebaudiana Extract; Citric
Acid	95% organic aloe

Additional formulation
information is not publicly
available | Different: The
subject and
predicate device
have differences in
formulation. These
differences do not
raise different
questions of safety
and effectiveness
(S&E). |
| pH | 4.5-5.5 | Not publicly available | Different: The
subject and
predicate devices
may differ in pH
specification.
Differences in pH
specification do not
raise different
questions S&E. |
| Osmolality | 150-300 mOsm/kg, 1:10
dilution | Not publicly available | Different: The
subject and
predicate devices
may differ in
osmolality
specification.

Table 2: Intended Use and Technological Characteristics Comparison

5

6

The subject and predicate devices have the same indications for use and the same intended use (i.e., to provide lubrication during intimate sexual activity). The subject and predicate devices have different technological characteristics, including different formulations, device specifications, and shelf-life. The different technological characteristics identified do not raise different questions of safety and effectiveness.

7

7. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 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." The following testing was conducted:

Acute Systemic Toxicity (ISO 10993-11:2017)
Cytotoxicity (Direct Contact, ISO 10993-5:2009) ●
. Sensitization (Guinea Pig Maximization Sensitization, ISO 10993-10:2010)
Irritation (Vaginal Irritation, ISO 10993-10:2010) ●

The results of this testing demonstrate that the subject lubricant is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.

Condom Compatibility

The compatibility of Wet Essential95 Personal Lubricant with condoms was evaluated in accordance with ASTM D7661-10(R) 2017 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results of this test showed Wet Essential95 Personal Lubricant to be compatible with natural rubber latex and polyisoprene condoms. Results showed Wet Essential95 Personal Lubricant not to be compatible with polyurethane condoms.

Shelf-Life

The subject device has a shelf-life of 8.5 months. Results from accelerated testing demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life.

8. Conclusion

The results of the testing described above demonstrate that Wet Essential95 Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.